A Study to Evaluate Preventive Treatments for GPRC5D-related Oral Events
a study on Multiple Myeloma
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UCSF
- Dates
- study startedstudy ends around
Description
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.
Official Title
A Phase 2, Open-label, Randomized Study to Evaluate GPRC5D-related Oral Events
Keywords
Multiple Myeloma, talquetamab, Prophylaxis A, Prophylaxis B, Prophylaxis C, Prophylaxis D, Ramantamig, Prophylaxis A and Talquetamab, Prophylaxis B and Talquetamab, Prophylaxis C and Talquetamab, Prophylaxis D and Talquetamab
Eligibility
You can join if…
Open to people ages 18 years and up
- 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 not related to multiple myeloma or associated therapy
- Be willing and able to adhere to the lifestyle restrictions specified in the protocol
You CAN'T join if...
- Contraindications or life-threatening known allergies, hypersensitivity, or intolerance to any study drug or its excipients
- Stroke, transient ischemic attack, or seizure within 6 months prior to screening
- Any of the following within 6 months prior to the first dose of study treatment: severe or unstable angina, myocardial infarction; major thromboembolytic event (e.g., pulmonary embolism, cerebrovascular accident), clinically significant ventricular arrythmia or heart failure New York Heart Association functional classification Class III or IV. Uncomplicated deep vein thrombosis is not considered exclusionary
- Major surgery or had significant traumatic injury within 2 weeks prior to the start of administration of study treatment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment
- A WETT score indicating severe dysgeusia at screening and confirmed prior to randomization. Also unresolved/severe dysgeusia referred by the participant or a finding in the physical examination/oral cavity inspection. Some examples include leukoplakia, prior mouth cancers, extensive dental caries, severe periodontitis, active oral infections, candidiasis, parotic gland removal, or radiotherapy with resultant xerostomia
Locations
- University of California San Francisco
accepting new patients
San Francisco California 94143 United States - University of Washington
accepting new patients
Seattle Washington 98109 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Janssen Research & Development, LLC
- ID
- NCT06500884
- Phase
- Phase 2 Multiple Myeloma Research Study
- Study Type
- Interventional
- Participants
- Expecting 210 study participants
- Last Updated
Please contact me about this study
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