The Multiple Myeloma Research Consortium (MMRC) today announced the initiation of a Phase Ib/II study of bendamustine (Treanda®), an anticancer agent currently approved for the treatment of chronic lymphocytic leukemia (CLL) and B-cell non-Hodgkin's lymphoma (NHL), in combination with lenalidomide (Revlimid®) and dexamethasone in patients with relapsed multiple myeloma. The trial, led by Shaji Kumar, MD, of Mayo Clinic, is open for enrollment at Mayo Clinic (Rochester, Minn.), City of Hope Cancer Center (Duarte, Calif.) and the University of Chicago (Chicago, Ill).
“As trials conducted through the MMRC IST Platform demonstrate, we are fully committed to sharing the risk of early-stage drug development with our partners in the biotech and pharmaceutical industry, and to implementing measures to enhance quality, and efficiency of these important investigator-initiated clinical trials”
This study marks the first clinical trial to be conducted using the MMRC's unique collaborative Investigator Sponsored Trial (IST) Platform. The MMRC IST Platform includes a range of programs developed to ensure the rapid execution of multi-site investigator initiated trials within the Consortium and to generate high-quality data from these clinical studies. These programs include protocol writing support, clinical project management, data and biostatistical management, trial data monitoring, and multi-site contract administration.
"Multi-center investigator sponsored trials such as these are critical to advance promising therapeutics that may otherwise have languished for lack of resources," said Dr. Kumar. "Our goal is to deliver meaningful data that will strengthen decisions for further clinical development and, may be used in support of regulatory submissions for drug approval."
The MMRC Collaborative IST Platform is the latest business solution developed to ensure high-quality trials are conducted as efficiently as possible within the Consortium network. Solutions such as these have helped the MMRC open its trials as much as 35 percent faster than the industry standard for oncology clinical trials. To date, 24 clinical trials have opened for enrollment.
"As trials conducted through the MMRC IST Platform demonstrate, we are fully committed to sharing the risk of early-stage drug development with our partners in the biotech and pharmaceutical industry, and to implementing measures to enhance quality, and efficiency of these important investigator-initiated clinical trials," said Susan Kelley, MD, Chief Medical Officer of the MMRC.
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