Lenalidomide +/- Daratumumab for Multiple Myeloma
(DRAMMATIC Trial)
Trial Summary
What is the purpose of this trial?
Patients are enrolled to screening (Reg Step 1) prior to or after ASCT but prior to Reg Step 2. Patients are followed until they will begin Maintenance and then registered to Reg Step 2 (first randomization). Patients are randomized between Lenalidomide for 2 years and Lenalidomide + Daratumumab/rHuPH20. After 2 years of Maintenance, MRD is assessed to guide further therapy. MRD-positive patients will continue with the assigned treatment. MRD-negative patients will be further randomized (Reg Step 3) to either continue or discontinue the assigned treatment. Patients are treated for up to 7 years from Step 2 reg and followed for up to 15 years.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, you must not have received any investigational agents within 14 days prior to registration, and you must be able to take DVT prophylaxis (blood clot prevention medication).
What data supports the effectiveness of the drug combination Lenalidomide and Daratumumab for treating multiple myeloma?
Research shows that adding daratumumab to lenalidomide and dexamethasone significantly improves outcomes for patients with multiple myeloma, including longer periods without disease progression and higher overall survival rates. In one study, the combination had an 80% response rate, indicating it is effective in treating this condition.12345
Is the combination of Lenalidomide and Daratumumab safe for treating multiple myeloma?
The combination of Lenalidomide and Daratumumab has been studied in multiple myeloma patients and is generally considered safe. Common side effects include low blood cell counts (neutropenia, thrombocytopenia, anemia), nerve damage (peripheral sensory neuropathy), and infections. Infusion-related reactions, mostly mild, can occur, especially during the first treatment.45678
What makes the drug Lenalidomide combined with Daratumumab unique for treating multiple myeloma?
This drug combination is unique because it pairs lenalidomide, an immunomodulatory drug, with daratumumab, a monoclonal antibody that targets CD38 on myeloma cells, enhancing the immune system's ability to kill these cancer cells. This combination has shown to improve progression-free survival and overall response rates in patients with multiple myeloma.457910
Research Team
Parameswaran Hari, MD
Principal Investigator
Medical College of Wisconsin
Amrita Y. Krishnan
Principal Investigator
City of Hope Medical Center
Eligibility Criteria
This trial is for adults aged 18-75 with symptomatic multiple myeloma who've had induction therapy and a stem cell transplant within the last year. They must be able to take oral meds, have good kidney and liver function, no severe lung issues or uncontrolled infections, and not allergic to study drugs. HIV-positive patients can join if their viral load is undetectable.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Maintenance Treatment
Participants receive Lenalidomide or Lenalidomide + Daratumumab/rHuPH20 for maintenance therapy
MRD Assessment and Continued Treatment
MRD is assessed to guide further therapy; MRD-positive patients continue treatment, MRD-negative patients are further randomized
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Daratumumab/rHuPH20
- Lenalidomide
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?
SWOG Cancer Research Network
Lead Sponsor
Southwest Oncology Group
Lead Sponsor
Janssen, LP
Industry Sponsor
Joaquin Duato
Janssen, LP
Chief Executive Officer since 2022
MBA from ESADE Business School
Biljana Naumovic
Janssen, LP
Chief Medical Officer since 2023
MD from Belgrade University Medical School
Adaptive
Collaborator
National Cancer Institute (NCI)
Collaborator