TALISMAN
Research type
Research Study
Full title
A Phase 2, Open-label, Randomized Study to Evaluate Prophylactic Interventions on Talquetamab-related Oral Toxicity
IRAS ID
1009729
Contact name
David Wright
Contact email
Sponsor organisation
Janssen-Cilag International NV
ISRCTN Number
ISRCTN72589181
Clinicaltrials.gov Identifier
Research summary
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 talquetamab
3. 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).REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
24/NE/0099
Date of REC Opinion
1 Aug 2024
REC opinion
Further Information Favourable Opinion