Myeloma Clinical Trials in Asia
The Asian Myeloma Network (AMN) has developed our own clinical trial network to facilitate early access to drugs in Asian countries and to conduct clinical trials that answers answer questions relevant to Asians.
To establish a way to conduct multi-center, multi-country clinical trials within Asia took two years. Now, the International Myeloma Foundation's Asian Myeloma Network (AMN) 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 pharmacovigilance. 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 multiple myeloma patients in Asia. For patients who experienced a sub-optimal 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. The trial is now fully accrued having recruited 146 patients across Korea, Japan, Singapore, Hong Kong, and Taiwan within 18 months. Data from an interim analysis has already been presented at the American Society of Hematology Meeting in December 2016.
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). This trial has now commenced in Singapore with three patients already recruited.
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. This trial has also commenced in Singapore and Japan.
In addition, two other trials in partnership with Johnson & Johnson, AMN004, using daratumumab in combination with thalidomide and dexamethasone in relapse myeloma; and AMN006, using daratumumab in combination with velcade and dexamethasone in newly diagnosed non-transplant eligible myeloma will commence in 2018.
Finally, in collaboration with AbbVie, we also have a study combining venetoclax with velcade and dexamethasone for relapse patients with extramedullary plasmacytomas that will start in 2018.
These collaborations will strengthen partnerships between the AMN and institutions, establish low-cost combinations of novel therapies that are relevant to Asia, and raise the profiles of the Asian community in the field of multiple myeloma research and treatments. We hope to one day leave a mark not just on multiple 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
- AMN002: Carfilzomib Thalidomide and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma
- AMN003: Pomalidomide-Cyclophosphamide-Dexamethasone (PCD) Versus Pomalidomide-Dexamethasone (PD) in Relapse or Refractory Myeloma
- AMN004: Phase 2 study of daratumumab in combination with thalidomide and dexamethasone in relapse and / or refractory myeloma https://clinicaltrials.gov/ct2/show/NCT03143036
- AMN006: Phase 2 study of daratumumab in combination with bortezomib and dexamethasone in newly diagnosed multiple myeloma https://clinicaltrials.gov/ct2/show/NCT03695744
- IMF’s Asian Myeloma Network Succeeds in Providing Access to Pomalidomide in Asia
- Bringing Next Generation Flow Cytometry to Japan
- Clinical profiles of multiple myeloma in Asia: an Asian Myeloma Network study
- The impact of upfront versus sequential use of bortezomib among patients with newly diagnosed multiple myeloma (MM): a joint analysis of the Singapore MM Study Group and the Korean MM Working Party for the Asian Myeloma Network
- Management of multiple myeloma in Asia: resource-stratified guidelines