A Randomised Controlled Trial of Adjunctive Plasma Exchange in Patients With Newly Diagnosed Multiple Myeloma and Acute Renal Failure [MERIT] MyEloma Renal Impairment Trial
18 Years
N/A
Both
Multiple Myeloma and Plasma Cell Neoplasm, Renal Failure
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
OBJECTIVES:
Primary
- 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.
Secondary
- 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
DISEASE CHARACTERISTICS:
- 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
electrophoresis
- 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
bisphosphonates
- No significant intrinsic renal disease unrelated to MM
PATIENT CHARACTERISTICS:
- 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
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy for MM
- Prior steroid therapy of ≤ 3 days duration for MM allowed
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Proportion of patients alive and dialysis-independent at 100 days
Safety Issue:
No
Principal Investigator
Gill Gaskin, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Hammersmith Hospital
Authority:
Unspecified
Study ID:
CDR0000523378
NCT ID:
NCT00416897
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
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