Teclistamab Combination Therapy for Multiple Myeloma
(MajesTEC-2 Trial)

Recruiting in Palo Alto (17 mi)

+33 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Janssen Research & Development, LLC

No Placebo Group

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?This trial tests the safety and tolerability of teclistamab when used with other treatments. It aims to find the best dose and ensure it is safe for patients. Teclistamab has shown promising results in treating a specific type of cancer.

Eligibility Criteria

This trial is for adults with multiple myeloma who have measurable disease and meet specific treatment requirements. Women of childbearing potential must test negative for pregnancy and agree to ongoing tests. Participants cannot have had prior BCMA-targeted therapy (except for one regimen), recent live vaccines, high steroid doses, or active brain involvement of cancer.

Inclusion Criteria

You have a specific type of disease that can be measured by certain standards at the screening.

My multiple myeloma diagnosis follows international guidelines.

Meet treatment regimen-specific requirements as specified for each treatment regimen

+2 more

Exclusion Criteria

You have tested positive for HIV.

I have or might have myeloma affecting my brain or spinal cord.

I have not received a live vaccine in the last 30 days.

+2 more

Participant Groups

The study is testing the safety and best dose of Teclistamab in combination with other anticancer drugs like Daratumumab, Pomalidomide, Lenalidomide, Bortezomib, and Nirogacestat in treating multiple myeloma.

6Treatment groups

Experimental Treatment

Group I: Treatment Regimen F: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (28-day Cycles)Experimental Treatment4 Interventions

Participants will receive teclistamab plus daratumumab plus lenalidomide plus bortezomib in 28-day cycles.

Group II: Treatment Regimen E: Teclistamab + Daratumumab + LenalidomideExperimental Treatment3 Interventions

Participants will receive teclistamab plus daratumumab plus lenalidomide.

Group III: Treatment Regimen D: Teclistamab + LenalidomideExperimental Treatment2 Interventions

Participants will receive teclistamab plus lenalidomide.

Group IV: Treatment Regimen C: Teclistamab + NirogacestatExperimental Treatment2 Interventions

Participants will receive teclistamab plus nirogacestat.

Group V: Treatment Regimen B: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (21-day Cycles)Experimental Treatment4 Interventions

Participants will receive teclistamab plus daratumumab plus lenalidomide plus bortezomib in 21-day cycles.

Group VI: Treatment Regimen A: Teclistamab + Daratumumab + PomalidomideExperimental Treatment3 Interventions

Participants will receive teclistamab plus daratumumab plus pomalidomide.

Teclistamab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Tecvayli for:

Relapsed or refractory multiple myeloma in adults who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody

🇪🇺 Approved in European Union as Tecvayli for:

Relapsed or refractory multiple myeloma in adults who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody, and have demonstrated disease progression since the last therapy