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A Randomised Controlled Trial of Adjunctive Plasma Exchange in Patients With Newly Diagnosed Multiple Myeloma and Acute Renal Failure [MERIT] MyEloma Renal Impairment Trial

Phase 3
18 Years
Open (Enrolling)
Multiple Myeloma and Plasma Cell Neoplasm, Renal Failure

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Trial Information

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
these patients.

- 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
annually thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 280 patients will be accrued for this study.

Inclusion Criteria


- Newly diagnosed multiple myeloma (MM), meeting ≥ 2 of the following criteria:

- Serum or urine* paraprotein

- Bone marrow showing > 10% plasma cells

- Lytic bone lesions NOTE: *The presence of typical myeloma kidney on renal biopsy
is considered equivalent to the demonstration of urine paraprotein by

- Acute renal failure attributable to MM, meeting both of the following criteria:

- Creatinine > 5.65 mg/dL OR urine output < 400 mL/day OR requires dialysis

- Unresponsive to treatment with fluids and/or treatment of hypercalcemia with

- No significant intrinsic renal disease unrelated to MM


- Platelet count ≥ 50,000/mm³

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- ALT and AST ≤ 2.5 times ULN

- No contraindications to study medication, including the following:

- Active or recent peptic ulcer

- Known significant cardiac insufficiency

- Allergy to study medications

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No known HIV positivity


- No prior chemotherapy for MM

- Prior steroid therapy of ≤ 3 days duration for MM allowed

Type of Study:


Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of patients alive and dialysis-independent at 100 days

Safety Issue:


Principal Investigator

Gill Gaskin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Hammersmith Hospital



Study ID:




Start Date:

March 2003

Completion Date:

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • Renal Failure
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • renal failure
  • Neoplasms
  • Acute Kidney Injury
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Renal Insufficiency