Lenalidomide for Multiple Myeloma

Recruiting at 154 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: National Cancer Institute (NCI)

Disqualifiers: Uncontrolled diabetes, Active infection, HIV, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

460 Participants Needed

Trial Summary

What is the purpose of this trial?

This randomized phase III trial studies lenalidomide to see how well it works compared to a placebo in treating patients with multiple myeloma who are undergoing autologous stem cell transplant. Giving chemotherapy before a peripheral blood stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Giving lenalidomide after autologous stem cell transplant may be an effective treatment for multiple myeloma.

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 Lenalidomide for treating multiple myeloma?

Research shows that Lenalidomide, especially when used continuously or combined with dexamethasone, helps patients with multiple myeloma live longer without the disease getting worse. It also improves their quality of life and is generally well tolerated with fewer side effects compared to similar drugs. ^{1 2 3 4 5}

What safety data exists for Lenalidomide (Revlimid) in humans?

Lenalidomide, used for multiple myeloma, can cause side effects like low white blood cell counts (neutropenia), low platelet counts (thrombocytopenia), blood clots, fatigue, skin rash, and stomach issues. These side effects are generally manageable with careful monitoring and dose adjustments. ^{1 6 7 8 9}

How is the drug lenalidomide unique in treating multiple myeloma?

Lenalidomide is unique because it is an immunomodulatory drug that not only directly attacks cancer cells but also enhances the body's immune response against them. It is more potent and has fewer side effects than its predecessor, thalidomide, and is often used in combination with dexamethasone to improve treatment outcomes for patients with relapsed or refractory multiple myeloma. ^{1 2 3 5 10}

Research Team

Philip L McCarthy

Principal Investigator

Alliance for Clinical Trials in Oncology

Eligibility Criteria

This trial is for patients with active multiple myeloma who need treatment and have responded to at least 2 months of induction therapy. They should not have had more than 12 months of prior treatments, no previous transplants, and must be able to collect enough stem cells for the procedure. Participants need good heart and lung function, controlled diabetes if present, no serious infections or HIV/Hepatitis B/C. Women of childbearing age must test negative for pregnancy and use two forms of birth control.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

My lungs work well enough to breathe without symptoms.

Creatinine =< 2 mg/dL

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Peripheral Blood Stem Cell Mobilization

Mobilization of autologous PBSC will be performed according to institutional guidelines

Varies

Autologous PBSC Transplantation

Patients receive melphalan intravenously and undergo autologous PBSCT

3-4 days

Maintenance Treatment

Patients receive lenalidomide or placebo orally once daily starting between day 100-110

Until disease progression or unacceptable toxicity

Follow-up

Participants are monitored for safety and effectiveness after treatment

Every 3 months for 1 year, then every 6 months

Treatment Details

Interventions

• Lenalidomide

Trial Overview The study tests whether lenalidomide improves outcomes in multiple myeloma patients after an autologous stem cell transplant compared to a placebo. Patients receive chemotherapy followed by their own previously collected stem cells to restore bone marrow function. Lenalidomide aims to boost the immune system against cancer cells post-transplant.

Participant Groups

Group I: Arm I (melphalan, autologous PBSCT, lenalidomide) Experimental Treatment 5 Interventions

Beginning between day 100-110, patients receive lenalidomide PO once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Group II: Arm II (melphalan, autologous PBSCT, placebo) Placebo Group 5 Interventions

Beginning between day 100-110, patients receive placebo PO once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Findings from Research

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]

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 (Revlimid) has been rapidly developed and recently approved for treating relapsed multiple myeloma, showing durable clinical responses, especially when combined with dexamethasone.

Clinical trials indicate that lenalidomide is generally well tolerated by patients, with manageable side effects, making it a promising option for those with relapsed and refractory multiple myeloma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lenalidomide in multiple myeloma. Richardson, PG., Mitsiades, C., Hideshima, T., 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]

Lenalidomide has become a crucial treatment option for multiple myeloma and del-5q myelodysplastic syndromes, and it has been tested for various other cancers, showcasing its broad therapeutic potential.

The drug received FDA approval for use in combination with dexamethasone for previously treated multiple myeloma, highlighting its efficacy and safety in this specific patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lenalidomide: a novel anticancer drug with multiple modalities. Galustian, C., Dalgleish, A.[2019]

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 has significantly improved treatment outcomes for patients with multiple myeloma, but it is associated with predictable adverse events such as neutropenia, venous thromboembolism, and gastrointestinal disturbances.

The adverse events linked to lenalidomide can be effectively managed through patient monitoring, supportive care, and dose adjustments, ensuring that patients can continue their treatment safely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lenalidomide treatment for patients with multiple myeloma: diagnosis and management of most frequent adverse events. Pérez Persona, E., Mesa, MG., García Sánchez, PJ., et al.[2018]

Lenalidomide, in combination with dexamethasone, was administered to 1438 patients with relapsed or refractory multiple myeloma, showing a median treatment duration of 15.4 weeks and confirming its efficacy in this patient population.

The most common adverse events included hematological issues (49%), gastrointestinal problems (59%), and fatigue (55%), with serious adverse events like pneumonia occurring in 8% of patients, highlighting the need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expanded safety experience with lenalidomide plus dexamethasone in relapsed or refractory multiple myeloma. Chen, C., Reece, DE., Siegel, D., et al.[2021]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

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

Lenalidomide in multiple myeloma. [2018]

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

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

5. England pubmed.ncbi.nlm.nih.gov

Lenalidomide: a novel anticancer drug with multiple modalities. [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. United States pubmed.ncbi.nlm.nih.gov

Lenalidomide treatment for patients with multiple myeloma: diagnosis and management of most frequent adverse events. [2018]

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

Expanded safety experience with lenalidomide plus dexamethasone in relapsed or refractory multiple myeloma. [2021]

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

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