What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, such as Teclistamab and Daratumumab, have several known side effects. Teclistamab, which targets BCMA and CD3, is associated with infections (e.g., upper respiratory tract infections, pneumonia), neutropenia, and infusion-related reactions. Daratumumab, targeting CD38, can cause higher rates of infections, including pneumonia, severe lymphocytopenia leading to viral reactivations and fungal infections, and infusion-related reactions. Both treatments may also result in various cytopenias.

What prior FDA approvals exist?

Daratumumab, an anti-CD38 monoclonal antibody, has been FDA-approved for the treatment of multiple myeloma and is often used in combination with other agents like bortezomib, lenalidomide, and dexamethasone. Isatuximab, another anti-CD38 monoclonal antibody, has also been approved for relapsed or refractory multiple myeloma in combination with pomalidomide and dexamethasone. Additionally, Belantamab mafodotin, targeting BCMA, has been approved for patients with relapsed or refractory multiple myeloma. These approvals highlight the ongoing development and use of targeted therapies in multiple myeloma treatment.

What other types of research exist?

Promising novel alternatives to Teclistamab Daratumumab for Multiple Myeloma patients include: <ol> <li>Isatuximab: Another anti-CD38 monoclonal antibody, often combined with pomalidomide and dexamethasone, showing efficacy in relapsed/refractory MM.</li> <li></li> </ol> Elotuzumab: Targets SLAMF7 and is used in combination with lenalidomide and dexamethasone, showing promising results in both pretreated and untreated MM patients. 3. CAR T-cell therapies: Specifically targeting BCMA, such as idecabtagene vicleucel (ide-cel) and ciltacabtagene autoleucel (cilta-cel), which have shown high response rates in clinical trials. 4. Selinexor: A selective inhibitor of nuclear export, used in combination with bortezomib and dexamethasone, effective in patients refractory to other treatments.

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Proteasome Inhibitor

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

Phase 3

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

Documented multiple myeloma as defined by the criteria: a. multiple myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria, b. measurable disease at screening as defined by any of the following: 1) serum M-protein level greater than or equal to (>=) 0.5 gram per deciliter (g/dL); or 2) urine M-protein level >=200 milligrams (mg)/24 hours; or 3) serum immunoglobulin free light chain >=10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio

Have an eastern cooperative oncology group (ECOG) performance status score of 0, 1, or 2 at screening and prior to the start of administration of study treatment

Must not have

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

Received a live, attenuated vaccine within 4 weeks before randomization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include reactions at the injection site, blood disorders like anemia or low platelets, infections due to weakened immune system, nerve damage symptoms such as numbness or tingling, fatigue, nausea, diarrhea, fever and shortness of breath.

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 and it can be measured by tests.

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

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

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I have been diagnosed with multiple myeloma with measurable disease.

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I've had 1-3 treatments for myeloma including specific drugs.

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

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

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I do not have plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary amyloid light chain amyloidosis.

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My condition did not improve after treatment with a CD38 antibody.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Progression Free Survival (PFS)

Secondary study objectives

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 Symptoms, Functioning, and Overall HRQoL as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Scale Score

Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Patient Global Impression - Severity (PGI-S)

+17 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: 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2650

Bortezomib

2005

Completed Phase 3

~1410

Daratumumab

2014

Completed Phase 3

~2380

Pomalidomide

2011

Completed Phase 2

~1060

0 / 10Eligibility 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 and Daratumumab are targeted therapies used in the treatment of Multiple Myeloma. Teclistamab is a bispecific T cell engager that targets BCMA on myeloma cells and CD3 on T cells, redirecting T cells to kill myeloma cells. Daratumumab is a monoclonal antibody that targets CD38 on myeloma cells, inducing cell death through antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). These mechanisms are significant for Multiple Myeloma patients as they offer targeted treatment options that enhance the immune system's ability to specifically attack myeloma cells, potentially improving treatment efficacy and reducing toxicity.