Lenalidomide + Dexamethasone +/- Daratumumab for Multiple Myeloma
Trial Summary
What is the purpose of this trial?
This phase III trial studies how well lenalidomide and dexamethasone works with or without daratumumab in treating patients with high-risk smoldering myeloma. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as daratumumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide and dexamethasone with daratumumab may work better in treating patients with smoldering myeloma.
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 cannot have had prior or concurrent systemic or radiation therapy for myeloma, and certain medications like erythropoietin and high-dose glucocorticosteroids are not allowed during the study.
What data supports the effectiveness of the drug combination of Lenalidomide, Dexamethasone, and Daratumumab for treating multiple myeloma?
Research shows that adding Daratumumab to Lenalidomide and Dexamethasone significantly improves outcomes for multiple myeloma patients. In studies, this combination reduced the risk of disease progression or death and increased the number of patients who responded well to treatment compared to using Lenalidomide and Dexamethasone alone.12345
Is the combination of Lenalidomide, Dexamethasone, and Daratumumab safe for treating multiple myeloma?
The combination of Lenalidomide, Dexamethasone, and Daratumumab has been generally well-tolerated in multiple myeloma patients, with common side effects including low blood cell counts (neutropenia, thrombocytopenia, anemia), nerve damage (peripheral sensory neuropathy), and infections. Infusion-related reactions were mostly mild and occurred during the first infusion.13456
How does the drug combination of Lenalidomide, Dexamethasone, and Daratumumab differ from other treatments for multiple myeloma?
The combination of Lenalidomide, Dexamethasone, and Daratumumab is unique because it includes Daratumumab, a monoclonal antibody that targets CD38 on myeloma cells, enhancing the immune system's ability to kill these cells. This combination has shown to significantly improve progression-free survival and overall response rates compared to Lenalidomide and Dexamethasone alone, making it a more effective option for patients with relapsed or refractory multiple myeloma.13467
Research Team
Natalie S Callander
Principal Investigator
ECOG-ACRIN Cancer Research Group
Eligibility Criteria
This trial is for adults with high-risk smoldering myeloma diagnosed within the last year. Participants must not have severe heart failure, active infections, or certain other health conditions. They should not be pregnant and must use effective contraception. Prior cancer treatments are disallowed except if it was curative and the patient has been disease-free for a set period.Inclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive lenalidomide and dexamethasone with or without daratumumab. Treatment repeats every 28 days for up to 24 cycles.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion. Follow-up occurs every 3, 6, or 12 months.
Treatment Details
Interventions
- Daratumumab (Immunotherapy)
- Dexamethasone (Corticosteroid)
- Lenalidomide (Immunomodulator)
Find a Clinic Near You
Who Is Running the Clinical Trial?
ECOG-ACRIN Cancer Research Group
Lead Sponsor
National Cancer Institute (NCI)
Collaborator