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

NCT06500884 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 64407564MMY20062023-506260-14-00
• Study Type: interventional
• Target: 210
• Locations: 7 countries
• Sites: 38

Brief 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, 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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (5)

• Percentage of Participants With Occurrence of Dysgeusia as Assessed by the Total Waterless Empirical Taste Test (WETT) Testing Score During the Prophylaxis Treatment Phase

  Dysgeusia is defined as total WETT score of 25th percentile or below according to the Normative WETT-SA53 percentile table. Taste assessment will be performed using taste strips (WETT). Four concentrations (4=lowest concentration, 1=highest concentration) will be used for each taste quality: sweet, sour, salty, bitter, and umami. Each test kit contains 53 taste strips distributed in 4 packs; and each taste strip is numbered (1 through 53). Participants will use each strip sequentially and record the flavor on a score card provided. The test will result in a maximum (that is, best) total score of 53. The score will be graded by a qualified site staff into a normative percentile score using a provided chart.

  Up to 12 months

• Percentage of Participants With Occurrence of Severe Dysgeusia During the Prophylaxis Treatment Phase

  Severe Dysgeusia is defined as a total WETT score of 10th percentile or below according to the normative WETT-SA53 percentile table. Taste assessment will be performed using taste strips (WETT). Four concentrations (4=lowest concentration, 1=highest concentration) will be used for each taste quality: sweet, sour, salty, bitter, and umami. Each test kit contains 53 taste strips distributed in 4 packs; and each taste strip is numbered (1 through 53). Participants will use each strip sequentially and record the flavor on a score card provided. The test will result in a maximum (that is, best) total score of 53. The score will be graded by a qualified site staff into a normative percentile score using a provided chart.

  Up to 12 months

• Time to the First Onset of Severe Dysgeusia During the Prophylaxis Treatment Phase

  Time to the first onset of severe dysgeusia is defined as time from the first dose date of talquetamab to the first onset date of severe dysgeusia according to the total WETT score. For participants without severe dysgeusia, time to the first onset will be censored. Taste assessment will be performed using taste strips (WETT). Four concentrations (4=lowest concentration, 1=highest concentration) will be used for each taste quality: sweet, sour, salty, bitter, and umami. Each test kit contains 53 taste strips distributed in 4 packs; and each taste strip is numbered (1 through 53). Participants will use each strip sequentially and record the flavor on a score card provided. The test will result in a maximum (that is, best) total score of 53. The score will be graded by a qualified site staff into a normative percentile score using a provided chart.

  Up to 12 months

• Percentage of Participants Who Report Resolution/Improvement of Dysgeusia During the Prophylaxis Treatment Phase

  Resolution/improvement is defined as 2 potential scenarios: 1) A dysgeusia downgraded to dysgeusia-free, that is (i.e.,) total WETT score of 25th percentile or below at visits prior to the end of month 3 becomes total WETT score above 25th percentile at the end of month 3. 2) Severe dysgeusia downgraded to non-severe dysgeusia, i.e., total WETT score of 10th percentile or below prior to the end of month 3 becomes total WETT score above 10th percentile at the end of month 3. Taste assessment will be performed using taste strips (WETT). Four concentrations will be used for each taste quality: sweet, sour, salty, bitter, \& umami. Each test kit contains 53 taste strips; numbered (1 through 53). Participants will use each strip sequentially and record flavor on score card provided. Test will result in maximum (i.e., best) total score of 53. Score will be graded by qualified staff into normative percentile score using provided chart.

  End of Month 3

• Percentage of Participants Who Report Resolution/Improvement of Dysgeusia During the Prophylaxis Treatment Phase

  Resolution/improvement is defined as 2 potential scenarios: 1) A dysgeusia downgraded to dysgeusia-free, that is (i.e.,) total WETT score of 25th percentile or below at visits prior to the end of month 7 becomes total WETT score above 25th percentile at the end of month 7. 2) Severe dysgeusia downgraded to non-severe dysgeusia, i.e., total WETT score of 10th percentile or below prior to the end of month 7 becomes total WETT score above 10th percentile at the end of month 7. Taste assessment will be performed using taste strips (WETT). Four concentrations will be used for each taste quality: sweet, sour, salty, bitter, \& umami. Each test kit contains 53 taste strips; numbered (1 through 53). Participants will use each strip sequentially and record flavor on score card provided. Test will result in maximum (i.e., best) total score of 53. Score will be graded by qualified staff into normative percentile score using provided chart.

  End of Month 7

Secondary Outcomes (23)

• Change From Baseline in WETT Testing Score Over Time

  Baseline up to 36 months

• Percentage of Time with Dysgeusia During the Prophylaxis Treatment Phase

  Up to 12 months

• Percentage of Participants with Treatment-Emergent Oral Toxicities (Dysgeusia, Oral Mucositis, Dysphagia, and Xerostomia) During the Prophylaxis Treatment Phase

  Up to 12 months

• Percentage of Participants with Treatment-Emergent Oral Toxicities (Dysgeusia, Oral Mucositis, Dysphagia, and Xerostomia) During the Study

  Up to 30 days after the last dose of study treatment (that is, approximately up to 36 months)

• Time to the First Onset of Treatment-Emergent Oral Toxicities (Dysgeusia, Oral Mucositis, Dysphagia, and Xerostomia)

  Up to 36 months

Study Arms (6)

Cohort A: Talquetamab

ACTIVE COMPARATOR

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.

Drug: Talquetamab

Cohort B: Prophylaxis A and Talquetamab

EXPERIMENTAL

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.

Drug: Talquetamab; Drug: Prophylaxis A

Cohort C: Prophylaxis B and Talquetamab

EXPERIMENTAL

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.

Drug: Talquetamab; Drug: Prophylaxis B

Cohort D: Prophylaxis C and Talquetamab

EXPERIMENTAL

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.

Drug: Talquetamab; Drug: Prophylaxis C

Cohort E: Prophylaxis D and Talquetamab

EXPERIMENTAL

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 D along with talquetamab therapy. Participants will start the assigned prophylaxis 1 day 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.

Drug: Talquetamab; Drug: Prophylaxis D

Cohort F: Ramantamig

EXPERIMENTAL

Participants with RRMM who are triple-class exposed (previously exposed to at least 1 PI, 1 IMiD, and an anti-CD38 mAb) will receive single step-up dose of ramantamig subcutaneously followed by the treatment dose until disease progression, death, unacceptable toxicity, withdrawal of consent, discontinuation of ramantamig, or end of study, whichever occurs first.

Drug: Ramantamig

Interventions

Prophylaxis B DRUG

Prophylaxis B will be administered orally.

Cohort C: Prophylaxis B and Talquetamab

Prophylaxis D DRUG

Prophylaxis D will be administered topically.

Cohort E: Prophylaxis D and Talquetamab

Ramantamig DRUG

Ramantamig will be administered subcutaneously.

Also known as: BCMAxGPRC5DxCD3

Cohort F: Ramantamig

Talquetamab DRUG

Talquetamab will be administered subcutaneously.

Also known as: CD3xGPRC5D

Cohort A: Talquetamab; Cohort B: Prophylaxis A and Talquetamab; Cohort C: Prophylaxis B and Talquetamab; Cohort D: Prophylaxis C and Talquetamab; Cohort E: Prophylaxis D and Talquetamab

Prophylaxis A DRUG

Prophylaxis A will be administered orally.

Cohort B: Prophylaxis A and Talquetamab

Prophylaxis C DRUG

Prophylaxis C will be administered orally.

Cohort D: Prophylaxis C and Talquetamab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (38)

University of California San Francisco

San Francisco, California, 94143, United States

RECRUITING

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

RECRUITING

Yale University School Of Medicine

New Haven, Connecticut, 06510, United States

RECRUITING

Icahn School of Medicine at Mt. Sinai

New York, New York, 10029, United States

RECRUITING

University of Rochester Medical Center

Rochester, New York, 14642, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27705, United States

RECRUITING

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

Virginia Commonwealth University - Massey Cancer Center

Richmond, Virginia, 23298, United States

RECRUITING

University of Washington

Seattle, Washington, 98109, United States

RECRUITING

Hospitais Integrados da Gavea SA DF Star

Brasília, 70390-140, Brazil

RECRUITING

Fundacao Universidade de Caxias do Sul

Caxias do Sul, 95070 560, Brazil

RECRUITING

Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer

Curitiba, 81520-060, Brazil

RECRUITING

Instituto D Or de Pesquisa e Ensino

Salvador, 41253 190, Brazil

RECRUITING

Clinica Medica Sao Germano S/S LTDA

São Paulo, 01455 010, Brazil

RECRUITING

Instituto D Or de Pesquisa e Ensino IDOR

São Paulo, 04543-000, Brazil

RECRUITING

VUMC Amsterdam

Amsterdam, 1081 HV, Netherlands

RECRUITING

Albert Schweitzer Ziekenhuis

Dordrecht, 3318 AT, Netherlands

RECRUITING

Erasmus MC

Rotterdam, 3015 CN, Netherlands

RECRUITING

Hospital Espanol Auxilio Mutuo Auxilio Mutuo Cancer Center

San Juan, 00918, Puerto Rico

RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

The Catholic University of Korea Seoul St Mary s Hospital

Seoul, 06591, South Korea

RECRUITING

Samsung Medical Center

Seoul, 135-230, South Korea

RECRUITING

Hosp. Univ. Germans Trias I Pujol

Badalona, 08916, Spain

RECRUITING

Hosp Clinic de Barcelona

Barcelona, 08036, Spain

RECRUITING

Hosp. Univ. Virgen de La Arrixaca

El Palmar, 30120, Spain

RECRUITING

Hosp. de Jerez de La Frontera

Jerez de la Frontera, 11407, Spain

RECRUITING

Hosp. Univ. Ramon Y Cajal

Madrid, 28034, Spain

RECRUITING

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hosp. Quiron Madrid Pozuelo

Pozuelo de Alarcón, 28223, Spain

RECRUITING

Hosp Clinico Univ de Salamanca

Salamanca, 37007, Spain

RECRUITING

Belfast City Hospital

Belfast, BT9 7AB, United Kingdom

RECRUITING

Colchester Hospital University NHS

Colchester, CO4 5JL, United Kingdom

RECRUITING

Eastbourne District General Hospital

Eastbourne, BN21 2UD, United Kingdom

RECRUITING

The Clatterbridge Cancer Centre

Liverpool, L7 8YA, United Kingdom

RECRUITING

University College London Hospitals

London, NW1 2BU, United Kingdom

RECRUITING

Hammersmith Hospital

London, W12 0HS, United Kingdom

RECRUITING

The Christie NHS Foundation Trust Christie Hospital

Manchester, M20 4BX, United Kingdom

RECRUITING

Newcastle Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

talquetamab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 15, 2024
• Study Start: August 26, 2024
• Primary Completion: April 15, 2026
• Study Completion (Estimated): April 30, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (9); BR (6); ES (8); PR (1); NL (3); GB (8); KR (3)