Who is conducting the MyDRUG clinical trial?
The Multiple Myeloma Research Foundation (MMRF) is funding and leading MyDRUG in collaboration of 17 renowned academic researchers and medical centers and several pharmaceutical and biotech companies.
What is the goal of the MyDRUG clinical trial?
The goal of MyDRUG is to improve the outcomes of patients with functionally high-risk MM by advancing individualized treatment approaches. It is an open label Phase 1/2 study of several different drugs, with treatment assignment guided by genomic analysis.
What is the MyDRUG protocol?
Patients with relapsed-refractory multiple myeloma, who have received at least one prior but no more than 3 prior therapies and were exposed to both a PI and an IMiD and had early relapse after initial treatment or primary refractory to initial treatment, are eligible to participate in MyDRUG.
Each patient who is eligible and consents to participate in MyDRUG will receive genomic screening. A sample from their bone marrow biopsy will be sent to the University of Michigan for genomic analysis. Based on the results, the patient will be assigned to receive therapy on one of several treatment arms.
There are six treatment arms in MyDRUG. Five are based on previously identified actionable mutations in multiple myeloma and test an investigational therapy that targets a specific mutation. Patients found not to have any actionable mutations will receive the standard of care triplet regimen of ixazomib, pomalidomide and dexamethasone. Each treatment arm will enroll up to 38 patients.
MyDRUG is a type of platform study that is designed with the flexibility to open and close treatment arms. This innovative study design not only has the potential to hasten the speed by which new treatments are tested but also more efficiently matches patients to treatments that are most likely be beneficial.