Shaji Kumar, MD
Investigators are taking a personalized approach to treating patients with multiple myeloma (MM) by introducing novel agents in combination with backbone chemotherapies, based on patients’ individual genetic profiles. Extensive genomic studies of patients with MM have led to an understanding that genetic abnormalities may be the drivers for disease in certain patient populations.
The trial is expected to enroll 228 patients at 17 sites across the United States beginning in early 2019. Each arm will be made up of 38 patients.
In 4 of the arms, patients will be assigned treatment based on specific genetic mutations. A fifth arm will include patients with t(11;14) translocations, who will receive venetoclax (Venclexta). The final arm will consist of patients who do not have an actionable genetic mutation; they will receive daratumumab (Darzalex) in combination with ixazomib (Ninlaro), pomalidomide (Pomalyst), and dexamethasone (Figure
Figure. MyDRUG Biomarker-Driven Study2
“We have identified subgroups of patients [whose biologies] behave differently, and we believe that some of these genetic abnormalities may be the drivers for the disease in some of these cases,” Kumar said.
Patients who are eligible to participate in the trial must have received at least 1 but no more than 3 prior therapies, have received both a proteasome inhibitor and immunomodulatory drug, have had early relapse after initial treatment, and have a report, at most 120 days old, from their enrollment in the MMRF002 genetic profiling study, also sponsored by the MMRF.
Personalizing the Treatment Landscape
“We are looking for proof of principle that using a targeted agent against a mutation can get rid of the cancer cells that carry the mutation,” Kumar said. “But at the same time, we also know that by using [just] 1 drug we are not going to be able to control myeloma in the long run, so what we are hoping to do is to combine the targeted agents with the conventional combinations and that way we can get rid of most of the myeloma cells and get prolonged efficacy.”
... to read the full story