Daratumumab-Based Regimens for Multiple Myeloma
(DeRIVE Trial)
Trial Summary
What is the purpose of this trial?
This phase II trial studies how well daratumumab, ixazomib, and dexamethasone with or without bortezomib work in treating patients with newly diagnosed multiple myeloma. Immunotherapy with monoclonal antibodies, such as daratumumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as ixazomib, dexamethasone, and bortezomib, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving daratumumab, ixazomib, and dexamethasone with or without bortezomib may work better in treating patients with multiple 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 take certain medications like strong CYP3A inducers (e.g., rifampin, carbamazepine) within 14 days before starting the trial. It's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug combination of Daratumumab, Bortezomib, and Dexamethasone for treating multiple myeloma?
Research shows that adding Daratumumab to Bortezomib and Dexamethasone significantly improves patient outcomes in multiple myeloma, including longer periods without disease progression and higher response rates compared to using Bortezomib and Dexamethasone alone. This combination has been effective in both newly diagnosed and relapsed cases of multiple myeloma.12345
Is daratumumab-based treatment safe for humans?
Daratumumab-based treatments, including combinations with bortezomib and dexamethasone, have been shown to be generally safe for humans. Common side effects include infusion-related reactions, neutropenia (low white blood cell count), thrombocytopenia (low platelet count), anemia (low red blood cell count), and infections, but these are typically manageable.12467
What makes the drug combination of Bortezomib, Daratumumab, Dexamethasone, and Ixazomib unique for treating multiple myeloma?
This drug combination is unique because it includes Daratumumab, a first-in-class monoclonal antibody that targets CD38 on multiple myeloma cells, enhancing the immune system's ability to kill these cancer cells. Additionally, the combination of these drugs offers a novel approach by integrating different mechanisms of action, potentially improving outcomes for patients who have relapsed or are resistant to other treatments.1891011
Research Team
Ajay K. Nooka, MD,MPH,FACP
Principal Investigator
Emory University
Eligibility Criteria
This trial is for adults with newly diagnosed multiple myeloma who are in good physical condition (ECOG PS 0-1) and have measurable disease. They can't have had certain other conditions or treatments, must agree to contraception if applicable, and be willing to follow the study rules. Pregnant women, those with allergies to study drugs, or patients treated previously with similar drugs are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Induction
Patients receive dexamethasone, daratumumab, and either ixazomib or bortezomib in cycles to treat multiple myeloma
Stem Cell Transplant
Eligible patients undergo stem cell transplant per standard of care
Maintenance
Patients continue treatment with dexamethasone, daratumumab, and ixazomib for up to 24 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Bortezomib
- Daratumumab
- Dexamethasone
- Ixazomib
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?
Emory University
Lead Sponsor
Takeda
Industry Sponsor
Dr. Naoyoshi Hirota
Takeda
Chief Medical Officer since 2020
MD from University of Tokyo
Christophe Weber
Takeda
Chief Executive Officer since 2015
PhD in Molecular Biology from Université de Montpellier
National Institutes of Health (NIH)
Collaborator
National Cancer Institute (NCI)
Collaborator
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