A Study to Evaluate Preventive Treatments for Talquetamab-related Oral Toxicity
NCT ID: NCT06500884
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
130 participants
INTERVENTIONAL
2024-08-26
2027-10-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort A: Talquetamab
Participants with relapsed or refractory multiple myeloma (RRMM) who are triple-class exposed (previously exposed to at least 1 proteasome inhibitor \[PI\], 1 immunomodulatory drug(s) \[IMiD\]), and an anti-CD38 monoclonal antibody \[mAb\]) will be treated with talquetamab subcutaneously until disease progression, death, unacceptable toxicity, withdrawal of consent, discontinuation of talquetamab, or end of study, whichever occurs first.
Talquetamab
Talquetamab will be administered subcutaneously.
Cohort B: Prophylaxis A and Talquetamab
Participants with RRMM who are triple-class exposed (previously exposed to at least 1 PI, 1 IMiD, and an anti-CD38 mAb) will receive prophylaxis A along with talquetamab therapy. Participants will start the assigned prophylaxis 7 days before starting talquetamab treatment. After step-up dosing of talquetamab therapy, participants will be treated with talquetamab with prophylaxes for up to 12 months during prophylaxis treatment phase (if there are clinical benefits prophylaxis treatment can continue beyond 12 months, at the treating physician's discretion, after consultation with sponsor). The Talquetamab treatment phase will continue from Cycle 1 Day 1 (C1D1) until disease progression, death, unacceptable toxicity, withdrawal of consent, discontinuation of talquetamab, or end of study, whichever occurs first.
Talquetamab
Talquetamab will be administered subcutaneously.
Prophylaxis A
Prophylaxis A will be administered orally.
Cohort C: Prophylaxis B and Talquetamab
Participants with RRMM who are triple-class exposed (previously exposed to at least 1 PI, 1 IMiD, and an anti-CD38 mAb) will receive prophylaxis B along with talquetamab therapy. Participants will start the assigned prophylaxis 7 days before starting talquetamab treatment. After step-up dosing of talquetamab therapy, participants will be treated with talquetamab with prophylaxes for up to 12 months during prophylaxis treatment phase (if there are clinical benefits prophylaxis treatment can continue beyond 12 months, at the treating physician's discretion, after consultation with sponsor). The Talquetamab treatment phase will continue from C1D1 until disease progression, death, unacceptable toxicity, withdrawal of consent, discontinuation of talquetamab, or end of study, whichever occurs first.
Talquetamab
Talquetamab will be administered subcutaneously.
Prophylaxis B
Prophylaxis B will be administered orally.
Cohort D: Prophylaxis C and Talquetamab
Participants with RRMM who are triple-class exposed (previously exposed to at least 1 PI, 1 IMiD, and an anti-CD38 mAb) will receive prophylaxis C along with talquetamab therapy. Participants will start the assigned prophylaxis 7 days before starting talquetamab treatment. After step-up dosing of talquetamab therapy, participants will be treated with talquetamab with prophylaxes for up to 12 months during prophylaxis treatment phase (if there are clinical benefits prophylaxis treatment can continue beyond 12 months, at the treating physician's discretion, after consultation with sponsor). The Talquetamab treatment phase will continue from C1D1 until disease progression, death, unacceptable toxicity, withdrawal of consent, discontinuation of talquetamab, or end of study, whichever occurs first.
Talquetamab
Talquetamab will be administered subcutaneously.
Prophylaxis C
Prophylaxis C will be administered orally.
Interventions
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Talquetamab
Talquetamab will be administered subcutaneously.
Prophylaxis A
Prophylaxis A will be administered orally.
Prophylaxis B
Prophylaxis B will be administered orally.
Prophylaxis C
Prophylaxis C will be administered orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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University of California San Francisco
San Francisco, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
Icahn School of Medicine at Mt. Sinai
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Virginia Commonwealth University - Massey Cancer Center
Richmond, Virginia, United States
University of Washington
Seattle, Washington, United States
Hospitais Integrados da Gavea SA DF Star
Brasília, , Brazil
Fundacao Universidade de Caxias do Sul
Caxias do Sul, , Brazil
Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer
Curitiba, , Brazil
Instituto D Or de Pesquisa e Ensino
Salvador, , Brazil
Clinica Medica Sao Germano S/S LTDA
São Paulo, , Brazil
Instituto D Or de Pesquisa e Ensino IDOR
São Paulo, , Brazil
VUMC Amsterdam
Amsterdam, , Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Hospital Espanol Auxilio Mutuo Auxilio Mutuo Cancer Center
San Juan, , Puerto Rico
Seoul National University Hospital
Seoul, , South Korea
The Catholic University of Korea Seoul St Mary s Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hosp. Univ. Germans Trias I Pujol
Badalona, , Spain
Hosp Clinic de Barcelona
Barcelona, , Spain
Hosp. Univ. Virgen de La Arrixaca
El Palmar, , Spain
Hosp. de Jerez de La Frontera
Jerez de la Frontera, , Spain
Hosp. Univ. Ramon Y Cajal
Madrid, , Spain
Hosp. Univ. 12 de Octubre
Madrid, , Spain
Hosp. Quiron Madrid Pozuelo
Pozuelo de Alarcón, , Spain
Hosp Clinico Univ de Salamanca
Salamanca, , Spain
Belfast City Hospital
Belfast, , United Kingdom
Colchester Hospital University NHS
Colchester, , United Kingdom
Eastbourne District General Hospital
Eastbourne, , United Kingdom
The Clatterbridge Cancer Centre
Liverpool, , United Kingdom
University College London Hospitals
London, , United Kingdom
Hammersmith Hospital
London, , United Kingdom
The Christie NHS Foundation Trust Christie Hospital
Manchester, , United Kingdom
Newcastle Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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64407564MMY2006
Identifier Type: OTHER
Identifier Source: secondary_id
2023-506260-14-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
64407564MMY2006
Identifier Type: -
Identifier Source: org_study_id