Lenalidomide for Multiple Myeloma

Not currently recruiting at 164 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests lenalidomide (also known as Revlimid) to determine its effectiveness in treating multiple myeloma, a type of blood cancer, in patients undergoing a stem cell transplant. The research compares lenalidomide to a placebo (a harmless pill with no effect) to assess its impact after the transplant process. Patients with active multiple myeloma who have received some form of initial treatment might be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering patients an opportunity to contribute to potentially groundbreaking treatment advancements.

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.

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

Research has shown that lenalidomide is usually well-tolerated by patients with multiple myeloma. One study found that combining lenalidomide with another drug improved response rates and extended patient survival compared to using the other drug alone. However, some side effects may occur. For instance, in a large study of newly diagnosed patients, 23% experienced a decrease in appetite, while only 3% experienced weight loss or malnutrition. This suggests that while lenalidomide can cause side effects, they are often manageable and not severe for most people. ^{1 2 3 4 5}

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

Lenalidomide is unique for treating multiple myeloma because it enhances the immune system's ability to attack cancer cells, differing from traditional chemotherapy methods that mostly kill both healthy and cancerous cells. Researchers are particularly excited about lenalidomide because it works as an immunomodulatory drug, which can potentially lead to more targeted and less toxic treatments. Unlike standard treatments like bortezomib or melphalan, lenalidomide is administered orally, offering a more convenient option for patients. Additionally, it can be continued as maintenance therapy, which might help in prolonging remission and improving overall outcomes.

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. One study found that lenalidomide helped patients live longer compared to some other treatments. In everyday use, more than half of the patients (55%) experienced cancer improvement with lenalidomide. It also extended the time patients lived without their disease worsening. In this trial, one group of participants will receive lenalidomide following a stem cell transplant, while another group will receive a placebo. These findings suggest that lenalidomide can benefit patients with multiple myeloma, especially after a stem cell transplant. ^{1 2 6 7 8}

Who Is on the Research Team?

Philip L McCarthy

Principal Investigator

Alliance for Clinical Trials in Oncology

Are You a Good Fit for This Trial?

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.

My multiple myeloma is active and needs treatment, and I've responded to initial therapy.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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 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 (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 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, 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]

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.

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.

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S2152265022017529

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 ...

8.

myeloma.org

myeloma.org/revlimid-lenalidomide

Revlimid (Lenalidomide)

In the phase III FIRST clinical trial, 23% of the newly diagnosed patients experienced a decreased appetite. Of those, only 3% had weight loss or malnutrition.