A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment
810 patients around the world
Available in United States, Brazil, Spain
Overall rationale of the study is that combination treatments of talquetamab,
daratumumab, pomalidomide and dexamethasone may lead to enhanced clinical responses in
treatment of relapsed or refractory multiple myeloma through multiple mechanisms of
action. The study is divided into 3 phases: screening, treatment (until confirmed
progressive disease, death, intolerable toxicity, withdrawal of consent, or end of the
study, whichever occurs first), and posttreatment follow-up (until death, withdrawal of
consent, loss to follow-up, or end of the study, whichever occurs first). Efficacy,
safety (physical examinations, neurologic examinations, Eastern Cooperative Oncology
Group [ECOG] performance status, clinical laboratory tests, vital signs, and AE
monitoring), pharmacokinetics (PK), immunogenicity, and biomarkers will be assessed at
specified time points. Total duration of study will be up to 6 years 6 months.