MRD-GUIDED SEQUENTIAL THERAPY FOR DEEP RESPONSE IN NEWLY DIAGNOSED MULTIPLE MYELOMA - MASTER-2 TRIAL

The purpose of the study is to determine the proportion of patients with lowest minimal residual disease (MRD) response obtainable after receiving 6 cycles of study treatment. Minimal residual disease is multiple myeloma cells below the level of 1 cancer cell out of 100,000 in the bone marrow. For patients who are MRD “positive” at the end of 6 cycles of therapy, this study will answer whether more patients can become and remain MRD “negative” with autologous hematopoietic cell transplantation (AHCT) plus a new immunotherapy called teclistamab in combination with daratumumab when compared with patients who undergo AHCT followed by lenalidomide (an established anti-myeloma drug) plus daratumumab. Daratumumab is currently FDA approved for the treatment of patients with multiple myeloma in several combinations. For the purpose of this study, daratumumab will also be considered an investigational agent for treatment and maintenance. Maintenance treatment in cancer is treatment that is given to help keep cancer from coming back after it has disappeared following the initial therapy. The combination of the 4 agents daratumumab, bortezomib, lenalidomide, and dexamethasone is referred to as Dara-VRd. Dara-VRd is not an FDA approved regimen for front line treatment of newly diagnosed multiple myeloma. Front line treatment is the first treatment given for a disease.Teclistamab is an FDA-approved immunotherapy for treatment of patients with relapsed or refractory multiple myeloma, but is not FDA- approved for newly diagnosed multiple myeloma.

Are you Eligible? (Inclusion Criteria)

• Must be 18 years or older - Have diagnosis of newly diagnosed multiple myeloma with indication for initiation of therapy - Cannot be pregnant or trying to become pregnant