What is the mechanism of action of this treatment?

The most common treatments for Multiple Myeloma include immunomodulatory drugs (IMiDs) like iberdomide and lenalidomide, which modulate the immune system to target and destroy cancer cells. Proteasome inhibitors, such as bortezomib, disrupt the protein degradation process in cancer cells, leading to cell death. Monoclonal antibodies, like daratumumab, target specific proteins on the surface of myeloma cells, marking them for destruction by the immune system. These treatments are essential for Multiple Myeloma patients as they offer multiple pathways to attack the cancer, potentially leading to better control of the disease and improved survival rates.

What side effects are associated with this type of intervention?

Immunomodulatory drugs (IMiDs) like lenalidomide and iberdomide, used in the treatment of multiple myeloma, commonly cause side effects such as fatigue, diarrhea, constipation, and an increased risk of infections. Hematologic toxicities like neutropenia, thrombocytopenia, and anemia are also frequent. Proteasome inhibitors, such as bortezomib, often lead to peripheral neuropathy, gastrointestinal issues, and cytopenias. Monoclonal antibodies, like daratumumab, can cause infusion-related reactions, respiratory infections, and fatigue. These treatments require careful monitoring to manage and mitigate adverse effects.

What prior FDA approvals exist?

The FDA has approved several immunomodulatory drugs for the treatment of Multiple Myeloma. Lenalidomide (Revlimid) and pomalidomide (Pomalyst) are notable examples, both of which modulate the immune system to target and destroy cancer cells. Lenalidomide is commonly used in both newly diagnosed and relapsed/refractory Multiple Myeloma, often in combination with other agents like dexamethasone. Pomalidomide is typically used in relapsed/refractory cases after other treatments have failed. These drugs have shown efficacy in prolonging progression-free survival and overall survival in Multiple Myeloma patients.

What other types of research exist?

Promising novel alternatives to Iberdomide for Multiple Myeloma patients include: 1) Daratumumab, an anti-CD38 monoclonal antibody, often combined with other agents like lenalidomide and dexamethasone. 2) Carfilzomib, a proteasome inhibitor, used in combinations such as with lenalidomide and dexamethasone. 3) Isatuximab, another anti-CD38 monoclonal antibody, combined with pomalidomide and dexamethasone. 4) Selinexor, a selective inhibitor of nuclear export, combined with bortezomib and dexamethasone. These therapies have shown effectiveness in clinical trials and are considered promising for treating Multiple Myeloma.

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Iberdomide vs Lenalidomide for Multiple Myeloma

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 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing two treatments, iberdomide and lenalidomide, to see which one is better at preventing cancer from coming back in patients with newly diagnosed multiple myeloma after a stem cell transplant. These treatments help the immune system fight off cancer cells. Lenalidomide has been used for the treatment of multiple myeloma, showing effectiveness and improving survival outcomes.

Who is the study for?

This trial is for individuals with newly diagnosed symptomatic multiple myeloma who've had 3-6 cycles of specific induction therapies and a stem cell transplant within the last year, achieving at least partial response. It's not for those with progressive disease post-transplant, smoldering or nonsecretory myeloma, central nervous system involvement by MM, or other malignancies in the past 5 years.

What is being tested?

The study compares two maintenance therapies after autologous stem cell transplantation in new multiple myeloma patients: Iberdomide versus Lenalidomide. The goal is to see which one is more effective as a long-term treatment following initial therapy and transplant.

What are the potential side effects?

Potential side effects of Iberdomide and Lenalidomide may include blood disorders like anemia or neutropenia, risk of infections due to low white blood cells, digestive issues such as diarrhea or constipation, fatigue, rash, and possibly increased risk of secondary cancers.

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

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

4Treatment groups

Experimental Treatment

Active Control

Group I: Arm A3: Iberdomide Dose 3Experimental Treatment1 Intervention

Group II: Arm A2: Iberdomide Dose 2Experimental Treatment1 Intervention

Group III: Arm A1: Iberdomide Dose 1Experimental Treatment1 Intervention

Group IV: Arm B: LenalidomideActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Iberdomide

2021

Completed Phase 1

~60

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

The most common treatments for Multiple Myeloma include immunomodulatory drugs (IMiDs) like iberdomide and lenalidomide, which modulate the immune system to target and destroy cancer cells. Proteasome inhibitors, such as bortezomib, disrupt the protein degradation process in cancer cells, leading to cell death. Monoclonal antibodies, like daratumumab, target specific proteins on the surface of myeloma cells, marking them for destruction by the immune system. These treatments are essential for Multiple Myeloma patients as they offer multiple pathways to attack the cancer, potentially leading to better control of the disease and improved survival rates.