Haematologica 2003 - Supplements

9.2 Renal complications.
243
MERIT – A new RCT of adjunctive plasma exchange in
patients with newly diagnosed multiple myeloma and
acute renal failure (ISRCTN37161699)
D Samson, G Gaskin, J Behrens, N Iggo, M Drayson, J
Dunn, G Jackson, K Hawkins, S Bell, J Lewis and J Brown.
Imperial College Faculty of Medicine, London, UK; St Helier
Hospital, Surrey, UK; Royal Sussex County Hospital, Brighton,
UK; University of Birmingham, UK; Royal Victoria Infirmary,
Newcastle, UK; Northern and Yorkshire Clinical Trials and
Research Unit, University of Leeds, UK. Email:
medseb@leeds.ac.uk
Introduction: MERIT (MyEloma Renal Impairment Trial) is a
new multicentre randomised controlled phase III trial for patients
with newly diagnosed multiple myeloma and acute renal failure,
developed on behalf of the UK Myeloma Forum and the UK
Renal Association. The trial is funded jointly by the Leukaemia
Research Foundation and Cancer Research UK and aims to
recruit a total of 286 patients in five years.
Aims: The primary aim of the trial is to determine whether the
addition of plasma exchange to chemotherapy increases the
likelihood of renal recovery in patients presenting with acute
renal failure and newly diagnosed multiple myeloma. It is
designed to detect an absolute improvement in recovery of renal
function of 20% (from 20% to 40%) at the 5% (2 sided) level of
significance. The primary endpoint will be the proportion of
patients alive and dialysis-independent at 100 days.
Secondary aims are to assess the value of plasma exchange on
overall survival and quality of life, the value of renal histology in
predicting recovery of renal function and the value of serum free
light chain assay in determining response of the myeloma and
recovery of renal function.
Why is the trial necessary?: Severe renal impairment is a serious
complication of multiple myeloma, contributing greatly to the
morbidity of the disease, and occurs in up to 20% of patients at
presentation. 25-50% of these patients will not respond to
standard measures, such as rehydration and correction of
hypercalcaemia. Overall, approximately 5% of all myeloma
patients will require long-term dialysis. Light chains produced by
the myeloma cells are thought to be responsible for much of the
renal damage, on the basis of a number of experimental models.
Plasma exchange removes free light chain and there are several
anecdotal reports of improvement in renal function in patients
following treatment. However, only two small randomised
controlled trials have been published and they reached opposing
conclusions regarding the value of plasma exchange.
Main eligibility criteria
Newly diagnosed myeloma
Acute renal failure (creatinine >500µmol/l, urine output