A Phase 2 Study to Evaluate Safety and Efficacy of Teclistamab- and Talquetamab-based Combination Regimens in Participants with Newly Diagnosed Transplant Eligible Multiple Myeloma
Phase 2 Study to Evaluate Safety and Efficacy of Teclistamab- and Talquetamab-based Combination Regimens in Participants with Newly Diagnosed Transplant Eligible Multiple Myeloma OBJECTIVES: The primary objective is to evaluate the safety and tolerability of teclistamab- and talquetamab-based combination regimens over the entire treatment phase for each arm, in participants with ND-TEMM The key secondary objective is to evaluate the efficacy of teclistamab- and talquetamab-based combination regimens as induction and post-transplant maintenance treatments, and teclistamab in combination with talquetamab as replacement for HDT+ASCT following induction
• \- 18 years of age to 70 years of age, inclusive
• Have an ECOG performance status score of 0 to 2 at screening
• Have clinical laboratory values meeting prespecified criteria during the Screening Phase.
• Participants in Arms A, A1, B, D, E, E1, F and F1 must also satisfy all of the following criteria to be enrolled in the study:
• 1\. Documented multiple myeloma requiring treatment as defined by the criteria below:
⁃ Multiple myeloma diagnosis according to the IMWG diagnostic criteria
⁃ Measurable disease at screening as defined by any of the following:
∙ Serum M-protein level ≥1.0 g/dL or
‣ Urine M-protein level ≥200 mg/24 hours or
‣ Serum immunoglobulin free light chain level ≥10 mg/dL and abnormal serum free light chain ratio
⁃ 2\. Newly diagnosed participants for whom HDT and ASCT is part of the intended treatment plan (except Arm D participants).
⁃ Participants Arm C and C2 must also satisfy all of the following criteria:
‣ Newly diagnosed multiple myeloma according to IMWG criteria.
‣ Must have received 4 to 6 cycles of 3 or 4 drug-induction therapy that includes a proteasome inhibitor and/or an IMiD with or without anti-CD38 monoclonal antibody and a single or tandem ASCT. Post-ASCT consolidation is permitted for up to 2 cycles as long as the total number of induction plus consolidation cycles does not exceed 6.
⁃ 3 Must have received only one line of therapy and achieved at least a PR as per IMWG 2016 without evidence of progression at the time of enrollment.
⁃ 4\. Must have received HDT and ASCT within 12 months of the start of induction therapy and be within 6 months of the last ASCT (7 months for participants who received consolidation) at the time of enrollment.