Actively Recruiting
MAGENTA: Phase I Study of 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
52 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
Researchers are evaluating the combination of mezigdomide and talquetamab, along with dexamethasone, in adults with relapsed and refractory multiple myeloma who have been exposed to three prior lines of therapy including immunomodulatory drugs, proteasome inhibitors, and anti-CD38 antibodies. This phase 1 open-label study aims to find the recommended dose and schedule of these drugs and to assess their effects on the cancer. The study is estimating treatment duration up to one year or until disease progression or withdrawal. Participants are assigned to one of two cohorts. Cohort A first receives talquetamab with dexamethasone, then a combination of mezigdomide, talquetamab, and dexamethasone. Talquetamab is injected under the skin on specified days within 28-day cycles, while mezigdomide and dexamethasone are taken orally on scheduled days. Cohort B begins after Cohort A and involves a pre-phase with mezigdomide and dexamethasone, followed by treatment with all three drugs in a step-up dosing pattern. Treatment continues until disease progression or participant withdrawal. Participants will undergo regular assessments including monitoring for dose-limiting toxicities, adverse events, response to treatment, and survival outcomes over an estimated total of three years. The study tracks safety and effectiveness measures such as overall response rate, progression-free survival, and overall survival. Laboratory tests, physical exams, and other evaluations will be performed throughout treatment and follow-up periods to monitor health and treatment effects.
CONDITIONS
Brief 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 informed consent before any study procedure not part of normal care
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Age 18 years or older
- Measurable multiple myeloma defined by serum monoclonal protein ≥ 0.5 g/dL, urine monoclonal protein ≥ 200 mg/24 hours, or serum free light chain ≥ 100 mg/L with abnormal ratio
- Previously treated relapsed and refractory multiple myeloma with at least three prior therapy lines including immunomodulatory drug, proteasome inhibitor, and anti-CD38 antibody
- Disease progression on or within 60 days of last therapy
- Absolute neutrophil count ≥ 1000/μL without G-CSF within 14 days of screening
- Platelet count ≥ 50,000/μL without transfusion or thrombopoietin receptor agonists within 7 days of screening
- Hemoglobin ≥ 8 g/dL (transfusions allowed)
- Creatinine clearance ≥ 30 mL/min by MDRD or Cockcroft-Gault formula
- Serum bilirubin less than 1.5 times upper limit of normal, with exceptions for Gilbert's syndrome
- AST and ALT less than 2.5 times upper limit of normal
- Ability to comply with blood clot prevention medications
- Females of childbearing potential must have negative pregnancy tests and agree to contraception or abstinence
- Male participants must follow pregnancy prevention plan
- Agree to lifestyle considerations regarding blood donation, hospitalization proximity, and operating machinery
You will not qualify if you...
- Myeloma therapy or investigational drug within 2 weeks prior to treatment start or unresolved adverse events from earlier treatments
- Receiving any investigational agents
- 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 within 3 months
- Plasmapheresis within 7 days prior to study treatment
- Primary refractory disease
- Use of high dose corticosteroids (prednisone >10 mg/day or equivalent), low dose corticosteroids allowed for non-myeloma conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 1 year or until disease progression or withdrawal
Participants receive treatment with mezigdomide, talquetamab, and dexamethasone in a dose escalation schedule. Treatment includes subcutaneous injections of talquetamab and oral administration of mezigdomide and dexamethasone according to cohort-specific schedules. Treatment continues until disease progression or withdrawal of consent.
Multiple visits including weekly visits during initial dose escalation and biweekly or monthly visits during later cycles
Duration - Up to 2 years post last dose
Participants are monitored for safety and treatment outcomes including adverse events and disease progression after treatment ends.
Periodic visits for up to 2 years after treatment completion
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
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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