Iberdomide Maintenance Therapy for Multiple Myeloma

Recruiting at 1 trial location

Overseen By Marnee B Strege, BSN

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Nebraska

Must not be taking: Immunosuppressants, CYP3A4/5 inducers

Disqualifiers: Pregnancy, Disease progression, Plasma cell leukemia, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you've used certain medications like strong inhibitors or inducers of CYP3A4/5, or immunosuppressive medications within 14 days before starting the trial.

What data supports the effectiveness of the drug Iberdomide for multiple myeloma?

Iberdomide has shown enhanced tumor-killing and immune-boosting effects in preclinical models of multiple myeloma, especially when combined with other treatments like dexamethasone. It is also highly specific to certain proteins involved in the disease, which may help in treating patients who have become resistant to other therapies. ^{1 2 3 4 5}

Is Iberdomide safe for humans?

Iberdomide has been studied in combination with dexamethasone for patients with multiple myeloma, focusing on its safety and clinical activity. While specific safety data for Iberdomide alone is not detailed, it is part of a class of drugs known as immunomodulatory drugs, which have shown serious side effects in some cases, such as pneumonia and sepsis. Further research is needed to fully understand its safety profile. ^{2 4 5 6 7}

Research Team

Sarah A Holstein, MD, PhD

Principal Investigator

University of Nebraska

Eligibility Criteria

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.

Inclusion Criteria

I am at least 18 years old, or 19 if I live in Nebraska.

I can become pregnant and agree to use two forms of birth control or practice abstinence.

I have been diagnosed with active Multiple Myeloma.

Exclusion Criteria

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

Within the past 14 days, you have had low levels of certain blood cells, high levels of calcium in your blood, or liver or kidney problems.

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

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Iberdomide maintenance therapy post-autologous stem cell transplant, dosed at 1.0 mg PO daily for days 1-21 of a 28-day cycle

Until disease progression or toxicity

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Treatment Details

Interventions

• Iberdomide (Immunomodulatory Agent)

Trial Overview 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.

Participant Groups

Group I: Iberdomide Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+

Findings from Research

BCMA-directed therapies, such as antibody-drug conjugates and CAR T cells, have shown significant effectiveness in treating late-stage myeloma patients who have previously undergone various treatments, but the best order for using these therapies is still unclear.

After anti-BCMA therapy, there are several promising treatment options available, including alternative BCMA therapies and non-BCMA therapies, but more research is needed to personalize treatment strategies based on individual patient factors and disease characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Options at the time of relapse after anti-BCMA therapy. Razzo, B., Garfall, AL., Cohen, AD.[2023]

Recent advancements in anti-myeloma treatments, including thalidomide, lenalidomide, and bortezomib, have shown significant clinical responses, especially in patients who do not respond to traditional chemotherapy.

The review highlights the ongoing development of various novel therapeutic classes, such as second-generation proteasome inhibitors and HDAC inhibitors, which are currently in clinical trials or advanced preclinical stages, indicating a promising expansion of treatment options for myeloma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From the bench to the bedside: emerging new treatments in multiple myeloma. Mitsiades, CS., Hayden, PJ., Anderson, KC., et al.[2023]

The P-CAD regimen (cyclophosphamide and pirarubicin) showed a higher overall response rate of 85.7% and a median progression-free survival of 16.1 months in patients with relapse/refractory multiple myeloma, compared to the BD regimen, which had a response rate of 63.9% and a median progression-free survival of 13.7 months.

Both treatment regimens were associated with manageable adverse reactions, indicating that the P-CAD regimen is a promising and well-tolerated option for improving outcomes in patients with relapse/refractory multiple myeloma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of BD Regimen Combined with Cyclophosphamide and Pirarubicin in Treatment of Relapse/Refractory Multiple Myeloma]. Wang, YF., Xu, WJ., Chen, YL., et al.[2018]

Iberdomide combined with dexamethasone demonstrated meaningful clinical activity in heavily pretreated patients with relapsed or refractory multiple myeloma, achieving an overall response rate of 32% in the dose-escalation cohort and 26% in the dose-expansion cohort, indicating its potential effectiveness even in difficult-to-treat cases.

The treatment was generally safe, with a recommended phase 2 dose established at 1.6 mg, although some patients experienced serious adverse events, including neutropenia and infections, highlighting the need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Iberdomide plus dexamethasone in heavily pretreated late-line relapsed or refractory multiple myeloma (CC-220-MM-001): a multicentre, multicohort, open-label, phase 1/2 trial. Lonial, S., Popat, R., Hulin, C., et al.[2022]

Multiple myeloma remains an incurable disease with increasing incidence, and while current treatments using proteasome inhibitors and immunomodulatory drugs have improved outcomes, many patients still experience relapses and resistance.

Iberdomide, a new drug with high specificity for the Ikaros and Aiolos proteins, represents a promising direction in developing more targeted therapies for multiple myeloma, potentially improving treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review on the treatment of multiple myeloma with small molecular agents in the past five years. Zhang, Z., Liu, X., Zhao, L., et al.[2022]

A comprehensive analysis of adverse event reports for thalidomide, lenalidomide, and pomalidomide revealed significant safety signals, including thalidomide's association with cardiac disorders and lenalidomide's gastrointestinal issues, highlighting the need for careful monitoring in patients.

Pomalidomide was found to have a lower risk of venous thromboembolism compared to thalidomide and lenalidomide, making it a potentially safer option for patients, especially those with renal insufficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-marketing safety of immunomodulatory drugs in multiple myeloma: A pharmacovigilance investigation based on the FDA adverse event reporting system. Jiang, T., Su, H., Li, Y., et al.[2022]

In a study of 22 patients with relapsed or refractory multiple myeloma, the combination of bortezomib and dexamethasone (BD therapy) resulted in a high response rate, with 77.3% achieving at least a partial response, indicating its efficacy.

Switching to a once-weekly administration of bortezomib after initial twice-weekly treatment significantly reduced severe gastrointestinal side effects while maintaining the therapy's effectiveness, suggesting a safer dosing strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of bortezomib plus dexamethasone therapy for refractory or relapsed multiple myeloma: once-weekly administration of bortezomib may reduce the incidence of gastrointestinal adverse events. Fukushima, T., Nakamura, T., Iwao, H., et al.[2015]

References

1. United States pubmed.ncbi.nlm.nih.gov

Options at the time of relapse after anti-BCMA therapy. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

From the bench to the bedside: emerging new treatments in multiple myeloma. [2023]

3. China pubmed.ncbi.nlm.nih.gov

[Effect of BD Regimen Combined with Cyclophosphamide and Pirarubicin in Treatment of Relapse/Refractory Multiple Myeloma]. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Iberdomide plus dexamethasone in heavily pretreated late-line relapsed or refractory multiple myeloma (CC-220-MM-001): a multicentre, multicohort, open-label, phase 1/2 trial. [2022]

5. France pubmed.ncbi.nlm.nih.gov

A review on the treatment of multiple myeloma with small molecular agents in the past five years. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Post-marketing safety of immunomodulatory drugs in multiple myeloma: A pharmacovigilance investigation based on the FDA adverse event reporting system. [2022]

7. Greece pubmed.ncbi.nlm.nih.gov

Efficacy and safety of bortezomib plus dexamethasone therapy for refractory or relapsed multiple myeloma: once-weekly administration of bortezomib may reduce the incidence of gastrointestinal adverse events. [2015]