A Study to Evaluate Preventive Treatments for Talquetamab-related Oral Toxicity

Last updated: June 20, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Cancer

Bone Diseases

Cancer/tumors

Treatment

Prophylaxis C

Prophylaxis A

Talquetamab

Clinical Study ID

NCT06500884
64407564MMY2006
2023-506260-14-00
64407564MMY2006
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Multiple myeloma (MM) according to IMWG diagnostic criteria

  • Were triple-class exposed (received prior treatment with a PI, an IMiD, and antiCD38 mAb)

  • Documented evidence of progressive disease based on investigator's determination ofresponse by IMWG criteria on or after their last regimen

  • Have an Eastern Cooperative Oncology Group-performance status (ECOG-PS) of 0 or 1 atscreening. Participants with ECOG-PS 2 or 3 are eligible for the study if theECOG-PS score is related to stable physical limitations (e.g., wheelchair-bound dueto prior spinal cord injury) and not related to multiple myeloma or associatedtherapy

  • Be willing and able to adhere to the lifestyle restrictions specified in theprotocol

Exclusion

Exclusion Criteria:

  • Contraindications or life-threatening known allergies, hypersensitivity, orintolerance 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 significantventricular arrythmia or heart failure New York Heart Association functionalclassification Class III or IV. Uncomplicated deep vein thrombosis is not consideredexclusionary

  • Major surgery or had significant traumatic injury within 2 weeks prior to the startof administration of talquetamab, or will not have fully recovered from surgery, orhas major surgery planned during the time the participant is expected to be treatedin the study or within 2 weeks after administration of the last dose of studytreatment

  • A WETT score suggesting severe dysgeusia at screening. Also unresolved/severedysgeusia referred by the participant or a finding in the physical examination/oralcavity inspection. Some examples include leukoplakia, prior mouth cancers, extensivedental caries, severe periodontitis, active oral infections, candidiasis, paroticgland removal, or radiotherapy with resultant xerostomia

Study Design

Total Participants: 130
Treatment Group(s): 4
Primary Treatment: Prophylaxis C
Phase: 2
Study Start date:
August 26, 2024
Estimated Completion Date:
October 18, 2027

Connect with a study center

  • Instituto D Or de Pesquisa e Ensino IDOR

    Sao Paulo, 04543-000
    Brazil

    Active - Recruiting

  • Samsung Medical Center

    Seoul, 135-230
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • The Catholic University of Korea Seoul St Mary s Hospital

    Seoul, 06591
    Korea, Republic of

    Active - Recruiting

  • VUMC Amsterdam

    Amsterdam, 1081 HV
    Netherlands

    Active - Recruiting

  • Albert Schweitzer Ziekenhuis

    Dordrecht, 3318 AT
    Netherlands

    Active - Recruiting

  • Hospital Espanol Auxilio Mutuo Auxilio Mutuo Cancer Center

    San Juan, 00918
    Puerto Rico

    Active - Recruiting

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, 08916
    Spain

    Active - Recruiting

  • Hosp. Univ. Virgen de La Arrixaca

    El Palmar, 30120
    Spain

    Active - Recruiting

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

  • Hosp. Quiron Madrid Pozuelo

    Pozuelo de Alarcon, 28223
    Spain

    Active - Recruiting

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007
    Spain

    Active - Recruiting

  • Colchester Hospital University NHS

    Colchester, CO4 5JL
    United Kingdom

    Active - Recruiting

  • The Clatterbridge Cancer Centre

    Liverpool, L7 8YA
    United Kingdom

    Active - Recruiting

  • Hammersmith Hospital

    London, W12 0HS
    United Kingdom

    Active - Recruiting

  • University College London Hospitals

    London, NW1 2BU
    United Kingdom

    Active - Recruiting

  • The Christie NHS Foundation Trust Christie Hospital

    Manchester, M20 4BX
    United Kingdom

    Active - Recruiting

  • University of California San Francisco

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Colorado Blood Cancer Institute

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Yale University School Of Medicine

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mt. Sinai

    New York, New York 10029
    United States

    Active - Recruiting

  • University of Rochester Medical Center

    Rochester, New York 14642
    United States

    Active - Recruiting

  • Duke University Medical Center

    Durham, North Carolina 27705
    United States

    Active - Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Virginia Commonwealth University - Massey Cancer Center

    Richmond, Virginia 23298
    United States

    Active - Recruiting

  • University of Washington

    Seattle, Washington 98109
    United States

    Active - Recruiting

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