Lenalidomide Maintenance for Multiple Myeloma

Recruiting at 6 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: Anticoagulants

Must not be taking: Immunosuppressants, Antiretrovirals

Disqualifiers: Progressive myeloma, Plasma cell leukemia, Uncontrolled hypertension, Active hepatitis, 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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 5 years

108 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a Phase 2 study to assess the good and bad effects of maintenance therapy on patients who have been treated for myeloma and no longer show signs of this type of cancer.

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 must be able to take daily preventive blood-thinning medication like aspirin or warfarin.

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

Lenalidomide, used as maintenance therapy after stem-cell transplantation, has been shown to significantly extend the time patients live without their disease getting worse and improve overall survival in multiple myeloma patients, according to several clinical trials and a large observational study. ^{1 2 3 4 5}

Is lenalidomide safe for humans?

Lenalidomide is generally safe for humans, but it can cause some side effects like low blood cell counts, fatigue, skin rash, and blood clots. Careful monitoring and management of these side effects are important to prevent serious complications. ^{1 6 7 8 9}

How does the drug lenalidomide differ from other treatments for multiple myeloma?

Lenalidomide is unique because it is an immunomodulatory drug that offers improved potency and reduced toxicity compared to thalidomide, and it is used as a maintenance therapy after stem-cell transplantation to prolong progression-free survival in multiple myeloma patients. It is also effective for patients not eligible for transplantation, providing a longer-term treatment option with a manageable side effect profile. ^{1 2 4 10 11}

Research Team

Alexander Lesokhin, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for adults over 18 with plasma cell myeloma who've had prior treatment and are now stable or better. They must practice birth control, have good organ function, agree to a REMS program for drug safety, and take daily blood clot prevention meds. It's not for those with active hepatitis B/C, HIV, recent heart attacks or other cancers within 3 years, pregnant/breastfeeding women, or severe reactions to similar drugs.

Inclusion Criteria

My myeloma is stable or better after initial treatment.

I agree to use a condom during sex if my partner can get pregnant.

I can take daily medication to prevent blood clots.

Exclusion Criteria

I have been diagnosed with plasma cell leukemia.

My blood pressure or diabetes is not well-managed.

I have not been diagnosed or treated for another cancer within the last 3 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive lenalidomide 10 mg by mouth daily on days 1-21 of a 28-day cycle

5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Lenalidomide

Trial Overview The study tests Lenalidomide as a maintenance therapy in patients whose myeloma has been treated and is currently under control. The aim is to understand the benefits and risks of using this drug long-term after initial cancer treatment.

Participant Groups

Group I: Lenalidomide Experimental Treatment 1 Intervention

Subjects will receive lenalidomide 10 mg by mouth daily on days 1-21 of a 28-day cycle. Subjects may continue lenalidomide until disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or the end of the study (5 years); whatever comes first. Patients who complete at least four cycles of treatment will be considered evaluable.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Findings from Research

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 significantly improves progression-free survival (PFS) in patients with newly diagnosed multiple myeloma not eligible for stem-cell transplantation, as shown in randomized trials like the FIRST and MM-015 trials.

Continuous lenalidomide therapy is associated with less toxicity compared to thalidomide, maintaining tolerability without increasing the risk of neutropenia or second primary malignancies, making it a safer long-term treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lenalidomide: a review of its continuous use in patients with newly diagnosed multiple myeloma not eligible for stem-cell transplantation. McCormack, PL.[2018]

Lenalidomide is an effective treatment for patients with relapsed or refractory multiple myeloma, showing promising clinical activity and is approved by the FDA.

Common side effects of lenalidomide include neutropenia, thrombocytopenia, and thromboembolic events, necessitating careful monitoring to prevent serious complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lenalidomide: a new agent for patients with relapsed or refractory multiple myeloma. Tariman, JD.[2018]

Lenalidomide has shown significant efficacy in improving survival rates for patients with relapsed and refractory myeloma, especially when used alongside other treatments like bortezomib and thalidomide.

While lenalidomide is effective, it is associated with common side effects such as fatigue and thrombocytopenia, and its combination with other agents can increase the risk of blood clots, highlighting the importance of managing these adverse events for continued treatment success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lenalidomide for the treatment of relapsed and refractory multiple myeloma. van de Donk, NW., Görgün, G., Groen, RW., et al.[2021]

Lenalidomide combined with dexamethasone has been shown to be effective for treating relapsed/refractory multiple myeloma, and it has received approval from both the FDA and EMA for patients who have undergone at least one prior therapy.

The most common serious side effects include cytopenias and infections, but an expert panel has provided management strategies to minimize these risks, ensuring that patients can receive the full benefits of the treatment without unnecessary dose reductions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lenalidomide in combination with dexamethasone for the treatment of relapsed or refractory multiple myeloma. Palumbo, A., Dimopoulos, M., San Miguel, J., et al.[2018]

Lenalidomide, when combined with dexamethasone, is a safe and effective treatment for newly diagnosed multiple myeloma patients who cannot undergo autologous stem cell transplantation, providing rapid disease control.

Long-term use of lenalidomide has led to significant improvements in progression-free survival for patients ineligible for stem cell transplantation and has resulted in deep, durable remissions for those with relapsed or refractory multiple myeloma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An update on the use of lenalidomide for the treatment of multiple myeloma. Zagouri, F., Terpos, E., Kastritis, E., et al.[2018]

Thalidomide was the first maintenance therapy to show a clear benefit in progression-free survival (PFS) for multiple myeloma patients after high-dose therapy, marking a significant advancement in treatment options.

Emerging therapies like lenalidomide and bortezomib are being investigated for their potential to reduce relapse risk, but further research is needed to determine optimal dosing, duration, and long-term effects on survival and disease aggressiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maintenance therapy for myeloma: how much, how long, and at what cost? Attal, M., Roussel, M.[2020]

References

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

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

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

Lenalidomide: a review of its continuous use in patients with newly diagnosed multiple myeloma not eligible for stem-cell transplantation. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Carfilzomib, lenalidomide, and dexamethasone or lenalidomide alone as maintenance therapy after autologous stem-cell transplantation in patients with multiple myeloma (ATLAS): interim analysis of a randomised, open-label, phase 3 trial. [2023]

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

Lenalidomide after stem-cell transplantation for multiple myeloma. [2022]

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

Impact of post-ASCT maintenance therapy on outcomes in patients with newly diagnosed multiple myeloma in Connect MM. [2019]

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

Lenalidomide: a new agent for patients with relapsed or refractory multiple myeloma. [2018]

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

Lenalidomide for the treatment of relapsed and refractory multiple myeloma. [2021]

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

Lenalidomide in combination with dexamethasone for the treatment of relapsed or refractory multiple myeloma. [2018]

9. England pubmed.ncbi.nlm.nih.gov

An update on the use of lenalidomide for the treatment of multiple myeloma. [2018]

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

Evolving role of novel agents for maintenance therapy in myeloma. [2018]

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

Maintenance therapy for myeloma: how much, how long, and at what cost? [2020]