MajesTEC-3
Research type
Research Study
Full title
A Phase 3 Randomized Study Comparing Teclistamab in Combination with Daratumumab SC (Tec-Dara) versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants with Relapsed or Refractory Multiple Myeloma
IRAS ID
299954
Contact name
Charlotte Pawlyn
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2020-004742-11
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 8 months, 20 days
Research summary
This is a Phase 3, randomised study comparing teclistamab (the study drug) combined with daratumumab (known as Tec-Dara) with daratumumab, pomalidomide and dexamethasone (known as DPd) or daratumumab, bortezomib and dexamethasone (known as DVd) in participants with relapsed of refractory multiple myeloma who have previously received 1 to 3 prior line(s) of therapy (including lenalidomide and a proteasome inhibitor [PI, drugs that block the action of proteasomes, cellular complexes that break down proteins]).
Teclistamab is a bispecific antibody that activates a recipient's T cells (a type of white blood cell) to attack multiple myeloma cells expressing B-cell maturation antigen (BCMA), a protein found on the surface of most myeloma cells. Teclistamab is not approved for the treatment of multiple myeloma in any country. DPd and DVd are treatment combinations commonly used to treat multiple myeloma.
This study consists of a Screening Phase, a Treatment Phase and a Follow-up Phase. Participants who meet the inclusion criteria and complete the Screening Phase will be randomly selected to be in either Arm A or Arm B. Arm A participants will receive Tec-Dara. Arm B participants will receive either DPd or DVd, depending on which treatment their clinician decides is most appropriate. Treatment will continue until confirmed disease progression, death, intolerable toxicity, the participant withdraws consent, or the study ends.
REC name
Scotland B REC
REC reference
21/SS/0065
Date of REC Opinion
6 Oct 2021
REC opinion
Favourable Opinion