A Study to Evaluate Preventive Treatments for Talquetamab-related Oral Toxicity
A Phase 2, Open-label, Randomized Study to Evaluate Prophylactic Interventions on Talquetamab-related Oral Toxicity
Janssen Research & Development, LLC
130 participants
Aug 26, 2024
INTERVENTIONAL
Conditions
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, and to better characterize the signs or symptoms of talquetamab-related taste changes.
Eligibility
Inclusion Criteria5
- 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 Criteria5
- 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 talquetamab, 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 suggesting severe dysgeusia at screening. 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
Interventions
Talquetamab will be administered subcutaneously.
Prophylaxis A will be administered orally.
Prophylaxis B will be administered orally.
Prophylaxis C will be administered orally.
Locations(38)
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NCT06500884