Clinical Trial: Daratumumab, Ixazomib, and Dexamethasone With or Without Bortezomib in Patients With Newly Diagnosed Multiple Myeloma (DeRIVE)

A phase II study is open evaluating how well daratumumab, ixazomib, and dexamethasone work with or without bortezomib in treating patients with newly diagnosed multiple myeloma. Please not that for one of the patient groups, it will use two different types of proteasome inhibitors in consecutive order. 

• Open-Label: Patients and their doctors will know both the treatment and the dose that they will be receiving.
• Randomized: Participants will be divided into different groups randomly

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. Daratumumab specifically targets a protein called CD-38, which can sometimes be found in high numbers of myeloma cells. Ixazomib and Bortezomib are both types of immunotherapy called proteasome inhibitors, which can work by stopping the cancer cells from being able to multiply and function. This study seeks to understand if adding Bortezomib to the combination of drugs can help make this treatment regimen more effective.

This trial is scheduled to begin recruiting patients in June 2019, and is seeking 76 participants. Patients will be randomly assigned into two treatment groups, described below. Patients will receive some of the drugs orally, and some through intravenous infusion. Treatment cycles last either 21 or 28 days, and the study calls for 8 repeated cycles, as long as the patients don’t develop bad side effects and their myeloma doesn’t get worse.

Patient Group 1:

• Patients in this group will receive 8 cycles of Daratumumab, Ixazomib and dexamethasone (DId) as induction therapy. 
• Once the initial 8 cycles are completed, if the patient is eligible, they will then have a stem cell transplant. Once the transplant is completed, the patient can continue to receive Daratumumab, Ixazomib and dexamethasone (DId) as maintenance therapy for up to 24 months.

Patient Group 2:

• Patients in this group will receive 3 cycles of Daratumumab, Bortezomib and dexamethasone (DVd) followed by 5 cycles of Daratumumab, Ixazomib and dexamethasone (DId) as induction therapy.
• Once the initial 8 cycles are completed, if the patient is eligible, they will then have a stem cell transplant. Once the transplant is completed, the patient can continue to receive Daratumumab, Ixazomib and dexamethasone (DId) as maintenance therapy for up to 24 months.

In order to participate, patients must have newly diagnosed myeloma, and adequate cardiac, lung, kidney, liver and marrow function. Click the link below for the full inclusion and exclusion criteria, and to learn more about this study. You can also call SparkCures with any questions at (888) 828-2206.

DeRIVE Study