Lenalidomide + Dexamethasone +/- Daratumumab for Multiple Myeloma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether combining lenalidomide and dexamethasone with or without daratumumab is more effective for treating high-risk smoldering multiple myeloma. The researchers aim to determine if adding daratumumab, an immunotherapy drug, can more effectively halt the growth and spread of cancer cells. Suitable participants have received a diagnosis of high-risk smoldering multiple myeloma within the past year and exhibit specific disease markers, such as certain protein levels or genetic features, but do not yet show symptoms. As a Phase 3 trial, this study represents the final step before FDA approval, offering patients a chance to contribute to potentially groundbreaking treatment advancements.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study showed that patients treated with lenalidomide and dexamethasone had a response rate of about 50% and experienced generally manageable side effects. Most patients tolerated this combination well, with an average survival time of around three years.
When researchers added daratumumab to lenalidomide and dexamethasone, the results were encouraging. Over 90% of patients with newly diagnosed multiple myeloma responded well to the treatment, and the side effects remained mostly manageable.
Overall, these treatments have been well-tolerated, with most side effects being manageable. The safety data from these studies suggest that the treatment options in the trial are relatively safe for participants.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for multiple myeloma because they combine different drugs to potentially enhance effectiveness. Daratumumab is a standout as it’s an antibody that precisely targets the CD38 protein on myeloma cells, marking them for destruction by the immune system. This targeting mechanism differentiates it from traditional chemotherapy, which can affect both healthy and cancerous cells. Meanwhile, lenalidomide and dexamethasone work together to boost the immune system and reduce inflammation. This combination approach could offer improved outcomes by attacking the cancer from multiple angles and is especially promising for patients who have not responded well to existing therapies.
What evidence suggests that this trial's treatments could be effective for smoldering myeloma?
Research has shown that a combination of daratumumab, lenalidomide, and dexamethasone, which participants in this trial may receive, effectively treats multiple myeloma. One study found that this combination helps prevent cancer progression for an extended period. Patients using these drugs demonstrated strong and lasting improvements, with many reaching a point where almost no cancer is detectable. Another treatment arm in this trial involves lenalidomide and dexamethasone alone, common and effective treatments for both newly diagnosed and recurrent multiple myeloma. These drugs work by stopping cancer cells from growing and spreading. This provides strong evidence that these treatments effectively fight multiple myeloma.26789
Who Is on the Research Team?
Natalie S Callander
Principal Investigator
ECOG-ACRIN Cancer Research Group
Are You a Good Fit for This Trial?
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
Timeline for a Trial Participant
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.
What Are the Treatments Tested in This Trial?
Interventions
- Daratumumab
- Dexamethasone
- Lenalidomide
Daratumumab is already approved in European Union, United States for the following indications:
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Who Is Running the Clinical Trial?
ECOG-ACRIN Cancer Research Group
Lead Sponsor
National Cancer Institute (NCI)
Collaborator