Melphalan + Prednisone + Thalidomide/Lenalidomide for Multiple Myeloma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of two medication combinations in treating newly diagnosed multiple myeloma, a type of blood cancer. The trial compares melphalan (a chemotherapy drug) and prednisone paired with either thalidomide or lenalidomide to determine which combination better stops cancer cell growth. It is suitable for individuals diagnosed with symptomatic multiple myeloma who have experienced issues like anemia, high calcium levels, bone damage, or kidney problems. Participants should not have undergone extensive treatment for their myeloma before joining the trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you can continue taking bisphosphonates or growth factors like erythropoietin, although erythropoietin is discouraged due to increased risk of blood clots with thalidomide or lenalidomide.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that both thalidomide and lenalidomide, when combined with melphalan and prednisone, can help treat multiple myeloma. Now, consider safety.
Research indicates that the thalidomide combination can improve outcomes but may cause side effects, usually unrelated to blood. Some patients have experienced serious issues, such as nerve problems or skin reactions.
In contrast, the lenalidomide combination has been found to enhance patients' quality of life. Its side effects differ from those of thalidomide and are generally related to blood, such as low blood cell counts.
Both treatments have undergone extensive study. While they show promise, potential side effects must be considered. Prospective trial participants should discuss these with a doctor to determine the best course of action.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they offer new approaches for managing multiple myeloma. Unlike the standard regimen that typically uses bortezomib, cyclophosphamide, and dexamethasone, these treatments incorporate thalidomide or lenalidomide with melphalan and prednisone. Thalidomide and lenalidomide both belong to a class of drugs called immunomodulatory agents, which boost the immune system to fight cancer cells. Lenalidomide is particularly notable for its ability to inhibit tumor growth more effectively and with potentially fewer side effects than older drugs. These innovative combinations aim to improve patient outcomes by enhancing the body’s natural defenses against multiple myeloma.
What evidence suggests that this trial's treatments could be effective for multiple myeloma?
In this trial, participants will receive either a combination of melphalan, prednisone, and thalidomide or a combination of melphalan, prednisone, and lenalidomide. Research has shown that using melphalan, prednisone, and thalidomide can extend the lives of patients with multiple myeloma. Specifically, one study found that patients receiving this combination lived longer than those who did not. Conversely, combining lenalidomide with melphalan and prednisone has been found to improve the quality of life for those newly diagnosed with multiple myeloma. Studies also indicate that this combination works faster and slows the disease's progression. Both thalidomide and lenalidomide help by cutting off the blood supply to the cancer, potentially stopping the growth of multiple myeloma.12367
Who Is on the Research Team?
Alexander K Stewart
Principal Investigator
ECOG-ACRIN Cancer Research Group
Are You a Good Fit for This Trial?
This trial is for patients with newly diagnosed multiple myeloma. Eligible participants are those over 65 who declined alternative treatments, or adults under 65 not suitable for stem cell transplantation. They must have an ECOG performance status of <=2, no severe peripheral neuropathy, uncontrolled illnesses, active infections, or recent malignancies (with exceptions). Women of childbearing age must test negative for pregnancy and follow strict birth control measures.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction Therapy
Patients receive melphalan and prednisone with either thalidomide or lenalidomide. Treatment repeats every 28 days for up to 12 courses.
Maintenance Therapy
Patients continue to receive thalidomide or lenalidomide in the absence of disease progression.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion.
What Are the Treatments Tested in This Trial?
Interventions
- Lenalidomide
- Melphalan
- Prednisone
- Thalidomide
Lenalidomide is already approved in European Union, United States for the following indications:
- Multiple myeloma
- Myelodysplastic syndromes
- Mantle cell lymphoma
- Follicular lymphoma
- Marginal zone lymphoma
- Multiple myeloma
- Myelodysplastic syndromes
- Mantle cell lymphoma
- Follicular lymphoma
- Marginal zone lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor