MUK one
Research type
Research Study
Full title
An open label, multi-centre, randomised, parallel group phase II selection trial to identify the optimal starting dose of bendamustine (60 vs 100 mg/m2) when given in combination with thalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma
IRAS ID
55791
Contact name
Steve Schey
Sponsor organisation
University of Leeds
Eudract number
2010-021451-12
ISRCTN Number
ISRCTN90889843
Research summary
Multiple myeloma (MM) is a plasma cell tumour that is currently incurable. Every year, almost 4,000 new cases of multiple myeloma are diagnosed in the UK, equivalent to approximately 1% of all cancers. Median survival has improved incrementally since the introduction of alkylating agents. However the outlook for patients relapsing after optimal therapy remains poor and patients with disease refractory to initial treatments have an especially poor prognosis. Bendamustine hydrochloride is an alkylating anti-tumour agent with unique activity. Research has shown that high-dose bendamustine followed by stem cell support may be a feasible treatment for heavily pre-treated patients, including patients pre-treated with the newer therapeutic agents (e.g. thalidomide, lenalidomide, bortezomib) and not eligible for or refractory to high-dose melphalan; even in progressive disease.This study aims to identify whether bendamustine, when combined with thalidomide and dexamethasone is suffinciently active and tolerable for further investigation. The study also aims to identify the most efficacious and best tolerated dose of bendamustine when combined with thalidomide and dexamethasone (BTD) in relapsed/refractory MM. The findings of this study may then inform further phase III studies of BTD vs. current standard treatment with a novel agent in combination with an alkylating agent, in the de novo setting.
REC name
London - Dulwich Research Ethics Committee
REC reference
10/H0808/129
Date of REC Opinion
30 Sep 2010
REC opinion
Favourable Opinion