This Phase II, open-label, multicenter study will evaluate teclistamab in combination with pomalidomide administered using an alternative dosing approach in participants with relapsed or refractory multiple myeloma who have received 1-3 prior lines of therapy, including lenalidomide and anti-CD38 therapy. Teclistamab is a bispecific antibody that targets BCMA on myeloma cells and CD3 on T cells, bringing these cells into close proximity and activating T cells to induce targeted killing of BCMA-expressing myeloma cells. The study will assess the safety and efficacy of this treatment combination in participants with relapsed or refractory multiple myeloma.
≥18 years of age (or the legal age of majority, if greater than 18, in the jurisdiction in which the study is taking place) at the time of informed consent.
Multiple myeloma diagnosis according to IMWG diagnostic criteria.
Serum M-protein level ≥0.5 g/dL; or Serum Ig FLC ≥10 mg/dL and abnormal serum Ig kappa lambda FLC ratio.
Relapsed or refractory disease as defined below : a. Relapsed disease is defined as an initial response to previous treatment, followed by confirmed progressive disease by IMWG criteria >60 days after cessation of treatment. b. Refractory disease is defined as failure to achieve a response or confirmed progressive disease by IMWG criteria during previous treatment or ≤60 days after cessation of treatment.
Received any prior BCMA-directed therapy.
Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients (refer to the teclistamab IB and appropriate prescribing information).
Participants will be excluded if intolerant to dexamethasone.
Targeted therapy, epigenetic therapy, or treatment with an investigational drug or an invasive investigational medical device within 21 days or ≥5 half-lives, whichever is less