Teclistamab + Daratumumab for Multiple Myeloma
(MajesTEC-3 Trial)

Recruiting in Palo Alto (17 mi)

+243 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Janssen Research & Development, LLC

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial is testing a new antibody treatment combined with daratumumab for patients whose multiple myeloma has returned and does not respond to standard treatments. The treatment helps the immune system recognize and attack cancer cells by targeting a specific protein. Daratumumab, approved in 2015, is a monoclonal antibody targeting CD38 on multiple myeloma cells.

Eligibility Criteria

This trial is for people with relapsed or refractory multiple myeloma who have tried 1-3 previous treatments including a proteasome inhibitor and lenalidomide. They should be relatively active (ECOG score of 0, 1, or 2), not allergic to the drugs used in the study, haven't had live vaccines recently, and haven't been treated with BCMA-directed therapy.

Inclusion Criteria

I have been diagnosed with multiple myeloma and it can be measured by tests.

I can care for myself and am up and about more than 50% of my waking hours.

My cancer has worsened after my last treatment, as confirmed by my doctor.

+4 more

Exclusion Criteria

I have received treatment targeting BCMA before.

I have not had a live vaccine in the last 4 weeks.

I have taken a lot of steroids, like prednisone, recently.

+5 more

Participant Groups

The study tests Teclistamab combined with Daratumumab (Tec-Dara) against two other combinations: Daratumumab with Pomalidomide and Dexamethasone (DPd), or Daratumumab with Bortezomib and Dexamethasone (DVd). It aims to see which treatment works better for multiple myeloma that's come back or hasn't responded to past therapies.

2Treatment groups

Experimental Treatment

Group I: Arm B: DPd or DVdExperimental Treatment4 Interventions

Participants will be randomized either to daratumumab, pomalidomide, dexamethasone (DPd) treatment to receive daratumumab SC injection; pomalidomide orally; dexamethasone orally or intravenously, or to Daratumumab, Bortezomib, Dexamethasone (DVd) treatment to receive daratumumab SC injection; bortezomib SC injection, and dexamethasone orally or intravenously.

Group II: Arm A: Teclistamab-daratumumab (Tec-Dara)Experimental Treatment2 Interventions

Participants will receive teclistamab and daratumumab by subcutaneous (SC) injection. Step-up doses of teclistamab will be given prior to the first full dose.

Bortezomib is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Velcade for: