Abstract
Four drug companies will help to sponsor the Multiple Myeloma Research Foundation's effort to create a database of the changing tumor genomics of 1,000 multiple myeloma patients.
Four drug companies will help to sponsor the CoMMpass (Clinical Outcomes in Multiple Myeloma to Personal Assessment of Genetic Profiles) program, an ambitious effort led by the Multiple Myeloma Research Foundation (MMRF) to create a massive genomics database for 1,000 multiple myeloma patients during and after treatment.
Although the pharmaceutical firms agreed not to patent any agent developed as a result of the study, they will receive prioritized access to the study data for a few months, says Walter Capone, MBA, chief operating officer at MMRF in Norwalk, CT. After that, the data will be publicly available in a searchable, online database called Research Gateway.
Companies might use that exclusive period to design clinical trials and be more selective about which patients to test a drug in, says George Mulligan, director of translational medicine for Millennium: The Takeda Oncology Company in Cambridge, MA, one of the corporate backers.
The three other sponsoring companies are Bristol-Myers Squibb (New York City, NY), Johnson & Johnson (New Brunswick, NJ), and Onyx Pharmaceuticals (South San Francisco, CA), which is being acquired by Amgen (Thousand Oaks, CA). Capone says the MMRF hopes to find a fifth corporate sponsor and that contributions from the companies will eventually pay for half the cost of the $40 million project.
Enrollment for the study, which was announced last year, has begun at 60 sites in the United States and Canada, and 30 more sites in Europe will be added this year. In addition to the Research Gateway, the foundation is planning a companion website and database for study participants.
Patients may participate in CoMMpass regardless of how their multiple myeloma is being treated, says Capone. Capone expects patients to have an average of three bone marrow samples collected and sequenced over the 8 to 10 years of the study. Participants also agree to be contacted in the future if analysis of the database indicates a new actionable approach to treatment or a relevant clinical trial, says Mulligan.
Following patients over time is a distinguishing feature of the study, Mulligan says, because therapies and clinical trials need to account for the ways in which genetic mutations in a tumor may change during treatment and disease progression.
In addition to tumor genomics, the database will include clinical information, family history, full germline sequences, DNA methylation status, and RNA sequencing. The Translational Genomics Research Institute of Phoenix, AZ, will conduct the molecular profiling. “You name it and any reasonable tool that looks at tumors is built into this study,” says Mulligan.
