Iberdomide vs Lenalidomide for Multiple Myeloma

Recruiting at490 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Bristol-Myers Squibb

Must be taking: Proteasome inhibitors, Immunomodulatory drugs

Disqualifiers: Progressive disease, Smoldering myeloma, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Lenalidomide, a drug similar to Iberdomide, has shown effectiveness in treating multiple myeloma by stopping cancer cell growth and boosting the immune system. It has been proven to improve survival rates in patients, especially when used with other treatments like dexamethasone. ^{1 2 3 4 5}

Is lenalidomide safe for humans?

Lenalidomide, also known as Revlimid, is generally considered safe for humans and is approved for use in multiple myeloma and other conditions. It is more active than thalidomide and does not cause the nerve damage associated with thalidomide. ^{1 2 6 7 8}

How does the drug Iberdomide differ from Lenalidomide for treating multiple myeloma?

Iberdomide is a newer drug being compared to Lenalidomide for treating multiple myeloma. While both are immunomodulatory drugs (they help the immune system fight cancer), Iberdomide may offer different or improved effects, but specific details about its unique benefits or mechanisms compared to Lenalidomide are not provided in the available research. ^{1 2 4 5 6}

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

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.

Inclusion Criteria

I've had 3-6 cycles of specific cancer treatment and possibly a stem cell transplant.

I can take care of myself and am up and about more than half of my waking hours.

I have been diagnosed with symptomatic multiple myeloma.

Exclusion Criteria

My multiple myeloma has spread to my brain or spinal cord.

I have been cancer-free from other types of cancer for over 5 years.

My condition worsened after stem cell transplant or initial treatment didn't work.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either iberdomide or lenalidomide maintenance therapy after autologous stem cell transplantation

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• Iberdomide (Immunomodulatory Agent)
• Lenalidomide (Immunomodulatory Agent)

Trial Overview 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.

Participant Groups

Group I: Arm A3: Iberdomide Dose 3 Experimental Treatment 1 Intervention

Group II: Arm A2: Iberdomide Dose 2 Experimental Treatment 1 Intervention

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

Group IV: Arm B: Lenalidomide Active Control 1 Intervention

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Findings from Research

Lenalidomide is a powerful treatment for multiple myeloma (MM) that works by directly causing cancer cell death, preventing cancer cells from sticking to bone marrow, and enhancing the body's immune response against tumors.

In combination with dexamethasone, lenalidomide has shown superior effectiveness in clinical trials, leading to improved patient outcomes such as longer survival and FDA approval for treating relapsed MM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of lenalidomide in combination with dexamethasone for the treatment of multiple myeloma. Hideshima, T., Raje, N., Richardson, PG., et al.[2021]

The combination therapy of lenalidomide, bendamustine, and prednisolone (RBP) showed a high response rate in 88% of the 25 patients with relapsed/refractory multiple myeloma, indicating its efficacy as a treatment option.

While RBP was effective, many patients experienced increased hematological toxicity, necessitating dose reductions in subsequent treatment cycles, highlighting the need for careful monitoring during therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lenalidomide in combination with bendamustine and prednisolone in relapsed/refractory multiple myeloma: results of a phase 2 clinical trial (OSHO-#077). Beck, J., Schwarzer, A., Gläser, D., 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]

Immunomodulatory drugs like thalidomide and lenalidomide have shown significant effectiveness in treating multiple myeloma and related blood disorders, demonstrating high response rates across various treatment phases.

These drugs not only target cancer cells directly but also enhance the immune response within the bone marrow, and have been successfully combined with other treatments, leading to FDA approval for their use in multiple myeloma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic use of immunomodulatory drugs in the treatment of multiple myeloma. Raje, N., Hideshima, T., Anderson, KC.[2018]

Lenalidomide maintenance therapy significantly prolongs progression-free survival (PFS) in patients with newly diagnosed multiple myeloma after autologous stem-cell transplantation, as shown in pivotal phase 3 trials like IFM 2005-02 and CALGB 100104.

While lenalidomide is associated with some increased risks, such as grade 3/4 adverse events and a higher chance of second primary cancers, the overall survival benefits outweigh these risks, making it a valuable treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lenalidomide: A Review in Newly Diagnosed Multiple Myeloma as Maintenance Therapy After ASCT. Syed, YY.[2018]

Lenalidomide (REVLIMID®) is an effective treatment for multiple myeloma and transfusion-dependent anemia in myelodysplastic syndromes, showing better activity and less neurotoxicity compared to its predecessor, thalidomide.

This drug has multiple beneficial properties, including anti-inflammatory and antiangiogenic effects, and may play a significant role in treating various cancers beyond its current approved uses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The potential of immunomodulatory drugs in the treatment of solid tumors. Dalgleish, A., Galustian, C.[2018]

In a study of 184 patients with relapsed/refractory multiple myeloma, the generic lenalidomide (Rivelime®) showed similar efficacy to the brand-name version (Revlimid®) in terms of overall response rates and survival outcomes.

Both treatments resulted in comparable progression-free survival and overall survival rates, with manageable side effects, indicating that Rivelime® can be a safe and effective alternative to Revlimid® for long-term therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Generic Lenalidomide Rivelime Versus Brand-name Revlimid® in the Treatment of Relapsed/Refractory Multiple Myeloma: A Retrospective Single-center Experience on Efficacy, Safety and Survival Outcome. Beksac, M., Seval, GC., Koyun, D., et al.[2023]

Lenalidomide, when combined with dexamethasone, significantly improves time to progression in patients with multiple myeloma compared to placebo, as shown in two randomized, double-blind studies.

However, the treatment is associated with serious side effects, including increased risks of neutropenia, thrombocytopenia, and thromboembolic events, leading to its restricted distribution under the RevAssist program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lenalidomide in combination with dexamethasone for the treatment of multiple myeloma after one prior therapy. Hazarika, M., Rock, E., Williams, G., et al.[2020]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

A review of lenalidomide in combination with dexamethasone for the treatment of multiple myeloma. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Lenalidomide in combination with bendamustine and prednisolone in relapsed/refractory multiple myeloma: results of a phase 2 clinical trial (OSHO-#077). [2018]

3. 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]

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

Therapeutic use of immunomodulatory drugs in the treatment of multiple myeloma. [2018]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Lenalidomide: A Review in Newly Diagnosed Multiple Myeloma as Maintenance Therapy After ASCT. [2018]

6. England pubmed.ncbi.nlm.nih.gov

The potential of immunomodulatory drugs in the treatment of solid tumors. [2018]

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

Generic Lenalidomide Rivelime Versus Brand-name Revlimid® in the Treatment of Relapsed/Refractory Multiple Myeloma: A Retrospective Single-center Experience on Efficacy, Safety and Survival Outcome. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Lenalidomide in combination with dexamethasone for the treatment of multiple myeloma after one prior therapy. [2020]