What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, including monoclonal antibodies like daratumumab, elotuzumab, and isatuximab, often result in side effects such as neutropenia, infections (including pneumonia and upper respiratory tract infections), and lymphocytopenia. Daratumumab is associated with higher rates of infection and pneumonia, especially in patients with severe lymphocytopenia. Elotuzumab can lead to increased rates of lymphocytopenia and herpes zoster. Isatuximab is linked to higher frequencies of neutropenia and respiratory infections. Teclistamab, a bispecific antibody targeting BCMA and CD3, also shows similar side effects, including neutropenia and infections.

What prior FDA approvals exist?

Teclistamab is a bispecific monoclonal antibody targeting BCMA and CD3, engaging T-cells to kill myeloma cells. Similar FDA-approved treatments include belantamab mafodotin, an anti-BCMA antibody-drug conjugate, and chimeric antigen receptor (CAR) T-cell therapies like idecabtagene vicleucel and ciltacabtagene autoleucel, which also target BCMA. These therapies represent significant advancements in targeting BCMA for the treatment of relapsed or refractory multiple myeloma.

What other types of research exist?

Promising novel alternatives to Teclistamab for Multiple Myeloma patients include: 1) Daratumumab-based regimens, which have shown efficacy in various combinations such as with pomalidomide and dexamethasone. 2) Isatuximab, another anti-CD38 monoclonal antibody, often combined with pomalidomide and dexamethasone. 3) Elotuzumab, particularly in combination with lenalidomide and dexamethasone. 4) CAR T-cell therapies targeting BCMA, such as idecabtagene vicleucel and ciltacabtagene autoleucel, which have shown promising results in clinical trials.

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Proteasome Inhibitor

Teclistamab vs. PVd/Kd for Multiple Myeloma (MajesTEC-9 Trial)

Phase 3

Recruiting

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

Documented diagnosis of multiple myeloma as defined by the International Myeloma Working Group (IMWG) diagnostic criteria

Received 1 to 3 prior lines of antimyeloma therapy including specific prior treatments

Must not have

Received any prior B cell maturation antigen (BCMA)-directed therapy

Central nervous system (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 9 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing teclistamab, an antibody that helps the immune system find and destroy cancer cells, in patients with multiple myeloma who have not responded to previous treatments. It works by connecting immune cells with cancer cells to help destroy them. Teclistamab has shown promising results in early trials.

Who is the study for?

This trial is for people with multiple myeloma who've had 1-3 prior treatments but didn't respond well or their disease got worse. They must meet specific criteria for measurable disease, be able to follow the study's lifestyle rules, not be pregnant or breastfeeding, and have a decent ability to perform daily activities (ECOG score of 0-2). People can't join if they've had BCMA-targeted therapy before, certain allergies or conditions like CNS involvement in their cancer, recent live vaccines, or other specific blood disorders.

What is being tested?

The study aims to see how effective Teclistamab alone is compared to two other treatment combinations: Pomalidomide with Bortezomib and Dexamethasone (PVd), or Carfilzomib with Dexamethasone (Kd) in treating relapsed/refractory multiple myeloma. Participants will receive one of these therapies based on random assignment.

What are the potential side effects?

Teclistamab may cause infusion reactions, infections due to low white blood cell counts, tiredness, nausea. PVd/Kd treatments might lead to similar effects plus possible nerve damage from Bortezomib and heart issues from Carfilzomib.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with multiple myeloma according to international standards.

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I have had 1-3 treatments for myeloma, including specific ones.

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

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

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I have received treatment targeting BCMA before.

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My multiple myeloma has spread to my brain or spinal cord.

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I have a specific blood disorder like Waldenstrom's or POEMS syndrome.

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I have taken less than 140 mg of prednisone or its equivalent in the last 14 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 9 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 9 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 9 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Part 1: Progression-free Survival (PFS)

Part 2: Number of Participants Reporting Cytokine Release Syndrome (CRS) Cases by Severity

Secondary study objectives

Part 1 and 2: Complete Response (CR) or Better Response

Part 1 and 2: Number of Participants with Abnormal Laboratory Results

Part 1 and 2: Number of Participants with Adverse Events (AEs) by Severity

+16 more

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: TeclistamabExperimental Treatment1 Intervention

Participants will receive teclistamab monotherapy in Part 1 and an alternative dosing regimen of teclistamab in Part 2.

Group II: Pomalidomide, Bortezomib and Dexamethasone (PVd) or Carfilzomib and Dexamethasone (Kd)Experimental Treatment4 Interventions

Participants will receive either PVd or Kd based on principal investigator's choice during Part 1 of the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carfilzomib

2017

Completed Phase 3

~1430

Pomalidomide

2011

Completed Phase 2

~1020

Bortezomib

2005

Completed Phase 3

~1410

Dexamethasone

2007

Completed Phase 4

~2650

0 / 7Eligibility 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

Teclistamab is a bispecific monoclonal antibody that targets BCMA (B-cell maturation antigen) and CD3, effectively recruiting and activating T-cells to kill BCMA-expressing myeloma cells. This mechanism is crucial as it directly engages the immune system to target and eliminate cancer cells. Other common treatments include proteasome inhibitors like bortezomib and carfilzomib, which disrupt protein degradation in myeloma cells, leading to cell death, and immunomodulatory drugs like pomalidomide, which enhance the immune response against myeloma cells. These targeted therapies are essential for Multiple Myeloma patients as they offer more precise and effective treatment options, often with fewer side effects compared to traditional chemotherapy.