Tests ways to prevent taste changes from talquetamab in myeloma
Tests preventive treatments for taste changes caused by talquetamab in adults with multiple myeloma.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate Preventive Treatments for GPRC5D-related Oral Events
Key facts
- Where
- Amsterdam, Dordrecht, and Rotterdam, NetherlandsSee the 3 sites
- Phase
- Phase 2
Where in Netherlands
- Amsterdam UMC StichtingAmsterdam, NetherlandsTaking people
- Albert Schweitzer ZiekenhuisDordrecht, NetherlandsTaking people
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Janssen Research & Development, LLC
- Trial code
- NCT06500884EU 2023-506260-14-00
- Record updated
- 25 September 2026
- Original description
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.Read full original descriptionShow less
A Phase 2, Open-label, Randomized Study to Evaluate GPRC5D-related Oral Events
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.
Inclusion: 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.
Exclusion: 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; Contraindications or life-threatening known allergies, hypersensitivity, or intolerance to any study drug or its excipients.