Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT01208818
Status:
COMPLETED
Last Update Posted:
2017-12-08
First Post:
2010-09-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Studies in Patients With Multiple Myeloma and Renal Failure Due to Myeloma Cast Nephropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D000069286', 'term': 'Bortezomib'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D001897', 'term': 'Boronic Acids'}, {'id': 'D000148', 'term': 'Acids, Noncarboxylic'}, {'id': 'D000143', 'term': 'Acids'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D001896', 'term': 'Boron Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 284}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-07', 'studyFirstSubmitDate': '2010-09-23', 'studyFirstSubmitQcDate': '2010-09-23', 'lastUpdatePostDateStruct': {'date': '2017-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of renal response (if dialysis not mandatory at baseline: strata 1); Prevalence of patients free of dialysis (if dialysis required at baseline; strata 2)', 'timeFrame': '3 months after randomization', 'description': '* renal response is defined by creatinine≤ 170 µmol/l and/or DFG (modified MDRD) ≥ 40 ml/min/1.73m2\n* the absence of any dialysis requirement will be defined by an eDFG \\> 15 ml/min/1.73 m2, 15 days after the last hemodialysis session'}], 'secondaryOutcomes': [{'measure': 'Improvement in renal function', 'timeFrame': 'after 1 cycle of chemotherapy, at the end of chemotherapy, at 6 months and 1 year', 'description': '* DFG (modified MDRD)\n* hemodialysis requirement'}, {'measure': 'Hematological response', 'timeFrame': 'after 1 and 3 courses, at the end of chemotherapy and at 1 year', 'description': 'Partial Response (PR) Very Good Partial Response (VGPR) Complete Response (CR)'}, {'measure': 'Progression free survival (PFS)', 'timeFrame': '4 years', 'description': 'Time to progression, relapse or death from randomization'}, {'measure': 'Time to treatment Failure (TTF)', 'timeFrame': '4 years', 'description': 'Time from randomization to progression, relapse, non scheduled hematological treatment or death'}, {'measure': 'Overall survival (OS)', 'timeFrame': '4 years', 'description': 'Time to death from randomization'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Renal Failure With Uremic Nephropathy']}, 'referencesModule': {'references': [{'pmid': '29209721', 'type': 'DERIVED', 'citation': 'Bridoux F, Carron PL, Pegourie B, Alamartine E, Augeul-Meunier K, Karras A, Joly B, Peraldi MN, Arnulf B, Vigneau C, Lamy T, Wynckel A, Kolb B, Royer B, Rabot N, Benboubker L, Combe C, Jaccard A, Moulin B, Knebelmann B, Chevret S, Fermand JP; MYRE Study Group. Effect of High-Cutoff Hemodialysis vs Conventional Hemodialysis on Hemodialysis Independence Among Patients With Myeloma Cast Nephropathy: A Randomized Clinical Trial. JAMA. 2017 Dec 5;318(21):2099-2110. doi: 10.1001/jama.2017.17924.'}]}, 'descriptionModule': {'briefSummary': 'MYRE is a phase III multicentric controlled national clinical trial conducted in patients with multiple myeloma and renal failure related to myeloma cast nephropathy (MCN). Its aims are to assess (1) the efficacy of bortezomib plus dexamethasone (BD), compared with cyclophosphamide, plus bortezomib and dexamethasone (C-BD) in patients with inaugural MCN not requiring hemodialysis; and (2) in patients with inaugural severe renal failure secondary to biopsy-proven MCN and requiring hemodialysis that of an intensive hemodialysis regimen using either a dialyser with very high permeability to proteins (TheraliteTM) or a conventional high-flux dialyser, while receiving chemotherapy with BD.', 'detailedDescription': 'MYRE is a phase III multicentric controlled national clinical trial conducted in patients with multiple myeloma and renal failure related to myeloma cast nephropathy (MCN). Its aims are to assess (1) the efficacy of bortezomib plus dexamethasone (BD), compared with cyclophosphamide, plus bortezomib and dexamethasone (C-BD) in patients with inaugural MCN not requiring hemodialysis; and (2) in patients with inaugural severe renal failure secondary to biopsy-proven MCN and requiring hemodialysis that of an intensive hemodialysis regimen using either a dialyser with very high permeability to proteins (TheraliteTM) or a conventional high-flux dialyser, while receiving chemotherapy with BD.\n\nStudy hypotheses are: (1) in patients not requiring dialysis, based on renal response after 3 cycles as the main endpoint, to show a benefit of 30% in absolute rate from an expected 30% response rate in the control arm; and (2) in patients requiring hemodialysis, using the prevalence of patients free of dialysis after 3 cycles as the main endpoint, to show a benefit of at least 20% from an assumed rate of 50% in the control arm. A total sample size of 284 patients was computed to be enrolled (type I and II error rates at 5 and 20%, respectively).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>=18 years old\n* Serum creatinine \\> 170µmol/l and/or DFG \\< 40 ml/min/1.73 m2\n* Myeloma cast nephropathy (MCN)\n* Multiple myeloma\n* Informed consent\n* neutrophils \\>= 1 Giga/L and platelets \\>= 70 Giga/L\n\nExclusion Criteria:\n\n* Amylosis\n* Chronic renal Failure with eDFG \\< 30 ml/min/1.73 m2, unrelated to myeloma\n* Peripheral neuropathy\n* Contraindications to either corticosteroids or Bortezomib\n* Patient refusal\n* Known HIV infection\n* Concomitant severe disease including neoplasias (except basocellular carcinoma)\n* Liver failure, cytolysis, and/or cholestasis\n* Fertile women who refuse or cannot use effective contraception; Women pregnant or nursing; Women with positive test pregnancy (test before treatment initiation)'}, 'identificationModule': {'nctId': 'NCT01208818', 'acronym': 'MYRE', 'briefTitle': 'Studies in Patients With Multiple Myeloma and Renal Failure Due to Myeloma Cast Nephropathy', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Treatment of Renal Failure Due to Myeloma Cast Nephropathy: Comparison of Two Different Chemotherapy Regimens and Evaluation of Optimized Removal of Monoclonal Immunoglobulin Light Chains Using a High Permeability Hemodialysis Membrane.', 'orgStudyIdInfo': {'id': 'P081226'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'BD', 'interventionNames': ['Drug: Bortezomib +Dexamethasone regimen']}, {'type': 'EXPERIMENTAL', 'label': 'C-BD', 'interventionNames': ['Drug: Cyclophosphamide + Bortezomib + Dexamethasone regimen']}, {'type': 'EXPERIMENTAL', 'label': 'HCO', 'interventionNames': ['Drug: Bortezomib +Dexamethasone regimen', 'Device: HCO group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control HD', 'interventionNames': ['Drug: Bortezomib +Dexamethasone regimen', 'Device: conventional high-flux dialyzer']}], 'interventions': [{'name': 'Cyclophosphamide + Bortezomib + Dexamethasone regimen', 'type': 'DRUG', 'description': 'Dosing regimen (21 day-cycle):\n\n* Bortezomib 1.3 mg/m2 I.V. on days 1, 4, 8, and 11. An interval of at least 72 hours between each administration of bortezomib is required.\n* Dexamethasone 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12.\n* Cyclophosphamide 900 mg/m2 on day 1, through a short I.V. infusion The regimen is given for 3 cycles in the absence of serious side-effect.', 'armGroupLabels': ['C-BD']}, {'name': 'Bortezomib +Dexamethasone regimen', 'type': 'DRUG', 'description': 'Dosing regimen (21 day-cycle):\n\n* Bortezomib 1.3 mg/m2 I.V. on days 1, 4, 8, and 11. An interval of at least 72 hours between each administration of bortezomib is required.\n* Dexamethasone 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12. The regimen is given for 3 cycles in the absence of serious side-effect.', 'armGroupLabels': ['BD', 'Control HD', 'HCO']}, {'name': 'HCO group', 'type': 'DEVICE', 'description': 'TheraliteTM dialyzer of 2.1 m2 in surface', 'armGroupLabels': ['HCO']}, {'name': 'conventional high-flux dialyzer', 'type': 'DEVICE', 'description': 'conventional high-flux dialyzer; polyacrylonitrile, polysulfone, or PMMA dialysers, with an ultrafiltration coefficient \\> 14 ml/min and ≥ 1.8 m2 in surface, are recommended.', 'armGroupLabels': ['Control HD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Saint Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Jean-Paul Fermand, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital saint Louis, Paris, France'}, {'name': 'Franck Bridoux, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CHU Poitiers'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}