Mezigdomide and Talquetamab in Relapsed and Refractory Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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).
Eligibility criteria
Qualifiers
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of any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to their future medical care.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
Serum monoclonal protein ≥ 0.5 g/dL. Patients with IgD disease and lower amounts of monoclonal protein may be permitted to enroll with PI approval
Disqualifiers
Participants who have had myeloma therapy or investigational drug within 2 weeks prior to start of treatment or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier.
Participants who are receiving any investigational agents.
Prior therapy with mezigdomide or iberdomide.
Prior therapy with anti-GPRC5D therapy (e.g. talquetamab).
Trial design
Treatments tested in this trial
- Talquetamab
- Mezigdomide
- Dexamethasone
Treatment groups
25 Participants
are divided into 2 treatment groupsSponsors and collaborators
Massachusetts General Hospital
Lead sponsor
Celgene Corporation
Collaborator
Janssen Research and Development LLC
Collaborator
Source ClinicalTrials.gov