Actively Recruiting
Mezigdomide and Talquetamab in Relapsed and Refractory Multiple Myeloma
Led by Massachusetts General Hospital · Updated on 2026-04-13
25
Participants Needed
3
Research Sites
132 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
C
Celgene Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Mezigdomide and Talquetamab in Relapsed and Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant has given voluntary signed written informed consent before any study procedures
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Age 18 years or older
- Measurable multiple myeloma defined by one of: serum monoclonal protein 6 0.5 g/dL, 6 200 mg monoclonal protein in 24-hour urine, or serum free light chain 6 100 mg/L with abnormal ratio
- Previously treated relapsed and refractory multiple myeloma with at least three prior therapy lines including an immunomodulatory drug, proteasome inhibitor, and anti-CD38 antibody
- Disease progression on or within 60 days of last therapy completion
- Absolute neutrophil count 6 1000/bcL without granulocyte colony-stimulating factor within 14 days
- Platelet count 6 50,000/b5L without transfusion or thrombopoietin receptor agonists within 7 days
- Hemoglobin 6 8 g/dL; red blood cell transfusions allowed
- Creatinine clearance 6 30 mL/min by MDRD or Cockcroft-Gault formula
- Serum bilirubin less than 1.5 times upper limit of normal (ULN), with exceptions for Gilbert's syndrome
- Serum AST and ALT less than 2.5 times ULN
- Ability to follow thromboembolism prevention measures
- Females of childbearing potential must have two negative pregnancy tests before treatment and agree to ongoing testing and use of contraception or true abstinence
- Male subjects must follow the pregnancy prevention plan
- Agreement to lifestyle considerations including blood donation restrictions and activity limitations
You will not qualify if you...
- Myeloma therapy or investigational drug within 2 weeks before treatment start or unresolved adverse events from earlier treatments
- Receiving any investigational agents currently
- Prior therapy with mezigdomide or iberdomide
- Prior therapy with anti-GPRC5D therapy such as talquetamab
- Prior bispecific antibody therapy within 3 months
- Prior gene-modified adoptive cell therapy (e.g., CAR T-cells, NK cells) within 3 months
- Plasmapheresis within 7 days prior to treatment
- Primary refractory disease
- Use of high-dose corticosteroids; low-dose corticosteroids allowed for non-myeloma conditions
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
Research Team
A
Andrew J. Yee, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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