The Asian Myeloma Network has developed our own clinical trial network to facilitate early access to drugs in Asian countries and to conduct clinical trials that answers questions relevant to Asians.
To establish a way to conduct multi-center, multi-country clinical trials within Asia took two years. Now, we can partner with principal investigators coordinating trials across the sites and with a clinical research organization (CRO) that is in charge of data capture, statistical analysis, regular reports, and pharmocovigilence. We also partner with sites in charge of recruitment, data integrity and completeness, and the fulfillment of regulatory requirements.
In December 2014, we partnered with Celgene for our first trial (AMN001). This study examined the use of pomalidomide and dexamethasone in relapse myeloma; it was the first large study using this drug combination for relapse MM patients in Asia. For patients who experience a suboptimal response to this combination, we used cyclophosphamide. The hope was to optimize the use of pomalidomide in Asia.
The trial proved the AMN’s ability to collaborate with pharmaceutical companies, to recruit patients, and to perform results-based analyses. Furthermore, we recruited 124 patients within 18 months and will present our data at major international hematological conferences.
Due to the success of our first trials, many other groups have expressed interested in working with the AMN. Our second trial (AMN002) will use carfilzomib in combination with thalidomide and dexamethasone in relapse myeloma. This trial is supported by Amgen in collaboration with the Australian Leukemia and Lymphoma Group (ALLG). A third trial (AMN003), supported by Celgene, is a randomized study that compares pomalidomide in combination with cyclophosphamide and dexamethasone to solely pomalidomide and dexamethasone.
These collaborations will strengthen partnerships between the AMN and institutions, will establish low-cost combinations of novel therapies that are relevant to Asia, and will raise the profiles of the Asian community in the field of myeloma research and treatments. We hope to one day leave a mark not just on myeloma in Asia, but also throughout the world.
AMN Clinical Trials
- AMN001: Efficacy and Toxicity Study of Pomalidomide and Dexamethasone in Patients Who Have Relapsed After Exposure to Lenalidomide and Bortezomib – https://clinicaltrials.gov/ct2/show/NCT02158702