RecruitingPhase 1

A Study of Teclistamab and Mezigdomide in People With Multiple Myeloma

United States18 participantsStarted 2025-08-08

Plain-language summary

The researchers are doing this study to find out whether combining teclistamab and mezigdomide is a safe and effective treatment approach in people with relapsed/refractory multiple myeloma (MM).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patients with relapsed or refractory multiple myeloma who have been treated with a proteasome inhibitor, an IMiD, and an anti-CD38 antibody. Patients who have been treated with at least 2 prior lines of therapy are eligible. Multiple myeloma is defined by the International Myeloma Working Group (IMWG) updated criteria.
✓. Patients need to have measurable disease defined by one or more of the following:
✓. Serum myeloma (M)-protein greater than or equal to 0.5 g/dL (5 g/L).
✓. Urine M-protein greater or equal to 200 mg/24 h.
✓. Involved light chain (either kappa or lambda) \>10 mg/dL with an abnormal kappa: lambda ratio
✓. Plasmacytoma(s) that is new or definitely increased verified by imaging or biopsy.
✓. A bone marrow biopsy demonstrating \>30% infiltration of clonal plasma cells.
✓. Patients who have received prior BCMA-directed therapy \> 90 days prior including antibody drug conjugates or chimeric antigen receptor T-cell \[CAR T\] are eligible. BCMA presence on the cell surface should be confirmed in patients who have been treated with prior BCMA targeted therapies. Prior treatment with BCMA targeted bispecific antibodies is not allowed.

Exclusion criteria

✕. Prior treatment with a BCMA targeted bispecific antibody
✕. Prior treatment with mezigdomide
✕. Systemic anti-myeloma therapy (including systemic steroids) within ≤14 days, or plasmapheresis within 7 days prior to the first dose of study drug.
✕. Use of an investigational drug within 21 days or five half-lives (whichever is longer) preceding the first dose of study drug.
✕. Radiation therapy within ≤14 days prior to study entry (bone lesions requiring radiation may be treated with limited \[i.e., ≤ 25% of bone marrow in field\] radiation therapy during this period).
✕. Live, attenuated vaccine or investigational vaccine within 4 weeks before the first dose of study drug. Non-live or non-replicating vaccines authorized for emergency use (eg, COVID-19) by local health authorities are allowed
✕. Patients with a history of autologous stem cell transplant within 60 days or allogeneic stem cell transplant within 6 months prior to study enrollment.
✕. Patients who received CAR T therapy within 90 days prior to study enrollment

What they're measuring

Number of Participants With Dose Limiting Toxicity Assessed by CTCAE v5.0

Timeframe: 1 year

Trial details

NCT IDNCT07105059

SponsorMemorial Sloan Kettering Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-08-08

Contact for this trial

Malin Hultcrantz, MD, PhD

646-608-3714 hultcram@mskcc.org

View on ClinicalTrials.gov More Multiple Myeloma trials