Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2026-01-16 @ 1:33 AM
Study NCT ID:
NCT01889420
Status:
TERMINATED
Last Update Posted:
2015-07-31
First Post:
2013-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase I Trial of Everolimus, Pomalidomide and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'C467566', 'term': 'pomalidomide'}, {'id': 'D000068338', 'term': 'Everolimus'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D020123', 'term': 'Sirolimus'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dcandelaria@salud.unm.edu', 'phone': '505-272-4661', 'title': 'Dulcinea Quintana, MD', 'organization': 'University of New Mexico'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Low accrual led to early termination; only one subject was enrolled.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Combination Therapy', 'description': 'Pomalidomide: 1 tablet orally, daily for 21 days of a 28 day cycle (dose per cohort) Everolimus: 1 tablet orally for 21 days of a 28 day cycle (dose as per cohort) Dexamethasone 40 mg (20 mg \\>75yrs) orally, days 1, 8,15, 22 of a 28 day cycle\n\nCombination therapy: Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone.\n\nCycles will span 28 days. Dosage schedules will be:\n\n1. Everolimus daily for 28 days of a 28 day cycle;\n2. Pomalidomide daily for 21 days of a 28 day cycle\n3. Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle.', 'otherNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Alopecia (Hair loss)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Anemia (hemoglobin levels decreased)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 6, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypernatremia (high blood sodium)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypoalbuminemia (low blood albumin)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypokalemia (low blood potassium)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Infections and infestations - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Paresthesia (tingling, burning sensation)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Rash acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Tolerated Dosage (MTD)(Phase I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy', 'description': 'Pomalidomide: 1 tablet orally, daily for 21 days of a 28 day cycle (dose per cohort) Everolimus: 1 tablet orally for 21 days of a 28 day cycle (dose as per cohort) Dexamethasone 40 mg (20 mg \\>75yrs) orally, days 1, 8,15, 22 of a 28 day cycle\n\nCombination therapy: Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone.\n\nCycles will span 28 days. Dosage schedules will be:\n\n1. Everolimus daily for 28 days of a 28 day cycle;\n2. Pomalidomide daily for 21 days of a 28 day cycle\n3. Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle.'}], 'timeFrame': '2 years', 'description': 'The Maximum Tolerated Dose (MTD) will be determined by first identifying the dose level at which \\>= 30% of patients experience a Dose Limiting Toxicity (DLT) according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, over a 28 day cycle. DLT will be defined based on the rate of drug-related grade 3-5, non-hematological adverse events experienced within the first 4 weeks (1 cycle) for each combined dosage scheme. The MTD will be defined as one dosage level below which DLT was observed in \\>= 30% of patients.', 'reportingStatus': 'POSTED', 'populationDescription': 'There was only one patient enrolled. The MTD could not be calculated based on one patient.'}, {'type': 'SECONDARY', 'title': 'Toxicity Profile', 'timeFrame': '2 years', 'description': 'The toxicity profile will be described by specific adverse event rates among patients experiencing \\> grade 3 hematologic events (lasting \\>7 days) or grades 3-5 non-hematologic adverse events, according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, over a 28 day cycle. Specific events will be described as the numbers of patients experiencing them within each treatment cohort.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Anti-tumor Effect', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy', 'description': 'Pomalidomide: 1 tablet orally, daily for 21 days of a 28 day cycle (dose per cohort) Everolimus: 1 tablet orally for 21 days of a 28 day cycle (dose as per cohort) Dexamethasone 40 mg (20 mg \\>75yrs) orally, days 1, 8,15, 22 of a 28 day cycle\n\nCombination therapy: Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone.\n\nCycles will span 28 days. Dosage schedules will be:\n\n1. Everolimus daily for 28 days of a 28 day cycle;\n2. Pomalidomide daily for 21 days of a 28 day cycle\n3. Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle.'}], 'timeFrame': '3.5 years', 'description': 'Anti-tumor effect will be assessed based on serum protein electrophoresis (SPEP) of the monoclonal protein (M-protein) and plasma concentrations of K/L free light chains (FLC) after each 28-day cycle. Descriptive statistics will be used for this measurement.\n\nComplete response (CR): disappearance of any M-protein and FLC as measured by SPEP and/or FLC. Pre-existing plasmacytomas must have completely resolved.\n\nPartial response (PR): \\>50% reduction in M-protein and \\>50% reduction in the difference between involved and uninvolved FLC. Any plasmacytoma must have decreased in size by \\>50%.\n\nStable disease: not meeting criteria for CR, PR, or progressive disease (PD). PD: \\>25% increase from baseline in serum or urine M-protein (serum M-protein must increase by \\> 0.5 gm/dl; urine M-protein must increase by \\>200 mg /24 hr); or development of new plasmacytomas or new lytic bone lesions; or a measurable increase in the size of these lesions; or hypercalcemia (\\>11.5 mg/dl) attributed to MM.', 'reportingStatus': 'POSTED', 'populationDescription': 'There was only one patient enrolled. Anti-tumor effect cannot be reported accurately based on results from one patient.'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (RR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy', 'description': 'Pomalidomide: 1 tablet orally, daily for 21 days of a 28 day cycle (dose per cohort) Everolimus: 1 tablet orally for 21 days of a 28 day cycle (dose as per cohort) Dexamethasone 40 mg (20 mg \\>75yrs) orally, days 1, 8,15, 22 of a 28 day cycle\n\nCombination therapy: Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone.\n\nCycles will span 28 days. Dosage schedules will be:\n\n1. Everolimus daily for 28 days of a 28 day cycle;\n2. Pomalidomide daily for 21 days of a 28 day cycle\n3. Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle.'}], 'timeFrame': '3 years', 'description': 'ORR is the percentage of patients with a \\> Partial Response (PR). Response is assessed based on serum protein electrophoresis (SPEP) of the monoclonal protein (M-protein) and plasma concentrations of K/L free light chains (FLC) after each 28-day cycle.\n\nComplete response (CR): disappearance of any M-protein and FLC as measured by SPEP and/or FLC. Pre-existing plasmacytomas must have completely resolved.\n\nPR: \\>50% reduction in M-protein and \\>50% reduction in the difference between involved and uninvolved FLC. Any plasmacytoma must have decreased in size by \\>50%.\n\nStable disease: not meeting criteria for CR, PR, or progressive disease (PD). PD: \\>25% increase from baseline in serum or urine M-protein (serum M-protein must increase by \\> 0.5 gm/dl; urine M-protein must increase by \\>200 mg /24 hr); or development of new plasmacytomas or new lytic bone lesions; or a measurable increase in the size of these lesions; or hypercalcemia (\\>11.5 mg/dl) attributed to MM.', 'reportingStatus': 'POSTED', 'populationDescription': 'There was only one patient enrolled. Response rates cannot be accurately reported based on one patient.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Combination Therapy', 'description': 'Pomalidomide: 1 tablet orally, daily for 21 days of a 28 day cycle (dose per cohort) Everolimus: 1 tablet orally for 21 days of a 28 day cycle (dose as per cohort) Dexamethasone 40 mg (20 mg \\>75yrs) orally, days 1, 8,15, 22 of a 28 day cycle\n\nCombination therapy: Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone.\n\nCycles will span 28 days. Dosage schedules will be:\n\n1. Everolimus daily for 28 days of a 28 day cycle;\n2. Pomalidomide daily for 21 days of a 28 day cycle\n3. Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Combination Therapy', 'description': 'Pomalidomide: 1 tablet orally, daily for 21 days of a 28 day cycle (dose per cohort) Everolimus: 1 tablet orally for 21 days of a 28 day cycle (dose as per cohort) Dexamethasone 40 mg (20 mg \\>75yrs) orally, days 1, 8,15, 22 of a 28 day cycle\n\nCombination therapy: Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone.\n\nCycles will span 28 days. Dosage schedules will be:\n\n1. Everolimus daily for 28 days of a 28 day cycle;\n2. Pomalidomide daily for 21 days of a 28 day cycle\n3. Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Low accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-03', 'studyFirstSubmitDate': '2013-06-26', 'resultsFirstSubmitDate': '2015-07-03', 'studyFirstSubmitQcDate': '2013-06-27', 'lastUpdatePostDateStruct': {'date': '2015-07-31', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-07-03', 'studyFirstPostDateStruct': {'date': '2013-06-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Tolerated Dosage (MTD)(Phase I)', 'timeFrame': '2 years', 'description': 'The Maximum Tolerated Dose (MTD) will be determined by first identifying the dose level at which \\>= 30% of patients experience a Dose Limiting Toxicity (DLT) according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, over a 28 day cycle. DLT will be defined based on the rate of drug-related grade 3-5, non-hematological adverse events experienced within the first 4 weeks (1 cycle) for each combined dosage scheme. The MTD will be defined as one dosage level below which DLT was observed in \\>= 30% of patients.'}], 'secondaryOutcomes': [{'measure': 'Toxicity Profile', 'timeFrame': '2 years', 'description': 'The toxicity profile will be described by specific adverse event rates among patients experiencing \\> grade 3 hematologic events (lasting \\>7 days) or grades 3-5 non-hematologic adverse events, according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, over a 28 day cycle. Specific events will be described as the numbers of patients experiencing them within each treatment cohort.'}, {'measure': 'Anti-tumor Effect', 'timeFrame': '3.5 years', 'description': 'Anti-tumor effect will be assessed based on serum protein electrophoresis (SPEP) of the monoclonal protein (M-protein) and plasma concentrations of K/L free light chains (FLC) after each 28-day cycle. Descriptive statistics will be used for this measurement.\n\nComplete response (CR): disappearance of any M-protein and FLC as measured by SPEP and/or FLC. Pre-existing plasmacytomas must have completely resolved.\n\nPartial response (PR): \\>50% reduction in M-protein and \\>50% reduction in the difference between involved and uninvolved FLC. Any plasmacytoma must have decreased in size by \\>50%.\n\nStable disease: not meeting criteria for CR, PR, or progressive disease (PD). PD: \\>25% increase from baseline in serum or urine M-protein (serum M-protein must increase by \\> 0.5 gm/dl; urine M-protein must increase by \\>200 mg /24 hr); or development of new plasmacytomas or new lytic bone lesions; or a measurable increase in the size of these lesions; or hypercalcemia (\\>11.5 mg/dl) attributed to MM.'}, {'measure': 'Overall Response Rate (RR)', 'timeFrame': '3 years', 'description': 'ORR is the percentage of patients with a \\> Partial Response (PR). Response is assessed based on serum protein electrophoresis (SPEP) of the monoclonal protein (M-protein) and plasma concentrations of K/L free light chains (FLC) after each 28-day cycle.\n\nComplete response (CR): disappearance of any M-protein and FLC as measured by SPEP and/or FLC. Pre-existing plasmacytomas must have completely resolved.\n\nPR: \\>50% reduction in M-protein and \\>50% reduction in the difference between involved and uninvolved FLC. Any plasmacytoma must have decreased in size by \\>50%.\n\nStable disease: not meeting criteria for CR, PR, or progressive disease (PD). PD: \\>25% increase from baseline in serum or urine M-protein (serum M-protein must increase by \\> 0.5 gm/dl; urine M-protein must increase by \\>200 mg /24 hr); or development of new plasmacytomas or new lytic bone lesions; or a measurable increase in the size of these lesions; or hypercalcemia (\\>11.5 mg/dl) attributed to MM.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['myeloma', 'relapse', 'refractory', 'relapsed', 'pomalidomide', 'pomalyst', 'everolimus', 'afinitor', 'dexamethasone'], 'conditions': ['Multiple Myeloma in Relapse']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://cancer.unm.edu', 'label': 'UNM Cancer Center'}, {'url': 'http://www.nmcca.org', 'label': 'New Mexico Cancer Care Alliance'}]}, 'descriptionModule': {'briefSummary': 'This study is being conducted to test the possibility that a combination of three drugs, pomalidomide and everolimus with dexamethasone, may improve patient responses when compared with use of either drug alone, with dexamethasone in refractory/relapsed multiple myeloma.', 'detailedDescription': 'Given that pomalidomide is an FDA approved drug for patients with relapsed or progressive myeloma, and everolimus has been shown to have single agent activity in relapsed myeloma, it seems reasonable to combine these two active drugs in patients with relapsed/refractory disease. Given that low dose dexamethasone dramatically improved the response rate of pomalidomide, this drug will be added to the combination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge \\> 18 years\n\nRelapsed or progressive multiple myeloma (MM) (Progressive Disease), defined as a 25% increase from the lowest response value in ANY of the following:\n\nSerum M-protein (absolute increase ≥0.5 g/dL)\n\nUrine M-protein (absolute increase of ≥200 mg/24 hours)\n\nBone marrow plasma cell percentage (≥ 10% absolute increase) in absence of measurable M-protein\n\nDifference in kappa \\& lambda free light chain levels (ratio must be abnormal; absolute change must be \\>10 mg/dL)\n\nPatients are also considered to have progressive disease when:\n\nNew bone or soft tissue lesions (e.g. plasmacytomas) are identified; or\n\nThere is an unequivocal increase in the size of previously existing lesions; or\n\nThe development of an otherwise unexplained serum calcium \\>11.5 mg/dL\n\nHave received 1, but no more than 4 prior treatment regimens or lines of therapy for MM (Induction therapy followed by stem cell transplant \\& consolidation/maintenance therapy will be considered as one line of therapy)\n\nECOG Performance status 0 - 2\n\nLife expectancy of at least 12 weeks\n\nEvaluable MM with, at least one of the following, assessed within 21 days prior to randomization:\n\nSerum M-protein ≥ 0.5 g/dL, or Urine M-protein ≥ 200 mg/24 hour, or\n\nIn absence of detectable serum or urine M-protein, serum FLC (SFLC) \\> 100 mg/L (involved light chain) and/or an abnormal kappa/lamda ratio (\\>4:1 or \\<2:1), or\n\nMonoclonal plasma cells in a bone marrow biopsy/aspirate of \\>5%\n\nAdequate organ and marrow function as defined below:\n\n* Leukocytes ≥ 2,500/mcL\n* Absolute neutrophil count ≥ 1,500/mcL\n* Platelets ≥ 100,000/mcL\n* Total bilirubin \\< 2 X ULN\n* AST(SGOT)/ALT(SPGT) ≤ 2.5 X ULN\n* Creatinine \\< 1.5 X ULN\n\nContraception Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for duration of study, and for 90 days after completion of therapy.\n\nA female of child-bearing potential is considered to be any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n\n* No hysterectomy or bilateral oophorectomy; or\n* Not naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).\n\nMale patients must use an effective barrier method of contraception during study and for 3 months following the last dose if sexually active with a female of child-bearing potential.\n\nNo prior therapy with pomalidomide or everolimus.\n\nAbility to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\nHave had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.\n\nReceiving any other investigational agents. Minimum 4 week "washout" period is required.\n\nHistory of allergic reactions attributed to compounds of similar chemical or biologic composition to pomalidomide, everolimus, or other agents used in the study.\n\nUncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n\nPregnant or nursing (due to the rick for congenital abnormalities and the potential of this regimen to harm nursing infants).\n\nGlucocorticoid therapy (prednisone \\> 30 mg/day or equivalent) within 14 days prior to randomization.\n\nPOEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).\n\nPlasma cell leukemia or circulating plasma cells ≥ 2 × 10\\^9/L.\n\nWaldenstrom\'s Macroglobulinemia.\n\nPatients with known amyloidosis.\n\nFocal radiation therapy within 7 days prior to randomization. Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to randomization (i.e., prior radiation must have been to less than 30% of the bone marrow).\n\nImmunotherapy within 21 days prior to randomization.\n\nMyelodysplastic syndrome\n\nMajor surgery (excluding kyphoplasty) within 28 days\n\nKnown cirrhosis.\n\nSignificant neuropathy (Grades 3 to 4, or Grade 2 with pain) within 14 days\n\nOngoing graft-vs-host disease.\n\nUsing CYP3A4 inhibitors such as Ketoconazole, Ritonavir, Itraconazole, Erythromycin, Clarithromycin, Nelfinavir, Fluconazole, Amiodarone, Cyclosporine, Diltiazem, nefazadone,fluvoxamine, verapamil, chloramphenicol, Indinavir or saquinavir within 7 days of treatment.'}, 'identificationModule': {'nctId': 'NCT01889420', 'briefTitle': 'Phase I Trial of Everolimus, Pomalidomide and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma', 'organization': {'class': 'OTHER', 'fullName': 'New Mexico Cancer Research Alliance'}, 'officialTitle': 'Phase I Trial of Everolimus, Pomalidomide and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma', 'orgStudyIdInfo': {'id': 'INST 1304'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Combination therapy', 'description': 'Pomalidomide: 1 tablet orally, daily for 21 days of a 28 day cycle (dose per cohort) Everolimus: 1 tablet orally for 21 days of a 28 day cycle (dose as per cohort) Dexamethasone 40 mg (20 mg \\>75yrs) orally, days 1, 8,15, 22 of a 28 day cycle', 'interventionNames': ['Drug: Combination therapy']}], 'interventions': [{'name': 'Combination therapy', 'type': 'DRUG', 'otherNames': ['Pomalyst', 'Afinitor'], 'description': 'Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone.\n\nCycles will span 28 days. Dosage schedules will be:\n\n1. Everolimus daily for 28 days of a 28 day cycle;\n2. Pomalidomide daily for 21 days of a 28 day cycle\n3. Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle.', 'armGroupLabels': ['Combination therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'UNM Cancer Research and Treatment Center', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}], 'overallOfficials': [{'name': 'Ian Rabinowitz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of New Mexico Cancer Center'}, {'name': 'Ducinea D Quintana, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of New Mexico Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New Mexico Cancer Research Alliance', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novartis', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}