Clinical Trials
NCRI Myeloma Clinical Trials Committee Report
The NCRI has established a Myeloma Clinical Trials Committee Chaired by Dr Steve Schey, Secretary Dr Curley Morris, whose role is to support and co-ordinate clinical trials activity within the UK. The Myeloma CTC has met on a number of occasions during the past 6 months and working groups have been formed which have taken forward the design and approval of a number of clinical studies.
Ongoing Trials:
The group collates 2 ongoing trials. The MERIT study remains open for recruitment and although it has not met it’s target numbers it is now the largest randomised study of the management of renal failure yet conducted and the Committee believes it is important that eligible patients continued to be entered into the trial. It continues to have the support of the Renal Association. Myeloma IX has recruited extremely well and both arms are due to close later this year. The results will not, however, be known for some time and it is important that we develop a new trial to replace this study with the minimum of delay to allow us all to build on the success of this very important study.
MERIT (Open)
MyEloma Renal Impairment Trial - A randomised controlled trial of adjunctive plasmaexchange in patients with newly diagnosed multiple myeloma and acute renal failure
Dr Judith Behrens
Myeloma IX (Open)
A randomised controlled trial of VAD versus CTD chemotherapy in de novo myeloma patients.
Prof Gareth Morgan
Myeloma X-Intensive (Opening 2007)
A randomised controlled trial for post autologous stem cell transplantation relapsed myeloma patients suitable for a second autograft
Dr Gordon Cook
UKATT (Opening 2007)
A randomised, multicentre trial to assess the feasibility of conducting a future Phase III randomised trial in AL Amyloidosis, comparing CTD with SCT in patients with low risk of Treatment Related Mortality and CTD with Mel-Dex in patients with high risk of Treatment Related Mortality
Dr Julian Gilmore
MRC Myeloma XI (Pending)
Myelomatosis therapy trial for patients of all ages. A randomised trial comparing second generation vs third generation bisphosphonates, induction chemotherapy regimens (CVAD vs CTD, and MP vs CTDa) and thalidomide maintenance vs no maintenance therapy.
Professor Gareth Morgan
Myeloma-X Non-Intensive (Pending)
A randomised controlled trial for relapsed/ refractory myeloma patients unsuitable for autologous stem cell transplantation.
Dr Steve Schey
Trials Pending:
AL Amyloid. This Phase III study was successfully submitted to the CTAAC Feasibility Study Committee two years funding. UCL has agreed to act as sponsor.
Trials in Development:
There are 2 trials at different stages of development
1. The non-intensive relapsed myeloma study. This Phase III study is scheduled to be submitted in outline to HTA on April 2007. KCH has agreed, in principle, to act a sponsor.
2. Successor to MRC MM IX. This remains in development.
Other immuno-secretory studies are in the early stages of development and meetings are planned of interested parties to develop these further. These areas are
a). Phase II study of Waldenstromss macroglobulinaemia
b). Allogeneic stem cell transplantation
c). Phase II study of Anti-CD66 in relapsed disease.
d). Phase II study of Sirulimus, cyclophosphamide and dexamethasone in relapsed disease.