Iberdomide Maintenance Therapy for Multiple Myeloma

Not currently recruiting at 1 trial location

Overseen By Marnee B Strege, BSN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Nebraska

Must not be taking: Immunosuppressants, CYP3A4/5 inducers

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Until disease progression or toxicity

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medication called iberdomide for individuals with multiple myeloma, a type of blood cancer, who have already undergone a stem cell transplant. The goal is to determine if iberdomide can prevent cancer recurrence and cause fewer side effects than the current standard treatment, lenalidomide. Individuals who have recently had a stem cell transplant and are in partial remission or better might be suitable candidates. Participants will take iberdomide pills on a specific schedule and attend regular check-ups to monitor their health and the cancer's status. As a Phase 2 trial, this research measures how well iberdomide works in an initial, smaller group of people.

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.

Is there any evidence suggesting that iberdomide is likely to be safe for humans?

Research has shown that iberdomide has been generally safe in past studies. For example, when combined with other treatments like dexamethasone, it proved safe and had positive effects in patients who had already received many treatments for multiple myeloma. Another study confirmed that the safety of iberdomide, even when used with different medications, matched earlier research findings.

Although iberdomide is still being tested in clinical trials, these results suggest it is well-tolerated by patients. This provides some reassurance about its safety for those considering joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Iberdomide is unique because it offers a fresh approach to treating multiple myeloma by targeting specific proteins that play a role in the growth and survival of cancer cells. Unlike traditional therapies like proteasome inhibitors and immunomodulatory drugs, Iberdomide works by modulating the immune system in a novel way, potentially offering better outcomes with fewer side effects. Researchers are excited about Iberdomide's ability to be taken orally, providing a convenient option that fits into the daily routine of patients, compared to some existing treatments that require intravenous administration. This new mechanism and delivery method could make a significant difference in how patients manage their condition.

What evidence suggests that iberdomide might be an effective treatment for multiple myeloma?

Research has shown that iberdomide might help treat multiple myeloma, a type of blood cancer. In this trial, participants will receive iberdomide as a maintenance therapy. Previous studies found that combining iberdomide with treatments like daratumumab and dexamethasone led to cancer improvement in 93.1% of patients. Another study found that using iberdomide with bortezomib and dexamethasone also yielded promising results in early trials. Iberdomide targets a specific protein that controls cell growth, potentially making it a strong option for treating multiple myeloma. ^{1 5 6 7 8}

Who Is on the Research Team?

Sarah A Holstein, MD, PhD

Principal Investigator

University of Nebraska

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Iberdomide

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.

How Is the Trial Designed?

Group I: Iberdomide Experimental Treatment 1 Intervention

Iberdomide will be dosed at 1.0 mg orally daily on 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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. news.bms.com news.bms.com/news/corporate-financial/2025/Bristol-Myers-Squibb-Announces-Phase-3-EXCALIBER-RRMM-Study-Evaluating-Iberdomide-in-Combination-with-Standard-Therapies-Demonstrated-a-Significant-Improvement-in-Minimal-Residual-Disease-Negativity-Rates-in-Relapsed-or-Refractory-Multiple-Myeloma/default.aspx

Bristol Myers Squibb Announces Phase 3 EXCALIBER ... Stage 1 of the study identified 1.0 mg iberdomide as the optimal dose based on safety, pharmacokinetics, and efficacy data. In Stage 2, ...

2. onclive.com onclive.com/view/iberdomide-daratumumab-dexamethasone-is-effective-in-newly-diagnosed-multiple-myeloma

Iberdomide/Daratumumab/Dexamethasone Is Effective in ... The iberdomide-daratumumab-dexamethasone regimen achieved a 93.1% overall response rate in frail, transplant-ineligible multiple myeloma ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.7532

Iberdomide, bortezomib, and dexamethasone (IberVd) in ... IberVd has shown meaningful efficacy and safety in patients (pts) with TNE NDMM in the ongoing phase 1/2 CC-220-MM-001 trial (NCT02773030).

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04975997

NCT04975997 | Open-label Study Comparing Iberdomide, ... To evaluate clinical efficacy in terms of overall survival (OS) in participants with relapsed or refractory multiple myeloma (RRMM) treated with iberdomide, ...

5. healthtree.org healthtree.org/myeloma/community/articles/asco-25-iberdomide-for-older-mm-patients

Iberdomide Combo Effective in Older Myeloma Px Iberdomide Combination Shows Strong Results in Older Adults with Newly Diagnosed Myeloma. Some people with multiple myeloma are not eligible ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36209764/

Iberdomide plus dexamethasone in heavily pretreated late- ... Iberdomide plus dexamethasone was generally safe and showed meaningful clinical activity in heavily pretreated patients with multiple myeloma.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05560399

NCT05560399 | A Study of Iberdomide (CC-220) in ... This is a single-arm, open-label study evaluating the safety, tolerability and efficacy of Iberdomide (CC-220) in combination with Elotuzumab and Dexamethasone ...

8. myeloma.org myeloma.org/treatment/multiple-myeloma-medications/iberdomide

Iberdomide How Is Iberdomide Used in Multiple Myeloma? While still in clinical trials, iberdomide has demonstrated some positive results. For example, combination therapy ...