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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Talquetamab; Drug: Prophylaxis A; Drug: Prophylaxis B; Drug: Prophylaxis C; Drug: Prophylaxis D; Drug: Ramantamig

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study1@its.jnj.com

Study Locations

• Brazil
  • Brasília, Brazil, 70390-140
    • Recruiting
    • Hospitais Integrados da Gavea SA DF Star
  • Caxias do Sul, Brazil, 95070 560
    • Recruiting
    • Fundacao Universidade de Caxias do Sul
  • Curitiba, Brazil, 81520-060
    • Recruiting
    • Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer
  • Salvador, Brazil, 41253 190
    • Recruiting
    • Instituto D Or de Pesquisa e Ensino
  • São Paulo, Brazil, 01455 010
    • Recruiting
    • Clinica Medica Sao Germano S/S LTDA
  • São Paulo, Brazil, 04543-000
    • Recruiting
    • Instituto D Or de Pesquisa e Ensino IDOR
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • Recruiting
    • VUMC Amsterdam
  • Dordrecht, Netherlands, 3318 AT
    • Recruiting
    • Albert Schweitzer Ziekenhuis
  • Rotterdam, Netherlands, 3015 CN
    • Recruiting
    • Erasmus MC
• Puerto Rico
  • San Juan, Puerto Rico, 00918
    • Recruiting
    • Hospital Espanol Auxilio Mutuo Auxilio Mutuo Cancer Center
• South Korea
  • Seoul, South Korea, 03080
    • Recruiting
    • Seoul National University Hospital
  • Seoul, South Korea, 06591
    • Recruiting
    • The Catholic University of Korea Seoul St Mary s Hospital
  • Seoul, South Korea, 135-230
    • Recruiting
    • Samsung Medical Center
• Spain
  • Badalona, Spain, 08916
    • Recruiting
    • Hosp. Univ. Germans Trias I Pujol
  • Barcelona, Spain, 08036
    • Recruiting
    • Hosp Clinic de Barcelona
  • El Palmar, Spain, 30120
    • Recruiting
    • Hosp. Univ. Virgen de La Arrixaca
  • Jerez de la Frontera, Spain, 11407
    • Recruiting
    • Hosp. de Jerez de La Frontera
  • Madrid, Spain, 28034
    • Recruiting
    • Hosp. Univ. Ramon Y Cajal
  • Madrid, Spain, 28041
    • Recruiting
    • Hosp. Univ. 12 de Octubre
  • Pozuelo de Alarcón, Spain, 28223
    • Recruiting
    • Hosp. Quiron Madrid Pozuelo
  • Salamanca, Spain, 37007
    • Recruiting
    • Hosp Clinico Univ de Salamanca
• United Kingdom
  • Belfast, United Kingdom, BT9 7AB
    • Recruiting
    • Belfast City Hospital
  • Colchester, United Kingdom, CO4 5JL
    • Recruiting
    • Colchester Hospital University NHS
  • Eastbourne, United Kingdom, BN21 2UD
    • Recruiting
    • Eastbourne District General Hospital
  • Liverpool, United Kingdom, L7 8YA
    • Recruiting
    • The Clatterbridge Cancer Centre
  • London, United Kingdom, W12 0HS
    • Recruiting
    • Hammersmith Hospital
  • London, United Kingdom, NW1 2BU
    • Recruiting
    • University College London Hospitals
  • Manchester, United Kingdom, M20 4BX
    • Recruiting
    • The Christie NHS Foundation Trust Christie Hospital
  • Newcastle upon Tyne, United Kingdom, NE7 7DN
    • Recruiting
    • Newcastle Freeman Hospital
• United States
  • California
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California San Francisco
  • Colorado
    • Denver, Colorado, United States, 80218
      • Recruiting
      • Colorado Blood Cancer Institute
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Recruiting
      • Yale University School Of Medicine
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Icahn School of Medicine at Mt. Sinai
    • Rochester, New York, United States, 14642
      • Recruiting
      • University of Rochester Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Recruiting
      • Duke University Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals Cleveland Medical Center
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Recruiting
      • Virginia Commonwealth University - Massey Cancer Center
  • Washington
    • Seattle, Washington, United States, 98109
      • Recruiting
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Talquetamab; Talquetamab will be administered subcutaneously.; Other Names: CD3xGPRC5D
Experimental: 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.	Drug: Talquetamab; Talquetamab will be administered subcutaneously.; Other Names: CD3xGPRC5D; Drug: Prophylaxis A; Prophylaxis A will be administered orally.
Experimental: 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.	Drug: Talquetamab; Talquetamab will be administered subcutaneously.; Other Names: CD3xGPRC5D; Drug: Prophylaxis B; Prophylaxis B will be administered orally.
Experimental: 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.	Drug: Talquetamab; Talquetamab will be administered subcutaneously.; Other Names: CD3xGPRC5D; Drug: Prophylaxis C; Prophylaxis C will be administered orally.
Experimental: Cohort E: Prophylaxis D 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 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; Talquetamab will be administered subcutaneously.; Other Names: CD3xGPRC5D; Drug: Prophylaxis D; Prophylaxis D will be administered topically.
Experimental: Cohort F: Ramantamig; 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; Ramantamig will be administered subcutaneously.; Other Names: BCMAxGPRC5DxCD3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Time with Dysgeusia During the Prophylaxis Treatment Phase	Time with dysgeusia is defined as the accumulative days a participant had dysgeusia according to the total WETT score divided by the total days of talquetamab exposure. 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
Change from Baseline in Smell Identification Test Score	Smell identification testing will be performed using 4 booklets each containing 10 labels that will release a distinctive scent when scraped with a pencil. Participants will choose the appropriate scent from the associated options. The minimum possible score is a 0 and the maximum is a 40. A higher score indicates better smell/outcome.	Baseline (Day 1 Cycle 1), Day 1 Cycle 2 (each cycle duration=28-days)
Change From Baseline in WETT Testing Score Over Time	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.	Baseline up to 36 months
Percentage of Participants with Treatment-Emergent Oral Toxicities (Dysgeusia, Oral Mucositis, Dysphagia, and Xerostomia) During the Prophylaxis Treatment Phase	Oral toxicity including dysgeusia, oral mucositis, dysphagia, and xerostomia will be graded (including Grade 0 for dysgeusia) based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 5.0. Severity has 5 grades based on CTCAE criteria: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening consequences; and Grade 5: Death.	Up to 12 months
Percentage of Participants with Treatment-Emergent Oral Toxicities (Dysgeusia, Oral Mucositis, Dysphagia, and Xerostomia) During the Study	Oral toxicity including dysgeusia, oral mucositis, dysphagia, and xerostomia will be graded (including Grade 0 for dysgeusia) based on NCI-CTCAE, Version 5.0. Severity has 5 grades based on CTCAE criteria: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening consequences; and Grade 5: Death.	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)	Time to the first onset of treatment-emergent dysgeusia, oral mucositis, dysphagia, or xerostomia, will be reported.	Up to 36 months
Duration of Treatment-emergent Oral Toxicities (Dysgeusia, Oral Mucositis, Dysphagia, and Xerostomia)	Duration of treatment-emergent oral toxicities including dysgeusia, oral mucositis, dysphagia, and xerostomia will be reported in this outcome measure.	Up to 36 months
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 items (EORTC-QLQ-C30) Domains Scores Over Time	The EORTC-QLQ-C30 includes 30 items that make up 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea/vomiting), and 5 single symptom items (dyspnea, insomnia, appetite loss, constipation, and diarrhea) and a single impact item (financial difficulties). The recall period is 7 days, and responses are reported using verbal and numeric rating scales. The item and scale scores are transformed to a 0 to 100 scale. A high scale score represents a higher response level. A high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status represents high health related quality of life (HRQoL), but a high score for a symptom scale/item represents a high level of symptomatology/problems.	From Baseline, up to 12 months (Cohorts A to E); up to 24 months (for Cohort F)
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Oral Health (EORTC-QLQ-OH15) Domains Scores Over Time	The EORTC module QLQ-OH15 is a 15-item, well-accepted, and validated assessment tool focusing on oral problems and quality of life. The recall period for symptoms is 7 days and response options include 'not at all', "a little', 'quite a bit', and 'very much'. All of the items' measures range in score from 0 to 100. A high score for the symptom items represents a high level of symptomatology or problems.	From Baseline, up to 12 months (Cohorts A to E); up to 24 months (for Cohort F)
Percentage of Participants Reporting Oral Symptoms Using the Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)	PRO-CTCAE is a patient-reported item custom survey used to evaluate symptomatic treatment-emergent adverse events in participants on cancer clinical trials. The PRO-CTCAE custom survey consists of 18 items. Responses are provided on a 5-point Likert scale that ranges from 0 to 4. The recall period for symptoms is 7 days. Higher scores indicating greater severity/impact.	Up to 12 months (Cohorts A to E); Up to 24 months (for Cohort F)
Percentage of Participants Reporting Oral Symptoms Using the Short Xerostomia Inventory (SXI) Score	SXI is a validated questionnaire that explores how the participant experiences dry mouth (xerostomia) with 5 questions extracted from the original XI. Respondents are asked to choose 1 of 5 responses ("1-Never; 2-Hardly ever; 3-Occasionally; 4-Fairly often; and 5-Very often") to specific statements referring to the preceding 4 weeks. Each individual's responses are scored and summed to give a single XI score. Higher scores represent more severe symptoms.	Up to 12 months (Cohorts A to E); Up to 24 months (for Cohort F)
Percentage of Participants Reporting Oral Symptoms Using the Epstein Taste Survey (ETS)	The Epstein Taste Survey (ETS) consists of 17 items PRO instrument, specific to taste and smell changes. The ETS was developed for use in participants with head and neck cancer. This instrument will be used to measure treatment-related symptoms associated with talquetamab.	Up to 12 months (Cohorts A to E); Up to 24 months (for Cohort F)
Percentage of Participants Reporting Oral Symptoms Using the Scale of Subjective Total Taste Acuity (STTA)	The STTA is a tool to assess the overall acuity of taste based on a 4-point scale, where 0 reflects no change and 4 represents almost complete loss of taste function. Higher score indicating severity.	Up to 12 months (Cohorts A to E); Up to 24 months (for Cohort F)
Change from Baseline in Body Weight Over Time	Change from baseline in body weight will be reported.	From Baseline up to 36 months
Change from Baseline in Body Mass Index (BMI) Over Time	Change from baseline in BMI will be reported.	From Baseline up to 36 months
Percentage of Participants With Dose Reductions, Interruptions, and Discontinuations For Talquetamab and Ramantamig	Percentage of participants with dose reductions, dose interruptions, and dose discontinuations will be reported.	Up to 12 months (Cohorts A to E); Up to 24 months (for Cohort F)
Percentage of Participants With Overall Response Rate	Overall response rate is defined as the participants with a partial response (PR) or better according to the International Myeloma Working Group (IMWG) criteria.	Up to 36 months
Percentage of Participants With Complete Response (CR) or Better Response	CR or better response is defined as the participants who achieve a CR or better response according to the IMWG criteria.	Up to 36 months
Percentage of Participants With Very Good Partial Response (VGPR) or Better Response	VGPR or better response is defined as the percentage of participants who achieve a VGPR or better response according to the IMWG criteria.	Up to 36 months
Duration of Response (DOR)	Duration of response is defined as time from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria, or death due to any reason, whichever occurs first.	Up to 36 months
Time to Response (TTR)	Time to response is defined as the time between date of first dose of talquetamab or ramantamig and the first efficacy evaluation at which the participant has met all criteria for PR or better.	Up to 36 months
Progression-free Survival (PFS)	PFS is defined as the time from the date of first dose of talquetamab or ramantamig to the date of first documented disease progression, as defined in the IMWG criteria, or death due to any cause, whichever occurs first.	Up to 36 months
Number of Participants with Treatment-emergent Adverse Event (TEAEs)	An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Any AE occurring at or after the initial administration of study treatment through the day of last dose plus 30 days, or if beyond 30 days from last dose but is study treatment-related, is considered to be treatment-emergent.	Up to 36 months

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2024
• Primary Completion (Estimated): May 30, 2030
• Study Completion (Estimated): May 30, 2030

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: July 8, 2024
• First Posted (Actual): July 15, 2024

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma; talquetamab
• Other Study ID Numbers: 64407564MMY2006 (Janssen Research & Development, LLC); 2023-506260-14-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No