Evaluating treatments to prevent taste changes from talquetamab in multiple myeloma patients
A Phase 2, Open-label, Randomized Study to Evaluate GPRC5D-related Oral Events
This study is testing different treatments to see if they can help multiple myeloma patients avoid or lessen taste changes caused by the drug talquetamab.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Janssen Research & Development, LLC Industry-sponsored |
| Drugs / interventions | talquetamab |
| Locations | 38 sites (San Francisco, California and 37 other locations) |
| Trial ID | NCT06500884 on ClinicalTrials.gov |
What this trial studies
This study aims to identify preventive treatments that can reduce the occurrence, severity, and duration of taste changes (dysgeusia) associated with talquetamab in patients with relapse or refractory multiple myeloma. Participants will receive various prophylactic treatments during the preventive phase to assess their effectiveness. The study will also characterize the signs and symptoms related to talquetamab-induced taste changes. It is designed as a Phase 2 interventional trial to gather data on these preventive measures.
Who should consider this trial
Good fit: Ideal candidates include adults with relapse or refractory multiple myeloma who have previously been treated with multiple classes of therapies and have a stable performance status.
Not a fit: Patients who have contraindications to talquetamab or those with severe neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the quality of life for multiple myeloma patients undergoing treatment with talquetamab by minimizing unpleasant taste changes.
How similar studies have performed: While there is limited information on similar studies specifically targeting talquetamab-related taste changes, the approach of preventive treatment in oncology has shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
San Francisco, California and 37 other locations
- University of California San Francisco — San Francisco, California, United States (Recruiting)
- Colorado Blood Cancer Institute — Denver, Colorado, United States (Recruiting)
- Yale University School Of Medicine — New Haven, Connecticut, United States (Recruiting)
- Icahn School of Medicine at Mt. Sinai — New York, New York, United States (Recruiting)
- University of Rochester Medical Center — Rochester, New York, United States (Recruiting)
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (Recruiting)
- Virginia Commonwealth University - Massey Cancer Center — Richmond, Virginia, United States (Recruiting)
- University of Washington — Seattle, Washington, United States (Recruiting)
- Hospitais Integrados da Gavea SA DF Star — Brasília, Brazil (Recruiting)
- Fundacao Universidade de Caxias do Sul — Caxias do Sul, Brazil (Recruiting)
- Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer — Curitiba, Brazil (Recruiting)
- Instituto D Or de Pesquisa e Ensino — Salvador, Brazil (Recruiting)
- Clinica Medica Sao Germano S/S LTDA — São Paulo, Brazil (Recruiting)
- Instituto D Or de Pesquisa e Ensino IDOR — São Paulo, Brazil (Recruiting)
- VUMC Amsterdam — Amsterdam, Netherlands (Recruiting)
- Albert Schweitzer Ziekenhuis — Dordrecht, Netherlands (Recruiting)
- Erasmus MC — Rotterdam, Netherlands (Recruiting)
- Hospital Espanol Auxilio Mutuo Auxilio Mutuo Cancer Center — San Juan, Puerto Rico (Recruiting)
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
- The Catholic University of Korea Seoul St Mary s Hospital — Seoul, South Korea (Recruiting)
- Samsung Medical Center — Seoul, South Korea (Recruiting)
- Hosp. Univ. Germans Trias I Pujol — Badalona, Spain (Recruiting)
- Hosp Clinic de Barcelona — Barcelona, Spain (Recruiting)
- Hosp. Univ. Virgen de La Arrixaca — El Palmar, Spain (Recruiting)
- Hosp. de Jerez de La Frontera — Jerez de la Frontera, Spain (Recruiting)
- Hosp. Univ. Ramon Y Cajal — Madrid, Spain (Recruiting)
- Hosp. Univ. 12 de Octubre — Madrid, Spain (Recruiting)
- Hosp. Quiron Madrid Pozuelo — Pozuelo de Alarcón, Spain (Recruiting)
- Hosp Clinico Univ de Salamanca — Salamanca, Spain (Recruiting)
- Belfast City Hospital — Belfast, United Kingdom (Recruiting)
- Colchester Hospital University NHS — Colchester, United Kingdom (Recruiting)
- Eastbourne District General Hospital — Eastbourne, United Kingdom (Recruiting)
- The Clatterbridge Cancer Centre — Liverpool, United Kingdom (Recruiting)
- University College London Hospitals — London, United Kingdom (Recruiting)
- Hammersmith Hospital — London, United Kingdom (Recruiting)
- The Christie NHS Foundation Trust Christie Hospital — Manchester, United Kingdom (Recruiting)
- Newcastle Freeman Hospital — Newcastle upon Tyne, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.