Phase II Study of Fixed Duration Teclistamab or Talquetamab with Daratumumab for Frail Patients Newly Diagnosed with Multiple Myeloma

What this Trial Is About

Researchers are evaluating treatments for frail patients newly diagnosed with multiple myeloma. This open-label phase II study has two groups one receiving teclistamab with daratumumab, and the other receiving talquetamab with daratumumab. The main goal is to measure how long patients live without disease progression over 18 months. The study includes four phases an initial treatment phase with fixed durations of teclistamab-daratumumab or talquetamab-daratumumab a treatment-free interval a re-treatment phase if the disease progresses and a post-treatment follow-up period. All drugs are given by subcutaneous injection and continued until disease progression or intolerable side effects. Participants will have regular assessments including disease progression checks using established criteria, survival monitoring, and quality of life questionnaires. Researchers will also evaluate treatment responses, adverse events, and long-term outcomes up to nine years. The study involves scheduled follow-ups to monitor health and treatment effects throughout these phases.

Study for Frail Patients With Newly Diagnosed Multiple Myeloma Treated With Daratumumab With Teclistamab or Talquetamab.