Multiple Myeloma Research Foundation (MMRF) has announced an initiative designed to accelerate the evaluation of new investigational therapies for multiple myeloma. The MMRF, in collaboration with the U.S. Food and Drug Administration (FDA), the National Cancer Institute (NCI), pharmaceutical, biotech, and diagnostic industry members, academic center leaders, and patients, initiated the formal development of a Master Protocol to allow patients to participate in clinical trials evaluating several investigational therapies at once.
At a workshop held last month in Washington, DC, participants from the FDA, NCI, industry, academia, and the patient community endorsed a plan to move forward with the development of the complete master study protocol.
Critical Targeted Therapies
“We have made real progress in the battle against multiple myeloma, but there is still more work to do to bring new, effective, personalized treatments to patients,” said Walter M. Capone, President and Chief Executive Officer of MMRF. “The development of a Multiple Myeloma Master Protocol offers a promising solution to accelerate the development of critical targeted therapies to patients through a novel research model.”
Complementing the pursuit of novel drug classes and immunotherapies in multiple myeloma drug development is the promise of identifying new targeted therapies for patients with specific genetic alterations. The Multiple Myeloma Master Protocol would enable several phase II clinical trials to take place in parallel within a single study design. Patients would be assigned to an appropriate experimental therapy based on an analysis of their genetic alterations.
This approach, which has recently been applied in other cancers, allows multiple new therapies to be evaluated more rapidly than with a traditional trial design. Decisions to advance an investigational drug to phase III testing in a specific genetic subgroup, or to test a different drug in this subgroup, can be expedited, with the goal of getting new drugs to patients faster than ever before. ■