What is the mechanism of action of this treatment?

Immunomodulatory drugs (IMiDs) like iberdomide work by modulating the immune system to attack myeloma cells, inhibiting angiogenesis, and directly inducing cancer cell death. Proteasome inhibitors, such as bortezomib, disrupt the degradation of proteins within cancer cells, leading to cell cycle arrest and apoptosis. Monoclonal antibodies, like daratumumab, target specific antigens on myeloma cells, marking them for destruction by the immune system. These mechanisms are crucial for Multiple Myeloma patients as they offer targeted approaches to control the disease, reduce tumor burden, and improve survival rates.

What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, particularly immunomodulatory drugs like lenalidomide, pomalidomide, and thalidomide, have several known side effects. These include hematologic toxicities such as neutropenia, thrombocytopenia, and anemia. Non-hematologic side effects often include fatigue, gastrointestinal issues (nausea, vomiting, diarrhea, constipation), peripheral neuropathy, and increased risk of infections. Additionally, lenalidomide has been associated with a risk of thromboembolic events and second primary malignancies. These side effects necessitate careful monitoring and dose adjustments to manage toxicity.

What prior FDA approvals exist?

The FDA has approved several immunomodulatory drugs for the treatment of Multiple Myeloma, including lenalidomide and pomalidomide. Lenalidomide, often used in combination with dexamethasone, is a cornerstone in both initial and maintenance therapy for Multiple Myeloma. Pomalidomide, another immunomodulatory agent, is typically used in relapsed or refractory cases, often in combination with dexamethasone and other agents like daratumumab. These drugs have shown efficacy in prolonging progression-free survival and overall survival in various clinical trials.

What other types of research exist?

Promising novel alternatives to Iberdomide for Multiple Myeloma patients include antibody-drug-conjugates (ADCs), bispecific antibodies (BsAbs), and chimeric-antigen-receptor (CAR) T cell therapies. These therapies are in various stages of clinical development and have shown potential in increasing efficacy for Multiple Myeloma treatment.

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Iberdomide Maintenance Therapy for Multiple Myeloma

Phase 2

Recruiting

Led By Sarah A Holstein, MD, PhD

Research Sponsored by University of Nebraska

Eligibility Criteria Checklist

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

Must have

Subjects must have a documented history of a diagnosis of active Multiple Myeloma (MM)

Measurable disease documented at time of diagnosis (prior to induction and ASCT) as defined as: i. M-protein (serum and/or urine protein electrophoresis (SPEP or UPEP)): SPEP ≥ 0.5 g/dL or UPEP ≥ 200 mg/24 hours and/or ii. Light chain MM without measurable disease in the serum or urine: serum immunoglobulin free light chain ≥ 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa-lambda free light chain ratio

Must not have

Subject has nonsecretory MM, plasma cell leukemia or light chain amyloidosis

Subject with peripheral neuropathy ≥ Grade 2, gastrointestinal disease that may significantly alter the absorption of iberdomide or inability to take medications by mouth

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a medication called iberdomide to see if it can help prevent cancer from returning in patients who have had a stem cell transplant. The medication is taken by mouth and helps the immune system fight off any leftover cancer cells. The study will check if this treatment is safe and effective for these patients.

Who is the study for?

This trial is for adults with Multiple Myeloma who've had a stem cell transplant and are in partial or better response. They must have good organ function, no prior progression after initial therapy, and not be on other clinical trials. Women of childbearing potential must use contraception; men must agree to abstain or use condoms.

What is being tested?

The study tests the safety and effectiveness of iberdomide as maintenance therapy post-stem cell transplant in Multiple Myeloma patients. It will continue until disease progression or unacceptable toxicity occurs, comparing its results potentially with lenalidomide maintenance.

What are the potential side effects?

While specific side effects for iberdomide aren't listed here, similar drugs can cause blood clots, nerve damage (neuropathy), low blood counts leading to increased infection risk, fatigue, rash, dizziness, constipation or diarrhea.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with active Multiple Myeloma.

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My cancer was measurable by specific protein levels in my blood or urine at diagnosis.

Exclusion Criteria

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

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I have a type of blood cancer that doesn't produce typical markers.

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I do not have severe nerve damage, major gut issues affecting drug absorption, or trouble swallowing pills.

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My multiple myeloma has worsened after a stem cell transplant.

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I am pregnant, nursing, breastfeeding, or plan to become pregnant during the study.

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I have heart issues like recent heart attack, severe heart failure, or unstable angina.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

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

Proportion of subjects who are able to complete at least one year of therapy

Secondary study objectives

MRD-negativity rate at Day 100

MRD-negativity rate at One Year

MRD-negativity rate at Two Years

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: IberdomideExperimental Treatment1 Intervention

Iberdomide will be dosed at 1.0 mg PO daily for days 1-21 of a 28-day cycle

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Iberdomide

2021

Completed Phase 1

~60

0 / 7Eligibility 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

Immunomodulatory drugs (IMiDs) like iberdomide work by modulating the immune system to attack myeloma cells, inhibiting angiogenesis, and directly inducing cancer cell death. Proteasome inhibitors, such as bortezomib, disrupt the degradation of proteins within cancer cells, leading to cell cycle arrest and apoptosis. Monoclonal antibodies, like daratumumab, target specific antigens on myeloma cells, marking them for destruction by the immune system. These mechanisms are crucial for Multiple Myeloma patients as they offer targeted approaches to control the disease, reduce tumor burden, and improve survival rates.