Ignite Creation Date:
2025-12-25 @ 12:11 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT07284758
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-16
First Post:
2025-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory 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': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2030-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-12-09', 'studyFirstSubmitQcDate': '2025-12-09', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall response rate (ORR) per International Myeloma Working Group (IMWG) Response Criteria by an Independent Review Committee (IRC)', 'timeFrame': 'up to approximately 43 months'}], 'secondaryOutcomes': [{'measure': 'Duration of response (DoR; IRC assessed)', 'timeFrame': 'up to approximately 43 months'}, {'measure': 'Complete response (CR) rate (IRC assessed)', 'timeFrame': 'up to approximately 43 months'}, {'measure': 'Time to response (IRC assessed)', 'timeFrame': 'up to approximately 43 months'}, {'measure': 'Progression free survival (PFS; IRC assessed)', 'timeFrame': 'up to approximately 43 months'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'up to approximately 43 months'}, {'measure': 'Adverse events (AEs); serious AEs (SAEs); AEs leading to treatment interruption, reduction, or discontinuation; and deaths', 'timeFrame': 'within 30 to 35 days of the last dose of study treatment'}, {'measure': 'Plasma concentrations of cemsidomide', 'timeFrame': 'up to approximately 4 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cemsidomide', 'dexamethasone', 'Multiple Myeloma'], 'conditions': ['Multiple Myeloma', 'Relapsed/Refractory Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'This is a Phase 2, open-label, single-arm, multicenter study to assess the antimyeloma activity and further characterize the safety, tolerability, PK, and PD of cemsidomide in combination with dexamethasone in participants with relapsed/refractory multiple myeloma (r/r MM).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Be willing and able to provide signed informed consent for the study.\n2. Age ≥ 18 years at the time of signed consent.\n3. Subjects must have a documented diagnosis of MM and measurable disease at enrollment.\n4. Received at least 3 prior anti-myeloma regimens (for a minimum of 2 or more consecutive cycles) that must have included an immunomodulatory drug (i.e., IKZF 1/3 degrader), a proteasome inhibitor, an anti-CD38 antibody, and a T-cell engager (TCE) or chimeric antigen receptor T-cell (CAR-T) therapy, unless not available per local standard of care.\n5. Subjects need to have adequate organ function.\n6. Toxicities from prior anticancer therapies must have resolved to ≤ Grade 2.\n7. Female subjects may not be pregnant or intend to become pregnant, may not breastfeed or intend to breastfeed, or donate ova during their participation in this study until 30 days after the last dose of study treatment.\n8. Male subjects must agree to use a condom when having intercourse with a person of childbearing potential during the Treatment Period and for at least 30 days after the last dose of study treatment.\n9. Male subjects must refrain from donating sperm during the Treatment Period and for 30 days after discontinuation.\n10. Subjects must refrain from donating blood during study treatment and for 30 days after discontinuation.\n\nExclusion Criteria:\n\n1. Presence of myeloma in the central nervous system (CNS).\n2. Subjects with any of the following:\n\n * Systemic light chain amyloidosis\n * Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin changes (POEMS) Syndrome\n * Myelodysplastic syndrome (MDS).\n3. Previously treated with cemsidomide.\n4. Clinically significant impaired cardiac function or cardiac disease.\n5. Thromboembolic event within 3 months prior to enrollment.\n6. Known malignancy other than study indication that has progressed or required treatment within the past 3 years.\n7. Uncontrolled active systemic infection.\n8. Inability or difficulty swallowing tablets.\n\nNOTE: Other inclusion/exclusion criteria may apply, per protocol.'}, 'identificationModule': {'nctId': 'NCT07284758', 'acronym': 'MOMENTUM', 'briefTitle': 'A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma', 'organization': {'class': 'INDUSTRY', 'fullName': 'C4 Therapeutics, Inc.'}, 'officialTitle': 'A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma', 'orgStudyIdInfo': {'id': 'CFT7455-2101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cemsidomide + Dexamethasone:', 'description': 'Participants receive cemsidomide plus dexamethasone during a 28-day treatment cycle, and will continue to receive treatment until the participant meets one of the discontinuation criteria.', 'interventionNames': ['Drug: Cemsidomide', 'Drug: Dexamethasone']}], 'interventions': [{'name': 'Cemsidomide', 'type': 'DRUG', 'description': 'dosed orally (PO) once a day (QD) 14 days on/14 days off for each 28-day cycle', 'armGroupLabels': ['Cemsidomide + Dexamethasone:']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'dosed PO once a week (QW) on Days 1, 8, 15, and 22 for each 28-day cycle', 'armGroupLabels': ['Cemsidomide + Dexamethasone:']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90069', 'city': 'West Hollywood', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'James Berenson, MD', 'role': 'CONTACT'}], 'facility': 'Berenson Cancer Center', 'geoPoint': {'lat': 34.09001, 'lon': -118.36174}}], 'centralContacts': [{'name': 'Study Medical Officer', 'role': 'CONTACT', 'email': 'clinicaltrials@c4therapeutics.com', 'phone': '(617) 231-0700'}], 'overallOfficials': [{'name': 'Binod Dhakal, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical College of Wisconsin'}, {'name': 'Martin Kaiser, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Royal Marsden'}, {'name': 'Aurore Perrot, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universite de Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'C4 Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}