A Randomised Controlled Trial of Adjunctive Plasma Exchange in Patients With Newly Diagnosed Multiple Myeloma and Acute Renal Failure [MERIT] MyEloma Renal Impairment Trial
- Compare the effect of dexamethasone and cytotoxic chemotherapy with vs without plasma
exchange on the likelihood of renal recovery (i.e., dialysis-independent at 100 days)
in patients with newly diagnosed multiple myeloma and acute renal failure.
- Compare the overall survival of patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
- Determine the value of renal histology in predicting recovery of renal function in
- Determine the value of serum free light chain assay in determining disease response and
renal function recovery in these patients.
OUTLINE: This is a randomized, controlled, open-label, multicenter study. Patients are
stratified according to planned chemotherapy (vincristine and doxorubicin hydrochloride (VA)
or VA-like chemotherapy vs thalidomide-containing chemotherapy vs alkylating agent vs
other), frequency of chemotherapy courses (1-3 weekly vs 4 weekly), need for dialysis at
randomization (yes vs no), and age (< 65 years vs ≥ 65 years). Patients are randomized to 1
of 2 treatment arms.
- Arm I: Patients receive oral dexamethasone, at least twice daily, on days 1-4 and 9-12.
Patients undergo plasma exchange by cytocentrifugation or plasmafiltration over 2-3
hours in weeks 1 and 2 (7 treatments total; 4 of them in week 1). Patients then receive
planned chemotherapy per local clinician on days 17-100. Chemotherapy may continue
after 100 days at the discretion of the local clinician.
- Arm II: Patients receive dexamethasone and planned chemotherapy as in arm I. Quality of
life is assessed at baseline, day 100, and 6 and 12 months.
After completion of study treatment, patients are followed at 6 and 12 months and then
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 280 patients will be accrued for this study.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Proportion of patients alive and dialysis-independent at 100 days
Gill Gaskin, MD