What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, particularly those involving bispecific antibodies like Talquetamab and Teclistamab, often lead to hematologic toxicities such as neutropenia and lymphocytopenia, increasing infection risks. Non-hematologic side effects include fatigue, diarrhea, and hypocalcemia. Severe infections, including pneumonia and viral reactivations like herpes zoster, are also reported. Additionally, cytokine release syndrome (CRS) and neurotoxicity are potential risks associated with these T-cell engaging therapies.

What prior FDA approvals exist?

The FDA has approved several treatments for Multiple Myeloma that involve bispecific antibodies and other novel mechanisms. Teclistamab, a bispecific T-cell engager targeting BCMA/CD3, has shown a high rate of deep and durable responses in heavily pretreated patients. Other related FDA-approved treatments include anti-CD38 monoclonal antibodies like Daratumumab, which has been used in combination therapies to improve progression-free survival. Additionally, BCMA-directed therapies such as the antibody-drug conjugate Belantamab Mafodotin and BCMA-targeted CAR-T cell therapies like Idecabtagene Vicleucel have also been approved, offering new avenues for targeting multiple myeloma cells.

What other types of research exist?

Promising novel alternatives to Talquetamab + Teclistamab for Multiple Myeloma patients in 2024 include: 1) CAR-T cell therapies like Idecabtagene Vicleucel (Abecma) and Ciltacabtagene Autoleucel (Carvykti), which target BCMA on myeloma cells. 2) Monoclonal antibodies such as Daratumumab (anti-CD38) and Elotuzumab (anti-SLAMF7). 3) Small molecule inhibitors like Selinexor (XPO1 inhibitor) and Venetoclax (BCL-2 inhibitor). These therapies have shown significant efficacy in clinical trials and offer different mechanisms of action compared to bispecific antibodies.

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Monoclonal Antibodies

Talquetamab + Teclistamab for Multiple Myeloma (RedirecTT-1 Trial)

Phase 1 & 2

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

Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 at screening and immediately before the start of study drug administration

Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria

Must not have

Allogeneic stem cell transplant within 6 months before the first dose of study treatment

Active plasma cell leukemia (greater than [>]2.0*10^9/L plasma cells by standard differential), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M- protein, and skin changes), or primary amyloid light chain amyloidosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of two drugs, talquetamab and teclistamab, in patients whose multiple myeloma has come back or did not respond to previous treatments. The drugs aim to destroy cancer cells by targeting specific proteins on their surface.

Who is the study for?

This trial is for people with multiple myeloma that's come back or hasn't responded to treatment. They should be able to perform daily activities without significant issues (ECOG grade 0-1). Participants must have been diagnosed according to specific criteria and can't join if they've had certain other conditions, recent experimental therapies, or a stem cell transplant within the last six months.

What is being tested?

The study is testing combinations of Talquetamab and Teclistamab in those with relapsed or refractory multiple myeloma. It aims to find the best dose and schedule, assess safety at this dose, and see how well these drugs work against cancer, especially when it has spread outside the bone marrow.

What are the potential side effects?

Potential side effects may include reactions where the drug enters the body, changes in blood counts leading to increased infection risk or bleeding problems, fatigue, nausea, bone pain from disease activity changes due to treatment response.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or restricted in physically strenuous activity but can do light work.

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My multiple myeloma diagnosis follows international guidelines.

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My condition did not improve or worsened after the last treatment.

Exclusion Criteria

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

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I had a stem cell transplant from a donor within the last 6 months.

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I have a specific blood cancer or related condition.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 5 years

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

Part 1: Number of Participants with Dose Limiting Toxicity (DLT)

Part 1: Severity of DLT as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)

Part 2: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability

+2 more

Secondary study objectives

Part 1 and Part 2: Number of Participants with Anti-Drug Antibodies to Daratumumab

Part 1 and Part 2: Overall Response Rate (ORR)

Part 1 and Part 2: Serum Concentration of Daratumumab

+13 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Part 3: Phase 2Experimental Treatment2 Interventions

Participants will receive teclistamab + talquetamab combination therapy, at the RP2R selected from Part 1 and Part 2.

Group II: Part 2: Dose ExpansionExperimental Treatment3 Interventions

Participants will receive treatment doses (combination of tal+tec and dara+tal+tec regimens) which will be determined by the recommended Phase 2 regimen (s) (RP2R\[s\]) of the study treatment identified in Part 1.

Group III: Part 1: Dose EscalationExperimental Treatment3 Interventions

Participants will receive tec+tal with or without daratumumab in 28-day cycles following initial step-up doses.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Daratumumab

2014

Completed Phase 3

~2380

0 / 6Eligibility 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 immunomodulatory drugs, proteasome inhibitors, monoclonal antibodies, and bispecific antibodies. Bispecific antibodies, such as Talquetamab and Teclistamab, are designed to engage T-cells by targeting specific antigens on myeloma cells (GPRC5D and BCMA, respectively) and CD3 on T-cells, thereby directing the immune system to attack the cancer cells. This mechanism is crucial for Multiple Myeloma patients as it offers a targeted approach to eliminate malignant cells while potentially reducing damage to normal cells. Other treatments like proteasome inhibitors disrupt protein degradation in cancer cells, leading to apoptosis, and immunomodulatory drugs enhance the immune response against myeloma cells. Monoclonal antibodies target specific proteins on myeloma cells to mark them for destruction by the immune system. These therapies collectively improve response rates and duration of remission in Multiple Myeloma patients.

How best to use new therapies in multiple myeloma.