Study on Preventive Treatments for Taste Changes Caused by Talquetamab
Sponsor: Janssen Research & Development, LLC
ClinicalTrials ID:NCT06500884
This clinical trial aims to find ways to prevent or reduce taste changes, known as dysgeusia, that can occur with the use of the drug talquetamab. The study will focus on understanding and managing these taste changes during the preventive treatment phase.
Patient Parameters
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Program Overview
The goal of this study is to discover treatments that can help prevent or lessen the taste changes (dysgeusia) that some people experience when taking talquetamab. Researchers want to understand how often these taste changes happen, how severe they are, and how long they last. This will help in better managing these symptoms for patients undergoing treatment.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with multiple myeloma, a type of blood cancer.
- Previously treated with specific types of cancer drugs, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody.
- Evidence of the disease getting worse after the last treatment, as determined by a doctor.
- Have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory. Those with a score of 2 or 3 may still participate if their limitations are due to stable physical conditions not related to multiple myeloma.
- Willing to follow the lifestyle guidelines outlined in the study protocol.
Exclusion Criteria
- Severe allergies or intolerances to any of the study drugs or their ingredients.
- History of stroke, mini-stroke, or seizures within the last 6 months.
- Recent history (within 6 months) of serious heart problems, such as severe chest pain, heart attack, or major blood clots.
- Major surgery or significant injury within 2 weeks before starting the study treatment, or if not fully recovered from surgery.
- Severe taste changes at the start of the study, or any serious mouth conditions like leukoplakia, past mouth cancers, severe tooth decay, gum disease, active oral infections, or dry mouth due to past treatments.
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