Summary
What is the rationale for this study?
Multiple myeloma is a malignant plasma cell disorder that is characterised by the production of monoclonal proteins (M proteins), which are comprised of immunoglobulins (Ig) or fragments of Ig, which have subsequently lost their normal function.
The rationale for combning talquetamab and teclistamab in this study is the targeting of multiple proteins on the surface of multiple myeloma cells, resulting in cell lysis. Talquetamab and teclistamab are both bispecific antibodies, which are a new type of antibody-based immunotherapy.
How long does this study go for?
This study has 3 periods: screening phase (up to 28 days), treatment phase (start of study drug administration and continues until the completion of the end of treatment visit); and a post-treatment follow-up phase (after end of treatment and up to 16 weeks after last dose of study drug(s)). End of study is defined as 2 years after the last participant has received their initial dose of the treatment combination. Total duration of the study is approximately 5 years.
What is involved with this study?
In Part 1 (Dose Escalation), participants will receive teclistamab and talquetamab (tec+tal) ,with or without a targeted therapy called daratumumab in 28-day cycles following initial step-up doses until the recommended Phase 2 regimen (s) (RP2R[s]) are determined. All treatments will be administered by subcutaenous (SC) injection, which means an injection under the skin.
In Part 2 (Dose Expansion), participants will receive treatment doses (combination of tec+tal and dara+tal+tec regimens) which will be determined by the RP2R(s) of the study treatment identified in Part 1.
In Part 3, participants will receive tec+tal combination therapy, at the RP2R slected from Part 1 and Part 2.