OPTIMAL - Optimising Renal outcome in Myeloma renal failure
Research type
Research Study
Full title
Optimising Renal outcome in Myeloma renal failure A study of Thalidomide, Bendamustine, and Dexamethasone (BTD) vs Bortezomib, Bendamustine, and Dexamethasone (BBD) in patients with renal failure defined as a GFR below 30 mls/ min.
IRAS ID
118637
Contact name
Karthik Ramasamy
Contact email
Sponsor organisation
Oxford University Hospitals NHS Trust
Eudract number
2012-003947-31
ISRCTN Number
ISRCTN32505664
Duration of Study in the UK
2 years, 5 months, 27 days
Research summary
About 5,000 people are diagnosed with multiple myeloma each year in the UK. About 1 person in 200 will develop myeloma at some time in their life. The most common age at which people are diagnosed is about 72 years.
Kidney failure is a life threatening complication of myeloma. Up to 25% of patients diagnosed will develop kidney failure. This is due to large amounts of a protein produced by the myeloma cells known as light chains clogging up the kidney's normal filtering process.
OPTIMAL is a randomised clinical trial to establish whether thalidomide or bortezomib is more effective at reducing the level of light chains in the blood during the first two cycles of treatment and, if this response can predict the patient’s outcome to the next two cycles of treatment. A randomised study is one in which the participants are assigned by chance to groups that compare different treatments.
120 patients with multiple myeloma and renal failure are expected to be recruited from some 20 sites within the UK over two years. Patients consenting to enter into the study will undergo a number of investigations during the screening process, to assess their eligibility for the study. Eligible patients will be randomised to receive 4 cycles of either thalidomide in combination with bendamustine and dexamethasone, or bortezomib in combination with bendamustine and dexamethasone. Participants not suitable for bone marrow transplant may receive two further cycles of treatment. Bone marrow tissue, blood and urine samples will be taken at various times to confirm the diagnosis and to monitor the patient’s response to treatment.Analysis will be carried out on the data collected on each patient to assess if one treatment is superior to the other in reducing the level of tumour and treating kidney failure.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
13/NE/0361
Date of REC Opinion
3 Mar 2014
REC opinion
Further Information Favourable Opinion