A Phase 2, Open-label, Randomized Study to Evaluate GPRC5D-related Oral Events
Janssen Research & Development, LLC
Summary
The purpose of this study is to identify preventive treatments that can minimize the occurrence, severity, and duration of talquetamab-related taste changes (dysgeusia), during the prophylaxis (preventive) treatment phase, to better characterize the signs or symptoms of talquetamab-related taste changes and to better characterize the signs or symptoms of ramantamig-related taste changes.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Multiple myeloma (MM) according to IMWG diagnostic criteria * Were triple-class exposed (received prior treatment with a PI, an IMiD, and anti CD38 mAb) * Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen * Have an Eastern Cooperative Oncology Group-performance status (ECOG-PS) of 0 or 1 at screening. Participants with ECOG-PS 2 or 3 are eligible for the study if the ECOG-PS score is related to stable physical limitations (e.g., wheelchair-bound due to prior spinal cord injury) and…
Interventions
- DrugTalquetamab
Talquetamab will be administered subcutaneously.
- DrugProphylaxis A
Prophylaxis A will be administered orally.
- DrugProphylaxis B
Prophylaxis B will be administered orally.
- DrugProphylaxis C
Prophylaxis C will be administered orally.
- DrugProphylaxis D
Prophylaxis D will be administered topically.
- DrugRamantamig
Ramantamig will be administered subcutaneously.
Locations (38)
- University of California San FranciscoSan Francisco, California
- Colorado Blood Cancer InstituteDenver, Colorado
- Yale University School Of MedicineNew Haven, Connecticut
- Icahn School of Medicine at Mt. SinaiNew York, New York
- University of Rochester Medical CenterRochester, New York
- Duke University Medical CenterDurham, North Carolina