Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2025-12-28 @ 2:24 AM
Study NCT ID:
NCT05090566
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-19
First Post:
2021-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MagnetisMM-4: Umbrella Study of Elranatamab (PF-06863135) in Combination With Anti-Cancer Treatments in Multiple Myeloma
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': 'C550722', 'term': 'nirogacestat'}, {'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-02-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2021-10-08', 'studyFirstSubmitQcDate': '2021-10-21', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sub-Study A Phase 1: Dose Limiting Toxicity', 'timeFrame': 'approximately 35 days', 'description': 'Number of participants with Dose Limiting Toxicity'}, {'measure': 'Sub-Study A Phase 2: Objective Response Rate', 'timeFrame': 'assessed every 4 weeks (for approximately 2 years)', 'description': 'Objective response rate (IMWG response criteria)'}, {'measure': 'Sub-Study B Phase 1 Escalation: Dose Limiting Toxicity', 'timeFrame': 'approximately 42 days', 'description': 'Number of participants with Dose Limiting Toxicity'}], 'secondaryOutcomes': [{'measure': 'Sub-Study A Phase 1: Objective Response Rate', 'timeFrame': 'assessed every 4 weeks (for approximately 2 years)', 'description': 'Objective response rate (IMWG response criteria)'}, {'measure': 'Sub-Study A Phase 1 and Phase 2: Complete Response Rate', 'timeFrame': 'assessed every 4 weeks (for approximately 2 years)', 'description': 'Complete response rate (IMWG response criteria)'}, {'measure': 'Sub-Study A Phase 1 and Phase 2: Time to Response', 'timeFrame': 'assessed every 4 weeks (for approximately 2 years)', 'description': 'Time to response (IMWG criteria)'}, {'measure': 'Sub-Study A Phase 1 and 2: Duration of Response', 'timeFrame': 'assessed every 4 weeks (for approximately 2 years)', 'description': 'Duration of response (IMWG response criteria)'}, {'measure': 'Sub-Study A Phase 1 and Phase 2: Duration of Complete Response', 'timeFrame': 'assessed every 4 weeks (for approximately 2 years)', 'description': 'Duration of complete response (IMWG response criteria)'}, {'measure': 'Sub-Study A Phase 1 and Phase 2: Progression Free Survival', 'timeFrame': 'assessed every 4 weeks (for approximately 2 years)', 'description': 'Progression free survival (IMWG response criteria)'}, {'measure': 'Sub-Study A Phase 1 and Phase 2: Overall Survival', 'timeFrame': 'assessed for approximately 2 years', 'description': 'Overall survival'}, {'measure': 'Sub-Study A Phase 1 and Phase 2: Minimal Residual Disease Negativity Rate', 'timeFrame': 'assessed approximately every 12 months (for approximately 2 years)', 'description': 'Minimal residual disease negativity rate (IMWG response criteria)'}, {'measure': 'Sub-Study A Phase 1 and Phase 2: Frequency of Treatment-Emergent Adverse Events', 'timeFrame': 'assessed for approximately 2 years', 'description': 'Type and severity per NCI CTCAE v5 (CRS and ICANS assessed per ASTCT criteria)'}, {'measure': 'Sub-Study A Phase 1 and Phase 2: Frequency of Laboratory Abnormalities', 'timeFrame': 'assessed every cycle (each cycle approximately 28 days)', 'description': 'Type and severity per NCI CTCAE v5'}, {'measure': 'Sub-Study A Phase 1 and Phase 2: Immunogenicity of elranatamab in combination with nirogacestat', 'timeFrame': 'assessed approximately every 1 to 3 cycles (each cycle approximately 28 days)', 'description': 'Anti-drug antibodies and neutralizing antibodies against elranatamab'}, {'measure': 'Sub-Study A Phase 1 and Phase 2: Concentrations of elranatamab and/or nirogacestat', 'timeFrame': 'assessed approximately every 1 to 3 cycles (each cycle approximately 28 days)', 'description': 'Pre-dose and post-dose concentrations of elranatamab; pre-dose concentrations of nirogacestat'}, {'measure': 'Sub-Study A Phase 1: Maximum Observed Concentration (Cmax) for elranatamab', 'timeFrame': 'assessed after first elranatamab dose (approximately 3-7 days)', 'description': 'Cmax for elranatamab administration'}, {'measure': 'Sub-Study A Phase 1: Time to Maximum Concentration (Tmax) for elranatamab', 'timeFrame': 'assessed after first elranatamab dose (approximately 3-7 days)', 'description': 'Tmax for elranatamab administration'}, {'measure': 'Sub-Study A Phase 1: Area Under the Concentration versus Time Curve from Time 0 to the Last Measurable Concentration (AUClast) for elranatamab', 'timeFrame': 'assessed after first elranatamab dose (approximately 3-7 days)', 'description': 'AUClast for elranatamab administration'}, {'measure': 'Sub-Study B Phase 1 Escalation: Frequency of Treatment-Emergent Adverse Events', 'timeFrame': 'assessed for approximately 2 years', 'description': 'Type and severity per NCI CTCAE v5 (CRS and ICANS assessed per ASTCT criteria)'}, {'measure': 'Sub-Study B Phase 1 Escalation: Frequency of Laboratory Abnormalities', 'timeFrame': 'assessed every cycle (each cycle approximately 28 days)', 'description': 'Type and severity per NCI CTCAE v5'}, {'measure': 'Sub-Study B Phase 1 Escalation: Objective Response Rate', 'timeFrame': 'assessed every 4 weeks (for approximately 2 years)', 'description': 'Objective response rate (IMWG response criteria)'}, {'measure': 'Sub-Study B Phase 1 Escalation: Complete Response Rate', 'timeFrame': 'assessed every 4 weeks (for approximately 2 years)', 'description': 'Complete response rate (IMWG response criteria)'}, {'measure': 'Sub-Study B Phase 1 Escalation: Time to Response', 'timeFrame': 'assessed every 4 weeks (for approximately 2 years)', 'description': 'Time to response (IMWG criteria)'}, {'measure': 'Sub-Study B Phase 1 Escalation: Duration of Response', 'timeFrame': 'assessed every 4 weeks (for approximately 2 years)', 'description': 'Duration of response (IMWG response criteria)'}, {'measure': 'Sub-Study B Phase 1 Escalation: Duration of Complete Response', 'timeFrame': 'assessed every 4 weeks (for approximately 2 years)', 'description': 'Duration of complete response (IMWG response criteria)'}, {'measure': 'Sub-Study B Phase 1 Escalation: Progression Free Survival', 'timeFrame': 'assessed every 4 weeks (for approximately 2 years)', 'description': 'Progression free survival (IMWG response criteria)'}, {'measure': 'Sub-Study B Phase 1 Escalation: Overall Survival', 'timeFrame': 'assessed for approximately 2 years', 'description': 'Overall survival'}, {'measure': 'Sub-Study B Phase 1 Escalation: Minimal Residual Disease Negativity Rate', 'timeFrame': 'assessed approximately every 12 months (for approximately 2 years)', 'description': 'Minimal residual disease negativity ratio (IMWG response criteria)'}, {'measure': 'Sub-Study B Phase 1 Escalation: Immunogenicity of elranatamab in combination with lenalidomide', 'timeFrame': 'assessed approximately every 1 to 3 cycles (each cycle approximately 28 days)', 'description': 'Anti-drug antibodies and neutralizing antibodies against elranatamab'}, {'measure': 'Sub-Study B Phase 1 Escalation: Concentrations of elranatamab and/or lenalidomide', 'timeFrame': 'assessed approximately every 1 to 3 cycles (each cycle approximately 28 days)', 'description': 'Pre-dose and post-dose concentrations of elranatamab, pre-dose concentrations of lenalidomide'}, {'measure': 'Sub-Study B Phase 1 Escalation: Maximum Observed Concentrations (Cmax) for elranatamab', 'timeFrame': 'assessed after first elranatamab dose (approximately 3-7 days)', 'description': 'Cmax for elranatamab administration'}, {'measure': 'Sub-Study B Phase 1 Escalation: Time to Maximum Concentration (Tmax) for elranatamab', 'timeFrame': 'assessed after first elranatamab dose (approximately 3-7 days)', 'description': 'Tmax for elranatamab administration'}, {'measure': 'Sub-Study B Phase 1 Escalation: Area Under the Concentration versus Time Curve from Time 0 to the Last Measurable Concentration (AUClast) for elranatamab', 'timeFrame': 'assessed after first elranatamab dose (approximately 3-7 days)', 'description': 'AUClast for elranatamab administration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PF-06863135, Multiple Myeloma, BCMA, elranatamab, bispecific antibody, MagnetisMM-4'], 'conditions': ['Multiple Myeloma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C1071004', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the Recommended Phase 2 Dose and clinical benefit of elranatamab in combination with other anti-cancer therapies in participants with multiple myeloma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Relapsed/refractory multiple myeloma with at least 3 prior lines of therapy\n* Refractory to at least one IMiD, one proteasome inhibitor, and one anti-CD38 antibody\n* Measurable disease defined by at least one of the following:\n\n 1. Serum M-protein \\>/= 0.5 g/dL by SPEP\n 2. Urinary M-protein excretion \\>/= 200 mg/24 hours by UPEP\n 3. Serum immunoglobulin FLC \\>/= 10 mg/dL (\\>/= 100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio\n* ECOG performance status 0 -1\n* Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade \\</= 1\n\nExclusion Criteria:\n\n* Active plasma cell leukemia\n* Amyloidosis\n* Stem cell transplant with 12 weeks prior to enrollment, or active GVHD\n* POEMS syndrome\n* Any active uncontrolled bacterial, fungal, or viral infection\n* Impaired cardiovascular function or clinically significant cardiovascular diseases within 6 months prior to enrollment\n* Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study treatment (whichever is longer)\n* Sub-Study A Only: Previous treatment with BCMA bispecific antibody\n* Sub-Study B Only: Previous treatment with BCMA directed therapy'}, 'identificationModule': {'nctId': 'NCT05090566', 'briefTitle': 'MagnetisMM-4: Umbrella Study of Elranatamab (PF-06863135) in Combination With Anti-Cancer Treatments in Multiple Myeloma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 1B/2, OPEN LABEL UMBRELLA STUDY OF ELRANATAMAB (PF-06863135), A B-CELL MATURATION ANTIGEN (BCMA) CD3 BISPECIFIC ANTIBODY, IN COMBINATION WITH OTHER ANTI-CANCER TREATMENTS IN PARTICIPANTS WITH MULTIPLE MYELOMA', 'orgStudyIdInfo': {'id': 'C1071004'}, 'secondaryIdInfos': [{'id': 'Umbrella Study', 'type': 'OTHER', 'domain': 'Alias Study Number'}, {'id': 'MAGNETISMM-4', 'type': 'OTHER', 'domain': 'Alias Study Number'}, {'id': '2021-003885-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sub-Study A', 'description': 'BCMA-CD3 bispecific antibody + gamma secretase inhibitor', 'interventionNames': ['Drug: Elranatamab + Nirogacestat']}, {'type': 'EXPERIMENTAL', 'label': 'Sub-Study B', 'description': 'BCMA-CD3 bispecific antibody + immunomodulatory drug', 'interventionNames': ['Drug: Elranatamab + lenalidomide + dexamethasone']}], 'interventions': [{'name': 'Elranatamab + Nirogacestat', 'type': 'DRUG', 'otherNames': ['PF-06863135, Ogsiveo'], 'description': 'BCMA-CD3 bispecific antibody + gamma secretase inhibitor', 'armGroupLabels': ['Sub-Study A']}, {'name': 'Elranatamab + lenalidomide + dexamethasone', 'type': 'DRUG', 'otherNames': ['PF-06863135; Revlimid'], 'description': 'BCMA-CD3 bispecific antibody + immunomodulatory', 'armGroupLabels': ['Sub-Study B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner Gateway Medical Center', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner Gateway Medical Pavilion', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner MD Anderson Cancer Center', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner Health d.b.a. Banner MD Anderson Cancer Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Beverly Hills Cancer Center', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '91316', 'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Research Advisors', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '90020', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Research Advisors', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center Oncology IDS Pharmacy Attn:Suwicha Limvorasak ,PharmaD', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute (SOCCI)', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Research Advisors', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91356', 'city': 'Tarzana', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Tarzana', 'geoPoint': {'lat': 34.17334, 'lon': -118.55397}}, {'zip': '33146', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33146', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33442', 'city': 'Deerfield Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Sylvester Comprehensive Cancer Center- Deerfield Beach', 'geoPoint': {'lat': 26.31841, 'lon': -80.09977}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Sylvester Comprehensive Cancer Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'UHealth Tower', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'The Johns Hopkins University School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21231', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'OIDS, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21231', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Also Imaging Facility)', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': 'T2N 5G2', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Arthur J.E. Child Comprehensive Cancer Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Ottawa Hospital - General Campus', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'url': 'https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests', 'ipdSharing': 'YES', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}