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NCT06500884RecruitingPhase 2

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

A Phase 2, Open-label, Randomized Study to Evaluate GPRC5D-related Oral Events

Source: ClinicalTrials.gov · Last updated 25 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
210 (estimated)
First submitted
8 Jul 2024
Start date
26 Aug 2024
Primary completion date
30 May 2030
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT06500884
EU CT number
2023-506260-14-00

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 210
  • From 26 Aug 2024 to the primary completion date, 30 May 2030
  • 38 sites in 7 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • Contraindications or life-threatening known allergies, hypersensitivity, or intolerance to any study drug or its excipients

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (38)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
IDOR - Regional Brasilia
Coordinator of this site? Confirm its status
BrasíliaBrazilRecruiting
Fundacao Universidade de Caxias Do Sul
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Caxias do SulBrazilRecruiting
Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer
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CuritibaBrazilRecruiting
IDOR - Regional Bahia
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SalvadorBrazilRecruiting
Clinica Medica Sao Germano LTDA
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São PauloBrazilRecruiting
IDOR - Regional Sao Paulo
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São PauloBrazilRecruiting
Institut Catala d'Oncologia
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BadalonaSpainRecruiting
Hospital Clinic de Barcelona
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BarcelonaSpainRecruiting
Hospital de Jerez de la Frontera
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Jerez de la FronteraSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
Hospital Universitario Ramón y Cajal
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MadridSpainRecruiting
University Clinical Hospital Virgen De La Arrixaca
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MurciaSpainRecruiting
Hospital Universitario Quironsalud Madrid
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Pozuelo de AlarcónSpainRecruiting
Hospital Universitario De Salamanca
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SalamancaSpainRecruiting
Belfast City Hospital
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BelfastUnited KingdomRecruiting
Colchester Hospital University NHS
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ColchesterUnited KingdomRecruiting
Eastbourne District General Hospital
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EastbourneUnited KingdomRecruiting
The Clatterbridge Cancer Centre
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LiverpoolUnited KingdomRecruiting
University College London Hospitals
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LondonUnited KingdomRecruiting
Hammersmith Hospital
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LondonUnited KingdomRecruiting
The Christie NHS Foundation Trust - Christie Hospital
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ManchesterUnited KingdomRecruiting
Newcastle Freeman Hospital
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Newcastle upon TyneUnited KingdomCompleted
Seoul National University Hospital
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SeoulSouth KoreaRecruiting
The Catholic University of Korea, Seoul ST. Mary's Hospital
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SeoulSouth KoreaRecruiting
Samsung Medical Center
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SeoulSouth KoreaRecruiting
Amsterdam UMC Stichting
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AmsterdamNetherlandsRecruiting
Albert Schweitzer Ziekenhuis
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DordrechtNetherlandsRecruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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RotterdamNetherlandsRecruiting
Hospital Espanol Auxilio Mutuo Auxilio Mutuo Cancer Center
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San JuanPuerto RicoRecruiting
University Hospitals Cleveland Medical Center*
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ClevelandUnited StatesRecruiting
Colorado Blood Cancer Institute
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DenverUnited StatesRecruiting
Duke University Medical Center
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DurhamUnited StatesRecruiting
Yale University School Of Medicine
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New HavenUnited StatesRecruiting
Icahn School of Medicine at Mt. Sinai
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New YorkUnited StatesRecruiting
Virginia Commonwealth University/Massey Cancer Center
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RichmondUnited StatesRecruiting
University of Rochester Medical Center
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RochesterUnited StatesRecruiting
University of California San Francisco
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San FranciscoUnited StatesRecruiting
University of Washington
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SeattleUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.