What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, particularly those involving monoclonal antibodies like daratumumab, often result in side effects such as infections, fatigue, gastrointestinal issues (e.g., diarrhea, constipation), and infusion-related reactions. Combination regimens, such as those including bortezomib, lenalidomide, and dexamethasone, can lead to neuropathy, hematologic toxicities (e.g., neutropenia, thrombocytopenia), and cardiovascular events (e.g., hypertension, cardiac issues). Serious adverse events may include pneumonia, sepsis, and renal failure. These side effects are important considerations when evaluating the safety and tolerability of new treatments like Teclistamab.

What prior FDA approvals exist?

The FDA has approved several treatments for Multiple Myeloma, including monoclonal antibodies and proteasome inhibitors. Daratumumab, an anti-CD38 monoclonal antibody, has been approved for use in combination with other drugs like lenalidomide and bortezomib. Elotuzumab, targeting SLAMF7, is another monoclonal antibody approved for use with lenalidomide and dexamethasone. Bortezomib, a proteasome inhibitor, is commonly used in various combinations for Multiple Myeloma treatment. While teclistamab, a bispecific antibody targeting BCMA and CD3, is still under study, it represents a novel approach similar to other BCMA-targeting therapies like belantamab mafodotin, which has also received FDA approval.

What other types of research exist?

Promising novel alternatives to Teclistamab for Multiple Myeloma patients in 2024 include: 1) CAR-T cell therapies such as Idecabtagene Vicleucel (Abecma) and Ciltacabtagene Autoleucel (Carvykti), which target BCMA. 2) Bispecific antibodies like Elranatamab, which also targets BCMA and CD3. 3) Novel targeted agents such as Belantamab Mafodotin, an antibody-drug conjugate targeting BCMA. These therapies have shown significant efficacy in clinical trials and offer new options for patients with multiple myeloma.

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CAR T-cell Therapy

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

Phase 1

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have documented initial diagnosis of multiple myeloma according to international myeloma working group (IMWG) diagnostic criteria

Be older than 18 years old

Must not have

Active central nervous system (CNS) involvement or exhibition of clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required

Live, attenuated vaccine within 30 days before the first dose of study treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 year and 5 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions at the injection site, fatigue, nausea, diarrhea, fever; blood-related issues such as anemia; increased risk of infections; possible liver problems; and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My multiple myeloma diagnosis follows international guidelines.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

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

Select...

I have taken a high dose of steroids equivalent to 140 mg of prednisone or more in the last two weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 year and 5 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 year and 5 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 year and 5 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants with AEs by Severity

Number of Participants with Abnormalities in Laboratory Values

Number of Participants with Dose-Limiting Toxicity (DLT)

+1 more

Secondary study objectives

Complete Response (CR) or Better Response Rate

Duration of Response

Number of Participants with Presence of Anti-Drug Antibodies to Daratumumab

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Daratumumab

2014

Completed Phase 3

~2000

Pomalidomide

2011

Completed Phase 2

~1020

Lenalidomide

2005

Completed Phase 3

~2240

Bortezomib

2005

Completed Phase 3

~1410

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Multiple Myeloma treatments often target specific pathways to inhibit cancer cell growth and survival. Monoclonal antibodies like daratumumab target CD38 on myeloma cells, enhancing immune-mediated destruction. Proteasome inhibitors such as bortezomib disrupt protein degradation, leading to cancer cell death. Immunomodulatory drugs like lenalidomide enhance immune response and inhibit angiogenesis. Bispecific T cell engagers, such as teclistamab, simultaneously bind to BCMA on myeloma cells and CD3 on T cells, directing the immune system to attack the cancer. These mechanisms are crucial as they offer targeted approaches to manage and potentially overcome the disease, improving patient outcomes.