MAGENTA: Phase I Study of Mezigdomide and Talquetamab in Relapsed and Refractory Multiple Myeloma
Massachusetts General Hospital
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).
Description
This phase 1 open-label study will determine the recommended dose and schedule of mezigdomide and talquetamab in triple class exposed relapsed and refractory multiple myeloma. This study aims to enroll 25 participants including Cohorts A and B, and will follow a dose escalation schedule. Treatment is until progression or withdrawal of consent. The U.S. Food and Drug Administration (FDA) has not approved the combination of drugs mezigdomide, talquetamab, and dexamethasone as treatment for any disease. The FDA has not approved mezigdomide as a treatment for any disease. The FDA has approved talq…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participant has given voluntary signed written informed consent before performance of any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to their future medical care. * Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (see Appendix). * Age ≥ 18 years * Measurable disease of multiple myeloma as defined by at least one of the following: * Serum monoclonal protein ≥ 0.5 g/dL. Patients with IgD disease and lower amounts of monoclonal prote…
Interventions
- DrugTalquetamab
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).
- DrugMezigdomide
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).
- DrugDexamethasone
Administered orally once per day, at the schedule outlined in the Arm Descriptions.
Locations (3)
- Massachusetts General HospitalBoston, Massachusetts
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts