Recipient organisationNIHR Imperial Biomedical Research Centre
NIHR supportRecorded as supported by this research centre
PeriodApr 2025 — Ongoing
In plain English
AI plain-English summary
Talquetamab, a drug that activates T-cells to attack myeloma cells, causes mouth and taste problems that researchers are now testing preventive treatments to stop before they start. This matters because relapsed or refractory multiple myeloma—a blood cancer that returns or resists treatment—has limited options. Talquetamab works by binding to CD3 on T-cells and GPRC5D on myeloma cells, but its oral side effects can be severe enough to disrupt treatment. The study tests whether starting preventive mouthwashes, oral medications, or disintegrating tablets before the first dose and continuing them throughout treatment can reduce the number, intensity, or duration of taste changes compared to no prevention. If successful, these prophylactic interventions could allow patients to stay on talquetamab longer and with better quality of life, avoiding treatment interruptions that allow cancer to progress. The trial randomises participants into four groups: talquetamab alone, or combined with one of three different preventive regimens. Side effects are recorded throughout the treatment and follow-up phases. The research directly addresses a practical clinical problem—how to keep a promising immunotherapy tolerable enough for patients to benefit from it.
View original technical description
Relapsed or refractory multiple myeloma (MM) is a blood cancer that forms in a type of white blood cells (WBCs) called plasma cells. Drugs that activate T-cells (type of WBCs) to attack cancer cells may be an effective way to destroy them. Cancer is called relapsed if it comes back after treatment and is called ‘refractory’ if does not respond to treatment.Talquetamab (JNJ-64407564) binds to proteins called cluster of differentiation 3 (CD3) receptor, found on T-cells and G protein-coupled receptor family C group 5 member D (GPRC5D), found on myeloma cells. This activates the T-cells and leads to killing of myeloma cells.In this study, researchers want to learn how preventive measures started before the first dose of talquetamab and continued throughout the treatment phase, reduces the number, intensity, or length of time for taste change incidents related to talquetamab compared to no preventive measures.Study will include male and female participants 18 years or older with relapsed or refractory MM who have disease progression after receiving at least 1 of each of the following medication classes. PI, IMIDs, and anti-CD38 mAb.The study will be conducted as:1. Screening (Up to 28 days): Confirm if the participants can take part in the study.2. Treatment Phase (Up to 12 months): Participants will be divided into either of the 4 treatment groups in a random way to receive the treatment:• Cohort A: Talquetamab as an injection under the skin• Cohort B: Prophylaxis A mouth wash with talquetamab• Cohort C: Prophylaxis B by mouth with talquetamab• Cohort D: Prophylaxis C disintegrating tablets by mouth with talquetamab3. Follow-up Phase (Up to approximately 12 months): Participants will be followed-up for their overall health throughout the study.During the study, some tests such as blood and urine tests, neurological examination, and physical examination will be performed. Side effects will be recorded until study ends (Up to 12 to 30 months).
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