What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, including Teclistamab, Lenalidomide, and Dexamethasone, have various side effects. Teclistamab, a bispecific antibody, may cause cytokine release syndrome, infections, and cytopenias. Lenalidomide can lead to neutropenia, thrombocytopenia, fatigue, and gastrointestinal issues. Dexamethasone, a corticosteroid, often results in hyperglycemia, insomnia, mood changes, and increased risk of infections. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Multiple Myeloma, including monoclonal antibodies and combination therapies. Daratumumab, an anti-CD38 monoclonal antibody, has been approved in combination with bortezomib and dexamethasone for relapsed or refractory Multiple Myeloma. Elotuzumab, another monoclonal antibody, is approved in combination with lenalidomide and dexamethasone for patients who have received at least one prior therapy. Additionally, the combination of bortezomib, cyclophosphamide, and dexamethasone (VCd) is an important treatment option for relapsed Multiple Myeloma. These treatments, like Teclistamab, aim to target specific markers on myeloma cells to enhance the immune system's ability to fight the cancer.

What other types of research exist?

Promising alternatives to Teclistamab for Multiple Myeloma patients include: 1) Daratumumab (anti-CD38 monoclonal antibody) which has shown efficacy in combination with other agents like lenalidomide and dexamethasone. 2) Isatuximab (another anti-CD38 monoclonal antibody) used in combination with pomalidomide and dexamethasone. 3) Elotuzumab (targets SLAMF7) combined with lenalidomide and dexamethasone. 4) CAR T-cell therapies such as Idecabtagene vicleucel (targets BCMA) which have shown promising results in relapsed/refractory MM. These therapies offer different mechanisms of action and have demonstrated significant clinical benefits in MM treatment.

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Corticosteroid

Teclistamab vs Lenalidomide + Dexamethasone for Multiple Myeloma

Phase 2

Recruiting

Led By Irene C Ghobrial, MD

Research Sponsored by Irene Ghobrial, MD

Eligibility Criteria Checklist

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

Must have

Mandatory registration into the Revlimid REMS® program for participants randomized to lenalidomide

Age ≥18 years

Must not have

Myelodysplastic syndrome or active malignancies within the last 24 months

Other concurrent chemotherapy, immunotherapy, radiotherapy, or investigational therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through end of post-treatment follow up period, an average of 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called Teclistamab against a combination of two existing drugs, Lenalidomide and Dexamethasone, in people with high-risk smoldering multiple myeloma. The goal is to see which treatment is more effective in preventing the progression to active multiple myeloma. Teclistamab helps the immune system target cancer cells, while Lenalidomide and Dexamethasone work together to boost the immune response and reduce inflammation.

Who is the study for?

This trial is for adults over 18 with high-risk smoldering multiple myeloma, which is a pre-cancerous stage of plasma cell cancer without symptoms. Participants must have certain blood and bone marrow conditions, be able to perform daily activities (ECOG 0-2), and not have had previous SMM treatments in the last 6 months. Women who can bear children must follow strict pregnancy prevention measures.

What is being tested?

The study tests Teclistamab's effectiveness against a combination of Lenalidomide and Dexamethasone in patients with high-risk smoldering multiple myeloma. It aims to find out if early treatment can prevent progression to active multiple myeloma.

What are the potential side effects?

Possible side effects include immune system reactions, infections due to low white blood cell counts, fatigue, digestive issues from Dexamethasone or Lenalidomide, and potential infusion-related reactions from Teclistamab.

Eligibility Criteria

Inclusion Criteria

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

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I am registered in the Revlimid REMS program.

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I am 18 years old or older.

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I do not show signs of active multiple myeloma.

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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 not had myelodysplastic syndrome or any cancer in the last 2 years.

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I am not currently receiving any other cancer treatments.

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I do not have any unmanaged ongoing illnesses.

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I have symptoms of multiple myeloma or meet the CRAB criteria.

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I have a heart condition.

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I have not had major surgery in the last 2 weeks.

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I have not been diagnosed or treated for another cancer within the last 2 years.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through end of post-treatment follow up period, an average of 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through end of post-treatment follow up period, an average of 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through end of post-treatment follow up period, an average of 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

Complete Response Rate (CRR)

Secondary study objectives

Duration of Response (DOR)

Immunogenicity of Teclistamab in SMM

Minimal Residual Disease (MRD) Negativity

+8 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TeclistamabExperimental Treatment1 Intervention

Each study treatment cycle lasts 28 days. Participants will be randomized into either Teclistamab arm or Lenalidomine + Dexamethoasone arm - Teclistamab-Per Protocol

Group II: Lenalidomide + Dexamethasone (LD)Active Control2 Interventions

Each study treatment cycle lasts 28 days. Participants will be randomized into either Teclistamab arm or Lenalidomine + Dexamethoasone arm * Lenalidomine * Dexamethoasone

0 / 12Eligibility 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 cellular mechanisms to combat the disease. Bispecific antibodies like Teclistamab target BCMA (B-cell maturation antigen) and CD3, directing T-cells to kill myeloma cells, which is crucial for targeting the cancer cells directly and enhancing immune response. Other common treatments include proteasome inhibitors (e.g., bortezomib) that disrupt protein degradation in myeloma cells, leading to cell death, and immunomodulatory drugs (e.g., lenalidomide) that enhance the immune system's ability to fight cancer. Monoclonal antibodies (e.g., daratumumab) target specific antigens on myeloma cells to mark them for destruction by the immune system. These mechanisms are vital as they offer targeted approaches to reduce tumor burden, improve patient outcomes, and manage the disease more effectively.

Bispecific antibodies in acute lymphoblastic leukemia therapy.Multiple Myeloma: Current Advances and Future Directions.