MonumenTAL-3
Research type
Research Study
Full title
A Phase 3 Randomized Study Comparing Talquetamab in Combination with Daratumumab (SC) and Pomalidomide (Tal-DP) or Talquetamab (SC) in combination with Daratumumab SC (Tal-D) versus Daratumumab SC, Pomalidomide and Dexamethasone (DPd), in Participants With Relapsed or Refractory Multiple Myeloma who Have Received at Least 1 Prior Line of Therapy
IRAS ID
1006071
Contact name
David Wright
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2021-000202-22
ISRCTN Number
ISRCTN12220131
Clinicaltrials.gov Identifier
Research summary
Multiple myeloma is a blood cancer that affects certain types of white blood cells called plasma cells. Although treatments are available, multiple myeloma can come back after treatment or be resistant to standard treatment. Drugs that induce T cells (a type of white blood cells) to attack cancer cells may be an effective way to destroy cancer cells. Talquetamab (JNJ-64407564) is a modified antibody* that binds to T cells and myeloma cells. Talquetamab activates the T cells, which leads to killing of myeloma cells. *Antibody is a protein that helps protect the body against foreign matter. In this study, researchers want to study if Tal-DP and Tal-D keeps the participants’ cancer from getting worse for a longer period compared to DPd. Study includes male and female participants 18 years or older. Participants with multiple myeloma that has either come back after treatment or is resistant to standard treatment who have received at least 1 prior anticancer therapy will be enrolled. The study will be conducted as:
1 Screening (28 days)
2 Treatment Phase: Participants will receive 1 of 3 treatments in 28 day cycle:
•Talquetamab in combination with daratumumab subcutaneous (SC; as an injection under skin) and pomalidomide (Tal-DP) orally,
•Daratumumab SC in combination with pomalidomide orally and dexamethasone (DPd) either orally or as an injection in the veins,
•Talquetamab SC in combination with daratumumab SC (Tal-D)
3 Posttreatment Follow-up Phase: Participants will be followed-up for safety until death, withdrawal of consent, or end of study, whichever occurs first
During the study, some tests will be performed such as blood tests, physical and neurologic examinations, vital signs, ECOG performance status and questionnaires. Blood samples will be taken at multiple timepoints to see how body responds to treatment. Disease status will be checked based on IMWG criteria for multiple myeloma. Side effects will be recorded until study ends (up to 6 years 6 months)REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
22/WM/0261
Date of REC Opinion
9 Jan 2023
REC opinion
Further Information Favourable Opinion