Daratumumab + VRd for Multiple Myeloma
Trial Summary
What is the purpose of this trial?
This trial is testing if adding daratumumab to an existing three-drug treatment will improve outcomes for newly diagnosed multiple myeloma patients who are not planning a stem cell transplant. The combination of drugs works together to kill cancer cells in different ways. Daratumumab has shown efficacy in improving overall survival and progression-free survival in multiple myeloma patients when added to other treatment regimens.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that prior therapy for multiple myeloma, other than a short course of corticosteroids, is not allowed. It's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug combination Daratumumab + VRd for treating multiple myeloma?
Research shows that adding daratumumab to the combination of lenalidomide, bortezomib, and dexamethasone improves response rates in patients with newly diagnosed multiple myeloma. Additionally, studies indicate that daratumumab combined with these drugs prolongs the time patients live without the disease getting worse in relapsed or refractory multiple myeloma.12345
Is the combination of Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone safe for treating multiple myeloma?
The combination of Daratumumab with Bortezomib, Lenalidomide, and Dexamethasone 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.25678
What makes the drug combination of Daratumumab, Bortezomib, Dexamethasone, and Lenalidomide unique for treating multiple myeloma?
This drug combination is unique because it includes Daratumumab, a monoclonal antibody that targets CD38, enhancing the immune system's ability to fight cancer cells, and has shown to significantly prolong progression-free survival in multiple myeloma patients compared to standard treatments. Additionally, the combination therapy has been effective in both newly diagnosed and relapsed/refractory cases, offering a broader treatment option for patients.248910
Research Team
Janssen Research & Development, LLC Clinical Trial
Principal Investigator
Janssen Research & Development, LLC
Eligibility Criteria
This trial is for adults with untreated multiple myeloma who don't plan to have a stem cell transplant right away. They must have measurable disease, be able to perform daily activities (ECOG score 0-2), and women of childbearing age need two negative pregnancy tests before dosing. People can't join if they've had other cancer treatments or certain health conditions like severe neuropathy.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive daratumumab, bortezomib, lenalidomide, and dexamethasone (D-VRd) or bortezomib, lenalidomide, and dexamethasone (VRd) until disease progression or unacceptable toxicity
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Bortezomib
- Daratumumab
- Dexamethasone
- Lenalidomide
Bortezomib is already approved in European Union, United States, Canada, Japan for the following indications:
- Multiple myeloma
- Mantle cell lymphoma
- Multiple myeloma
- Mantle cell lymphoma
- Multiple myeloma
- Mantle cell lymphoma
- Multiple myeloma
- Mantle cell lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
Giacomo Salvadore
Janssen Research & Development, LLC
Chief Medical Officer since 2023
MD from the University of Rome, Tor Vergata
Ricardo Attar
Janssen Research & Development, LLC
Chief Executive Officer since 2008
PhD in Molecular Biology from the University of Buenos Aires