Phase II Study of Outpatient Teclistamab or Talquetamab Treatment for Adults with Relapsed or Refractory Multiple Myeloma

What this Trial Is About

Researchers are evaluating the outpatient use of two drugs, Teclistamab and Talquetamab, in adults with relapsed or refractory multiple myeloma RRMM. This phase II study focuses on how these drugs, which are bispecific antibodies targeting immune cells and myeloma cells, can be given safely outside of a hospital setting. The study also assesses how pre-treatment with tocilizumab or dexamethasone may reduce side effects like cytokine release syndrome CRS to enable outpatient administration. Participants receive one of three different treatment plans. One group receives step-up doses of Teclistamab followed by weekly dosing for up to twelve 28-day cycles, with possible dose reductions after 6 months. Another group receives Talquetamab with step-up doses followed by dosing every two weeks for six 28-day cycles, with possible dose reduction after four cycles. The third group receives Teclistamab with a dosing schedule that changes over 12 cycles, combined with oral dexamethasone. All treatments are given via subcutaneous injection, and pre-treatment medications are administered to help manage side effects. During the study, participants are closely monitored through safety assessments, including twice-daily measurements of body temperature and blood oxygen levels during the first two treatment cycles. Researchers track the incidence and severity of CRS and other side effects, hospital stays, response to treatment, survival, and quality of life. Participants must stay close to the treatment site and be accompanied by a competent adult during certain periods after dosing. The study continues until disease progression, unacceptable side effects, or completion of the treatment cycles, lasting up to 12 months for Teclistamab or 6 months for Talquetamab.

Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma