A Study to Evaluate Preventive Treatments for GPRC5D-related Oral Events

Recruiting now · Phase 2

Conditions studied: Multiple Myeloma

In brief

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, to better characterize the signs or symptoms of talquetamab-related taste changes and to better characterize the signs or symptoms of ramantamig-related taste changes.

Key facts

Study ID

NCT06500884

Run by

Janssen Research & Development, LLC

People needed

210

Starts

2024-08-26

Expected to finish

2030-05-30

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• University of California San Francisco — San Francisco, California, United States (enrolling)
• Colorado Blood Cancer Institute — Denver, Colorado, United States (enrolling)
• Yale University School Of Medicine — New Haven, Connecticut, United States (enrolling)
• Icahn School of Medicine at Mt. Sinai — New York, New York, United States (enrolling)
• University of Rochester Medical Center — Rochester, New York, United States (enrolling)
• Duke University Medical Center — Durham, North Carolina, United States (enrolling)
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (enrolling)
• Virginia Commonwealth University - Massey Cancer Center — Richmond, Virginia, United States (enrolling)
• University of Washington — Seattle, Washington, United States (enrolling)
• Hospitais Integrados da Gavea SA DF Star — Brasília, Brazil (enrolling)
• Fundacao Universidade de Caxias do Sul — Caxias do Sul, Brazil (enrolling)
• Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer — Curitiba, Brazil (enrolling)
• Instituto D Or de Pesquisa e Ensino — Salvador, Brazil (enrolling)
• Clinica Medica Sao Germano S/S LTDA — São Paulo, Brazil (enrolling)
• Instituto D Or de Pesquisa e Ensino IDOR — São Paulo, Brazil (enrolling)
• VUMC Amsterdam — Amsterdam, Netherlands (enrolling)
• Albert Schweitzer Ziekenhuis — Dordrecht, Netherlands (enrolling)
• Erasmus MC — Rotterdam, Netherlands (enrolling)
• Hospital Espanol Auxilio Mutuo Auxilio Mutuo Cancer Center — San Juan, Puerto Rico (enrolling)
• Seoul National University Hospital — Seoul, South Korea (enrolling)
• The Catholic University of Korea Seoul St Mary s Hospital — Seoul, South Korea (enrolling)
• Samsung Medical Center — Seoul, South Korea (enrolling)
• Hosp. Univ. Germans Trias I Pujol — Badalona, Spain (enrolling)
• Hosp Clinic de Barcelona — Barcelona, Spain (enrolling)
• Hosp. Univ. Virgen de La Arrixaca — El Palmar, Spain (enrolling)

Full record on ClinicalTrials.gov

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