Clinical Trials
NCRI Myeloma Clinical Trials Committee Report
Preliminary results from MM IX on responses were presented at ASH 2007 and it is hoped that outcome data will be presented later in 2009.
The Myeloma CTC meets on a regular basis to take forward the design and approval of clinical studies. The group has worked to develop the UKMFÕs role within the National Cancer Research Institute Myeloma Clinical Trials Committee (NCRI Myeloma CTC) resulting in the integration of the NCRI and UKMF Myeloma CTCs enhancing the working relationship between the two groups. Discussions with CTAAC re trial design and funding earlier in the year were enlightening and constructive in identifying mutual areas of concern that should help secure funding for trials in the future.
The CTC has agreed a strategy to promote, support and develop a rolling programme of trials over the next 3 years to develop a portfolio of a phase III de novo trial and a randomised, phase II, relapsed intensive and non-intensive study. It is also supporting the development of a smaller phase II randomised trial to address the role of early versus late autologous stem cell transplantation in the era of novel therapies with the view of utilising the data to inform a later phase III trial. Support is also being given to devise studies in both de novo and relapsed Amyloidosis incollaboration with the National Amyloidosis Centre and WaldenstromÕs Macroglobulinaemia in collaboration with the NCRI Lymphoma CTC. In addition it is promoting studies examining supportive care and quality of life studies.
The Intensive Relapse Study Group has worked with the Committee to secure funding from the CTAAC for a phase 3 study, Myeloma X (Intensive), that opened in Spring 2008. A new de novo study, to replace the highly successful Myeloma IX trial that closed in November 2007, is awaiting final funding approval from CTAAC. It is hoped this will be successful and it is anticipated that the trial will open by the 3rd quarter of 2009.
