Viewing Study NCT06215118


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Ignite Modification Date: 2025-12-26 @ 4:03 AM
Study NCT ID: NCT06215118
Status: RECRUITING
Last Update Posted: 2025-12-18
First Post: 2024-01-10
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) and Iberdomide in Patients With Relapsed or Refractory Multiple Myeloma (MagnetisMM-30)
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D012008', 'term': 'Recurrence'}], '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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000624220', 'term': 'iberdomide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 87}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-03-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2024-01-10', 'studyFirstSubmitQcDate': '2024-01-10', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1: Number of participants with dose limiting toxicity (DLT)', 'timeFrame': 'Cycle 1, about 28 days', 'description': 'Dose limiting toxicity rate based on dose limiting toxicity evaluable participants'}, {'measure': 'Part 2: Number of participants with Adverse Events (AE) by Seriousness and Relationship to Treatment', 'timeFrame': 'Assessed from baseline up to 90 days after last dose of study treatment', 'description': 'Number of participants with AE among participants who take at least 1 dose of study intervention. AEs are categorized by seriousness and relationship to treatment. Relatedness to study drug is assessed by investigator.'}], 'secondaryOutcomes': [{'measure': 'Part 1: Number of participants with Adverse Events (AE) by Seriousness and Relationship to Treatment', 'timeFrame': 'Assessed from baseline up to 90 days after last dose of study treatment', 'description': 'Number of participants with AE among participants who take at least 1 dose of study intervention. AEs are categorized by seriousness and relationship to treatment. Relatedness to study drug is assessed by investigator.'}, {'measure': 'Part 1 and Part 2: Number of Participants with Adverse Events (AE) characterized by type, frequency, severity', 'timeFrame': 'Assessed from baseline up to 90 days after last dose of study treatment', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibly of causal relationship'}, {'measure': 'Part 1 and Part 2: Number of Participants with Clinically Significant Change from Baseline in Laboratory Abnormalities', 'timeFrame': 'Assessed from baseline up to 90 days after last dose of study treatment', 'description': 'Laboratory abnormalities as characterized by type, frequency, severity'}, {'measure': 'Part 1 and Part 2: Percentage of Participants with Objective Response Rate (ORR)', 'timeFrame': 'Assessed for approximately 2 years', 'description': 'Percent of participants having confirmed Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR) per IMWG criteria as determined by investigator'}, {'measure': 'Part 1 and Part 2: Percentage of Participants with Complete Response Rate (CRR)', 'timeFrame': 'Assessed for approximately 2 years', 'description': 'Percent of participants having Complete Response/ Stringent Complete Response (CR+sCR) per IMWG criteria as determined by investigator'}, {'measure': 'Part 1 and Part 2: Time to Response (TTR)', 'timeFrame': 'Assessed for approximately 2 years', 'description': 'For participants with an objective response per IMWG criteria, TTR is the time from first dose to the first documentation of objective response that is subsequently confirmed'}, {'measure': 'Part 1 and Part 2: Duration of Response (DOR)', 'timeFrame': 'Assessed for approximately 2 years', 'description': 'For participants with an objective response per IMWG criteria, DOR is the time from first documentation of objective response that is subsequently confirmed until the first documentation of confirmed progressive disease (PD) per IMWG criteria'}, {'measure': 'Part 1 and Part 2: Duration of Complete Response (DOCR)', 'timeFrame': 'Assessed for approximately 2 years', 'description': 'For participants with a Complete Response/ Stringent Complete Response (CR+sCR) per IMWG criteria, DOCR is the time from the first documentation of CR/sCR that is subsequently confirmed until the first documentation of confirmed progressive disease (PD) per IMWG criteria'}, {'measure': 'Part 1 and Part 2: Time of Progression Free Survival (PFS)', 'timeFrame': 'Assessed for approximately 2 years', 'description': 'Progression free survival (IMWG criteria)'}, {'measure': 'Part 1 and Part 2: Time of Overall Survival (OS)', 'timeFrame': 'Assessed for approximately 2 years', 'description': 'The duration of time from first dose of study treatment to death'}, {'measure': 'Part 1 and Part 2: Minimal Residual Disease (MRD) Negativity Rate', 'timeFrame': 'Assessed for approximately 2 years', 'description': 'The proportion of participants achieving CR+sCR with negative MRD per IMWG sequencing criteria, from the date of first dose until the first documentation of confirmed progressive disease (PD), death, or start of new anticancer therapy.'}, {'measure': 'Part 1 and Part 2: Concentrations of elranatamab', 'timeFrame': 'Assessed for approximately 2 years', 'description': 'Pre-dose and post-dose concentrations of elranatamab'}, {'measure': 'Part 1 and Part 2: Concentrations of iberdomide', 'timeFrame': 'Assessed for approximately 4 months', 'description': 'Pre-dose concentrations of iberdomide'}, {'measure': 'Part 1 and Part 2: Percentage of participants with positive anti-drug antibodies (ADA) against elranatamab', 'timeFrame': 'Assessed for approximately 2 years', 'description': 'Percent of participants with positive ADA to elranatamab when given in combination with iberdomide'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['elranatamab', 'PF-06863135', 'iberdomide', 'relapsed', 'refractory', 'RRMM', 'BCMA', 'MagnetisMM', 'Bispecific antibody', 'CC-220'], 'conditions': ['Multiple Myeloma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C1071030', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of the study is to understand how safe and tolerable is elranatamab when given along with iberdomide.\n\nThere are 2 parts to this study. Part 1 will look at how safe and tolerable is elranatamab when given with iberdomide. Part 2 will look at the correct amount of this combination that can be given to patients with relapsed or refractory multiple myeloma.\n\nMyeloma is a type of cancer that begins in plasma cells (white blood cells that produce antibodies). Refractory means a disease or condition that does not respond to treatment. Relapsed means the return of a disease after a period of improvement.\n\nAll study medicines are given in cycles that last 28 days. Everyone taking part in this study will receive elranatamab as a shot under the skin. Iberdomide will be taken by mouth once a day for 21 days over a 28-day cycle.\n\nParticipants will receive study medicine until:\n\n* their disease progresses or,\n* they experience unacceptable side effects or,\n* they choose to no longer take part in the study.\n\nThe study will look at the experiences of people receiving the study medicines. This will help see if the study medicines are safe and can be used for multiple myeloma treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Prior diagnosis of multiple myeloma as defined by IMWG criteria\n* Measurable disease based on IMWG criteria as defined by at least 1 of the following:\n* Serum M-protein ≥0.5 g/dL by SPEP\n* Urinary M-protein excretion ≥200 mg/24 hour by UPEP\n* Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FL ratio (\\<0.26 or \\>1.65)\n* Part 1: Received 2-4 prior lines of therapy for multiple myeloma, consisting of at least 1 immunomodulatory drug and 1 proteasome inhibitor.\n* Part 2: Received 1-3 prior lines of therapy for multiple myeloma, consisting of at least 1 immunomodulatory drug and 1 proteasome inhibitor.\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* Plasma cell leukemia, Smoldering multiple myeloma, Waldenström's macroglobulinemia, Amyloidosis, POEMS Syndrome\n* Impaired cardiovascular function or clinically significant cardiovascular diseases\n* Stem cell transplant within 12 weeks prior to enrollment or active graft vs host disease\n* Participants with any active, uncontrolled bacterial, fungal, or viral infection\n* Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ\n* Previous treatment with:\n* BCMA-directed or CD3 redirecting therapy\n* Iberdomide (CC-220) or Mezigdomide\n* Administration of strong inhibitor or inducer of CYP3A4/5 within 2 weeks prior to dosing and during the study\n* Administration with an investigational product within 30 days preceding the first dose of study intervention\n* Participant is unable or unwilling to undergo protocol required thromboembolism prophylaxis"}, 'identificationModule': {'nctId': 'NCT06215118', 'briefTitle': 'A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135) and Iberdomide in Patients With Relapsed or Refractory Multiple Myeloma (MagnetisMM-30)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 1B, OPEN-LABEL STUDY OF ELRANATAMAB IN COMBINATION WITH IBERDOMIDE IN PARTICIPANTS WITH RELAPSED REFRACTORY MULTIPLE MYELOMA', 'orgStudyIdInfo': {'id': 'C1071030'}, 'secondaryIdInfos': [{'id': 'MagnetisMM-30', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1 Dose Escalation', 'description': 'Non-randomized elranatamab plus iberdomide', 'interventionNames': ['Drug: Elranatamab', 'Drug: Iberdomide']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 Dose Randomization', 'description': 'Randomized elranatamab plus iberdomide', 'interventionNames': ['Drug: Elranatamab', 'Drug: Iberdomide']}], 'interventions': [{'name': 'Elranatamab', 'type': 'DRUG', 'otherNames': ['PF-06863135'], 'description': 'BCMA-CD3 bispecific antibody', 'armGroupLabels': ['Part 1 Dose Escalation', 'Part 2 Dose Randomization']}, {'name': 'Iberdomide', 'type': 'DRUG', 'otherNames': ['CC-220', 'BMS-986382'], 'description': 'cereblon-modulating agent', 'armGroupLabels': ['Part 1 Dose Escalation', 'Part 2 Dose Randomization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Emory University Hospital Midtown', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Winship Cancer Institute of Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Winship Cancer Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Indiana CTSI Clinical Research Center (ICRC)', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Indiana University Health University Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center (IUSCCC)', 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'lon': -95.94043}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Dartmouth-Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '07920', 'city': 'Basking Ridge', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'MSK Basking Ridge', 'geoPoint': {'lat': 40.70621, 'lon': -74.54932}}, {'zip': '07748', 'city': 'Middletown', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'MSK Monmouth', 'geoPoint': {'lat': 40.39428, 'lon': -74.11709}}, {'zip': '07645', 'city': 'Montvale', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'MSK Bergen', 'geoPoint': {'lat': 41.04676, 'lon': -74.02292}}, {'zip': '11725', 'city': 'Commack', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'MSK Commack', 'geoPoint': {'lat': 40.84288, 'lon': -73.29289}}, {'zip': '10604', 'city': 'Harrison', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'MSK Westchester', 'geoPoint': {'lat': 40.96899, 'lon': -73.71263}}, {'zip': '11101', 'city': 'Long Island City', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy', 'geoPoint': {'lat': 40.74482, 'lon': -73.94875}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center - Main Campus', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11553', 'city': 'Uniondale', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'MSK Nassau', 'geoPoint': {'lat': 40.70038, 'lon': -73.59291}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '2170', 'city': 'Liverpool', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Liverpool Hospital', 'geoPoint': {'lat': -33.91938, 'lon': 150.92588}}, {'zip': '2298', 'city': 'Waratah', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Calvary Mater Newcastle', 'geoPoint': {'lat': -32.90667, 'lon': 151.72647}}, {'zip': '4814', 'city': 'Douglas', 'state': 'Queensland', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Townsville University Hospital', 'geoPoint': {'lat': -19.32394, 'lon': 146.75234}}, {'zip': '3002', 'city': 'East Melbourne', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Epworth Freemasons', 'geoPoint': {'lat': -37.81667, 'lon': 144.9879}}, {'zip': '3121', 'city': 'Richmond', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Epworth Hospital', 'geoPoint': {'lat': -37.81819, 'lon': 145.00176}}, {'zip': '3121', 'city': 'Richmond', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Slade Pharmacy', 'geoPoint': {'lat': -37.81819, 'lon': 145.00176}}, {'zip': 'E3B 5N5', 'city': 'Fredericton', 'state': 'New Brunswick', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Dr. Everett Chalmers Regional Hospital', 'geoPoint': {'lat': 45.94541, 'lon': -66.66558}}, {'zip': 'H1T 2M4', 'city': 'Montreal', 'state': 'Quebec', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'facility': "CIUSSS de l'Est-de-l'Île-de-Montréal", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'J1H 5N4', 'city': 'Sherbrooke', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'facility': "Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer", 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}], 'centralContacts': [{'name': 'Pfizer CT.gov Call Center', 'role': 'CONTACT', 'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021'}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', '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'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}