What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, particularly those involving immunomodulatory drugs like lenalidomide, pomalidomide, and thalidomide, often have side effects including increased risk of infections, fatigue, diarrhea, constipation, and muscle spasms. Lenalidomide and similar drugs can also cause hematologic toxicities such as neutropenia, anemia, and thrombocytopenia. Additionally, there is a risk of serious infections, particularly in the lower respiratory tract, and other nonhematologic toxicities like hyperglycemia, hypertension, and rash. These side effects are important considerations when evaluating treatment options with your doctor.

What prior FDA approvals exist?

The FDA has approved several immunomodulatory drugs for the treatment of Multiple Myeloma, including lenalidomide, pomalidomide, and thalidomide. Lenalidomide, often used in combination with dexamethasone, has shown efficacy in reducing tumor burden and maintaining long-term tumor suppression. Pomalidomide, combined with dexamethasone, is approved for patients who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor. Thalidomide, one of the earlier immunomodulatory drugs, is also used in combination regimens. These drugs work by modulating the immune system and inducing apoptosis in myeloma cells, similar to the mechanism of action being studied for Mezigdomide.

What other types of research exist?

Promising novel alternatives to Mezigdomide for Multiple Myeloma patients include: 1) Milatuzumab, a humanized anti-CD74 monoclonal antibody, which has shown increased efficacy when combined with bortezomib, doxorubicin, or dexamethasone. 2) Selinexor, an oral selective inhibitor of nuclear export, which has demonstrated efficacy in combination with bortezomib and dexamethasone. 3) Daratumumab, an anti-CD38 monoclonal antibody, which has been effective in combination with carfilzomib and dexamethasone. 4) Isatuximab, another anti-CD38 monoclonal antibody, which has shown promise in combination with pomalidomide and dexamethasone.

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Proteasome Inhibitor

Mezigdomide + Carfilzomib + Dexamethasone for Multiple Myeloma (SUCCESSOR-2 Trial)

Phase 3

Recruiting

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new drug called Mezigdomide combined with two other drugs to treat patients whose blood cancer has come back or not responded to previous treatments. The new drug aims to stop cancer cells from growing and spreading.

Who is the study for?

This trial is for individuals with multiple myeloma who've had at least one prior treatment, including lenalidomide and an anti-CD38 monoclonal antibody. They should have shown some response to previous treatments and must have disease progression after the last regimen. Those previously treated with mezigdomide or carfilzomib, or recent stem cell transplant recipients cannot participate.

What is being tested?

The SUCCESSOR-2 study is testing Mezigdomide combined with Carfilzomib and Dexamethasone (MeziKD) against just Carfilzomib and Dexamethasone (Kd). The goal is to see which combination works better for relapsed or refractory multiple myeloma.

What are the potential side effects?

Potential side effects include immune system suppression leading to infections, blood clots, fatigue, nausea, diarrhea, muscle pain, fever from infusion reactions. Long-term risks may involve bone marrow suppression causing anemia or bleeding problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 5 years

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

Treatment Details

Study Objectives

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

Secondary study objectives

Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30)

Change From Baseline in the European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20)

Complete Response (CR) Or Better (CRR)

+3 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

Active Control

Group I: MeziKd (Mezigdomide + Carfilzomib + Dexamethasone)Experimental Treatment3 Interventions

Group II: Kd (Carfilzomib + Dexamethasone)Active Control2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2650

Mezigdomide

2023

Completed Phase 1

~40

Carfilzomib

2017

Completed Phase 3

~1430

Do I qualify?Apply below to find out

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

Common treatments for Multiple Myeloma include immunomodulatory drugs (IMiDs) like Mezigdomide, proteasome inhibitors, and monoclonal antibodies. IMiDs induce apoptosis in myeloma cells and enhance the immune system's ability to target these cells. Proteasome inhibitors, such as carfilzomib, disrupt protein degradation in cancer cells, leading to cell death. Monoclonal antibodies, like daratumumab, specifically target antigens on myeloma cells, facilitating their destruction by the immune system. These mechanisms are crucial as they offer multiple pathways to attack myeloma cells, improving treatment efficacy and patient outcomes.

Experimental approaches in the treatment of multiple myeloma.