Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT05623020
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2022-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135), Daratumumab, Lenalidomide or Elranatamab and Lenalidomide Compared With Daratumumab, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C556306', 'term': 'daratumumab'}, {'id': 'D000077269', 'term': 'Lenalidomide'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 966}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2031-11-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2022-10-26', 'studyFirstSubmitQcDate': '2022-11-11', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1 Dose Limiting Toxicity', 'timeFrame': 'From the first dose of elranatamab/first full dose in combination with EDR until 28 days (+/- visit window) from the first administration of elranatamab with daratumumab and lenalidomide'}, {'measure': 'Part 2: Progression free survival by blinded independent central review', 'timeFrame': 'From randomization up to 79 months.'}, {'measure': 'Part 2: Minimal Residual Disease negativity rate', 'timeFrame': 'At 12 months after randomization'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'From date of randomization up to 79 months'}, {'measure': 'Overall minimal residual disease negativity rate', 'timeFrame': 'From date of randomization up to 79 months'}, {'measure': 'Sustained MRD negativity rate (Part 2)', 'timeFrame': 'From date of randomization up to 79 months'}, {'measure': 'Duration of minimal residual disease negativity (Part 2)', 'timeFrame': 'From date of minimal residual disease negative status up to 79 months'}, {'measure': 'PFS by investigator', 'timeFrame': 'From date of randomization up to 79 months'}, {'measure': 'PFS2 by investigator (Part 2)', 'timeFrame': 'From the date of randomization up to 79 months'}, {'measure': 'Objective Response Rate', 'timeFrame': 'From the date of randomization up to 79 months'}, {'measure': 'Complete Response Rate', 'timeFrame': 'From the date of randomization up to 79 months'}, {'measure': 'Time to Response', 'timeFrame': 'From the date of randomization to date of confirmed objective response up to 79 months'}, {'measure': 'Duration of Response', 'timeFrame': 'From the date of confirmed objective response up to 79 months'}, {'measure': 'Duration of Complete Response', 'timeFrame': 'From the date of confirmed complete response up to 79 months'}, {'measure': 'Frequency of treatment-emergent adverse events', 'timeFrame': 'From the date of first dose of study intervention up to 79 months'}, {'measure': 'Frequency of abnormal laboratory results', 'timeFrame': 'From the date of first dose of study intervention up to 79 months'}, {'measure': 'Pharmacokinetics of elranatamab when used in the elranatamab + daratumumab + lenalidomide or elranatamab + lenalidomide combinations', 'timeFrame': 'From date of first dose of study intervention up to 79 months', 'description': 'Predose and post dose concentrations of elranatamab'}, {'measure': 'Incidence of Anti-Drug Antibody and Neutralizing Antibody against elranatamab', 'timeFrame': 'From date of first dose of study intervention up to 79 months', 'description': 'Immunogenicity of elranatamab'}, {'measure': 'Pharmacokinetics of daratumumab and lenalidomide when used in the elranatamab+daratumumab+lenalidomide or elranatamab+lenalidomide combinations (Part 1)', 'timeFrame': 'From date of first dose of study intervention up to 79 months', 'description': 'Predose concentrations of daratumumab and lenalidomide'}, {'measure': 'Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (Part 2)', 'timeFrame': 'From date the informed consent is signed up to 79 months', 'description': 'Higher scores on the functional scales represent higher levels of functioning. Higher scores on the global health status/quality of life scale represent higher health status/quality of life. Higher scores on the symptom scales/items represent a greater presence of symptoms.'}, {'measure': 'Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire -Myeloma 20 (Part 2)', 'timeFrame': 'From date the informed consent is signed up to 79 months', 'description': 'Higher scores on the functioning subscales (body image, future perspective) represent higher levels of functioning, whereas higher scores on the symptom subscales (disease symptoms, side effects) represent a greater presence of symptoms'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Elranatamab', 'PF-06863135', 'B-Cell Maturation Antigen', 'Daratumumab', 'Lenalidomide', 'Multiple myeloma', 'MagnetisMM-6'], 'conditions': ['Multiple Myeloma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C1071006', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Elranatamab is a bispecific antibody: binding of elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity. The main purpose of the study is to evaluate if the combination of Elranatamab, Daratumumab and Lenalidomide or Elranatamab and Lenalidomide offers superior clinical benefit compared with the combination of Daratumumab, Lenalidomide and Dexamethasone in people with multiple myeloma.\n\nThere are 2 parts to this study. Part 1 will characterize the safety and tolerability of elranatamab in combination with daratumumab and lenalidomide or in combination with lenalidomide and will identify the optimal dose(s) of the combination regimen. Part 2 of the study will evaluate the minimal residual disease (MRD) negativity rate and the progression free survival (PFS) of the combination of elranatamab, daratumumab, and lenalidomide or elranatamab and lenalidomide compared with the combination of daratumumab, lenalidomide, and dexamethasone in participants with newly diagnosed transplant-ineligible multiple myeloma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of multiple myeloma (MM) as defined by IMWG criteria (Rajkumar et al., 2014)\n* Measurable disease based on IMWG criteria as defined by at least 1 of the following:\n\n * Serum M-protein ≥0.5 g/dL;\n * Urinary M-protein excretion ≥200 mg/24 hours;\n * Involved FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\\<0.26 or \\>1.65).\n* Part 1: Participants with relapsed/refractory multiple myeloma (RRMM) who have received 1-2 prior lines of therapy including at least one immunomodulatory drug and one proteasome inhibitor: or participants with newly-diagnosed multiple myeloma (NDMM) that are transplant-ineligible as defined by age ≥65 years or transplant-ineligible as defined by age \\<65 years with comorbidities impacting the possibility of transplant.\n* Part 2: participants with newly-diagnosed multiple myeloma that are transplant-ineligible as defined by age ≥65 years or transplant-ineligible as defined by age \\<65 years with comorbidities impacting the possibility of transplant\n* ECOG performance status ≤2.\n* Not pregnant and willing to use contraception\n* For participants with RRMM: Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.\n\nExclusion Criteria:\n\n* Smoldering Multiple Myeloma.\n* Monoclonal gammopathy of undetermined significance.\n* Waldenströms Macroglobulinemia\n* Plasma cell leukemia.\n* Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) COVID-19/SARS-CoV-2, HBV, HCV, and known HIV or AIDS-related illness.\n* Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ, or Stage 0/1 with minimal risk of recurrence per investigator.\n* For participants with RRMM: Previous treatment with a BCMA-directed therapy or anti-CD38-directed therapy within 6 months preceding the first dose of study intervention in this study. Stem cell transplant ≤3 months prior to first dose of study intervention or active GVHD.\n* For participants with NDMM: Previous systemic treatment for MM except for a short course of corticosteroids (ie, up to 4 days of 40 mg dexamethasone or equivalent before the first dose of study intervention).\n* Live attenuated vaccine administered within 4 weeks of the first dose of study intervention.\n* Administration of investigational product (eg, drug or vaccine) concurrent with study intervention or within 30 days (or as determined by the local requirement) preceding the first dose of study intervention used in this study.'}, 'identificationModule': {'nctId': 'NCT05623020', 'acronym': 'MagnetisMM-6', 'briefTitle': 'A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135), Daratumumab, Lenalidomide or Elranatamab and Lenalidomide Compared With Daratumumab, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'MAGNETISMM-6: AN OPEN-LABEL, 2-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) + DARATUMUMAB + LENALIDOMIDE OR ELRANATAMAB + LENALIDOMIDE VERSUS DARATUMUMAB + LENALIDOMIDE + DEXAMETHASONE IN TRANSPLANT-INELIGIBLE PARTICIPANTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA', 'orgStudyIdInfo': {'id': 'C1071006'}, 'secondaryIdInfos': [{'id': '2021-000803-20', 'type': 'EUDRACT_NUMBER'}, {'id': '2024-514139-50-00', 'type': 'REGISTRY', 'domain': 'CTIS (EU)'}, {'id': 'MAGNETISMM-6', 'type': 'OTHER', 'domain': 'Alias study number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1, Dose Level 1: Elranatamab + Daratumumab + Lenalidomide', 'interventionNames': ['Drug: Elranatamab', 'Drug: Daratumumab', 'Drug: Lenalidomide']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1, Multiple Dose Levels, Elranatamab + Daratumumab + Lenalidomide', 'interventionNames': ['Drug: Elranatamab', 'Drug: Daratumumab', 'Drug: Lenalidomide']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 Randomized Arm A: Elranatamab + Daratumumab + Lenalidomide', 'interventionNames': ['Drug: Elranatamab', 'Drug: Daratumumab', 'Drug: Lenalidomide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part 2 Randomized Arm B: Daratumumab + Lenalidomide + Dexamethasone', 'interventionNames': ['Drug: Daratumumab', 'Drug: Lenalidomide', 'Drug: Dexamethasone']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Elranatamab + Lenalidomide', 'interventionNames': ['Drug: Elranatamab', 'Drug: Lenalidomide']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Randomized Arm A: Elranatamab + Lenalidomide', 'interventionNames': ['Drug: Elranatamab', 'Drug: Lenalidomide']}], 'interventions': [{'name': 'Elranatamab', 'type': 'DRUG', 'description': 'Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.', 'armGroupLabels': ['Part 1, Dose Level 1: Elranatamab + Daratumumab + Lenalidomide', 'Part 1, Multiple Dose Levels, Elranatamab + Daratumumab + Lenalidomide', 'Part 1: Elranatamab + Lenalidomide', 'Part 2 Randomized Arm A: Elranatamab + Daratumumab + Lenalidomide', 'Part 2: Randomized Arm A: Elranatamab + Lenalidomide']}, {'name': 'Daratumumab', 'type': 'DRUG', 'description': 'Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.', 'armGroupLabels': ['Part 1, Dose Level 1: Elranatamab + Daratumumab + Lenalidomide', 'Part 1, Multiple Dose Levels, Elranatamab + Daratumumab + Lenalidomide', 'Part 2 Randomized Arm A: Elranatamab + Daratumumab + Lenalidomide', 'Part 2 Randomized Arm B: Daratumumab + Lenalidomide + Dexamethasone']}, {'name': 'Lenalidomide', 'type': 'DRUG', 'description': 'Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.', 'armGroupLabels': ['Part 1, Dose Level 1: Elranatamab + Daratumumab + Lenalidomide', 'Part 1, Multiple Dose Levels, Elranatamab + Daratumumab + Lenalidomide', 'Part 1: Elranatamab + Lenalidomide', 'Part 2 Randomized Arm A: Elranatamab + Daratumumab + Lenalidomide', 'Part 2 Randomized Arm B: Daratumumab + Lenalidomide + Dexamethasone', 'Part 2: Randomized Arm A: Elranatamab + Lenalidomide']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Randomized', 'armGroupLabels': ['Part 2 Randomized Arm B: Daratumumab + Lenalidomide + Dexamethasone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4217', 'city': 'Benowa', 'state': 'Queensland', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Pindara Private Hospital', 'geoPoint': {'lat': -28.0077, 'lon': 153.38583}}, {'zip': '3065', 'city': 'Fitzroy', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'facility': "St Vincent's Hospital Melbourne", 'geoPoint': {'lat': -37.79839, 'lon': 144.97833}}, {'zip': '3002', 'city': 'Melbourne', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Epworth Freemasons', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'The Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': 'B3H 2Y9', 'city': 'Halifax', 'state': 'Nova Scotia', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'QEII Health Sciences Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'B3S 0H6', 'city': 'Halifax', 'state': 'Nova Scotia', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Nova Scotia Health Authority', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Princess Margaret Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '100091', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '350001', 'city': 'Fuzhou', 'state': 'Fujian', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Fujian Medical University Union Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Southern Medical University Nanfang Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510555', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '210008', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Nanjing Drum Tower Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '215006', 'city': 'Suzhou', 'state': 'Jiangsu', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'The First Affiliated Hospital of Soochow University', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'zip': '200434', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': "Tongji University - 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