Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:20 AM
Study NCT ID:
NCT03951220
Status:
COMPLETED
Last Update Posted:
2025-08-19
First Post:
2019-05-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Development and Pilot Testing of a New MR Imaging Protocol to Quantify Myeloma Disease Burden and Bone Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D008998', 'term': 'Monoclonal Gammopathy of Undetermined Significance'}, {'id': 'D000075122', 'term': 'Smoldering Multiple Myeloma'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006942', 'term': 'Hypergammaglobulinemia'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015502', 'term': 'Absorptiometry, Photon'}, {'id': 'D014554', 'term': 'Urination'}], 'ancestors': [{'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003720', 'term': 'Densitometry'}, {'id': 'D010783', 'term': 'Photometry'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D014553', 'term': 'Urinary Tract Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gaurav.agarwal@medsci.ox.ac.uk', 'phone': '07826636655', 'title': 'Gaurav Agarwal', 'organization': 'University of Oxford'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': '* Unable to collect data for the total spinal hole volume and total spine collapse volume at the point of novel MR scan, due to technical challenges.\n* Whilst data collection is complete, there were delays in completing the analysis for Osteotronix FSA data due to disruptions with COVID-19, therefore the results have not been reported in this Study Report at time of submission. However, there is ongoing engagement with Osteotronix to complete this analysis.'}}, 'adverseEventsModule': {'timeFrame': 'The intention of this study was to assess the value of disease assessment of candidate biomarkers (using DW-MRI and analysis of peripheral blood). Therefore, all-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed.', 'description': 'The intention of this study was to assess the value of disease assessment of candidate biomarkers (using DW-MRI and analysis of peripheral blood).\n\nTherefore, all-Cause Mortality, Serious, and Other \\[Not Including Serious\\] Adverse Events were not monitored/assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1- Myeloma', 'description': 'Participants recruited with myeloma', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 2- MGUS', 'description': 'Participants recruited with MGUS', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Group 3- Healthy Volunteers', 'description': 'Participants recruited as healthy volunteers', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Outcome 1: Quantifying Tumour Burden [Correlations With Apparent Diffusion Coefficient (ADC) Measurements]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1a: New Myeloma', 'description': 'All patients with new myeloma at recruitment.'}, {'id': 'OG001', 'title': 'Group 1b: Relapsed Myeloma', 'description': 'All patients with relapsed myeloma at recruitment.'}], 'classes': [{'title': 'ADC vs serum paraprotein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.66', 'groupId': 'OG000', 'lowerLimit': '-0.99', 'upperLimit': '0.82'}, {'value': 'NA', 'comment': "Only one data point, so not amenable to Pearson's correlation coefficient", 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'ADC vs serum paraprotein-associated immunoglobulin level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.28', 'groupId': 'OG000', 'lowerLimit': '-0.79', 'upperLimit': '0.48'}, {'value': '0.48', 'comment': 'Only three data points, hence 95% confidence interval cannot be reliably calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline', 'description': 'Primary Objective 1: To assess whether the novel magnetic resonance (MR) protocol and exploratory bone biomarkers can improve quantification of tumour burden in patients with new or relapsed myeloma at baseline assessment, compared to paraprotein levels alone.\n\nThis particular section analysed the correlation between the Apparent Diffusion Coefficient (ADC) measurements (from the Diffusion Weighted Magnetic Resonance Imaging (DW-MRI) component of the sequences) of lytic bone lesions, with standard clinical correlates of tumour burden (serum paraprotein, and serum paraprotein-associated immunoglobulin level).\n\nThe measurement of ADC from DW-MRI is further described by Messiou et. al. \\[1\\]\n\n\\[1\\] Messiou, Christina, et al. "Guidelines for acquisition, interpretation, and reporting of whole-body MRI in myeloma: myeloma response assessment and diagnosis system (MY-RADS)." Radiology 291.1 (2019): 5-13.', 'unitOfMeasure': "Pearson's correlation coefficient", 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subset of Group 1a and 1b, on active chemotherapy, with lytic bone lesions identified on baseline novel MR scan, amenable to ADC measurement, and a paired baseline serum paraprotein, or paraprotein-associated immunoglobulin, level available (where measurement was unsuccessful the number analysed is lower than the overall number analysed).\n\nGroup 1c, 2 and 3 participants did not have a lytic bone lesion identified on novel MR scan, and were therefore not included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Primary Outcome 1: Quantifying Tumour Burden [Correlations With Myeloma Response Assessment and Diagnosis System (MY-RADS) Pattern of Disease]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MY-RADS: Normal', 'description': 'MY-RADS disease pattern classification, as assessed by an expert MSK Radiologist, on baseline scans'}, {'id': 'OG001', 'title': 'MY-RADS: Focal', 'description': 'MY-RADS disease pattern classification, as assessed by an expert MSK Radiologist, on baseline scans'}, {'id': 'OG002', 'title': 'MY-RADS: Micronodular', 'description': 'MY-RADS disease pattern classification, as assessed by an expert MSK Radiologist, on baseline scans'}, {'id': 'OG003', 'title': 'MY-RADS: Not Determined', 'description': 'MY-RADS disease pattern classification, as assessed by an expert MSK Radiologist, on baseline scans'}], 'classes': [{'categories': [{'measurements': [{'value': '13.1', 'spread': '9.4', 'groupId': 'OG000'}, {'value': '11.7', 'spread': '7.8', 'groupId': 'OG001'}, {'value': '5.4', 'spread': 'NA', 'comment': 'Only one data point, hence standard deviation could not be calculated', 'groupId': 'OG002'}, {'value': '17.2', 'spread': 'NA', 'comment': 'Only one data point, hence standard deviation could not be calculated', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.7343', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'At baseline', 'description': 'Primary Objective 1: To assess whether the novel MR protocol and exploratory bone biomarkers can improve quantification of tumour burden in patients with new or relapsed myeloma at baseline assessment, compared to paraprotein levels alone.\n\nParticipants\' baseline novel MR scan was analysed by an expert radiologist, and pattern of disease was qualitatively classified using the MY-RADS (Myeloma Response Assessment and Diagnosis System) imaging recommendations, described in Figure 2 by Messiou et. al. \\[1\\].\n\nThis particular section analysed whether standard clinical correlate of tumour burden (serum paraprotein) differed by radiological pattern of disease (e.g., normal, focal, diffuse).\n\n\\[1\\] Messiou, Christina, et al. "Guidelines for acquisition, interpretation, and reporting of whole-body MRI in myeloma: myeloma response assessment and diagnosis system (MY-RADS)." Radiology 291.1 (2019): 5-13.', 'unitOfMeasure': 'grams per liter (g/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Population is all participants who had a novel MR scan at baseline with: i) available MY-RADS pattern of disease assessment; ii) available baseline serum paraprotein.'}, {'type': 'PRIMARY', 'title': 'Primary Outcome 1: Quantifying Tumour Burden (Correlations With Bone Turnover Markers)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline P1NP', 'description': 'Baseline measurements of P1NP (Procollagen type 1 N-terminal Propeptide).'}, {'id': 'OG001', 'title': 'Baseline CTX-1', 'description': 'Baseline measurements of CTX-1 (Type I Collagen Cross-Linked C-Telopeptide).'}, {'id': 'OG002', 'title': 'Baseline ALP', 'description': 'Baseline measurements of ALP (Alkaline Phosphatase).'}, {'id': 'OG003', 'title': 'Baseline DKK1', 'description': 'Baseline measurements of DKK1 (Dickkopf WNT Signaling Pathway Inhibitor 1).'}, {'id': 'OG004', 'title': 'Baseline Sclerostin', 'description': 'Baseline measurements of sclerostin.'}, {'id': 'OG005', 'title': 'Baseline RANKL:OPG', 'description': 'Baseline measurements of the ratio between RANKL and OPG (osteoprotegerin).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.31', 'groupId': 'OG000', 'lowerLimit': '-0.10', 'upperLimit': '0.64'}, {'value': '0.01', 'groupId': 'OG001', 'lowerLimit': '-0.41', 'upperLimit': '0.42'}, {'value': '-0.18', 'groupId': 'OG002', 'lowerLimit': '-0.54', 'upperLimit': '0.24'}, {'value': '0.39', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '0.68'}, {'value': '0.23', 'groupId': 'OG004', 'lowerLimit': '-0.17', 'upperLimit': '0.57'}, {'value': '-0.02', 'groupId': 'OG005', 'lowerLimit': '-0.42', 'upperLimit': '0.38'}]}]}], 'analyses': [{'pValue': '0.0445', 'groupIds': ['OG003'], 'paramType': 'Spearman (r)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.39', 'ciLowerLimit': '0.00', 'ciUpperLimit': '0.68', 'statisticalMethod': "Spearman's rank correlation coeffcieitn", 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Correlation'}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline', 'description': "Primary Objective 1: To assess whether the novel Magnetic Resonance (MR) protocol and exploratory bone biomarkers can improve quantification of tumour burden in patients with new or relapsed myeloma at baseline assessment, compared to paraprotein levels alone.\n\nThis section examined correlation between baseline bone biomarkers and baseline serum paraprotein in a pooled cohort of patients from Groups 1 and 2, using Spearman's Rank Correlation Coefficients.", 'unitOfMeasure': "Spearman's rank correlation coefficient", 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pooled cohort of patients from Groups 1 and 2 who had measured: i) available baseline serum paraprotein; ii) by baseline bone biomarkers.'}, {'type': 'PRIMARY', 'title': 'Primary Outcome 2: Quantifying Bone Loss - Inter-Group Differences in Baseline Serum P1NP (Procollagen Type 1 N-terminal Propeptide)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1a: New Myeloma', 'description': 'Cohort of patients recruited as new myeloma at baseline'}, {'id': 'OG001', 'title': 'Group 1b: Relapsed Myeloma', 'description': 'Cohort of patients recruited as relapsed myeloma at baseline'}, {'id': 'OG002', 'title': 'Group 1c: Smouldering Myeloma', 'description': 'Cohort of patients recruited as smouldering myeloma at baseline'}, {'id': 'OG003', 'title': 'Group 2: MGUS', 'description': 'Cohort of patients recruited as MGUS at baseline'}], 'classes': [{'categories': [{'measurements': [{'value': '38.6', 'spread': '23.1', 'groupId': 'OG000'}, {'value': '39.5', 'spread': '24.0', 'groupId': 'OG001'}, {'value': '39.6', 'spread': '23.1', 'groupId': 'OG002'}, {'value': '39.3', 'spread': '23.3', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0079', 'groupIds': ['OG001', 'OG003'], 'pValueComment': "Dunn's multiple comparisons test", 'groupDescription': 'For baseline P1NP', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0482', 'groupIds': ['OG000', 'OG002'], 'pValueComment': "Dunn's multiple comparison test", 'groupDescription': 'For baseline sclerostin', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'At baseline', 'description': 'Primary Outcome 2: To assess whether the novel magnetic resonance (MR) protocol and exploratory bone turnover markers can improve quantification of bone loss in patients with myeloma (new, relapsed, smouldering) and Monoclonal Gammopathy Of Uncertain Significance (MGUS) at baseline assessment, compared to Dual-energy X-ray Absorptiometry (DXA) and established bone turnover markers alone.\n\nThis particular section analysed the inter-group difference in baseline serum P1NP (Procollagen Type 1 N-terminal Propeptide) bone turnover marker levels, in patients from Groups 1a (new myeloma), 1b (relapsed myeloma), 1c (smouldering myeloma) and 2 (MGUS).', 'unitOfMeasure': 'microgram per litre', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants recruited at baseline from Groups 1 and 2 who had successful measurement of baseline serum P1NP.'}, {'type': 'PRIMARY', 'title': 'Primary Outcome 2: Quantifying Bone Loss - Inter-Group Differences in Baseline Serum CTX-1 (Collagen Cross-Linked C-Telopeptide Type I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1a: New Myeloma', 'description': 'Cohort of patients recruited as new myeloma at baseline'}, {'id': 'OG001', 'title': 'Group 1b: Relapsed Myeloma', 'description': 'Cohort of patients recruited as relapsed myeloma at baseline'}, {'id': 'OG002', 'title': 'Group 1c: Smouldering Myeloma', 'description': 'Cohort of patients recruited as smouldering myeloma at baseline'}, {'id': 'OG003', 'title': 'Group 2: MGUS', 'description': 'Cohort of patients recruited as MGUS at baseline'}], 'classes': [{'categories': [{'measurements': [{'value': '0.38', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '0.40', 'spread': '0.35', 'groupId': 'OG001'}, {'value': '0.39', 'spread': '0.32', 'groupId': 'OG002'}, {'value': '0.39', 'spread': '0.32', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline', 'description': 'Primary Outcome 2: To assess whether the novel magnetic resonance (MR) protocol and exploratory bone turnover markers can improve quantification of bone loss in patients with myeloma (new, relapsed, smouldering) and Monoclonal Gammopathy Of Uncertain Significance (MGUS) at baseline assessment, compared to Dual-energy X-ray Absorptiometry (DXA) and established bone turnover markers alone.\n\nThis particular section analysed the inter-group difference in baseline serum CTX-1 (Collagen Cross-Linked C-Telopeptide Type I) bone turnover marker levels, in patients from Groups 1a (new myeloma), 1b (relapsed myeloma), 1c (smouldering myeloma) and 2 (MGUS).', 'unitOfMeasure': 'microgram per litre', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants recruited at baseline from Groups 1 and 2 who had successful measurement of baseline serum CTX-1.'}, {'type': 'PRIMARY', 'title': 'Primary Outcome 2: Quantifying Bone Loss - Inter-Group Differences in Baseline Serum ALP (Alkaline Phosphatase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1a: New Myeloma', 'description': 'Cohort of patients recruited as new myeloma at baseline'}, {'id': 'OG001', 'title': 'Group 1b: Relapsed Myeloma', 'description': 'Cohort of patients recruited as relapsed myeloma at baseline'}, {'id': 'OG002', 'title': 'Group 1c: Smouldering Myeloma', 'description': 'Cohort of patients recruited as smouldering myeloma at baseline'}, {'id': 'OG003', 'title': 'Group 2: MGUS', 'description': 'Cohort of patients recruited as MGUS at baseline'}], 'classes': [{'categories': [{'measurements': [{'value': '73.8', 'spread': '34.2', 'groupId': 'OG000'}, {'value': '73.3', 'spread': '34.9', 'groupId': 'OG001'}, {'value': '72.2', 'spread': '32.0', 'groupId': 'OG002'}, {'value': '74.0', 'spread': '33.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline', 'description': 'Primary Outcome 2: To assess whether the novel magnetic resonance (MR) protocol and exploratory bone turnover markers can improve quantification of bone loss in patients with myeloma (new, relapsed, smouldering) and Monoclonal Gammopathy Of Uncertain Significance (MGUS) at baseline assessment, compared to Dual-energy X-ray Absorptiometry (DXA) and established bone turnover markers alone.\n\nThis particular section analysed the inter-group difference in baseline serum ALP (Alkaline Phosphatase) bone turnover marker levels, in patients from Groups 1a (new myeloma), 1b (relapsed myeloma), 1c (smouldering myeloma) and 2 (MGUS).', 'unitOfMeasure': 'international units per litre', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants recruited at baseline from Groups 1 and 2 who had successful measurement of baseline serum ALP.'}, {'type': 'PRIMARY', 'title': 'Primary Outcome 2: Quantifying Bone Loss - Inter-Group Differences in Baseline Serum DKK1 (Dickkopf WNT Signaling Pathway Inhibitor 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1a: New Myeloma', 'description': 'Cohort of patients recruited as new myeloma at baseline'}, {'id': 'OG001', 'title': 'Group 1b: Relapsed Myeloma', 'description': 'Cohort of patients recruited as relapsed myeloma at baseline'}, {'id': 'OG002', 'title': 'Group 1c: Smouldering Myeloma', 'description': 'Cohort of patients recruited as smouldering myeloma at baseline'}, {'id': 'OG003', 'title': 'Group 2: MGUS', 'description': 'Cohort of patients recruited as MGUS at baseline'}], 'classes': [{'categories': [{'measurements': [{'value': '3963.6', 'spread': '3666.8', 'groupId': 'OG000'}, {'value': '4018.9', 'spread': '3506.5', 'groupId': 'OG001'}, {'value': '3759.2', 'spread': '3175.6', 'groupId': 'OG002'}, {'value': '3924.5', 'spread': '3568.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline', 'description': 'Primary Outcome 2: To assess whether the novel magnetic resonance (MR) protocol and exploratory bone turnover markers can improve quantification of bone loss in patients with myeloma (new, relapsed, smouldering) and Monoclonal Gammopathy Of Uncertain Significance (MGUS) at baseline assessment, compared to Dual-energy X-ray Absorptiometry (DXA) and established bone turnover markers alone.\n\nThis particular section analysed the inter-group difference in baseline serum DKK1 (Dickkopf WNT Signaling Pathway Inhibitor 1) bone turnover marker levels, in patients from Groups 1a (new myeloma), 1b (relapsed myeloma), 1c (smouldering myeloma) and 2 (MGUS).', 'unitOfMeasure': 'picogram per litre', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants recruited at baseline from Groups 1 and 2 who had successful measurement of baseline serum DKK1.'}, {'type': 'PRIMARY', 'title': 'Primary Outcome 2: Quantifying Bone Loss - Inter-Group Differences in Baseline Serum Sclerostin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1a: New Myeloma', 'description': 'Cohort of patients recruited as new myeloma at baseline'}, {'id': 'OG001', 'title': 'Group 1b: Relapsed Myeloma', 'description': 'Cohort of patients recruited as relapsed myeloma at baseline'}, {'id': 'OG002', 'title': 'Group 1c: Smouldering Myeloma', 'description': 'Cohort of patients recruited as smouldering myeloma at baseline'}, {'id': 'OG003', 'title': 'Group 2: MGUS', 'description': 'Cohort of patients recruited as MGUS at baseline'}], 'classes': [{'categories': [{'measurements': [{'value': '168.5', 'spread': '84.1', 'groupId': 'OG000'}, {'value': '165.5', 'spread': '85.1', 'groupId': 'OG001'}, {'value': '166.9', 'spread': '86.9', 'groupId': 'OG002'}, {'value': '164.9', 'spread': '83.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline', 'description': 'Primary Outcome 2: To assess whether the novel magnetic resonance (MR) protocol and exploratory bone turnover markers can improve quantification of bone loss in patients with myeloma (new, relapsed, smouldering) and Monoclonal Gammopathy Of Uncertain Significance (MGUS) at baseline assessment, compared to Dual-energy X-ray Absorptiometry (DXA) and established bone turnover markers alone.\n\nThis particular section analysed the inter-group difference in baseline serum sclerostin bone turnover marker levels, in patients from Groups 1a (new myeloma), 1b (relapsed myeloma), 1c (smouldering myeloma) and 2 (MGUS).', 'unitOfMeasure': 'picogram per litre', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants recruited at baseline from Groups 1 and 2 who had successful measurement of baseline serum sclerostin.'}, {'type': 'PRIMARY', 'title': 'Primary Outcome 2: Quantifying Bone Loss - Inter-Group Differences in Baseline Serum Ratio of RANKL (Receptor Activator of Nuclear Factor Kappa-Β Ligand) and OPG (Osteoprotegerin)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1a: New Myeloma', 'description': 'Cohort of patients recruited as new myeloma at baseline'}, {'id': 'OG001', 'title': 'Group 1b: Relapsed Myeloma', 'description': 'Cohort of patients recruited as relapsed myeloma at baseline'}, {'id': 'OG002', 'title': 'Group 1c: Smouldering Myeloma', 'description': 'Cohort of patients recruited as smouldering myeloma at baseline'}, {'id': 'OG003', 'title': 'Group 2: MGUS', 'description': 'Cohort of patients recruited as MGUS at baseline'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0170', 'spread': '0.0205', 'groupId': 'OG000'}, {'value': '0.0176', 'spread': '0.0221', 'groupId': 'OG001'}, {'value': '0.0397', 'spread': '0.1524', 'groupId': 'OG002'}, {'value': '0.0386', 'spread': '0.1494', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline', 'description': 'Primary Outcome 2: To assess whether the novel magnetic resonance (MR) protocol and exploratory bone turnover markers can improve quantification of bone loss in patients with myeloma (new, relapsed, smouldering) and Monoclonal Gammopathy Of Uncertain Significance (MGUS) at baseline assessment, compared to Dual-energy X-ray Absorptiometry (DXA) and established bone turnover markers alone.\n\nThis particular section analysed the inter-group difference in baseline ratio between RANKL (Receptor Activator of Nuclear Factor Kappa-Β Ligand) and OPG (Osteoprotegerin) \\[calculated as RANKL (pg/L) divided by OPG (pg/L)\\] bone turnover marker levels, in patients from Groups 1a (new myeloma), 1b (relapsed myeloma), 1c (smouldering myeloma) and 2 (MGUS).', 'unitOfMeasure': 'RANKL (pg/L) to OPG (pg/L) ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants recruited at baseline from Groups 1 and 2 who had successful measurement of both baseline serum RANKL and baseline serum OPG.'}, {'type': 'PRIMARY', 'title': 'Primary Outcome 2: Quantifying Bone Loss (Inter-Biomarker Correlations)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline CTX-1', 'description': 'Baseline measurements of CTX-1 (Type I Collagen Cross-Linked C-Telopeptide).'}, {'id': 'OG001', 'title': 'Baseline ALP', 'description': 'Baseline measurements of ALP (Alkaline Phosphatase).'}, {'id': 'OG002', 'title': 'Baseline DKK1', 'description': 'Baseline measurements of DKK1 (Dickkopf WNT Signaling Pathway Inhibitor 1).'}, {'id': 'OG003', 'title': 'Baseline Sclerostin', 'description': 'Baseline measurements of sclerostin.'}, {'id': 'OG004', 'title': 'Baseline RANKL:OPG', 'description': 'Baseline measurements of the ratio between RANKL and OPG (osteoprotegerin).'}], 'classes': [{'title': "Baseline P1NP (Spearman's Rank Correlation Coefficient)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.70', 'groupId': 'OG000', 'lowerLimit': '0.51', 'upperLimit': '0.82'}, {'value': '0.37', 'groupId': 'OG001', 'lowerLimit': '0.10', 'upperLimit': '0.58'}, {'value': '0.12', 'groupId': 'OG002', 'lowerLimit': '-0.16', 'upperLimit': '0.39'}, {'value': '0.22', 'groupId': 'OG003', 'lowerLimit': '-0.07', 'upperLimit': '0.47'}, {'value': '-0.10', 'groupId': 'OG004', 'lowerLimit': '-0.37', 'upperLimit': '0.19'}]}]}, {'title': "Baseline CTX-1 (Spearman's Rank Correlation Coefficient)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.25', 'groupId': 'OG001', 'lowerLimit': '-0.04', 'upperLimit': '0.50'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '-0.28', 'upperLimit': '0.29'}, {'value': '0.32', 'groupId': 'OG003', 'lowerLimit': '0.03', 'upperLimit': '0.55'}, {'value': '-0.21', 'groupId': 'OG004', 'lowerLimit': '-0.47', 'upperLimit': '0.09'}]}]}, {'title': "Baseline ALP (Spearman's Rank Correlation Coefficient)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.09', 'groupId': 'OG002', 'lowerLimit': '-0.19', 'upperLimit': '0.36'}, {'value': '-0.04', 'groupId': 'OG003', 'lowerLimit': '-0.31', 'upperLimit': '0.24'}, {'value': '-0.23', 'groupId': 'OG004', 'lowerLimit': '-0.48', 'upperLimit': '0.06'}]}]}, {'title': "Baseline DKK1 (Spearman's Rank Correlation Coefficient)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.11', 'groupId': 'OG003', 'lowerLimit': '-0.16', 'upperLimit': '0.37'}, {'value': '0.13', 'groupId': 'OG004', 'lowerLimit': '-0.15', 'upperLimit': '0.39'}]}]}, {'title': "Baseline Sclerostin (Spearman's Rank Correlation Coefficient)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.29', 'groupId': 'OG004', 'lowerLimit': '-0.53', 'upperLimit': '-0.01'}]}]}, {'title': "Baseline RANKL:OPG (Spearman's Rank Correlation Coefficient)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline', 'description': "Primary Outcome 2: To assess whether the novel magnetic resonance (MR) protocol and exploratory bone turnover markers can improve quantification of bone loss in patients with myeloma (new, relapsed, smouldering) and Monoclonal Gammopathy Of Uncertain Significance (MGUS) at baseline assessment, compared to Dual-energy X-ray Absorptiometry (DXA) and established bone turnover markers alone.\n\nIn this particular section, Spearman's rank correlation coefficient was performed to assess correlations between all pairs of bone turnover markers, measured at baseline in a pooled cohort of participants from Groups 1 and 2:\n\n1. P1NP (Procollagen Type 1 N-terminal Propeptide);\n2. CTX-1 (Collagen Cross-Linked C-Telopeptide Type I);\n3. ALP (Alkaline Phosphatase);\n4. DKK1 (Dickkopf WNT Signaling Pathway Inhibitor 1);\n5. Sclerostin;\n6. Ratio of RANKL (Receptor Activator of Nuclear Factor Kappa-Β Ligand) to OPG (Osteoprotegerin).", 'unitOfMeasure': "Spearman's rank correlation coefficient", 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pooled population of participants from Groups 1 and 2 who had bone biomarkers measured at baseline.'}, {'type': 'PRIMARY', 'title': 'Primary Outcome 2: Quantifying Bone Loss [Correlations Between Bone Turnover Markers, DXA (Dual-energy X-ray Absorptiometry) and ADC (Apparent Diffusion Coefficient)]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline P1NP', 'description': 'Baseline measurements of P1NP (Procollagen type 1 N-terminal Propeptide).'}, {'id': 'OG001', 'title': 'Baseline CTX-1', 'description': 'Baseline measurements of CTX-1 (Type I Collagen Cross-Linked C-Telopeptide).'}, {'id': 'OG002', 'title': 'Baseline ALP', 'description': 'Baseline measurements of ALP (Alkaline Phosphatase).'}, {'id': 'OG003', 'title': 'Baseline DKK1', 'description': 'Baseline measurements of DKK1 (Dickkopf WNT Signaling Pathway Inhibitor 1).'}, {'id': 'OG004', 'title': 'Baseline Sclerostin', 'description': 'Baseline measurements of sclerostin.'}, {'id': 'OG005', 'title': 'Baseline RANKL:OPG', 'description': 'Baseline measurements of the ratio between RANKL and OPG (osteoprotegerin).'}], 'classes': [{'title': "DXA BMD for L1-4 (Spearman's Rank Correlation Coefficient)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '53', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.02', 'groupId': 'OG000', 'lowerLimit': '-0.26', 'upperLimit': '0.29'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-0.29', 'upperLimit': '0.29'}, {'value': '0.16', 'groupId': 'OG002', 'lowerLimit': '-0.12', 'upperLimit': '0.41'}, {'value': '0.25', 'groupId': 'OG003', 'lowerLimit': '-0.03', 'upperLimit': '0.49'}, {'value': '0.54', 'groupId': 'OG004', 'lowerLimit': '0.31', 'upperLimit': '0.71'}, {'value': '-0.02', 'groupId': 'OG005', 'lowerLimit': '-0.30', 'upperLimit': '0.26'}]}]}, {'title': "DXA BMD for Femoral Neck (Spearman's Rank Correlation Coefficient)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}, {'value': '51', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.09', 'groupId': 'OG000', 'lowerLimit': '-0.20', 'upperLimit': '0.37'}, {'value': '0.14', 'groupId': 'OG001', 'lowerLimit': '-0.16', 'upperLimit': '0.41'}, {'value': '0.11', 'groupId': 'OG002', 'lowerLimit': '-0.17', 'upperLimit': '0.38'}, {'value': '0.19', 'groupId': 'OG003', 'lowerLimit': '-0.10', 'upperLimit': '0.44'}, {'value': '0.40', 'groupId': 'OG004', 'lowerLimit': '0.13', 'upperLimit': '0.61'}, {'value': '0.10', 'groupId': 'OG005', 'lowerLimit': '-0.19', 'upperLimit': '0.37'}]}]}, {'title': "Novel MR ADC Measurement (Spearman's Rank Correlation Coefficient)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.09', 'groupId': 'OG000', 'lowerLimit': '-0.52', 'upperLimit': '0.64'}, {'value': '-0.06', 'comment': "Insufficient number of paired baseline CTX-1 and novel MR ADC values to enable statistical detection of Spearman's Rank correlation coefficient", 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '-0.27', 'groupId': 'OG002', 'lowerLimit': '-0.74', 'upperLimit': '0.37'}, {'value': '-0.01', 'groupId': 'OG003', 'lowerLimit': '-0.59', 'upperLimit': '0.58'}, {'value': '-0.42', 'groupId': 'OG004', 'lowerLimit': '-0.81', 'upperLimit': '0.21'}, {'value': '0.09', 'groupId': 'OG005', 'lowerLimit': '-0.30', 'upperLimit': '0.26'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline', 'description': "Primary Outcome 2: To assess whether the novel magnetic resonance (MR) protocol and exploratory bone turnover markers can improve quantification of bone loss in patients with myeloma (new, relapsed, smouldering) and Monoclonal Gammopathy Of Uncertain Significance (MGUS) at baseline assessment, compared to Dual-energy X-ray Absorptiometry (DXA) and established bone turnover markers alone.\n\nIn this particular section, in a pooled cohort of participants from Groups 1 and 2, Spearman's rank correlation coefficients were calculated between all baseline bone turnover biomarkers and:\n\n1. Baseline novel MR Apparent Diffusion Coefficient (ADC) measurements;\n2. Baseline DXA (Dual-energy X-ray Absorptiometry) BMD (Bone Mineral Density) at lumbar spine (L1-4);\n\n2\\) Baseline DXA (Dual-energy X-ray Absorptiometry) BMD (Bone Mineral Density) at femoral neck.", 'unitOfMeasure': "Spearman's rank correlation coefficient", 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pooled population of participants from Groups 1 and 2. Where the numbers analysed are lower than the overall number of participants analysed, this reflects either failure of paired measurements for bone turnover marker and DXA and ADC, or that ADC measurements were not indicated because baseline novel MR scan did not show a lytic lesion.'}, {'type': 'PRIMARY', 'title': "Primary Outcome 1+2: Quantifying Tumour Burden (Total Spinal 'Hole' Volume)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1- Myeloma', 'description': 'Group 1a: New Myeloma; Group 1b: Relapsed Myeloma Group;1c: Smouldering Myeloma\n\nBaseline AND Follow-Up Assessment:\n\nNovel MR Whole body DXA scan Blood and urine samples QOL \\& scan experience questionnaires'}, {'id': 'OG001', 'title': 'Group 2- MGUS', 'description': 'Baseline AND Follow-Up Assessment:\n\nNovel MR Whole body DXA scan Blood and urine samples QOL \\& scan experience questionnaires'}, {'id': 'OG002', 'title': 'Group 3- Healthy Volunteers', 'description': 'Baseline Assessment ONLY:\n\n* Novel MR\n* QOL \\& scan experience questionnaires'}], 'classes': [{'title': 'Largest spinal hole volume'}, {'title': 'Total spinal hole volume'}], 'timeFrame': 'At baseline', 'description': '* This was intended as a novel end-point produced by OCMR scientists, in which high-resolution 3D imaging of the spine and pelvis are analysed for lytic lesions (holes).\n* Unfortunately, we were unable to collect data for the total spinal hole volume and total spine collapse volume at the point of novel MR scan, due to technical challenges.', 'reportingStatus': 'POSTED', 'populationDescription': '\\- Unfortunately, we were unable to collect data for the total spinal hole volume and total spine collapse volume at the point of novel MR scan, due to technical challenges.'}, {'type': 'PRIMARY', 'title': "Primary Outcome 1+2: Quantifying Tumour Burden (Total Spinal 'Collapse' Volume)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1- Myeloma', 'description': 'Group 1a: New Myeloma; Group 1b: Relapsed Myeloma Group;1c: Smouldering Myeloma\n\nBaseline AND Follow-Up Assessment:\n\nNovel MR Whole body DXA scan Blood and urine samples QOL \\& scan experience questionnaires'}, {'id': 'OG001', 'title': 'Group 2- MGUS', 'description': 'Baseline AND Follow-Up Assessment:\n\nNovel MR Whole body DXA scan Blood and urine samples QOL \\& scan experience questionnaires'}, {'id': 'OG002', 'title': 'Group 3- Healthy Volunteers', 'description': 'Baseline Assessment ONLY:\n\n* Novel MR\n* QOL \\& scan experience questionnaires'}], 'classes': [{'title': 'Largest spinal collapse volume'}, {'title': 'Total spinal collapse volume'}], 'timeFrame': 'At baseline', 'description': '* This was intended as a novel end-point produced by OCMR scientists, in which high-resolution 3D imaging of the spine and pelvis are analysed for the extent of vertebral collapse.\n* Unfortunately, we were unable to collect data for the total spinal hole volume and total spine collapse volume at the point of novel magnetic resonance (MR) scan, due to technical challenges.', 'reportingStatus': 'POSTED', 'populationDescription': '\\- Unfortunately, we were unable to collect data for the total spinal hole volume and total spine collapse volume at the point of novel MR scan, due to technical challenges.'}, {'type': 'PRIMARY', 'title': 'Primary Outcome 1+2: Quantifying Tumour Burden [Osteotronix Fine Structural Analysis (FSA), Trabecular Wall Thickness]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1- Myeloma', 'description': 'Group 1a: New Myeloma; Group 1b: Relapsed Myeloma Group;1c: Smouldering Myeloma\n\nBaseline AND Follow-Up Assessment:\n\nNovel MR Whole body DXA scan Blood and urine samples QOL \\& scan experience questionnaires'}, {'id': 'OG001', 'title': 'Group 2- MGUS', 'description': 'Baseline AND Follow-Up Assessment:\n\nNovel MR Whole body DXA scan Blood and urine samples QOL \\& scan experience questionnaires'}, {'id': 'OG002', 'title': 'Group 3- Healthy Volunteers', 'description': 'Baseline Assessment ONLY:\n\n* Novel MR\n* QOL \\& scan experience questionnaires'}], 'classes': [{'title': 'Fine Structural Analysis Trabecular Wall Thickness'}, {'title': 'Fine Structural Analysis Trabecular Wall Separation'}], 'timeFrame': 'At baseline', 'description': "* Osteotronix' fineSA® (Fine Structural Analysis, FSA) technology extracts microstructural information from Magnetic Resonance Imaging (MRI) data sets, as a correlate of trabecular wall thickness, to indicate bone remodelling. The FSA metric has been shown to correlate tightly with gold standard bone density measurements in rats \\[Evans et al, 2014\\] and human cadaveric spine specimens \\[Rafferty et al, 2016\\].\n* In this study, we had collected data during the novel MR protocol at both baseline and follow-up time points. However, we were unable to complete analysis of the FSA metrics, because of disruptions due to COVID-19, therefore the results have not been possible to report.", 'reportingStatus': 'POSTED', 'populationDescription': '\\- In this study, we had collected data during the novel MR protocol at both baseline and follow-up time points. However, we were unable to complete analysis of the FSA metrics as the company we contracted to undertake this was dissolved, an alternative is not available and there is no remaining budget. Therefore the results will never be possible to report.'}, {'type': 'SECONDARY', 'title': 'Secondary Outcome 1: Detect Longitudinal Changes in Tumour Load With Therapy [MY-RADS RAC (Myeloma Response Assessment and Diagnosis System Response Assessment Classification) vs IMWG (International Myeloma Working Group) Response Group Classification]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'IMWG: Relapse', 'description': 'IMWG classification of therapy response'}, {'id': 'OG001', 'title': 'IMWG: Progressive', 'description': 'IMWG classification of therapy response'}, {'id': 'OG002', 'title': 'IMWG: Stable', 'description': 'IMWG classification of therapy response'}, {'id': 'OG003', 'title': 'IMWG: Partial Response', 'description': 'IMWG classification of therapy response'}, {'id': 'OG004', 'title': 'IMWG: Very Good Partial Response', 'description': 'IMWG classification of therapy response'}, {'id': 'OG005', 'title': 'IMWG: Complete Response', 'description': 'IMWG classification of therapy response'}], 'classes': [{'categories': [{'title': 'MY-RADS RAC 1: Highly likely to be responding', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'MY-RADS RAC 2: Likely to be responding', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'MY-RADS RAC 3: Stable', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.015', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'statisticalMethod': 'Fisher-Freeman-Halton exact test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Comparison between baseline and follow-up at 6 months.', 'description': 'Secondary Objective 1: To assess whether the novel Magnetic Resonance (MR) protocol can improve detection of longitudinal changes in tumour burden in patients with new or relapsed myeloma during therapy, compared to the International Myeloma Working Group (IMWG) Response Group classification alone.\n\nThis section compared two indicators of therapy response:\n\n1. IMWG Response Group classification \\[1\\], based on % change in serum paraprotein\n2. MY-RADS RAC (Myeloma Response Assessment and Diagnosis System Response Assessment Classification) based on expert radiologist interpretation of paired novel MR imaging, guided by Messiou et. al. criteria \\[2\\].\n\nRef:\n\n1. https://www.myeloma.org/resource-library/international-myeloma-working-group-imwg-uniform-response-criteria-multiple\n2. Messiou, Christina, et al. "Guidelines for acquisition, interpretation, and reporting of whole-body MRI in myeloma: myeloma response assessment and diagnosis system (MY-RADS)." Radiology 291.1 (2019): 5-13.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from Group 1 who had successfully measured paired novel MR scans and serum paraproteins, between baseline and 6-month follow-up, and with a successfully graded MY-RADS RAC, and IMWG Response Group classifications.'}, {'type': 'SECONDARY', 'title': 'Secondary Outcome 1: Detect Longitudinal Changes in Tumour Load With Therapy [MY-RADS RAC (Myeloma Response Assessment and Diagnosis System Response Assessment Classification) vs % Change in ADC (Apparent Diffusion Coefficient)]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1a: New Myeloma', 'description': 'Patients from Group 1a who had MY-RADS RAC score'}, {'id': 'OG001', 'title': 'Group 1b: Relapsed Myeloma', 'description': 'Patients from Group 1b who had MY-RADS RAC score'}], 'classes': [{'title': 'MY-RADS RAC 1: Highly likely to be responding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.45', 'spread': 'NA', 'comment': '1 data point, not amenable to standard deviation calculation', 'groupId': 'OG000'}, {'value': '1.40', 'spread': 'NA', 'comment': '1 data point, not amenable to standard deviation calculation', 'groupId': 'OG001'}]}]}, {'title': 'MY-RADS RAC 2: Likely to be responding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.29', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '0.57', 'spread': 'NA', 'comment': '1 data point, not amenable to standard deviation calculation', 'groupId': 'OG001'}]}]}, {'title': 'MY-RADS RAC 3: Stable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.61', 'spread': '0.45', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Comparison between baseline and follow-up at 6 month', 'description': 'Secondary Objective 1: To assess whether the novel Magnetic Resonance (MR) protocol can improve detection of longitudinal changes in tumour burden in patients with new or relapsed myeloma during therapy, compared to the International Myeloma Working Group (IMWG) Response Group classification alone.\n\nThis section compared two indicators of therapy response:\n\n1. % change in Apparent Diffusion Coefficient (ADC) measurements in participants where there was a lytic bone lesion identified on both baseline and follow-up novel MR scan amenable to ADC measurement \\[1\\].\n2. MY-RADS RAC (Myeloma Response Assessment and Diagnosis System Response Assessment Classification) based on expert radiologist interpretation of paired novel MR imaging, guided by Messiou et. al. criteria \\[1\\].\n\nRef:\n\n\\[1\\] Messiou, Christina, et al. "Guidelines for acquisition, interpretation, and reporting of whole-body MRI in myeloma: myeloma response assessment and diagnosis system (MY-RADS)." Radiology 291.1 (2019): 5-13', 'unitOfMeasure': 'ADC Ratio (follow-up / baseline)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with new or relapsed myeloma who had successfully measured paired novel MR scans at baseline and 6-month follow-up, with a successfully graded MY-RADS RAC, and a lytic bone lesion also a lytic bone lesion amenable to longitudinal calculation of % change in ADC.'}, {'type': 'SECONDARY', 'title': 'Secondary Outcome 1: Detect Longitudinal Changes in Tumour Load With Therapy [% Change in ADC (Apparent Diffusion Coefficient) vs IMWG (International Myeloma Working Group) Response Group Classification]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1a: New Myeloma', 'description': 'Patients with new myeloma who had a lytic bone lesion amenable to longitudinal ADC measurement, and IMWG response classification.'}, {'id': 'OG001', 'title': 'Group 1b: Relapsed Myeloma', 'description': 'Patients with relapsed myeloma who had a lytic bone lesion amenable to longitudinal ADC measurement, and IMWG response classification.'}], 'classes': [{'title': 'IMWG: Progressive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': 'NA', 'comment': 'Single value, not amenable to calculation of standard deviation', 'groupId': 'OG000'}]}]}, {'title': 'IMWG: Partial Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.90', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '0.99', 'spread': '0.59', 'groupId': 'OG001'}]}]}, {'title': 'IMWG: Very Good Partial Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': 'NA', 'comment': 'Single value, not amenable to calculation of standard deviation', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Comparison between baseline and follow-up at 6month', 'description': 'Secondary Objective 1: To assess whether the novel Magnetic Resonance (MR) protocol can improve detection of longitudinal changes in tumour burden in patients with new or relapsed myeloma during therapy, compared to the International Myeloma Working Group (IMWG) Response Group classification alone.\n\nThis section compared two indicators of therapy response:\n\n1. IMWG Response Group classification \\[1\\], based on % change in serum paraprotein\n2. % change in Apparent Diffusion Coefficient (ADC) measurements in participants where there was a lytic bone lesion identified on both baseline and follow-up novel MR scan amenable to ADC measurement \\[2\\].\n\nRef:\n\n1. https://www.myeloma.org/resource-library/international-myeloma-working-group-imwg-uniform-response-criteria-multiple\n2. Messiou, Christina, et al. "Guidelines for acquisition, interpretation, and reporting of whole-body MRI in myeloma: myeloma response assessment and diagnosis system (MY-RADS)." Radiology 291.1 (2019): 5-13', 'unitOfMeasure': 'ADC Ratio (follow-up / baseline)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had successfully measured paired serum paraprotein (amenable to IMWG Response Group classification) and novel MR scans (with a lytic bone lesion amenable to ADC measurement, with a successfully calculated % change in ADC) at baseline and 6-month follow-up.'}, {'type': 'SECONDARY', 'title': 'Secondary Outcome 2: Detect Longitudinal Changes in Bone Microarchitecture With Therapy (% Change in Bone Turnover Markers)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '29', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '% Change in P1NP', 'description': '% Change in measurements of P1NP (Procollagen type 1 N-terminal Propeptide).'}, {'id': 'OG001', 'title': '% Change in CTX-1', 'description': '% Change in measurements of CTX-1 (Type I Collagen Cross-Linked C-Telopeptide).'}, {'id': 'OG002', 'title': '% Change in ALP', 'description': '% Change in measurements of ALP (Alkaline Phosphatase).'}, {'id': 'OG003', 'title': '% Change in DKK1', 'description': '% Change in measurements of DKK1 (Dickkopf WNT Signaling Pathway Inhibitor 1).'}, {'id': 'OG004', 'title': '% Change in Sclerostin', 'description': '% Change in measurements of sclerostin.'}, {'id': 'OG005', 'title': '% Change in RANKL:OPG', 'description': '% Change in measurements of the ratio between RANKL and OPG (osteoprotegerin).'}], 'classes': [{'title': 'IMWG Responder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.94', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '0.89', 'spread': '0.73', 'groupId': 'OG001'}, {'value': '0.85', 'spread': '0.22', 'groupId': 'OG002'}, {'value': '0.63', 'spread': '0.40', 'groupId': 'OG003'}, {'value': '1.22', 'spread': '0.64', 'groupId': 'OG004'}, {'value': '1.09', 'spread': '0.81', 'groupId': 'OG005'}]}]}, {'title': 'IMWG Non-Responder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.95', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '1.18', 'spread': '0.51', 'groupId': 'OG001'}, {'value': '0.98', 'spread': '0.23', 'groupId': 'OG002'}, {'value': '1.15', 'spread': '0.59', 'groupId': 'OG003'}, {'value': '1.18', 'spread': '0.41', 'groupId': 'OG004'}, {'value': '1.51', 'spread': '1.04', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG003'], 'statisticalMethod': 'Mann-Whitney test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Comparison between baseline and follow-up at 6month', 'description': 'Secondary Objective 2: To assess whether the novel Magnetic Resonance (MR) protocol and exploratory bone biomarkers can improve detection of longitudinal changes in bone loss in patients with myeloma (new, relapsed, smouldering) and Monoclonal Gammopathy of Undetermined Significance (MGUS) during therapy, compared to Dual-energy X-ray Absorptiometry (DXA) and established bone biomarkers alone.\n\nThis section examined whether longitudinal change in bone turnover markers differed by chemotherapy responders vs non-responders.\n\n* The % change in bone biomarker measurements was expressed as a ratio of follow-up / baseline of paired measurements\n* Participants were classified by International Myeloma Working Group (IMWG) Response Group classification, as responder (partial response, very good partial response or complete response) or non-responder (stable, progressive or relapse).', 'unitOfMeasure': 'Ratio (follow-up divided by baseline)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pooled cohort of participants from Groups 1 and 2 who had a IMWG response classification (responder vs non-responder) and paired serum bone turnover markers measured at baseline and follow-up.'}, {'type': 'SECONDARY', 'title': 'Secondary Outcome 2: Detect Longitudinal Changes in Bone Microarchitecture With Therapy (Correlations Between % Change in Bone Turnover Markers)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '% Change in CTX-1', 'description': '% Change in measurements of CTX-1 (Type I Collagen Cross-Linked C-Telopeptide).'}, {'id': 'OG001', 'title': '% Change in ALP', 'description': '% Change in measurements of ALP (Alkaline Phosphatase).'}, {'id': 'OG002', 'title': '% Change in DKK1', 'description': '% Change in measurements of DKK1 (Dickkopf WNT Signaling Pathway Inhibitor 1).'}, {'id': 'OG003', 'title': '% Change in Sclerostin', 'description': '% Change in measurements of sclerostin.'}, {'id': 'OG004', 'title': '% Change in RANKL:OPG', 'description': '% Change in measurements of the ratio between RANKL and OPG (osteoprotegerin).'}], 'classes': [{'title': '% Change in P1NP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.41', 'groupId': 'OG000', 'lowerLimit': '0.10', 'upperLimit': '0.64'}, {'value': '0.36', 'groupId': 'OG001', 'lowerLimit': '0.05', 'upperLimit': '0.61'}, {'value': '0.12', 'groupId': 'OG002', 'lowerLimit': '-0.20', 'upperLimit': '0.41'}, {'value': '0.32', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '0.58'}, {'value': '0.41', 'groupId': 'OG004', 'lowerLimit': '0.09', 'upperLimit': '0.65'}]}]}, {'title': '% Change in CTX-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG001', 'lowerLimit': '-0.24', 'upperLimit': '0.39'}, {'value': '0.11', 'groupId': 'OG002', 'lowerLimit': '-0.22', 'upperLimit': '0.42'}, {'value': '0.26', 'groupId': 'OG003', 'lowerLimit': '-0.08', 'upperLimit': '0.54'}, {'value': '-0.03', 'groupId': 'OG004', 'lowerLimit': '-0.37', 'upperLimit': '0.32'}]}]}, {'title': '% Change in ALP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.23', 'groupId': 'OG002', 'lowerLimit': '-0.08', 'upperLimit': '0.51'}, {'value': '-0.01', 'groupId': 'OG003', 'lowerLimit': '-0.32', 'upperLimit': '0.31'}, {'value': '-0.13', 'groupId': 'OG004', 'lowerLimit': '-0.44', 'upperLimit': '0.21'}]}]}, {'title': '% Change in DKK1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.13', 'groupId': 'OG003', 'lowerLimit': '-0.18', 'upperLimit': '0.43'}, {'value': '0.14', 'groupId': 'OG004', 'lowerLimit': '-0.20', 'upperLimit': '0.44'}]}]}, {'title': '% Change in Sclerostin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.37', 'groupId': 'OG004', 'lowerLimit': '0.06', 'upperLimit': '0.62'}]}]}, {'title': '% Change in RANKL:OPG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Comparison between baseline and follow-up at 6month', 'description': "Secondary Objective 2: To assess whether the novel Magnetic Resonance (MR) protocol and exploratory bone biomarkers can improve detection of longitudinal changes in bone loss in patients with myeloma (new, relapsed, smouldering) and Monoclonal Gammopathy of Undetermined Significance (MGUS) during therapy, compared to Dual-energy X-ray Absorptiometry (DXA) and established bone biomarkers alone.\n\nThis particular section examined the correlation between longitudinal changes in bone turnover markers between one another (calculated as a ratio of follow-up measurement divided by baseline measurement). Spearman's rank correlation was performed for the longitudinal % change between different biomarkers, to assess the relationship between longitudinal changes in these measures.", 'unitOfMeasure': "Spearman's rank correlation coefficient", 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pooled population of participants from Groups 1 and 2 who had paired measurements of follow-up and baseline bone turnover markers.\n\nFor some rows, the total number of participants analysed are less than the overall number of participants analysed, due to assay failure of some bone biomarkers variably on individual samples.'}, {'type': 'SECONDARY', 'title': 'Secondary Outcome 2: Detect Longitudinal Changes in Bone Microarchitecture With Therapy [Correlations Between % Change in Bone Turnover Markers With % Change in Bone Mineral Density (BMD) or Apparent Diffusion Coefficient (ADC)]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '42', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '% Change in P1NP', 'description': '% Change in measurements of P1NP (Procollagen type 1 N-terminal Propeptide).'}, {'id': 'OG001', 'title': '% Change in CTX-1', 'description': '% Change in measurements of CTX-1 (Type I Collagen Cross-Linked C-Telopeptide).'}, {'id': 'OG002', 'title': '% Change in ALP', 'description': '% Change in measurements of ALP (Alkaline Phosphatase).'}, {'id': 'OG003', 'title': '% Change in DKK1', 'description': '% Change in measurements of DKK1 (Dickkopf WNT Signaling Pathway Inhibitor 1).'}, {'id': 'OG004', 'title': '% Change in Sclerostin', 'description': '% Change in measurements of sclerostin.'}, {'id': 'OG005', 'title': '% Change in RANKL:OPG', 'description': '% Change in measurements of the ratio between RANKL and OPG (osteoprotegerin).'}], 'classes': [{'title': '% Change in Novel MR ADC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-0.39', 'comment': "Insufficient number of participants with paired ADC measurements from paired novel MR scans, to enable statistical detection of Spearman's Rank correlation coefficient", 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.31', 'comment': "Insufficient number of participants with paired ADC measurements from paired novel MR scans, to enable statistical detection of Spearman's Rank correlation coefficient", 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '-0.50', 'comment': "Insufficient number of participants with paired ADC measurements from paired novel MR scans, to enable statistical detection of Spearman's Rank correlation coefficient", 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '-0.32', 'comment': "Insufficient number of participants with paired ADC measurements from paired novel MR scans, to enable statistical detection of Spearman's Rank correlation coefficient", 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '-0.32', 'comment': "Insufficient number of participants with paired ADC measurements from paired novel MR scans, to enable statistical detection of Spearman's Rank correlation coefficient", 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '-0.14', 'comment': "Insufficient number of participants with paired ADC measurements from paired novel MR scans, to enable statistical detection of Spearman's Rank correlation coefficient", 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': '% Change in DXA BMD (L1-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '42', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-0.12', 'groupId': 'OG000', 'lowerLimit': '-0.42', 'upperLimit': '0.21'}, {'value': '-0.10', 'groupId': 'OG001', 'lowerLimit': '-0.41', 'upperLimit': '0.23'}, {'value': '0.02', 'groupId': 'OG002', 'lowerLimit': '-0.29', 'upperLimit': '0.33'}, {'value': '0.02', 'groupId': 'OG003', 'lowerLimit': '-0.29', 'upperLimit': '0.33'}, {'value': '0.24', 'groupId': 'OG004', 'lowerLimit': '-0.08', 'upperLimit': '0.51'}, {'value': '-0.17', 'groupId': 'OG005', 'lowerLimit': '-0.48', 'upperLimit': '0.16'}]}]}, {'title': '% Change in DXA BMD (Femoral Neck)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '36', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-0.20', 'groupId': 'OG000', 'lowerLimit': '-0.50', 'upperLimit': '0.13'}, {'value': '-0.10', 'groupId': 'OG001', 'lowerLimit': '-0.41', 'upperLimit': '0.24'}, {'value': '-0.17', 'groupId': 'OG002', 'lowerLimit': '-0.47', 'upperLimit': '0.16'}, {'value': '-0.09', 'groupId': 'OG003', 'lowerLimit': '-0.39', 'upperLimit': '0.24'}, {'value': '0.00', 'groupId': 'OG004', 'lowerLimit': '-0.32', 'upperLimit': '0.32'}, {'value': '-0.45', 'groupId': 'OG005', 'lowerLimit': '-0.68', 'upperLimit': '-0.13'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Comparison between baseline and follow-up at 6month', 'description': "Secondary Objective 2: To assess whether the novel Magnetic Resonance (MR) protocol and exploratory bone biomarkers can improve detection of longitudinal changes in bone loss in patients with myeloma (new, relapsed, smouldering) and Monoclonal Gammopathy of Undetermined Significance (MGUS) during therapy, compared to Dual-energy X-ray Absorptiometry (DXA) and established bone biomarkers alone.\n\nThis section examined the correlation (using Spearman's Rank Correlation Coefficient) between longitudinal changes (expressed as a ratio of follow-up / baseline of paired measurements) in bone turnover markers and:\n\n1. Longitudinal changes in DXA Bone Mineral Density (BMD) at lumbar spine (L1-4) and femoral neck;\n2. Longitudinal changes in novel MR Apparent Diffusion Coefficient (ADC) measurements.", 'unitOfMeasure': "Spearman's rank correlation coefficient", 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from Groups 1 and 2 were analysed who had a paired bone turnover marker measurements available.\n\nWhere the number analysed for an outcome measure is lower than the overall number of participants analysed, this is due to failure of measurement of either DXA BMD or novel MR ADC, or because ADC measurement was not indicated due to lack of a lytic bone lesion identified on MR.'}, {'type': 'SECONDARY', 'title': "Secondary Objective 3: Assess Participants' Quality of Life Throughout the Study", 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1- Myeloma', 'description': 'Participants recruited with myeloma'}, {'id': 'OG001', 'title': 'Group 2- MGUS', 'description': 'Participants recruited with MGUS'}, {'id': 'OG002', 'title': 'Group 3- Healthy Volunteers', 'description': 'Participants recruited as healthy volunteers'}], 'classes': [{'title': 'Baseline: Mobility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.29', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '1.23', 'spread': '0.44', 'groupId': 'OG001'}, {'value': '1.00', 'spread': '0.00', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: Self-Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.11', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '1.08', 'spread': '0.28', 'groupId': 'OG001'}, {'value': '1.00', 'spread': '0.00', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: Usual Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.45', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '1.15', 'spread': '0.38', 'groupId': 'OG001'}, {'value': '1.00', 'spread': '0.00', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: Pain/Discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.63', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '1.54', 'spread': '0.52', 'groupId': 'OG001'}, {'value': '1.08', 'spread': '0.29', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: Anxiety/Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.11', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '1.08', 'spread': '0.28', 'groupId': 'OG001'}, {'value': '1.00', 'spread': '0.00', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: Health Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '72.8', 'spread': '22.6', 'groupId': 'OG000'}, {'value': '83.9', 'spread': '7.7', 'groupId': 'OG001'}, {'value': '87.9', 'spread': '5.9', 'groupId': 'OG002'}]}]}, {'title': 'Follow-Up: Mobility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.34', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '1.33', 'spread': '0.49', 'groupId': 'OG001'}]}]}, {'title': 'Follow-Up: Self-Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.07', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '1.17', 'spread': '0.39', 'groupId': 'OG001'}]}]}, {'title': 'Follow-Up: Usual Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.38', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '1.25', 'spread': '0.45', 'groupId': 'OG001'}]}]}, {'title': 'Follow-Up: Pain/Discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.59', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '1.42', 'spread': '0.51', 'groupId': 'OG001'}]}]}, {'title': 'Follow-Up: Anxiety/Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.21', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '1.08', 'spread': '0.29', 'groupId': 'OG001'}]}]}, {'title': 'Follow-Up: Health Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '75.1', 'spread': '20.5', 'groupId': 'OG000'}, {'value': '79.0', 'spread': '15.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and six months', 'description': "Secondary Objective 3: To assess how quality of life compares between groups and longitudinally in patients with myeloma, Monoclonal Gammopathy of Undetermined Significance (MGUS), and healthy volunteers.\n\nThe EuroQol 5-Dimension (EQ-5D) assess the mobility, self-care, usual activities, pain/discomfort, anxiety and depression on a 5-point scale, in which a lower score represents better quality of life (1 = 'no problems', 5 = maximum problems, for each domain). The second part of the EQ-5D assess health on a scale where 100 is the best health and 0 is the worst health.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants from Groups 1, 2 and 3 were invited to complete EQ5D questionnaires at baseline and 6-month follow-up visits.\n\nThe total number of patients analysed for each EQ5D question varied slightly depending on how many responses were received from the questionnaires.'}, {'type': 'SECONDARY', 'title': "Secondary Outcome 4: Assess Participants' Experience of Novel Magnetic Resonance (MR) and Dual-energy X-ray Absorptiometry (DXA) Scans", 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1- Myeloma', 'description': 'Participants recruited with myeloma'}, {'id': 'OG001', 'title': 'Group 2- MGUS', 'description': 'Participants recruited with MGUS'}, {'id': 'OG002', 'title': 'Group 3- Healthy Volunteers', 'description': 'Participants recruited as healthy volunteers'}], 'classes': [{'title': 'Baseline novel MR scan experience: Q1 = Overall Experience', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.10', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '2.10', 'spread': '0.93', 'groupId': 'OG001'}, {'value': '2.13', 'spread': '0.92', 'groupId': 'OG002'}]}]}, {'title': 'Baseline novel MR scan experience: Q2 = Adverse Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.30', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '0.31', 'spread': '0.47', 'groupId': 'OG001'}, {'value': '0.33', 'spread': '0.47', 'groupId': 'OG002'}]}]}, {'title': 'Baseline novel MR scan experience: Q3 = Length of Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.39', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '1.40', 'spread': '0.49', 'groupId': 'OG001'}, {'value': '1.40', 'spread': '0.50', 'groupId': 'OG002'}]}]}, {'title': 'Baseline novel MR scan experience: Q4 = Pain/Discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.75', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '1.74', 'spread': '0.87', 'groupId': 'OG001'}, {'value': '1.73', 'spread': '0.89', 'groupId': 'OG002'}]}]}, {'title': 'Baseline novel MR scan experience: Q5 = How Likely to Re-participate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.34', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '3.36', 'spread': '0.92', 'groupId': 'OG001'}, {'value': '3.34', 'spread': '0.96', 'groupId': 'OG002'}]}]}, {'title': 'Baseline novel MR scan experience: Q6 = How Similar to Expectations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '1.00', 'spread': '0.00', 'groupId': 'OG002'}]}]}, {'title': 'Baseline novel MR scan experience: Q7 = Comfort with Staff', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '1.00', 'spread': '0.00', 'groupId': 'OG002'}]}]}, {'title': 'Follow-up novel MR scan experience: Q1 = Overall Experience', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.17', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '2.20', 'spread': '1.11', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up novel MR scan experience: Q2 = Adverse Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.27', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '0.28', 'spread': '0.45', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up novel MR scan experience: Q3 = Length of Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.30', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '1.33', 'spread': '0.48', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up novel MR scan experience: Q4 = Pain/Discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.44', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '1.48', 'spread': '0.82', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up novel MR scan experience: Q5 = How Likely to Re-participate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.29', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '3.33', 'spread': '1.05', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up novel MR scan experience: Q6 = How Similar to Expectations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up novel MR scan experience: Q7 = Comfort with Staff', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.98', 'spread': '0.16', 'groupId': 'OG001'}]}]}, {'title': 'Baseline DXA scan experience: Q1 = Overall Experience', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.58', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '1.61', 'spread': '0.72', 'groupId': 'OG001'}]}]}, {'title': 'Baseline DXA scan experience: Q2 = Adverse Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.11', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.33', 'groupId': 'OG001'}]}]}, {'title': 'Baseline DXA scan experience: Q3 = Length of Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Baseline DXA scan experience: Q4 = Pain/Discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.17', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '1.16', 'spread': '0.42', 'groupId': 'OG001'}]}]}, {'title': 'Baseline DXA scan experience: Q5 = How Likely to Re-participate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.51', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '3.53', 'spread': '0.83', 'groupId': 'OG001'}]}]}, {'title': 'Baseline DXA scan experience: Q6 = How Similar to Expectations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.98', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.98', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Baseline DXA scan experience: Q7 = Comfort with Staff', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up DXA scan experience: Q1 = Overall Experience', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.65', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '1.71', 'spread': '0.83', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up DXA scan experience: Q2 = Adverse Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '0.30', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up DXA scan experience: Q3 = Length of Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.05', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '1.07', 'spread': '0.26', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up DXA scan experience: Q4 = Pain/Discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.12', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '1.19', 'spread': '0.55', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up DXA scan experience: Q5 = How Likely to Re-participate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.63', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '3.67', 'spread': '0.85', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up DXA scan experience: Q6 = How Similar to Expectations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.00', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up DXA scan experience: Q7 = Comfort with Staff', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.00', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '0.98', 'spread': '0.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and six months', 'description': 'This questionnaire assesses the experience of the Novel Magnetic Resonance (MR) and Dual-energy X-ray Absorptiometry (DXA) scans. Answers were recorded on a 5 point Likert scale where the lower number represents a better outcome.\n\nScale descriptors:\n\nQ1 (Overall Experience): 1 (Very comfortable)/ 2 (Comfortable)/ 3 (Neither comfortable or uncomfortable)/ 4 (Uncomfortable)/ 5 (Very uncomfortable) Q2 (Adverse Effects): 1 (YES) / 0 (NO) Q3 (Length of Time): 0 (Too short) / 1 (Just right) / 2 (Too long) Q4 (Pain/Discomfort): 1 (No Increase)/ 2 (Mild Increase)/ 3 (Moderate Increase)/ 4 (High Increase)/ 5 (Severe Increase) Q5 (Likely to Reparticipate): 0 (Extremely Unlikely) / 1 (Unlikely) / 2 (Neither Likely or Unlikely) / 3 (Likely) / 4 (Extremely Likely) Q6 (How similar to expectations): 1 (YES) / 0 (NO) Q7 (Comfort with Staff): 1 (YES) / 0 (NO)', 'unitOfMeasure': 'Score on a scale (see description above)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline: all participants from Groups 1,2,3 were invited for novel MR scan, and only participants from Groups 1 and 2 were invited for DXA Follow-up: only participants from Groups 1 and 2 were invited for a novel MR scan and also a DXA.'}, {'type': 'POST_HOC', 'title': 'Post-Hoc Analysis: Relationship Between Intercurrent Chemotherapy and Baseline Magnetic Resonance (MR) Apparent Diffusion Coefficient (ADC) Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1a: New Myeloma', 'description': 'All patients with new myeloma at recruitment.'}, {'id': 'OG001', 'title': 'Group 1b: Relapsed Myeloma', 'description': 'All patients with relapsed myeloma at recruitment.'}], 'classes': [{'title': 'Baseline ADC: Ongoing Chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1084.5', 'spread': '432.5', 'groupId': 'OG000'}, {'value': '1215.3', 'spread': '319.4', 'groupId': 'OG001'}]}]}, {'title': 'Baseline ADC: Recent (<1yr) Chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '751.7', 'spread': '134.8', 'groupId': 'OG001'}]}]}, {'title': 'Baseline ADC: Never Chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '547.5', 'spread': '74.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline', 'description': 'We first addressed an important practical limitation of the study design. Patients with new myeloma usually commenced chemotherapy imminently after their diagnosis, typically a few months before they were able to consent for the present study. Therefore, most patients had already started chemotherapy at the point of baseline novel Magnetic Resonance (MR) scan, and had received variable durations of chemotherapy at baseline and follow-up scans. We hypothesised that this may be a potential confounding factor, as more recent chemotherapy may reduce tumour cellularity and therefore increase diffusion \\[and therefore Apparent Diffusion Coefficient (ADC) measurements\\] at lytic bone lesions.\n\nIn this particular section, we analysed the difference between baseline ADC measurements in patients with new and relapsed myeloma, grouped by time elapsed since chemotherapy (ongoing, recent or never chemotherapy).', 'unitOfMeasure': 's/mm^2 (ADC measurement unit)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis included patients from Groups 1a and 1b who had a novel MR scan at baseline, with a lytic bone lesion identified amenable to ADC measurement.'}, {'type': 'POST_HOC', 'title': 'Post-Hoc Analysis: Relationship Between Intercurrent Chemotherapy and Follow-Up Magnetic Resonance (MR) Apparent Diffusion Coefficient (ADC) Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1a: New Myeloma', 'description': 'All patients with new myeloma at recruitment.'}, {'id': 'OG001', 'title': 'Group 1b: Relapsed Myeloma', 'description': 'All patients with relapsed myeloma at recruitment.'}], 'classes': [{'title': 'Follow-Up ADC: Ongoing Chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1875', 'spread': '205', 'groupId': 'OG000'}, {'value': '1415', 'spread': '968.7', 'groupId': 'OG001'}]}]}, {'title': 'Follow-Up ADC: Recent (<1yr) Chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1252.3', 'spread': '634.7', 'groupId': 'OG000'}, {'value': '900', 'groupId': 'OG001'}]}]}, {'title': 'Follow-Up ADC: Historic Chemotherapy (>1yr)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '648', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At follow-up', 'description': 'We first addressed an important practical limitation of the study design. Patients with new myeloma usually commenced chemotherapy imminently after their diagnosis, typically a few months before they were able to consent for the present study. Therefore, most patients had already started chemotherapy at the point of baseline novel Magnetic Resonance (MR) scan, and had received variable durations of chemotherapy at baseline and follow-up scans. We hypothesised that this may be a potential confounding factor, as more recent chemotherapy may reduce tumour cellularity and therefore increase diffusion \\[and therefore Apparent Diffusion Coefficient (ADC) measurements\\] at lytic bone lesions.\n\nIn this particular section, we analysed the difference between follow-up ADC measurements in patients with new and relapsed myeloma, grouped by time elapsed since chemotherapy (ongoing, recent or never chemotherapy).', 'unitOfMeasure': 's/mm^2 (ADC measurement unit)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis included patients from Groups 1a and 1b who had a novel MR scan at follow-up, with a lytic bone lesion identified amenable to ADC measurement.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1- Myeloma', 'description': 'Group 1a: New Myeloma; Group 1b: Relapsed Myeloma Group;1c: Smouldering Myeloma\n\nBaseline AND Follow-Up Assessment:\n\nNovel MR Whole body DXA scan Blood and urine samples QOL \\& scan experience questionnaires'}, {'id': 'FG001', 'title': 'Group 2- MGUS', 'description': 'Baseline AND Follow-Up Assessment:\n\nNovel MR Whole body DXA scan Blood and urine samples QOL \\& scan experience questionnaires'}, {'id': 'FG002', 'title': 'Group 3- Healthy Volunteers', 'description': 'Baseline Assessment ONLY:\n\n* Novel MR\n* QOL \\& scan experience questionnaires'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Enrolment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'Baseline Assessment', 'comment': 'GROUP 1 \\& 2 ASSESSMENT\n\n* Experimental MR\n* Whole body DXA scan\n* Blood and urine samples\n* QOL \\& scan experience questionnaires\n\nGROUP 3 ASSESSMENT\n\n* Experimental MR\n* QOL \\& scan experience questionnaires', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'Follow-Up Assessment', 'comment': 'GROUP 1 \\& 2 ASSESSMENT\n\n* Experimental MR\n* Whole body DXA scan\n* Blood and urine samples\n* QOL \\& scan experience questionnaires\n\nGROUP 3 ASSESSMENT\n\n• (No follow-up)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'comment': 'Group 3 participants did not attend follow-up', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants from Groups 1 and 2 were identified and approached by a healthcare professional in the oncology clinic at the Churchill Hospital, Oxford. Group 3 participants were typically partners of the participants from Groups 1 and 2 and were recruited at the same time.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1- Myeloma', 'description': 'Group 1a: New Myeloma Group 1b: Relapsed Myeloma Group 1c: Smouldering Myeloma\n\nBaseline AND Follow-Up Assessment:\n\n* Novel MR\n* Whole body DXA scan\n* Blood and urine samples\n* QOL \\& scan experience questionnaires'}, {'id': 'BG001', 'title': 'Group 2- MGUS', 'description': 'Baseline AND Follow-Up Assessment:\n\n* Novel MR\n* Whole body DXA scan\n* Blood and urine samples\n* QOL \\& scan experience questionnaires'}, {'id': 'BG002', 'title': 'Group 3- Healthy Volunteers', 'description': 'Baseline Assessment ONLY:\n\n* Novel MR\n* QOL \\& scan experience questionnaires'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '67.7', 'groupId': 'BG000', 'lowerLimit': '40.9', 'upperLimit': '85.3'}, {'value': '65.5', 'groupId': 'BG001', 'lowerLimit': '54.3', 'upperLimit': '82.3'}, {'value': '60.5', 'groupId': 'BG002', 'lowerLimit': '35.2', 'upperLimit': '75.5'}, {'value': '65.6', 'groupId': 'BG003', 'lowerLimit': '35.2', 'upperLimit': '85.3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Total 67 participants: Group 1a (new myeloma = 14), Group 1b (relapsed myeloma = 12), Group 1c (smouldering myeloma = 15), Group 2 (MGUS = 14), Group 3 (healthy volunteer = 12)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-21', 'size': 1577982, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-04-19T05:45', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Bloods and urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-31', 'studyFirstSubmitDate': '2019-05-01', 'resultsFirstSubmitDate': '2022-01-31', 'studyFirstSubmitQcDate': '2019-05-14', 'lastUpdatePostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-31', 'studyFirstPostDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Outcome 1: Quantifying Tumour Burden [Correlations With Apparent Diffusion Coefficient (ADC) Measurements]', 'timeFrame': 'At baseline', 'description': 'Primary Objective 1: To assess whether the novel magnetic resonance (MR) protocol and exploratory bone biomarkers can improve quantification of tumour burden in patients with new or relapsed myeloma at baseline assessment, compared to paraprotein levels alone.\n\nThis particular section analysed the correlation between the Apparent Diffusion Coefficient (ADC) measurements (from the Diffusion Weighted Magnetic Resonance Imaging (DW-MRI) component of the sequences) of lytic bone lesions, with standard clinical correlates of tumour burden (serum paraprotein, and serum paraprotein-associated immunoglobulin level).\n\nThe measurement of ADC from DW-MRI is further described by Messiou et. al. \\[1\\]\n\n\\[1\\] Messiou, Christina, et al. "Guidelines for acquisition, interpretation, and reporting of whole-body MRI in myeloma: myeloma response assessment and diagnosis system (MY-RADS)." Radiology 291.1 (2019): 5-13.'}, {'measure': 'Primary Outcome 1: Quantifying Tumour Burden [Correlations With Myeloma Response Assessment and Diagnosis System (MY-RADS) Pattern of Disease]', 'timeFrame': 'At baseline', 'description': 'Primary Objective 1: To assess whether the novel MR protocol and exploratory bone biomarkers can improve quantification of tumour burden in patients with new or relapsed myeloma at baseline assessment, compared to paraprotein levels alone.\n\nParticipants\' baseline novel MR scan was analysed by an expert radiologist, and pattern of disease was qualitatively classified using the MY-RADS (Myeloma Response Assessment and Diagnosis System) imaging recommendations, described in Figure 2 by Messiou et. al. \\[1\\].\n\nThis particular section analysed whether standard clinical correlate of tumour burden (serum paraprotein) differed by radiological pattern of disease (e.g., normal, focal, diffuse).\n\n\\[1\\] Messiou, Christina, et al. "Guidelines for acquisition, interpretation, and reporting of whole-body MRI in myeloma: myeloma response assessment and diagnosis system (MY-RADS)." Radiology 291.1 (2019): 5-13.'}, {'measure': 'Primary Outcome 1: Quantifying Tumour Burden (Correlations With Bone Turnover Markers)', 'timeFrame': 'At baseline', 'description': "Primary Objective 1: To assess whether the novel Magnetic Resonance (MR) protocol and exploratory bone biomarkers can improve quantification of tumour burden in patients with new or relapsed myeloma at baseline assessment, compared to paraprotein levels alone.\n\nThis section examined correlation between baseline bone biomarkers and baseline serum paraprotein in a pooled cohort of patients from Groups 1 and 2, using Spearman's Rank Correlation Coefficients."}, {'measure': 'Primary Outcome 2: Quantifying Bone Loss - Inter-Group Differences in Baseline Serum P1NP (Procollagen Type 1 N-terminal Propeptide)', 'timeFrame': 'At baseline', 'description': 'Primary Outcome 2: To assess whether the novel magnetic resonance (MR) protocol and exploratory bone turnover markers can improve quantification of bone loss in patients with myeloma (new, relapsed, smouldering) and Monoclonal Gammopathy Of Uncertain Significance (MGUS) at baseline assessment, compared to Dual-energy X-ray Absorptiometry (DXA) and established bone turnover markers alone.\n\nThis particular section analysed the inter-group difference in baseline serum P1NP (Procollagen Type 1 N-terminal Propeptide) bone turnover marker levels, in patients from Groups 1a (new myeloma), 1b (relapsed myeloma), 1c (smouldering myeloma) and 2 (MGUS).'}, {'measure': 'Primary Outcome 2: Quantifying Bone Loss - Inter-Group Differences in Baseline Serum CTX-1 (Collagen Cross-Linked C-Telopeptide Type I)', 'timeFrame': 'At baseline', 'description': 'Primary Outcome 2: To assess whether the novel magnetic resonance (MR) protocol and exploratory bone turnover markers can improve quantification of bone loss in patients with myeloma (new, relapsed, smouldering) and Monoclonal Gammopathy Of Uncertain Significance (MGUS) at baseline assessment, compared to Dual-energy X-ray Absorptiometry (DXA) and established bone turnover markers alone.\n\nThis particular section analysed the inter-group difference in baseline serum CTX-1 (Collagen Cross-Linked C-Telopeptide Type I) bone turnover marker levels, in patients from Groups 1a (new myeloma), 1b (relapsed myeloma), 1c (smouldering myeloma) and 2 (MGUS).'}, {'measure': 'Primary Outcome 2: Quantifying Bone Loss - Inter-Group Differences in Baseline Serum ALP (Alkaline Phosphatase)', 'timeFrame': 'At baseline', 'description': 'Primary Outcome 2: To assess whether the novel magnetic resonance (MR) protocol and exploratory bone turnover markers can improve quantification of bone loss in patients with myeloma (new, relapsed, smouldering) and Monoclonal Gammopathy Of Uncertain Significance (MGUS) at baseline assessment, compared to Dual-energy X-ray Absorptiometry (DXA) and established bone turnover markers alone.\n\nThis particular section analysed the inter-group difference in baseline serum ALP (Alkaline Phosphatase) bone turnover marker levels, in patients from Groups 1a (new myeloma), 1b (relapsed myeloma), 1c (smouldering myeloma) and 2 (MGUS).'}, {'measure': 'Primary Outcome 2: Quantifying Bone Loss - Inter-Group Differences in Baseline Serum DKK1 (Dickkopf WNT Signaling Pathway Inhibitor 1)', 'timeFrame': 'At baseline', 'description': 'Primary Outcome 2: To assess whether the novel magnetic resonance (MR) protocol and exploratory bone turnover markers can improve quantification of bone loss in patients with myeloma (new, relapsed, smouldering) and Monoclonal Gammopathy Of Uncertain Significance (MGUS) at baseline assessment, compared to Dual-energy X-ray Absorptiometry (DXA) and established bone turnover markers alone.\n\nThis particular section analysed the inter-group difference in baseline serum DKK1 (Dickkopf WNT Signaling Pathway Inhibitor 1) bone turnover marker levels, in patients from Groups 1a (new myeloma), 1b (relapsed myeloma), 1c (smouldering myeloma) and 2 (MGUS).'}, {'measure': 'Primary Outcome 2: Quantifying Bone Loss - Inter-Group Differences in Baseline Serum Sclerostin', 'timeFrame': 'At baseline', 'description': 'Primary Outcome 2: To assess whether the novel magnetic resonance (MR) protocol and exploratory bone turnover markers can improve quantification of bone loss in patients with myeloma (new, relapsed, smouldering) and Monoclonal Gammopathy Of Uncertain Significance (MGUS) at baseline assessment, compared to Dual-energy X-ray Absorptiometry (DXA) and established bone turnover markers alone.\n\nThis particular section analysed the inter-group difference in baseline serum sclerostin bone turnover marker levels, in patients from Groups 1a (new myeloma), 1b (relapsed myeloma), 1c (smouldering myeloma) and 2 (MGUS).'}, {'measure': 'Primary Outcome 2: Quantifying Bone Loss - Inter-Group Differences in Baseline Serum Ratio of RANKL (Receptor Activator of Nuclear Factor Kappa-Β Ligand) and OPG (Osteoprotegerin)', 'timeFrame': 'At baseline', 'description': 'Primary Outcome 2: To assess whether the novel magnetic resonance (MR) protocol and exploratory bone turnover markers can improve quantification of bone loss in patients with myeloma (new, relapsed, smouldering) and Monoclonal Gammopathy Of Uncertain Significance (MGUS) at baseline assessment, compared to Dual-energy X-ray Absorptiometry (DXA) and established bone turnover markers alone.\n\nThis particular section analysed the inter-group difference in baseline ratio between RANKL (Receptor Activator of Nuclear Factor Kappa-Β Ligand) and OPG (Osteoprotegerin) \\[calculated as RANKL (pg/L) divided by OPG (pg/L)\\] bone turnover marker levels, in patients from Groups 1a (new myeloma), 1b (relapsed myeloma), 1c (smouldering myeloma) and 2 (MGUS).'}, {'measure': 'Primary Outcome 2: Quantifying Bone Loss (Inter-Biomarker Correlations)', 'timeFrame': 'At baseline', 'description': "Primary Outcome 2: To assess whether the novel magnetic resonance (MR) protocol and exploratory bone turnover markers can improve quantification of bone loss in patients with myeloma (new, relapsed, smouldering) and Monoclonal Gammopathy Of Uncertain Significance (MGUS) at baseline assessment, compared to Dual-energy X-ray Absorptiometry (DXA) and established bone turnover markers alone.\n\nIn this particular section, Spearman's rank correlation coefficient was performed to assess correlations between all pairs of bone turnover markers, measured at baseline in a pooled cohort of participants from Groups 1 and 2:\n\n1. P1NP (Procollagen Type 1 N-terminal Propeptide);\n2. CTX-1 (Collagen Cross-Linked C-Telopeptide Type I);\n3. ALP (Alkaline Phosphatase);\n4. DKK1 (Dickkopf WNT Signaling Pathway Inhibitor 1);\n5. Sclerostin;\n6. Ratio of RANKL (Receptor Activator of Nuclear Factor Kappa-Β Ligand) to OPG (Osteoprotegerin)."}, {'measure': 'Primary Outcome 2: Quantifying Bone Loss [Correlations Between Bone Turnover Markers, DXA (Dual-energy X-ray Absorptiometry) and ADC (Apparent Diffusion Coefficient)]', 'timeFrame': 'At baseline', 'description': "Primary Outcome 2: To assess whether the novel magnetic resonance (MR) protocol and exploratory bone turnover markers can improve quantification of bone loss in patients with myeloma (new, relapsed, smouldering) and Monoclonal Gammopathy Of Uncertain Significance (MGUS) at baseline assessment, compared to Dual-energy X-ray Absorptiometry (DXA) and established bone turnover markers alone.\n\nIn this particular section, in a pooled cohort of participants from Groups 1 and 2, Spearman's rank correlation coefficients were calculated between all baseline bone turnover biomarkers and:\n\n1. Baseline novel MR Apparent Diffusion Coefficient (ADC) measurements;\n2. Baseline DXA (Dual-energy X-ray Absorptiometry) BMD (Bone Mineral Density) at lumbar spine (L1-4);\n\n2\\) Baseline DXA (Dual-energy X-ray Absorptiometry) BMD (Bone Mineral Density) at femoral neck."}, {'measure': "Primary Outcome 1+2: Quantifying Tumour Burden (Total Spinal 'Hole' Volume)", 'timeFrame': 'At baseline', 'description': '* This was intended as a novel end-point produced by OCMR scientists, in which high-resolution 3D imaging of the spine and pelvis are analysed for lytic lesions (holes).\n* Unfortunately, we were unable to collect data for the total spinal hole volume and total spine collapse volume at the point of novel MR scan, due to technical challenges.'}, {'measure': "Primary Outcome 1+2: Quantifying Tumour Burden (Total Spinal 'Collapse' Volume)", 'timeFrame': 'At baseline', 'description': '* This was intended as a novel end-point produced by OCMR scientists, in which high-resolution 3D imaging of the spine and pelvis are analysed for the extent of vertebral collapse.\n* Unfortunately, we were unable to collect data for the total spinal hole volume and total spine collapse volume at the point of novel magnetic resonance (MR) scan, due to technical challenges.'}, {'measure': 'Primary Outcome 1+2: Quantifying Tumour Burden [Osteotronix Fine Structural Analysis (FSA), Trabecular Wall Thickness]', 'timeFrame': 'At baseline', 'description': "* Osteotronix' fineSA® (Fine Structural Analysis, FSA) technology extracts microstructural information from Magnetic Resonance Imaging (MRI) data sets, as a correlate of trabecular wall thickness, to indicate bone remodelling. The FSA metric has been shown to correlate tightly with gold standard bone density measurements in rats \\[Evans et al, 2014\\] and human cadaveric spine specimens \\[Rafferty et al, 2016\\].\n* In this study, we had collected data during the novel MR protocol at both baseline and follow-up time points. However, we were unable to complete analysis of the FSA metrics, because of disruptions due to COVID-19, therefore the results have not been possible to report."}], 'secondaryOutcomes': [{'measure': 'Secondary Outcome 1: Detect Longitudinal Changes in Tumour Load With Therapy [MY-RADS RAC (Myeloma Response Assessment and Diagnosis System Response Assessment Classification) vs IMWG (International Myeloma Working Group) Response Group Classification]', 'timeFrame': 'Comparison between baseline and follow-up at 6 months.', 'description': 'Secondary Objective 1: To assess whether the novel Magnetic Resonance (MR) protocol can improve detection of longitudinal changes in tumour burden in patients with new or relapsed myeloma during therapy, compared to the International Myeloma Working Group (IMWG) Response Group classification alone.\n\nThis section compared two indicators of therapy response:\n\n1. IMWG Response Group classification \\[1\\], based on % change in serum paraprotein\n2. MY-RADS RAC (Myeloma Response Assessment and Diagnosis System Response Assessment Classification) based on expert radiologist interpretation of paired novel MR imaging, guided by Messiou et. al. criteria \\[2\\].\n\nRef:\n\n1. https://www.myeloma.org/resource-library/international-myeloma-working-group-imwg-uniform-response-criteria-multiple\n2. Messiou, Christina, et al. "Guidelines for acquisition, interpretation, and reporting of whole-body MRI in myeloma: myeloma response assessment and diagnosis system (MY-RADS)." Radiology 291.1 (2019): 5-13.'}, {'measure': 'Secondary Outcome 1: Detect Longitudinal Changes in Tumour Load With Therapy [MY-RADS RAC (Myeloma Response Assessment and Diagnosis System Response Assessment Classification) vs % Change in ADC (Apparent Diffusion Coefficient)]', 'timeFrame': 'Comparison between baseline and follow-up at 6 month', 'description': 'Secondary Objective 1: To assess whether the novel Magnetic Resonance (MR) protocol can improve detection of longitudinal changes in tumour burden in patients with new or relapsed myeloma during therapy, compared to the International Myeloma Working Group (IMWG) Response Group classification alone.\n\nThis section compared two indicators of therapy response:\n\n1. % change in Apparent Diffusion Coefficient (ADC) measurements in participants where there was a lytic bone lesion identified on both baseline and follow-up novel MR scan amenable to ADC measurement \\[1\\].\n2. MY-RADS RAC (Myeloma Response Assessment and Diagnosis System Response Assessment Classification) based on expert radiologist interpretation of paired novel MR imaging, guided by Messiou et. al. criteria \\[1\\].\n\nRef:\n\n\\[1\\] Messiou, Christina, et al. "Guidelines for acquisition, interpretation, and reporting of whole-body MRI in myeloma: myeloma response assessment and diagnosis system (MY-RADS)." Radiology 291.1 (2019): 5-13'}, {'measure': 'Secondary Outcome 1: Detect Longitudinal Changes in Tumour Load With Therapy [% Change in ADC (Apparent Diffusion Coefficient) vs IMWG (International Myeloma Working Group) Response Group Classification]', 'timeFrame': 'Comparison between baseline and follow-up at 6month', 'description': 'Secondary Objective 1: To assess whether the novel Magnetic Resonance (MR) protocol can improve detection of longitudinal changes in tumour burden in patients with new or relapsed myeloma during therapy, compared to the International Myeloma Working Group (IMWG) Response Group classification alone.\n\nThis section compared two indicators of therapy response:\n\n1. IMWG Response Group classification \\[1\\], based on % change in serum paraprotein\n2. % change in Apparent Diffusion Coefficient (ADC) measurements in participants where there was a lytic bone lesion identified on both baseline and follow-up novel MR scan amenable to ADC measurement \\[2\\].\n\nRef:\n\n1. https://www.myeloma.org/resource-library/international-myeloma-working-group-imwg-uniform-response-criteria-multiple\n2. Messiou, Christina, et al. "Guidelines for acquisition, interpretation, and reporting of whole-body MRI in myeloma: myeloma response assessment and diagnosis system (MY-RADS)." Radiology 291.1 (2019): 5-13'}, {'measure': 'Secondary Outcome 2: Detect Longitudinal Changes in Bone Microarchitecture With Therapy (% Change in Bone Turnover Markers)', 'timeFrame': 'Comparison between baseline and follow-up at 6month', 'description': 'Secondary Objective 2: To assess whether the novel Magnetic Resonance (MR) protocol and exploratory bone biomarkers can improve detection of longitudinal changes in bone loss in patients with myeloma (new, relapsed, smouldering) and Monoclonal Gammopathy of Undetermined Significance (MGUS) during therapy, compared to Dual-energy X-ray Absorptiometry (DXA) and established bone biomarkers alone.\n\nThis section examined whether longitudinal change in bone turnover markers differed by chemotherapy responders vs non-responders.\n\n* The % change in bone biomarker measurements was expressed as a ratio of follow-up / baseline of paired measurements\n* Participants were classified by International Myeloma Working Group (IMWG) Response Group classification, as responder (partial response, very good partial response or complete response) or non-responder (stable, progressive or relapse).'}, {'measure': 'Secondary Outcome 2: Detect Longitudinal Changes in Bone Microarchitecture With Therapy (Correlations Between % Change in Bone Turnover Markers)', 'timeFrame': 'Comparison between baseline and follow-up at 6month', 'description': "Secondary Objective 2: To assess whether the novel Magnetic Resonance (MR) protocol and exploratory bone biomarkers can improve detection of longitudinal changes in bone loss in patients with myeloma (new, relapsed, smouldering) and Monoclonal Gammopathy of Undetermined Significance (MGUS) during therapy, compared to Dual-energy X-ray Absorptiometry (DXA) and established bone biomarkers alone.\n\nThis particular section examined the correlation between longitudinal changes in bone turnover markers between one another (calculated as a ratio of follow-up measurement divided by baseline measurement). Spearman's rank correlation was performed for the longitudinal % change between different biomarkers, to assess the relationship between longitudinal changes in these measures."}, {'measure': 'Secondary Outcome 2: Detect Longitudinal Changes in Bone Microarchitecture With Therapy [Correlations Between % Change in Bone Turnover Markers With % Change in Bone Mineral Density (BMD) or Apparent Diffusion Coefficient (ADC)]', 'timeFrame': 'Comparison between baseline and follow-up at 6month', 'description': "Secondary Objective 2: To assess whether the novel Magnetic Resonance (MR) protocol and exploratory bone biomarkers can improve detection of longitudinal changes in bone loss in patients with myeloma (new, relapsed, smouldering) and Monoclonal Gammopathy of Undetermined Significance (MGUS) during therapy, compared to Dual-energy X-ray Absorptiometry (DXA) and established bone biomarkers alone.\n\nThis section examined the correlation (using Spearman's Rank Correlation Coefficient) between longitudinal changes (expressed as a ratio of follow-up / baseline of paired measurements) in bone turnover markers and:\n\n1. Longitudinal changes in DXA Bone Mineral Density (BMD) at lumbar spine (L1-4) and femoral neck;\n2. Longitudinal changes in novel MR Apparent Diffusion Coefficient (ADC) measurements."}, {'measure': "Secondary Objective 3: Assess Participants' Quality of Life Throughout the Study", 'timeFrame': 'At baseline and six months', 'description': "Secondary Objective 3: To assess how quality of life compares between groups and longitudinally in patients with myeloma, Monoclonal Gammopathy of Undetermined Significance (MGUS), and healthy volunteers.\n\nThe EuroQol 5-Dimension (EQ-5D) assess the mobility, self-care, usual activities, pain/discomfort, anxiety and depression on a 5-point scale, in which a lower score represents better quality of life (1 = 'no problems', 5 = maximum problems, for each domain). The second part of the EQ-5D assess health on a scale where 100 is the best health and 0 is the worst health."}, {'measure': "Secondary Outcome 4: Assess Participants' Experience of Novel Magnetic Resonance (MR) and Dual-energy X-ray Absorptiometry (DXA) Scans", 'timeFrame': 'At baseline and six months', 'description': 'This questionnaire assesses the experience of the Novel Magnetic Resonance (MR) and Dual-energy X-ray Absorptiometry (DXA) scans. Answers were recorded on a 5 point Likert scale where the lower number represents a better outcome.\n\nScale descriptors:\n\nQ1 (Overall Experience): 1 (Very comfortable)/ 2 (Comfortable)/ 3 (Neither comfortable or uncomfortable)/ 4 (Uncomfortable)/ 5 (Very uncomfortable) Q2 (Adverse Effects): 1 (YES) / 0 (NO) Q3 (Length of Time): 0 (Too short) / 1 (Just right) / 2 (Too long) Q4 (Pain/Discomfort): 1 (No Increase)/ 2 (Mild Increase)/ 3 (Moderate Increase)/ 4 (High Increase)/ 5 (Severe Increase) Q5 (Likely to Reparticipate): 0 (Extremely Unlikely) / 1 (Unlikely) / 2 (Neither Likely or Unlikely) / 3 (Likely) / 4 (Extremely Likely) Q6 (How similar to expectations): 1 (YES) / 0 (NO) Q7 (Comfort with Staff): 1 (YES) / 0 (NO)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myeloma', 'Monoclonal Gammopathy of Undetermined Significance (MGUS)', 'Smouldering Myeloma']}, 'descriptionModule': {'briefSummary': 'In the proposed study, the investigators will aim to develop and pilot a Magnetic Resonance (MR) imaging protocol and assess its ability to achieve the following: quantification of tumour burden and bone loss, detecting longitudinal changes in tumour load with therapy and detecting longitudinal changes in microarchitecture with therapy. The investigators also aim to investigate whether bone loss is better, worse or the same with different imaging techniques. This will be investigated by correlating the DXA imaging data with Diffusion-Weighted Magnetic Resonance Imaging (DWMRI) to see if it is possible to achieve quantifiable data of bone density.', 'detailedDescription': 'In the proposed study, the investigators will aim to develop and pilot a Magnetic Resonance (MR) imaging protocol and assess its ability to achieve the following: quantification of tumour burden and bone loss, detecting longitudinal changes in tumour load with therapy and detecting longitudinal changes in microarchitecture with therapy. The investigators also aim to investigate whether bone loss is better, worse or the same with different imaging techniques. This will be investigated by correlating the DXA imaging data with Diffusion-Weighted Magnetic Resonance Imaging (DWMRI) to see if it is possible to achieve quantifiable data of bone density.\n\nUsing the expertise of the Oxford Centre For Clinical Magnetic Resonance Research (OCMR) for imaging protocol development, and the new Fine Structural Analysis (FSA, Osteotronix Ltd, formerly Acuitas Medical) bone density quantification MRI method (Rafferty et al 2016), the investigators will test a single protocol which combines three emerging experimental imaging sequences into a simple, non-invasive whole body imaging protocol to quantify disease burden and bone disease. This has never been done before; if shown to be feasible, such a method would have two important applications: to precisely guide commissioned therapies in the clinic, so improving patient management; and as an exciting, novel research tool for the longitudinal combined assessment of tumour burden and cancer-induced bone disease in response to therapy.\n\nThe investigators hypothesize that this imaging tool will be superior to the combined current standard-of-care investigations in the quantification of tumour burden and bone loss. There are currently no tools available for quantifying structural changes to bone and overall bone loss in myeloma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants in Groups 1 \\& 2 will be recruited via the Haematology Outpatients clinic in Churchill Hospital.\n\nGroup 3 participants will be recruited from the community', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria (All Groups):\n\n* Participant is able to and willing to give informed consent for participation in the study.\n* Male or Female, aged 18 years or above.\n\nInclusion Criteria (Groups 1 and 2):\n\n* Newly diagnosed myeloma or newly relapsed myeloma eligible for next therapy.\n* Smouldering myeloma or intermediate or high risk MGUS.\n* Patients attending Oxford NHS Haematology-Oncology centre.\n* Diagnoses of MGUS, Smouldering Myeloma and MM made in accordance with the clinical diagnostic criteria set forth by IMWG (International Myeloma Working Group).\n\nExclusion Criteria (All Groups):\n\n* Those who are unable or unwilling to give informed consent.\n* Women who may be pregnant, breast feeding or women of child-bearing potential who are unwilling or unable to take sufficient precautionary measures will be excluded due to DXA imaging.\n\nExclusion Criteria (Groups 1 and 2):\n\n* Signs of Spinal Cord Compression.\n* Patients with documented metastatic lesions from another type of malignancy.\n* Known contraindication for a MRI scan, including unacceptable pain on lying flat for 1 hour.'}, 'identificationModule': {'nctId': 'NCT03951220', 'acronym': 'LOOMIS', 'briefTitle': 'The Development and Pilot Testing of a New MR Imaging Protocol to Quantify Myeloma Disease Burden and Bone Loss', 'organization': {'class': 'OTHER', 'fullName': 'Oxford University Hospitals NHS Trust'}, 'officialTitle': 'The Development and Pilot Testing of a New Magnetic Resonance (MR) Imaging Protocol to Quantify Both Myeloma Disease Burden and Associated Bone Loss', 'orgStudyIdInfo': {'id': '12548'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1- Myeloma', 'description': 'Participants will be recruited at the point of either diagnosis or relapse. Any standard investigations that the clinician deems necessary will be carried out. Following recruitment, participants will undergo the first study appointment, the experimental combined MR imaging protocol, the DXA imaging scan and the bone biomarker blood and urine tests.\n\nThis will be repeated at 6 months.', 'interventionNames': ['Other: Diffusion Weighted Magnetic Resonance Imaging (DWMRI)', 'Other: DXA scan', 'Other: Bloods and urine']}, {'label': 'Group 2- MGUS', 'description': 'Participants will be recruited at the point of either diagnosis or relapse. Any standard investigations that the clinician deems necessary will be carried out. Following recruitment, participants will undergo the first study appointment, the experimental combined MR imaging protocol, the DXA imaging scan and the bone biomarker blood and urine tests.\n\nThis will be repeated at 6 months.', 'interventionNames': ['Other: Diffusion Weighted Magnetic Resonance Imaging (DWMRI)', 'Other: DXA scan', 'Other: Bloods and urine']}, {'label': 'Group 3- Healthy Volunteers', 'description': 'Participants will have the experimental combined MR imaging.', 'interventionNames': ['Other: Diffusion Weighted Magnetic Resonance Imaging (DWMRI)']}], 'interventions': [{'name': 'Diffusion Weighted Magnetic Resonance Imaging (DWMRI)', 'type': 'OTHER', 'description': 'Using the expertise of the Oxford Centre For Clinical Magnetic Resonance Research (OCMR) for imaging protocol development, and the new Fine Structural Analysis (FSA, Osteotronix Ltd, formerly Acuitas Medical) bone density quantification MRI method (Rafferty et al 2016), we will test a single protocol which combines three emerging experimental imaging sequences into a simple, non-invasive whole body imaging protocol to quantify disease burden and bone disease. To our knowledge, this has never been done before; if shown to be feasible, such a method would have two important applications: to precisely guide commissioned therapies in the clinic, so improving patient management; and as an exciting, novel research tool for the longitudinal combined assessment of tumour burden and cancer-induced bone disease in response to therapy.', 'armGroupLabels': ['Group 1- Myeloma', 'Group 2- MGUS', 'Group 3- Healthy Volunteers']}, {'name': 'DXA scan', 'type': 'OTHER', 'description': 'Used to assess bone density', 'armGroupLabels': ['Group 1- Myeloma', 'Group 2- MGUS']}, {'name': 'Bloods and urine', 'type': 'OTHER', 'description': 'Samples will be taken to assess bone biomarkers', 'armGroupLabels': ['Group 1- Myeloma', 'Group 2- MGUS']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'OX3 7LE', 'city': 'Oxford', 'state': 'Oxfordshire', 'country': 'United Kingdom', 'facility': 'Churchill Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Karthik Ramasamy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oxford Hospitals NHS Foundation Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oxford University Hospitals NHS Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'Amgen', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Primary Investigator', 'investigatorFullName': 'Karthik Ramasamy', 'investigatorAffiliation': 'Oxford University Hospitals NHS Trust'}}}}