What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, such as bispecific antibodies like Teclistamab and Talquetamab, and monoclonal antibodies like daratumumab, often lead to side effects including neutropenia, lymphocytopenia, and increased risk of infections such as pneumonia and viral reactivations (e.g., herpes zoster). Lenalidomide, another common agent, can cause fatigue, nausea, and a higher rate of grade 3 or 4 infections. Dexamethasone, often used in combination therapies, can contribute to immunosuppression and other corticosteroid-related side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Multiple Myeloma, particularly those targeting BCMA. Belantamab mafodotin was the first anti-BCMA therapy approved for relapsed/refractory Multiple Myeloma. Additionally, bispecific T cell engagers (BiTEs) like teclistamab, which targets BCMA and CD3, and chimeric antigen receptor (CAR) T cell therapies such as idecabtagene vicleucel and ciltacabtagene autoleucel have shown promising results. These therapies represent significant advancements in targeting specific antigens in Multiple Myeloma treatment.

What other types of research exist?

Promising novel alternatives for Multiple Myeloma treatment in 2024 include: 1) CAR T-cell therapies such as idecabtagene vicleucel (Abecma) and ciltacabtagene autoleucel (Carvykti), which target BCMA. 2) Antibody-drug conjugates like belantamab mafodotin (Blenrep), which also targets BCMA. 3) Newer immunomodulatory drugs (IMiDs) such as iberdomide. 4) Next-generation proteasome inhibitors like oprozomib. These therapies offer different mechanisms of action and have shown promising results in clinical trials.

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Monoclonal Antibodies

Tec-DR and Tal-DR for Multiple Myeloma (MajesTEC-7 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

Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2

Have a diagnosis of multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria

Must not have

Known contraindications to the use of daratumumab or lenalidomide per local prescribing information

Received any prior therapy for multiple myeloma or smoldering myeloma other than a short course of corticosteroids (not to exceed 40 milligrams [mg] of dexamethasone, or equivalent per day for a maximum of 4 days, total of 160 mg dexamethasone or equivalent). In addition, received a cumulative dose of systemic corticosteroids equivalent to greater than or equals to (>=)20 mg of dexamethasone during the Screening Phase

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline up to 9 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing two new drug combinations to see if they work better than the current standard treatment for multiple myeloma. The new treatments aim to help the immune system find and destroy cancer cells more effectively.

Who is the study for?

This trial is for adults with newly diagnosed multiple myeloma who can't have high-dose chemotherapy with stem cell transplant due to age or other health issues. They should be able to perform daily activities (ECOG score 0-2) and must not plan on pregnancy or fathering children during the study.

What is being tested?

The study compares two treatments: Teclistamab combined with Daratumumab and Lenalidomide (Tec-DR), versus Talquetamab with the same combination (Tal-DR). The goal is to see which treatment works better compared to a standard therapy of Daratumumab, Lenalidomide, and Dexamethasone.

What are the potential side effects?

Possible side effects include allergic reactions to medication ingredients, infusion-related reactions from drugs like Teclistamab or Talquetamab, and any known risks associated with Daratumumab or Lenalidomide as per their prescribing information.

Eligibility Criteria

Inclusion Criteria

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

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

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I have been diagnosed with multiple myeloma.

Exclusion Criteria

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

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I am not allergic or unable to take daratumumab or lenalidomide.

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I have only used a short course of steroids for my myeloma, not exceeding the specified dose.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline up to 9 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline up to 9 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline 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

12-Month Minimal Residual Disease (MRD)-Negative Complete Response (CR)

Progression Free Survival (PFS)

Secondary study objectives

Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30)

Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)

Change from Baseline in Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

+14 more

Awards & Highlights

Pivotal Trial

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

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Teclistamab, Daratumumab SC, and Lenalidomide (Tec-DR)Experimental Treatment3 Interventions

Participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab and lenalidomide.

Group II: Talquetamab, Daratumumab SC, and Lenalidomide (Tal-DR)Experimental Treatment3 Interventions

Participants will receive talquetamab as SC injection in combination with daratumumab and lenalidomide.

Group III: Daratumumab SC, Lenalidomide, and Dexamethasone (DRd)Active Control3 Interventions

Participants will receive daratumumab as SC injection with lenalidomide and dexamethasone.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Daratumumab

2014

Completed Phase 3

~2380

Lenalidomide

2005

Completed Phase 3

~2240

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

The most common treatments for Multiple Myeloma include bispecific antibodies like teclistamab and talquetamab, which engage T cells to target and kill myeloma cells by binding to BCMA and CD3, and GPRC5D and CD3, respectively. Proteasome inhibitors (e.g., bortezomib) disrupt protein degradation, leading to cancer cell death. Immunomodulatory drugs (e.g., lenalidomide) enhance immune response and inhibit myeloma cell growth. Monoclonal antibodies (e.g., daratumumab) target specific proteins on myeloma cells to induce immune-mediated destruction. These mechanisms are crucial as they offer targeted approaches to eliminate myeloma cells, improving patient outcomes and potentially reducing side effects compared to traditional chemotherapy.

Geographic and Racial Disparities in Access to Chimeric Antigen Receptor-T Cells and Bispecific Antibodies Trials for Multiple Myeloma.New investigational drugs with single-agent activity in multiple myeloma.Waldenström macroglobulinemia.