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

Last updated: February 12, 2026
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Cancer/tumors

Lymphoproliferative Disorders

Multiple Myeloma

Treatment

Prophylaxis A

Talquetamab

Prophylaxis B

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 A
Phase: 2
Study Start date:
August 26, 2024
Estimated Completion Date:
April 30, 2029

Connect with a study center

  • Hospitais Integrados da Gavea SA DF Star

    Brasília 3469058, 70390-140
    Brazil

    Active - Recruiting

  • Fundacao Universidade de Caxias do Sul

    Caxias do Sul 3466537, 95070 560
    Brazil

    Active - Recruiting

  • Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer

    Curitiba 3464975, 81520-060
    Brazil

    Active - Recruiting

  • Instituto D Or de Pesquisa e Ensino

    Salvador 3450554, 41253 190
    Brazil

    Active - Recruiting

  • Instituto D Or de Pesquisa e Ensino IDOR

    Sao Paulo, 04543-000
    Brazil

    Site Not Available

  • Clinica Medica Sao Germano S/S LTDA

    São Paulo 3448439, 01455 010
    Brazil

    Active - Recruiting

  • Instituto D Or de Pesquisa e Ensino IDOR

    São Paulo 3448439, 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

    Site Not Available

  • The Catholic University of Korea Seoul St Mary s Hospital

    Seoul, 06591
    Korea, Republic of

    Active - Recruiting

  • VUMC Amsterdam

    Amsterdam, 1081 HV
    Netherlands

    Site Not Available

  • VUMC Amsterdam

    Amsterdam 2759794, 1081 HV
    Netherlands

    Active - Recruiting

  • Albert Schweitzer Ziekenhuis

    Dordrecht, 3318 AT
    Netherlands

    Site Not Available

  • Albert Schweitzer Ziekenhuis

    Dordrecht 2756669, 3318 AT
    Netherlands

    Active - Recruiting

  • Erasmus MC

    Rotterdam, 3015 CN
    Netherlands

    Site Not Available

  • Erasmus MC

    Rotterdam 2747891, 3015 CN
    Netherlands

    Active - Recruiting

  • Hospital Espanol Auxilio Mutuo Auxilio Mutuo Cancer Center

    San Juan, 00918
    Puerto Rico

    Site Not Available

  • Hospital Espanol Auxilio Mutuo Auxilio Mutuo Cancer Center

    San Juan 4568127, 00918
    Puerto Rico

    Active - Recruiting

  • Samsung Medical Center

    Seoul 1835848, 135-230
    South Korea

    Active - Recruiting

  • Seoul National University Hospital

    Seoul 1835848, 03080
    South Korea

    Active - Recruiting

  • The Catholic University of Korea Seoul St Mary s Hospital

    Seoul 1835848, 06591
    South Korea

    Active - Recruiting

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, 08916
    Spain

    Site Not Available

  • Hosp. Univ. Germans Trias I Pujol

    Badalona 3129028, 08916
    Spain

    Active - Recruiting

  • Hosp Clinic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hosp Clinic de Barcelona

    Barcelona 3128760, 08036
    Spain

    Active - Recruiting

  • Hosp. Univ. Virgen de La Arrixaca

    El Palmar, 30120
    Spain

    Site Not Available

  • Hosp. Univ. Virgen de La Arrixaca

    El Palmar 2518293, 30120
    Spain

    Active - Recruiting

  • Hosp. de Jerez de La Frontera

    Jerez de la Frontera 2516326, 11407
    Spain

    Active - Recruiting

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

  • Hosp. Univ. 12 de Octubre

    Madrid 3117735, 28041
    Spain

    Active - Recruiting

  • Hosp. Univ. Ramon Y Cajal

    Madrid 3117735, 28034
    Spain

    Active - Recruiting

  • Hosp. Quiron Madrid Pozuelo

    Pozuelo de Alarcon, 28223
    Spain

    Site Not Available

  • Hosp. Quiron Madrid Pozuelo

    Pozuelo de Alarcón 3112989, 28223
    Spain

    Active - Recruiting

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007
    Spain

    Site Not Available

  • Hosp Clinico Univ de Salamanca

    Salamanca 3111108, 37007
    Spain

    Active - Recruiting

  • Belfast City Hospital

    Belfast 2655984, BT9 7AB
    United Kingdom

    Active - Recruiting

  • Colchester Hospital University NHS

    Colchester, CO4 5JL
    United Kingdom

    Site Not Available

  • Colchester Hospital University NHS

    Colchester 2652618, CO4 5JL
    United Kingdom

    Active - Recruiting

  • Eastbourne District General Hospital

    Eastbourne, BN21 2UD
    United Kingdom

    Site Not Available

  • Eastbourne District General Hospital

    Eastbourne 2650497, BN21 2UD
    United Kingdom

    Active - Recruiting

  • The Clatterbridge Cancer Centre

    Liverpool, L7 8YA
    United Kingdom

    Site Not Available

  • The Clatterbridge Cancer Centre

    Liverpool 2644210, L7 8YA
    United Kingdom

    Active - Recruiting

  • Hammersmith Hospital

    London, W12 0HS
    United Kingdom

    Site Not Available

  • University College London Hospitals

    London, NW1 2BU
    United Kingdom

    Active - Recruiting

  • Hammersmith Hospital

    London 2643743, W12 0HS
    United Kingdom

    Active - Recruiting

  • University College London Hospitals

    London 2643743, NW1 2BU
    United Kingdom

    Active - Recruiting

  • The Christie NHS Foundation Trust Christie Hospital

    Manchester, M20 4BX
    United Kingdom

    Site Not Available

  • The Christie NHS Foundation Trust Christie Hospital

    Manchester 2643123, M20 4BX
    United Kingdom

    Active - Recruiting

  • Newcastle Freeman Hospital

    Newcastle Upon Tyne, NE7 7DN
    United Kingdom

    Site Not Available

  • Newcastle Freeman Hospital

    Newcastle upon Tyne 2641673, NE7 7DN
    United Kingdom

    Active - Recruiting

  • University of California San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

  • University of California San Francisco

    San Francisco 5391959, California 5332921 94143
    United States

    Active - Recruiting

  • Colorado Blood Cancer Institute

    Denver, Colorado 80218
    United States

    Site Not Available

  • Colorado Blood Cancer Institute

    Denver 5419384, Colorado 5417618 80218
    United States

    Active - Recruiting

  • Yale University School Of Medicine

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Yale University School Of Medicine

    New Haven 4839366, Connecticut 4831725 06510
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mt. Sinai

    New York, New York 10029
    United States

    Site Not Available

  • University of Rochester Medical Center

    Rochester, New York 14642
    United States

    Site Not Available

  • Icahn School of Medicine at Mt. Sinai

    New York 5128581, New York 5128638 10029
    United States

    Active - Recruiting

  • University of Rochester Medical Center

    Rochester 5134086, New York 5128638 14642
    United States

    Active - Recruiting

  • Duke University Medical Center

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Duke University Medical Center

    Durham 4464368, North Carolina 4482348 27705
    United States

    Active - Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland 5150529, Ohio 5165418 44106
    United States

    Active - Recruiting

  • Virginia Commonwealth University - Massey Cancer Center

    Richmond, Virginia 23298
    United States

    Site Not Available

  • Virginia Commonwealth University - Massey Cancer Center

    Richmond 4781708, Virginia 6254928 23298
    United States

    Active - Recruiting

  • University of Washington

    Seattle, Washington 98109
    United States

    Site Not Available

  • University of Washington

    Seattle 5809844, Washington 5815135 98109
    United States

    Active - Recruiting

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