The Multiple Myeloma Research Foundation (MMRF) has announced the enrollment of the first patient in its Horizon Clinical Trials Program. This adaptive platform trial, conducted across the Multiple Myeloma Research Consortium (MMRC), aims to identify optimal treatment strategies for patients with relapsed and refractory myeloma.
The MMRC Horizon trial will simultaneously test multiple novel drugs and therapeutic approaches to determine the best combination, sequence, and duration of therapy. The adaptive design allows for modifications to the study based on emerging data, potentially accelerating the development of more precise treatments.
Adaptive Trial Design
The Horizon program employs an adaptive clinical trial design with multiple arms to test different therapies. This approach offers key advantages over traditional trials, including the flexibility to make prospectively planned modifications to certain elements of the study design to efficiently facilitate the development of more precise treatments.
"The MMRC has a proven record of opening nearly 100 clinical trials and generating evidence to inform optimal treatment strategies for patients. Despite a multitude of approved therapies for multiple myeloma, patients and physicians still face complex questions around the most effective treatment combinations, sequencing, and duration," said Michael Andreini, President and Chief Executive Officer of the MMRF.
Teclistamab Evaluation
The first arm of the Horizon trial is enrolling patients and will evaluate dosing approaches with Tecvayli (teclistamab), manufactured by Johnson & Johnson. This initial phase focuses on refining the administration of an already approved therapy to maximize its benefit.
"Johnson & Johnson is committed to advancing therapies for multiple myeloma across all stages of the disease," said Imran Khan, MD, PhD, Vice President, Medical Affairs, Hematology, Innovative Medicine, Johnson & Johnson. "As a leader in multiple myeloma, we have a responsibility to continue to understand how our approved therapies can help patients in the clinical setting. We’re pleased to support the MMRF in conducting this research."
Significance of the Horizon Program
The Horizon clinical trial concept is designed to test multiple new treatment strategies in a timely manner, significantly reducing the time it would take to obtain results. The benefit it offers myeloma patients cannot be emphasized enough.
Multiple myeloma is the second most common blood cancer in the U.S., with an estimated 35,750 new cases and 12,590 deaths this year. While new therapies have improved outcomes, most patients eventually relapse, highlighting the need for optimized treatment approaches. The MMRF has raised over $600 million for research, opened nearly 100 clinical trials, and helped bring 15+ FDA-approved therapies to market, which have tripled the life expectancy of myeloma patients.
