Established by the International Myeloma Foundation, the Global Clinical Trials Forum is a committee of the nation’s leading multiple myeloma experts.
The Forum’s goal is two-fold: to form a coalition that will work collaboratively on myeloma-related projects, and to avoid duplication of efforts and dilution of valuable resources by various cooperative groups working on myeloma trials in the United States. Multiple clinical trials are required to assess the best impact of new myeloma therapies. These trials need to be organized in a cohesive way to ensure that the final results provide clear comparative data.
Like coalitions in Europe, the Global Clinical Trials Forum will work to achieve consensus in order to accelerate clinical trial development, approval, activation, and accrual. Historically, while there has been some level of cooperation between the various groups in the US in inter-group clinical trials, these groups have not worked in as open a fashion as their European counterparts. The framework of the Global Clinical Trials Forum will facilitate input from all the major stakeholders in the most productive way. This will include both critical input for pharmaceutical trial design and facilitation of the National Cancer Institute’s Cancer Therapy Evaluation Program (CTEP) within the cooperative group setting.
The Forum’s first meeting took place on April 17-18 in Santa Monica, CA. The participants were welcomed by Drs. Brian Durie and S. Vincent Rajkumar with introductory remarks. In discussing myeloma clinical trials in the United States, Dr. Rajukumar represented the Eastern Cooperative Oncology Group (ECOG) as its co-chair, Dr. Durie represented the Southwest Oncology Group (SWOG) as its co-chair, and Dr. Sergio Giralt represented the Clinical Trials Network (CTN). Within these groups, hundreds of institutions across America take part in large-scale randomized phase III clinical trials.
The European cooperative groups were represented by Dr. Antonio Palumbo of Italy, who is a delegate for the European Hematology Association (EHA). Statistical issues in trial design were addressed by Dr. John Crowley of Cancer Research And Biostatistics (CRAB). The CTEP perspective was presented by Dr. Howard Streicher.
To establish priorities for the Global Clinical Trials Forum, the participants separated into smaller breakout groups that focused on specific issues. Trial design and statistical issues were tackled by Drs. Crowley and Streicher along with IMF Scientific Advisory Board Chairman, Dr. Robert A. Kyle. Frontline therapy was the issue addressed by Drs. Rajkumar, Durie, and Palumbo. Transplant related issues were broached by Drs. Giralt, William Bensinger, and Mohamad Hussein. New myeloma drugs and the issue of disease relapse were addressed by Drs. Ken Anderson, Sagar Lonial, Ruben Niesvizky, and Shaji Kumar. Along with Dr. Robert Vescio, and IMF president Susie Novis, IMF Board member Mike Katz was a member of the breakout group that discussed patient issues and supportive care. The breakout sessions were followed by presentations from all subgroups.
Next, issues related to transplantation, maintenance therapy, refractory disease, treatments for newly diagnosed myeloma, and how to achieve the best results for a patients in various circumstances were debated by the participants. The presentations and debates resulted in the formulation of action items and concepts for new clinical trials. And, as the discussion progressed, a consensus began to emerge. Finally, a plan for a joint SWOG-ECOG clinical trial was presented and reviewed by members of the Forum, and the participants signed off on the plan. This was truly an exciting moment.
The next step for the Global Clinical Trials Forum was to submit the plan for a joint SWOG-ECOG clinical trial for review by SWOG and by ECOG. The plan has been approved by each cooperative group. With the Forum acting as an umbrella for the existing myeloma cooperative groups, patients are more likely to benefit from the accelerated path to more effective treatments for the disease.
Global Clinical Trials Forum Inaugural Meeting Participants:
Jerome Zeldis (Celgene)
Tod Hyde (Celgene)
Dixie Esseltine (Millennium)
Jackie Hilgers (MIlllennium, SWOG)
Michael Myers ( J & J, MIllennium)
Craig Tendler (Ortho Biotech)
(Adapted from an interview in Myeloma Today with Mike Katz)