What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, such as combinations of bortezomib, dexamethasone, and immunomodulatory drugs like pomalidomide, often result in side effects including peripheral neuropathy, gastrointestinal issues (nausea, diarrhea, constipation), fatigue, and hematologic toxicities (neutropenia, thrombocytopenia). Specific regimens may also lead to increased risks of infections, hypertension, and secondary malignancies. For instance, bortezomib is associated with peripheral neuropathy and gastrointestinal distress, while pomalidomide can cause neutropenia and increased infection rates.

What prior FDA approvals exist?

The FDA has approved several treatments for Multiple Myeloma, particularly for relapsed or refractory cases. Pomalidomide, a drug similar to Mezigdomide as it is also a Cereblon E3 Ligase Modulator, has been approved in combination with bortezomib and dexamethasone (PVd). Other notable approvals include lenalidomide, another Cereblon E3 Ligase Modulator, often used in combination with dexamethasone and other agents like bortezomib. Additionally, combinations such as elotuzumab with pomalidomide and dexamethasone (EPd) and carfilzomib with dexamethasone and daratumumab (KdD) have also been approved for treating relapsed or refractory multiple myeloma.

What other types of research exist?

Promising novel alternatives to Mezigdomide for Multiple Myeloma patients include ABT-737 (a Bcl-2/Bcl-X(L)/Bcl-w inhibitor), NVP-BEZ235 (a dual PI3K/mTOR inhibitor), and marizomib (a proteasome inhibitor). These agents have demonstrated potential in enhancing anti-myeloma activity and overcoming drug resistance in preclinical studies.

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Proteasome Inhibitor

Mezigdomide Combo vs. Pomalidomide Combo for Multiple Myeloma (SUCCESSOR-1 Trial)

Phase 3

Recruiting

Research Sponsored by Celgene

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

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing two drug combinations to find out which one is better and safer for patients with multiple myeloma that has come back or not responded to previous treatments. The drugs work together to kill cancer cells by stopping their growth, helping the immune system attack them, and making it harder for them to survive.

Who is the study for?

This trial is for people with Multiple Myeloma who've had 1-3 previous treatments and were previously treated with lenalidomide. They must have measurable disease, responded at least minimally to past therapy, and not have had a poor reaction or no response to bortezomib. Those who progressed on proteasome inhibitors recently or have been treated with mezigdomide/pomalidomide can't join.

What is being tested?

The study compares two drug combinations for relapsed/refractory Multiple Myeloma: Mezigdomide with Bortezomib and Dexamethasone (MeziVd) versus Pomalidomide with the same additional drugs (PVd). It aims to see which combo works better after prior therapies including lenalidomide.

What are the potential side effects?

Possible side effects include reactions related to immune system suppression such as infections, blood clots, fatigue, gastrointestinal issues like nausea or constipation, nerve damage that may cause pain or numbness, and potential blood cell count changes leading to anemia or bleeding risks.

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 European Organization for Research and Treatment of Cancer - Quality of Life C30 questionnaire (EORTC QLQ-C30) scores

Change from baseline in European Organization for Research and Treatment of Cancer - Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20) score

Complete Response (CR) or better

+5 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

2Treatment groups

Experimental Treatment

Group I: PVd (pomalidomide, bortezomib and dexamethasone)Experimental Treatment3 Interventions

Group II: MeziVd (mezigdomide, bortezomib and dexamethasone)Experimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pomalidomide

2011

Completed Phase 2

~1060

Bortezomib

2005

Completed Phase 3

~1410

Dexamethasone

2007

Completed Phase 4

~2650

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

Multiple Myeloma treatments often target specific cellular mechanisms to inhibit cancer cell growth and survival. Mezigdomide, like other Cereblon E3 Ligase Modulators (e.g., lenalidomide, pomalidomide), works by binding to the cereblon protein, leading to the degradation of key proteins that promote myeloma cell survival and proliferation. Bortezomib, a proteasome inhibitor, disrupts protein degradation, causing an accumulation of toxic proteins in cancer cells, leading to cell death. Dexamethasone, a corticosteroid, reduces inflammation and directly induces apoptosis in myeloma cells. These mechanisms are crucial as they target the cancer cells' ability to grow and survive, offering effective treatment options for patients with Multiple Myeloma, especially those with relapsed or refractory disease.