Mezigdomide and Talquetamab in Relapsed and Refractory Multiple Myeloma
NCT07032714 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2026-04-13
Summary
This is a phase 1 study to find the recommended dose and schedule of mezigdomide and talquetamab in relapsed and refractory multiple myeloma (RRMM), and to test the effects of the drugs on cancer. Cohort A will receive talquetamab + dexamethasone, then mezigdomide + talquetamab,+ dexamethasone. After Cohort A, Cohort B will evaluate mezigdomide + dexamethasone followed by step-up dosing of talquetamab (mezigdomide + talquetamab,+ dexamethasone).
Conditions
- Relapsed Refractory Multiple Myeloma (RRMM)
Interventions
- DRUG
-
Talquetamab is injected under the skin (subcutaneously injected) by trained medical staff. During first cycle of talquetamab, the dose of talquetamab will increase until the goal dose (treatment dose) is reached (pre-determined dose escalation).
- DRUG
-
Administered orally once per day (days 1-21 of applicable 28-day cycles; Days 1-7 of the 7-day Cohort B pre-phase cycle).
- DRUG
-
Administered orally once per day, at the schedule outlined in the Arm Descriptions.
Sponsors & Collaborators
-
Celgene Corporation
collaborator INDUSTRY -
Janssen Research and Development LLC
collaborator UNKNOWN -
Massachusetts General Hospital
lead OTHER
Principal Investigators
-
Andrew J. Yee, MD · Massachusetts General Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-12-19
- Primary Completion
- 2027-07-01
- Completion
- 2028-07-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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