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Plasma Exchange When Myeloma Presents as Acute Renal Failure
A Randomized, Controlled Trial
- William F. Clark, MD;
- A. Keith Stewart, MD;
- Gail A. Rock, MD;
- Marion Sternbach, MD;
- David M. Sutton, MD;
- Brendan J. Barrett, MD;
- A. Paul Heidenheim, MA;
- Amit X. Garg, MD;
- David N. Churchill, MD; and
- the Canadian Apheresis Group
- From University of Western Ontario, London, Ontario, Canada; University of Toronto, Toronto, Ontario, Canada; University of Ottawa, Ottawa, Ontario, Canada; McMaster University, Hamilton, Ontario, Canada; and Memorial University of Newfoundland, St. John's, Newfoundland, Canada.
Abstract
Background: Two small, randomized trials provide conflicting evidence about the benefits of plasma exchange for patients with acute renal failure at the onset of multiple myeloma.
Objective: To assess the effect of 5 to 7 plasma exchanges on a composite outcome in patients with acute renal failure at the onset of multiple myeloma.
Design: Randomized, open, controlled trial, stratified by chemotherapy and dialysis dependence, conducted from 1998 to 2004.
Setting: Hospital plasma exchange units in 14 Canadian medical centers.
Participants: 104 patients between 18 and 81 years of age with acute renal failure at the onset of myeloma.
Intervention: Study participants were randomly assigned to conventional therapy plus 5 to 7 plasma exchanges of 50 mL per kg of body weight of 5% human serum albumin for 10 days or conventional therapy alone. Ninety-seven participants completed the 6-month follow-up.
Measurements: The primary outcome was a composite measure of death, dialysis dependence, or glomerular filtration rate less than 0.29 mL·s−2·m−2 (<30 mL/min per 1.73 m2).
Results: At enrollment, the plasma exchange and control groups were similar for dialysis dependence, chemotherapy, sex, age, hypercalcemia, serum albumin level, 24-hour urine protein level, serum creatinine level, and Durie–Salmon staging. The primary composite end point occurred in 33 of 57 (57.9%) patients in the plasma exchange group and in 27 of 39 (69.2%) patients in the control group (difference between groups, 11.3% [95% CI, −8.3% to 29.1%]; P = 0.36). One third of patients in each group died.
Limitations: The study was small, used a composite outcome, and did not use renal biopsy as an inclusion criterion. Recruiting physicians were blinded to treatment allocation but not to treatment thereafter.
Conclusions: In patients with acute renal failure at the onset of multiple myeloma, there is no conclusive evidence that 5 to 7 plasma exchanges substantially reduce a composite outcome of death, dialysis dependence, or glomerular filtration rate less than 0.29 mL·s−2·m−2 (<30 mL/min per 1.73 m2) at 6 months.
Article and Author Information
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ClinicalTrials.gov identifier: NCT00120263.
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Grant Support: By the Canadian Institute of Health Research, Gambro BCT, and The Kidney Foundation of Canada.
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Potential Financial Conflicts of Interest: Grants received: W.F. Clark (Kidney Foundation of Canada, Canadian Institute of Health Research, Gambro BCT).
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Requests for Single Reprints: William F. Clark, MD, London Health Sciences Centre, 800 Commissioners Road East, London, Ontario N6A 4G5, Canada.
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Current Author Addresses: Drs. Clark and Garg and Mr. Heidenheim: London Health Sciences Centre, 800 Commissioners Road East, London, Ontario N6A 4G5, Canada.
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Dr. Stewart: Princess Margaret Hospital, 620 University Avenue, Toronto, Ontario M5G 2C1, Canada.
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Dr. Rock: The Ottawa Hospital, 1053 Carling Avenue, Ottawa, Ontario K1Y 4E9, Canada.
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Drs. Sternbach and Churchill: McMaster University, St. Joseph's Hospital, 50 Charlton East, Hamilton, Ontario L8N 1A6, Canada.
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Dr. Sutton: Toronto General Hospital, 200 Elizabeth Street, Toronto, Ontario M5C 2G4, Canada.
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Dr. Barrett: Memorial University of Newfoundland, 300 Prince Philip Drive, St. Johns, Newfoundland A1B 3V6, Canada.
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Author Contributions: Conception and design: W.F. Clark, A.K. Stewart, G.A. Rock, M. Sternbach, B.J. Barrett, A.P. Heidenheim, D.N. Churchill.
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Analysis and interpretation of the data: W.F. Clark, A.K. Stewart, B.J. Barrett, A.P. Heidenheim, A.X. Garg, D.N. Churchill.
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Drafting of the article: W.F. Clark, A.K. Stewart, A.P. Heidenheim, D.N. Churchill.
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Critical revision of the article for important intellectual content: W.F. Clark, A.K. Stewart, M. Sternbach, D.M. Sutton, B.J. Barrett, A.P. Heidenheim, A.X. Garg, D.N. Churchill.
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Final approval of the article: W.F. Clark, A.K. Stewart, A.X. Garg, D.N. Churchill.
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Provision of study materials or patients: W.F. Clark, G.A. Rock, M. Sternbach, D.M. Sutton, D.N. Churchill.
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Statistical expertise: W.F. Clark, A.P. Heidenheim, A.X. Garg, D.N. Churchill.
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Obtaining of funding: W.F. Clark, A.K. Stewart, D.N. Churchill.
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Administrative, technical, or logistic support: W.F. Clark, G.A. Rock.
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Collection and assembly of data: W.F. Clark, A.P. Heidenheim, D.N. Churchill.
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