Abstracts of Clinical Meeting on 12-July-2002

MERIT; Myeloma and Renal Impairment Trial (previously known as PRIME)

Judith Behrens, Consultant Haematologist. St Helier Hospital, Surrey SM5 1AA

Presentation to explain the change in acronym for the basically unchanged trial, outlining the different arrangements for the administration and statistical support for the trial and highlighting the main points of the trial for those who are unfamiliar with it.

A randomised controlled trial of adjunctive plasma exchange in patients with newly diagnosed multiple myeloma and acute renal failure

from the Renal Association and the UK Myeloma Forum. Gill Gaskin, Diana Samson, Sue Bell, Julia Brown, Kim Hawkins, Mark Drayson, Judith Behrens, Neil Iggo, Graham Jackson.

Why is this trial needed?

Severe renal failure is an important complication of myeloma. Acute renal failure unresponsive to rehydration/correction of hypercalcaemia complicates 5-10% of new cases of myeloma. About 5% of myeloma patients require long-term dialysis. Plasma exchange has potential to reduce rate of permanent renal failure by removal of immunoglobulin light chains, which are responsible for much of the renal damage. There is conflicting evidence in existing literature with only two small randomised controlled trials, one with clear benefit. Pooled data: renal recovery from dialysis in 2/16 patients treated with drugs only, and 14/20 treated with drugs + plasma exchange.

Why now?

There is diversity of current practice in the UK with centre-centre variation, with between 0-100% of patients receiving plasma exchange. Is it unnecessarily costly treatment or does it avoid renal failure & dialysis? There is enthusiasm for a trial with both strong patient and specialist society support. 32 UK centres have expressed interest in participation and it provides an opportunity to combine haematologists' track-record of trials with nephrologists' new enthusiasm for evidence-based practice. An ongoing Canadian study confirms the need to know whether plasma exchange is beneficial and provides an opportunity for meta-analysis and with the prospect of better treatments for myeloma it is more important than ever that patients are not burdened by consequences of established renal failure.

Design overview

Status of funding bids

 

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