A Study to Evaluate Preventive Treatments for Talquetamab-related Oral Toxicity

Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Jul 8, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at ways to prevent a side effect called distorted taste (or dysgeusia) that some patients experience while taking a medication called talquetamab for multiple myeloma, a type of blood cancer. The researchers want to find treatments that can help reduce how often this side effect happens, how severe it is, and how long it lasts. They are also interested in better understanding the signs and symptoms related to this taste change.

To join the study, participants need to be between the ages of 65 to 74 and must have been diagnosed with multiple myeloma based on specific medical guidelines. They should have received certain types of previous treatments and have stable physical health. However, there are some health conditions that would prevent someone from participating, such as serious heart issues or severe allergies to any of the study medications. If someone decides to take part in this trial, they will be closely monitored and can expect to follow specific lifestyle guidelines during the study. This research is important to help improve the quality of life for patients undergoing treatment for multiple myeloma.

Gender

ALL

Eligibility criteria

• 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