NCT07032714 Mezigdomide and Talquetamab in Relapsed and Refractory Multiple Myeloma
| NCT ID | NCT07032714 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Massachusetts General Hospital |
| Condition | Relapsed Refractory Multiple Myeloma (RRMM) |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2025-12-19 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 25 participants in total. It began in 2025-12-19 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
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of any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to their future medical care.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 protein may be permitted to enroll with PI approval * ≥ 200 mg of monoclonal protein in the urine on 24-hour urine protein electrophoresis * Serum free light chain (FLC) ≥ 100 mg/L (10 mg/dL) and abnormal serum free light chain ratio * Previously treated relapsed and refractory multiple myeloma: * Patients must have received at least three prior lines of therapy; * Prior therapy including an immunomodulatory drug, proteasome inhibitor, and anti-CD38 antibody (either in separate regimens or within the same regimen); and * Disease progression on, or within 60 days of completion of last therapy. * ANC ≥ 1000/μL. G-CSF is not permitted within 14 days of screening. * Platelet count ≥ 50,000/µL. Platelet transfusion and thrombopoietin receptor agonists are not permitted within 7 days of screening. * Hemoglobin ≥ 8 g/dL. Red blood cell transfusions are permitted to meet eligibility criteria. * Calculated creatinine clearance of ≥ 30 mL/min by Modified Diet in Renal Disease (MDRD) formula or Cockcroft-Gault formula * Serum bilirubin values \< 1.5 x ULN. Isolated bilirubin x 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%. Patients with elevated bilirubin due to Gilbert's syndrome may be permitted with PI approval (e.g. total bilirubin \<3 mg/dL and normal direct bilirubin); and * Serum aspartate transaminase (ALT) and aspartate transaminase (AST) values \< 2.5 × the upper limit of normal (ULN) of the institutional laboratory reference range. * Must be able to comply with thromboembolism prophylaxis with e.g. acetylsalicylic acid (ASA), apixaban, rivaroxaban, lower molecular weight heparin, or equivalent. * Females of childbearing potential (FCBP) must: * Have 2 negative pregnancy tests as verified by the Investigator prior to starting study therapy. The subject must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment. This applies even if the subject practices true abstinence from heterosexual contact. * Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use and be able to comply with two reliable forms of contraception as defined by the Pregnancy Prevention Plan. * Male subjects must follow the mezigdomide Pregnancy Prevention Plan (see Appendix). * Agree to follow the lifestyle considerations in Section 3.4 regarding blood donation, hospitalization and being in proximity to the hospital, and driving or operating heavy machinery. Exclusion Criteria: * 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). * Prior therapy with bispecific antibody therapy within three months * Prior therapy with gene-modified adoptive cell therapy (e.g. CAR T-cells, NK cells) within three months * Plasmapheresis within seven days prior to start of study treatment. * Primary refractory disease. * Concomitant high dose corticosteroids. Low dose corticosteroids (maximum dose prednisone 10 mg/day or equivalent) are permitted if given for disorders other than myeloma, e.g. adrenal insufficiency, rheumatoid arthritis, etc.
Contact & Investigator
Andrew J. Yee, MD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT07032714 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Relapsed Refractory Multiple Myeloma (RRMM). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07032714 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07032714 currently recruiting?
Yes, NCT07032714 is actively recruiting participants. Contact the research team at ayee1@mgh.harvard.edu for enrollment information.
Where is the NCT07032714 trial being conducted?
This trial is being conducted at Boston, United States, Boston, United States, Boston, United States.
Who is sponsoring the NCT07032714 clinical trial?
NCT07032714 is sponsored by Massachusetts General Hospital. The principal investigator is Andrew J. Yee, MD at Massachusetts General Hospital. The trial plans to enroll 25 participants.