Lenalidomide Maintenance for Multiple Myeloma

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of lenalidomide (Revlimid) as a maintenance therapy for individuals with multiple myeloma, a type of blood cancer. It targets patients who have already undergone treatment and show no signs of cancer. Participants will take lenalidomide in cycles, and the trial will assess its positive and negative effects over time. It may suit those treated for multiple myeloma who currently have stable disease or better. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness 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 must be able to take daily preventive blood-thinning medication like aspirin or warfarin.

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

Research has shown that lenalidomide, also known as Revlimid, has been used to treat multiple myeloma. In past studies, some patients experienced side effects, such as an increased risk of heart attacks and strokes, particularly when combined with dexamethasone. However, lenalidomide alone can still help keep the cancer inactive.

Lenalidomide is already FDA-approved for treating multiple myeloma and other conditions, indicating thorough safety testing. Patients with mild kidney problems usually don't need to adjust their dose, allowing for flexible use.

While risks exist, many people tolerate lenalidomide well, especially with regular medical check-ups. Patients considering this treatment should discuss the potential risks and benefits with their healthcare provider. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for multiple myeloma?

Researchers are excited about lenalidomide for multiple myeloma because it offers a unique approach to maintenance therapy. Unlike traditional chemotherapy, which targets and kills rapidly dividing cells indiscriminately, lenalidomide modulates the immune system to help it fight the cancer more effectively. This immunomodulatory effect, combined with its oral administration, makes it a more convenient and targeted option compared to other treatments that often require hospital visits and intravenous administration. Additionally, lenalidomide's ability to potentially extend the period of remission and delay disease progression sets it apart from existing therapies.

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

Research has shown that lenalidomide effectively treats multiple myeloma, a type of blood cancer. In earlier studies, patients who took lenalidomide lived longer overall compared to those who received treatments like MPT (a combination of melphalan, prednisone, and thalidomide). These patients also experienced longer periods without cancer recurrence. Additionally, real-world data indicates that many patients tolerate the treatment well. This evidence suggests that lenalidomide can be an effective option for managing multiple myeloma after initial treatment. ^{6 7 8 9 10}

Who Is on the Research Team?

Alexander Lesokhin, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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, 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9972020/

Real‐world data on lenalidomide dosing and outcomes in ... The objective of our study was to understand the dosing, efficacy, and tolerability of lenalidomide among TI NDMM patients in the real‐world setting.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0959804924017647

Characteristics and outcomes in patients with lenalidomide ... Outcomes were suboptimal: 55 % response rate, 10-mo median PFS, and 28-mo median OS. •. New, effective therapies are needed for this difficult-to-treat ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5774211/

Final analysis of survival outcomes in the phase 3 FIRST ... Rd continuous significantly extended OS compared with MPT and resulted in comparable OS to that with Rd18 in patients with multiple myeloma.

4. esmoopen.com esmoopen.com/article/S2059-7029(25)01383-3/fulltext

A network meta-analysis of randomized clinical trials in ... Comparative efficacy of lenalidomide-free regimens in patients with relapsed/refractory multiple myeloma (RRMM) previously exposed to ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2152265025000229

Real-World Treatment Patterns and Outcomes in Patients ... We report population-based real-world data on patients aged ≥ 65 years, most (81%) with comorbidities, who have lenalidomide-refractory multiple myeloma.

6. fda.gov fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-safety-review-update-cancer-drug-revlimid-lenalidomide-and-risk

Safety review update of cancer drug Revlimid Know that, in clinical trials of patients newly diagnosed with multiple myeloma, those patients treated with Revlimid had an increased risk of ...

7. myeloma.org myeloma.org/revlimid-lenalidomide

Revlimid (Lenalidomide) The risk is even higher for people with multiple myeloma who take dexamethasone with Revlimid. Heart attacks and strokes are also more frequent in people who ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3256976/

Safety and Efficacy of Lenalidomide in Relapsed or ... Combination lenalidomide and dexamethasone (Len+Dex) has been shown to increase response rates and prolong survival compared with dexamethasone alone.

9. ema.europa.eu ema.europa.eu/en/documents/product-information/revlimid-epar-product-information_en.pdf

Revlimid, INN-lenalidomide - European Medicines Agency No dose adjustments are required for patients with mild renal impairment and multiple myeloma, myelodysplastic syndromes, mantle cell lymphoma, or follicular ...

10. clinical-lymphoma-myeloma-leukemia.com clinical-lymphoma-myeloma-leukemia.com/article/S2152-2650(22)01752-9/fulltext

Generic Lenalidomide Rivelime Versus Brand-name ... This study aimed to compare use of original brand-name lenalidomide (Revlimid®) vs. generic equivalent (Rivelime®) in terms of efficacy, safety and survival ...