A Study to Evaluate Preventive Treatments for GPRC5D-related Oral Events
NCT06500884 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 210
Last updated 2026-05-08
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.
Conditions
Interventions
- DRUG
-
Talquetamab will be administered subcutaneously.
- DRUG
-
Prophylaxis A
Prophylaxis A will be administered orally.
- DRUG
-
Prophylaxis B
Prophylaxis B will be administered orally.
- DRUG
-
Prophylaxis C
Prophylaxis C will be administered orally.
- DRUG
-
Prophylaxis D
Prophylaxis D will be administered topically.
- DRUG
-
Ramantamig
Ramantamig will be administered subcutaneously.
Sponsors & Collaborators
-
Janssen Research & Development, LLC
lead INDUSTRY
Principal Investigators
-
Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-08-26
- Primary Completion
- 2030-05-30
- Completion
- 2030-05-30
- FDA Drug
- Yes
Countries
- United States
- Brazil
- Netherlands
- Puerto Rico
- South Korea
- Spain
- United Kingdom
Study Locations
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