Lenalidomide +/- Ixazomib + Dexamethasone for Multiple Myeloma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of different drug combinations for people with multiple myeloma that persists after a stem cell transplant. Researchers compare lenalidomide alone to a combination of lenalidomide, ixazomib citrate (a proteasome inhibitor), and dexamethasone (a corticosteroid). Lenalidomide helps the immune system fight cancer, while ixazomib citrate and dexamethasone aim to stop cancer cells from growing. Individuals who have undergone a stem cell transplant, are on lenalidomide maintenance, and have some remaining myeloma might be suitable for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to early findings.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications, but it does mention that you should not have taken certain strong inhibitors or inducers of specific enzymes within 14 days before starting the trial. It's best to discuss your current medications with the trial team to ensure they don't interfere with the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the combination of ixazomib, lenalidomide, and dexamethasone is generally well-tolerated by patients with multiple myeloma. Studies have found that adding ixazomib to lenalidomide and dexamethasone can help patients live longer without their cancer worsening.
Regarding safety, researchers have tested this treatment combination in both controlled trials and real-world settings. These studies indicate that while some side effects occur, they are usually manageable. For example, patients might feel tired, have diarrhea, or experience low blood counts, but these are common with many cancer treatments.
Lenalidomide alone has also been extensively studied. It is already approved for other conditions, so its safety profile is well-known. Patients often handle it well, though it can cause side effects like low blood counts or a rash.
Overall, evidence suggests these treatments are fairly safe, with side effects typical of cancer therapies.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for multiple myeloma because they introduce a novel combination approach. Ixazomib citrate, part of the experimental arm, is an oral proteasome inhibitor that works by interfering with cancer cell proteins, leading to cell death—offering a convenient oral option compared to the more traditional, intravenous proteasome inhibitors. Additionally, when combined with lenalidomide and dexamethasone, ixazomib citrate may enhance the treatment's effectiveness by targeting the cancer cells through different mechanisms. This combination could potentially lead to better outcomes and improved quality of life for patients by providing an all-oral regimen.
What evidence suggests that this trial's treatments could be effective for multiple myeloma?
Research has shown that adding ixazomib to lenalidomide and dexamethasone, which participants in this trial may receive, can benefit people with multiple myeloma. Studies have found that this combination allows patients to live longer without their cancer worsening, with an average of about 20.6 months before disease progression. In contrast, another group in this trial will receive lenalidomide alone, which has a response rate of about 55%, but the cancer typically worsens after about 10 months. This evidence suggests that the combination treatment might be more effective for those with remaining multiple myeloma after a transplant.12467
Who Is on the Research Team?
Andrzej Jakubowiak, MD, PhD
Principal Investigator
University of Chicago
Are You a Good Fit for This Trial?
This trial is for multiple myeloma patients with residual disease after a donor stem cell transplant. They must have been on lenalidomide maintenance for 3-4 months, have measurable residual disease, and proper organ function. Women of childbearing potential and men must agree to effective contraception methods. Exclusions include uncontrolled conditions like heart issues or diabetes, recent infections or surgeries, other cancer treatments within 30 days, certain drug allergies, severe neuropathy, CNS involvement, and QTc >470 msec.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either lenalidomide alone or in combination with ixazomib citrate and dexamethasone for 12 courses, each lasting 28 days
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
What Are the Treatments Tested in This Trial?
Interventions
- Dexamethasone
- Ixazomib Citrate
- Lenalidomide
Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:
- Inflammation
- Allergic reactions
- Respiratory diseases
- Skin conditions
- Eye diseases
- Immune system disorders
- Inflammatory conditions
- Allergic states
- Respiratory diseases
- Blood disorders
- Neoplastic diseases
- Nervous system disorders
- Inflammation
- Allergic reactions
- Respiratory diseases
- Skin conditions
- Eye diseases
- Inflammatory conditions
- Allergic states
- Respiratory diseases
- Blood disorders
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Chicago
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Multiple Myeloma Research Foundation
Collaborator