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Looking for participantsPhase2

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

Sponsor: Janssen Research & Development, LLC

NCT ID: NCT06500884

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Talquetamab (drug), Prophylaxis A (drug), Prophylaxis B (drug), Prophylaxis C (drug)
How long the study runs
Study runs about 69 months (dates as stated)
About the drug or intervention
Talquetamab — drug: Talquetamab will be administered subcutaneously. · Prophylaxis A — drug: Prophylaxis A will be administered orally. · Prophylaxis B — drug: Prophylaxis B will be administered orally. · Prophylaxis C — drug: Prophylaxis C will be administered orally. · Prophylaxis D — drug: Prophylaxis D will be administered topically. · Ramantamig — drug: Ramantamig will be administered subcutaneously.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
210
Started
2024-08-26
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for multiple myeloma
  • • Phase2 - 210 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with multiple myeloma

Where?

  • • Belfast - Belfast City Hospital
  • • Colchester - Colchester Hospital University NHS
  • • Eastbourne - Eastbourne District General Hospital
  • • Liverpool - The Clatterbridge Cancer Centre
  • • +4 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Multiple Myeloma

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

CD38

Treatment history

Treatments you must have had:

  • ✓ a PI

What the study is looking for

  • ✓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...
  • ✓Be willing and able to adhere to the lifestyle restrictions specified in the protocol

Who cannot take part

  • ✗Contraindications or life-threatening known allergies, hypersensitivity, or intolerance to any the study treatment or its...
  • ✗Stroke, transient ischemic attack, or seizure within 6 months prior to screening
See the full criteria
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

Where Is This Study? (8 UK sites)

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
Hospital R&D contact (matched)

Jo-Anne Taylor

esh-tr.researchanddevelopment@nhs.net0300 13 14 500 ext 771439

The Clatterbridge Cancer Centre

Liverpool L7 8YA, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Maria Maguire

maria.maguire2@nhs.net0151 556 5321

University College London Hospitals

London NW1 2BU, United Kingdom

Recruiting
Hospital R&D contact (matched)

Rajinder Sidhu - Associate Director, Research Governance and Operations

uclh.jro-communications@nhs.net020 3447 9825

Hammersmith Hospital

London W12 0HS, United Kingdom

Recruiting

The Christie NHS Foundation Trust Christie Hospital

Manchester M20 4BX, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Innovation Office

the-christie.ri@nhs.net---

Newcastle Freeman Hospital

Newcastle upon Tyne NE7 7DN, United Kingdom

COMPLETED

How to Get in Touch

Study Contact

Sponsor contact

CONTACT

844-434-4210 Participate-In-This-Study1@its.jnj.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09