The Multiple Myeloma Research Consortium (MMRC): Accelerated Start up and Accrual Metrics Speeds Drug Development

• Published in: Blood 2011-11, Vol.118 (21), p.1024-1024
• Main Authors: Wear, Sandra M., Richardson, Paul G., Revta, Carolyn, Vij, Ravi, Fiala, Mark, Lonial, Sagar, Mitchell, Alaina R., Siegel, David S., Aleman, Adolfo, Jakubowiak, Andrzej J, Durecki, Diane E, Reece, Donna E., Gul, Engin, Chari, Ajai, Jagannath, Sundar, La, Lisa, Hofmeister, Craig C., Bowers, Mindy A, Stewart, A. Keith, Hagerty, Rachel, Wolf, Jeffrey L., Pelle-Day, Geraldine, Krishnan, Amrita, Duarte, Lupe, Zimmerman, Todd M., Larsen, Daniel, Kumar, Shaji, Birgin, Ann, Raje, Noopur S., Roy, Vivek, Maharaj, Michele, Fay, Joseph W., Messing, Tracey, Ott, Robert F, Tasca, Leah, Anderson, Kenneth C., Giusti, Kathy
• Format: Article
• Language: English
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood.V118.21.1024.1024

Abstract 1024 The MMRC is a non-profit, disease-focused consortium founded in 2004. Sixteen North American member institutions with expertise in multiple myeloma (MM) work collaboratively with the MMRC Inc. (Norwalk, CT) and numerous pharmaceutical partners to speed development of new treatment options to MM patients. In December 2007, MMRC Inc. implemented business solutions to address barriers to rapid activation of phase I-II trials and established benchmarks for initiating and conducting these studies. In December 2010, we reported significantly faster trial start up and accrual data from previous years1,2. Today, we update and expand on MMRC performance data and analysis of progress. Twenty-five (25) trials conducted within the Consortium from May 2006 to July 2011 had sufficient start up trial data for review. FPFD was defined as the time from the member institutions' receipt of the final protocol (FP) from the trial sponsor, to the time the first patient was dosed on the trial at any participating MMRC member institution. With respect to enrollment, pre-study enrollment commitment (EC) established between MMRC and the study sponsor was defined as the total number of subjects committed to receive at least one dose of study drug across all participating MMRC centers on a trial; baseline enrollment timeline (BET) was prospectively defined as the target time period to attain EC. Mean time to FPFD in the recent group of trials (RG; n=18; Sept 08-Jul 11) held steady at 131 calendar days from receipt of FP as compared to 181 days for the early group of trials (EG; n=7; Jun06-Sept08) representing a 28% reduction in time to FPFD. More importantly, there was a 20% decrease in time to FPFD by all participating MMRC centers on any MMRC trial from 189 days in the RG compared to 236 days in the EG representing an important achievement especially in the Phase I/II arena. MMRC trial accrual data was available for 17/25 trials (2 EG trials were missing data and 6 RG trials continue enrolling). The pre-study mean MMRC EC was 44 subjects per trial (n=19 trials; 849 patients); the mean actual MMRC enrollment was 49 subjects per trial (n=19; 935 patients through July 11) representing a 10% over enrollment versus committed enrollment. A total of 17/19 evaluable trials (89%) met their EC; 12/19 trials met EC within BET (71%) of which 8/12 trials (67%) reached EC 34% faster than their BET (representing a mean reduction of 4.5 months). The overall pre-study mean BET for 19