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A Study to Evaluate Preventive Treatments for Talquetamab-related Oral Toxicity
Trial Status: active
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.
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 not related to multiple myeloma or associated therapy
Be willing and able to adhere to the lifestyle restrictions specified in the protocol
Exclusion Criteria
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
Additional locations may be listed on ClinicalTrials.gov for NCT06500884.
