Multiple MyelomaPhase 2TalismanNCT06500884
A Study to Evaluate Preventive Treatments for GPRC5D-related Oral Events
A Phase 2 study testing Talquetamab, Prophylaxis A and Prophylaxis B in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 38 sites in 7 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Talquetamab, Prophylaxis A and Prophylaxis B
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 38 sitesin 7 countries
- Study dates
- 26 Aug 2024to 30 May 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
38 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
38 sites in 7 countries
United States9 sites, 9 recruiting
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
- Recruiting
Colorado Blood Cancer Institute
Denver, Colorado, 80218
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27705
- Recruiting
Yale University School Of Medicine
New Haven, Connecticut, 06510
- Recruiting
Icahn School of Medicine at Mt. Sinai
New York, New York, 10029
- Recruiting
Virginia Commonwealth University - Massey Cancer Center
Richmond, Virginia, 23298
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14642
- Recruiting
University of California San Francisco
San Francisco, California, 94143
- Recruiting
University of Washington
Seattle, Washington, 98109
Spain8 sites, 8 recruiting
- Recruiting
Hosp. Univ. Germans Trias I Pujol
Badalona, 08916
- Recruiting
Hosp Clinic de Barcelona
Barcelona, 08036
- Recruiting
Hosp. Univ. Virgen de La Arrixaca
El Palmar, 30120
- Recruiting
Hosp. de Jerez de La Frontera
Jerez de la Frontera, 11407
- Recruiting
Hosp. Univ. Ramon Y Cajal
Madrid, 28034
- Recruiting
Hosp. Univ. 12 de Octubre
Madrid, 28041
- Recruiting
Hosp. Quiron Madrid Pozuelo
Pozuelo de Alarcón, 28223
- Recruiting
Hosp Clinico Univ de Salamanca
Salamanca, 37007
United Kingdom8 sites, 7 recruiting
- Recruiting
Belfast City Hospital
Belfast, BT9 7AB
- Recruiting
Colchester Hospital University NHS
Colchester, CO4 5JL
- Recruiting
Eastbourne District General Hospital
Eastbourne, BN21 2UD
- Recruiting
The Clatterbridge Cancer Centre
Liverpool, L7 8YA
- Recruiting
University College London Hospitals
London, NW1 2BU
- Recruiting
Hammersmith Hospital
London, W12 0HS
- Recruiting
The Christie NHS Foundation Trust Christie Hospital
Manchester, M20 4BX
- Completed
Newcastle Freeman Hospital
Newcastle upon Tyne, NE7 7DN
Brazil6 sites, 6 recruiting
- Recruiting
IDOR - Regional Brasilia
Brasília, 70390-140
- Recruiting
Fundacao Universidade de Caxias do Sul
Caxias do Sul, 95070 560
- Recruiting
Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer
Curitiba, 81520-060
- Recruiting
IDOR - Regional Bahia
Salvador, 41253-190
- Recruiting
IDOR - Regional Sao Paulo
São Paulo, 01401 002
- Recruiting
Clinica Medica Sao Germano LTDA
São Paulo, 04537 081
Netherlands3 sites, 3 recruiting
- Recruiting
VUMC Amsterdam
Amsterdam, 1081 HV
- Recruiting
Albert Schweitzer Ziekenhuis
Dordrecht, 3318 AT
- Recruiting
Erasmus MC
Rotterdam, 3015 CN
South Korea3 sites, 3 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
- Recruiting
The Catholic University of Korea Seoul St Mary s Hospital
Seoul, 06591
- Recruiting
Samsung Medical Center
Seoul, 135-230
Puerto Rico1 site, 1 recruiting
- Recruiting
Hospital Espanol Auxilio Mutuo Auxilio Mutuo Cancer Center
San Juan, 00918
About this study
Official title: 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.
- Conditions
- Multiple Myeloma
- Being tested
- Talquetamab, Prophylaxis A, Prophylaxis B, Prophylaxis C, Prophylaxis D
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TalquetamabDrug
Also called CD3xGPRC5D
Talquetamab will be administered subcutaneously.
Prophylaxis ADrug
Prophylaxis A will be administered orally.
Prophylaxis BDrug
Prophylaxis B will be administered orally.
Prophylaxis CDrug
Prophylaxis C will be administered orally.
Prophylaxis DDrug
Prophylaxis D will be administered topically.
RamantamigDrug
Also called BCMAxGPRC5DxCD3
Ramantamig will be administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Ramantamig |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: End of Month 7
Secondary outcomes (23)
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.
Measured: Baseline up to 36 months
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.
Measured: Up to 12 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Baseline up to 36 months
Change from Baseline in Body Mass Index (BMI) Over Time
Change from baseline in BMI will be reported.
Measured: 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.
Measured: Up to 12 months (Cohorts A to E); Up to 24 months (for Cohort F)
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.
Measured: Baseline (Day 1 Cycle 1), Day 1 Cycle 2 (each cycle duration=28-days)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start26 Aug 2024
- Primary completion30 May 2030 (estimated)
- Study completion30 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500884
- Sponsor's protocol ID
- 64407564MMY2006
- Other IDs
- 2023-506260-14-00, 2023
- Acronym
- Talisman
- Status last verified
- Sep 2026
- First submitted
- 8 Jul 2024
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-label, Randomized Study to Evaluate GPRC5D-related Oral Events
- ClinicalTrials.gov ID
- NCT06500884
- Acronym / sponsor ID
- Talisman / 64407564MMY2006
- Conditions
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- 30 May 2030 (estimated)
- Study completion
- 30 May 2030 (estimated)
- First posted
- 15 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Talquetamab | Active comparator | Drug: TalquetamabParticipants 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. |
| Cohort B: Prophylaxis A and Talquetamab | Experimental | Drug: Talquetamab, Drug: Prophylaxis AParticipants 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. |
| Cohort C: Prophylaxis B and Talquetamab | Experimental | Drug: Talquetamab, Drug: Prophylaxis BParticipants 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. |
| Cohort D: Prophylaxis C and Talquetamab | Experimental | Drug: Talquetamab, Drug: Prophylaxis CParticipants 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. |
| Cohort E: Prophylaxis D and Talquetamab | Experimental | Drug: Talquetamab, Drug: Prophylaxis DParticipants 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. |
| Cohort F: Ramantamig | Experimental | Drug: RamantamigParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TalquetamabAlso: CD3xGPRC5DTalquetamab will be administered subcutaneously. | Drug | 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 AProphylaxis A will be administered orally. | Drug | Cohort B: Prophylaxis A and Talquetamab |
| Prophylaxis BProphylaxis B will be administered orally. | Drug | Cohort C: Prophylaxis B and Talquetamab |
| Prophylaxis CProphylaxis C will be administered orally. | Drug | Cohort D: Prophylaxis C and Talquetamab |
| Prophylaxis DProphylaxis D will be administered topically. | Drug | Cohort E: Prophylaxis D and Talquetamab |
| RamantamigAlso: BCMAxGPRC5DxCD3Ramantamig will be administered subcutaneously. | Drug | Cohort F: Ramantamig |
Primary outcome
Percentage of Participants With Occurrence of Dysgeusia as Assessed by the Total Waterless Empirical Taste Test (WETT) Testing Score During the Prophylaxis Treatment Phase
Time frame: Up to 12 months
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.
Percentage of Participants With Occurrence of Severe Dysgeusia During the Prophylaxis Treatment Phase
Time frame: Up to 12 months
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.
Time to the First Onset of Severe Dysgeusia During the Prophylaxis Treatment Phase
Time frame: Up to 12 months
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.
Percentage of Participants Who Report Resolution/Improvement of Dysgeusia During the Prophylaxis Treatment Phase
Time frame: End of Month 3
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.
Percentage of Participants Who Report Resolution/Improvement of Dysgeusia During the Prophylaxis Treatment Phase
Time frame: End of Month 7
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.
23 secondary outcomes
Change From Baseline in WETT Testing Score Over Time
Time frame: Baseline up to 36 months
Percentage of Time with Dysgeusia During the Prophylaxis Treatment Phase
Time frame: Up to 12 months
Percentage of Participants with Treatment-Emergent Oral Toxicities (Dysgeusia, Oral Mucositis, Dysphagia, and Xerostomia) During the Prophylaxis Treatment Phase
Time frame: Up to 12 months
Percentage of Participants with Treatment-Emergent Oral Toxicities (Dysgeusia, Oral Mucositis, Dysphagia, and Xerostomia) During the Study
Time frame: 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 frame: Up to 36 months
Duration of Treatment-emergent Oral Toxicities (Dysgeusia, Oral Mucositis, Dysphagia, and Xerostomia)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: Up to 12 months (Cohorts A to E); Up to 24 months (for Cohort F)
Change from Baseline in Body Weight Over Time
Time frame: From Baseline up to 36 months
Change from Baseline in Body Mass Index (BMI) Over Time
Time frame: From Baseline up to 36 months
Percentage of Participants With Dose Reductions, Interruptions, and Discontinuations For Talquetamab and Ramantamig
Time frame: Up to 12 months (Cohorts A to E); Up to 24 months (for Cohort F)
Change from Baseline in Smell Identification Test Score
Time frame: Baseline (Day 1 Cycle 1), Day 1 Cycle 2 (each cycle duration=28-days)
Percentage of Participants With Overall Response Rate
Time frame: Up to 36 months
Percentage of Participants With Complete Response (CR) or Better Response
Time frame: Up to 36 months
Percentage of Participants With Very Good Partial Response (VGPR) or Better Response
Time frame: Up to 36 months
Duration of Response (DOR)
Time frame: Up to 36 months
Time to Response (TTR)
Time frame: Up to 36 months
Progression-free Survival (PFS)
Time frame: Up to 36 months
Number of Participants with Treatment-emergent Adverse Event (TEAEs)
Time frame: Up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
38 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Talquetamab, Prophylaxis A and Prophylaxis B in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 38 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Spain, United Kingdom, Brazil, Netherlands and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Occurrence of Dysgeusia as Assessed by the Total Waterless Empirical Taste Test (WETT) Testing Score During the Prophylaxis Treatment Phase (time frame: Up to 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.