MonumenTAL-1
Dose Escalation Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma (MonumenTAL-1)
What will happen during the trial?
The study will be conducted in 2 parts: dose escalation and dose expansion. The study will evaluate safety, tolerability, pharmacokinetics and preliminary antitumor activity of Talquetamab administered to adult participants with relapsed or refractory multiple myeloma. The overall safety of the study drug will be assessed by physical examinations, Eastern Cooperative Oncology Group performance status, laboratory tests, vital signs, electrocardiograms, adverse event monitoring, and concomitant medication usage. Disease evaluations will include peripheral blood and bone marrow assessments at screening (performed within 28 days) and to confirm stringent complete response (sCR), complete response (CR), or relapse from CR. The end of study (study completion) is defined as the last study assessment for the last participant in the study. Study record NCT04634552 is Phase 2 part of this study and study record NCT03399799 is Phase 1 part of this study.
More Information
- Trial Status
- Accepting patients
- Trial Phase
- Phase 1
- Enrollment
- 320 patients (estimated)
- Sponsors
- Janssen Research & Development LLC
- Tags
- Bispecific Antibody, CD3, GPRC5D
- Trial Type
- Treatment
- Last Update
- 2 months ago
- SparkCures ID
- 938
- NCT Identifier
- NCT03399799
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