In a recent video interview with Applied Clinical Trials, Michael Andreini, president and CEO of the Multiple Myeloma Research Foundation (MMRF), discussed challenges in multiple myeloma clinical trials, including inefficiency, lack of focus on critical patient questions, and underrepresentation of diverse patient populations. Andreini also highlighted the Horizon clinical trial and how MMRF is working to address unmet need in the myeloma research space.
ACT: Could you tell us about the design of the Horizon clinical trial?
Andreini: First of all, conducting clinical trials at the MMRF is not new to us. We have a consortium of 14 leading centers in the United States, have conducted nearly 100 clinical trials to date, and Horizon is really the next evolution of our clinical research strategy. What Horizon is, is an adaptive platform trial for patients with relapsed and refractory myeloma, and because it’s a platform trial, we can test multiple treatment strategies at once under a single master protocol against a common control. Because this trial is also adaptive in its design, it’s evergreen in nature, so we can more efficiently then add new treatment arms to the study as new hypotheses are developed, we can close treatment arms if we feel like this treatment is not serving patients in the best way anymore. Also, we can add new controls to the platform as the standards of care might change over time. Really, the results of this are that it’s a much more efficient clinical trial design that can start up more quickly, that can enroll patients more quickly, and can really evolve with the needs of patients and the research community over time. The other thing is that we’ve built into the design of the trial, a very robust strategy to ensure that we enroll representative patient population as part of the trial, so we’ve nominated an independent diversity officer to advise on strategy and execution as part of the trial. We’ve stated mandates in the protocol for representation from specific racial and ethnic groups. We’ve broadened the eligibility criteria as much as possible. We’re including over 30 satellite community sites in diverse locations to ensure we have a diverse catchment area for the trial. Then also, we’ve built in financial assistance for patients as part of this trial, through a part of our family reach to ensure that we lower as many financial barriers as possible for participation, to cover things like travel costs, lost work days, child care, food, which are real things that can really impact patients abilities to enroll and participate in a clinical trial.