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Trial of Plasma Exchange for Acute Renal Failure at the Onset of Myeloma

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ClinicalTrials.gov Identifier: NCT00120263
Recruitment Status : Completed
First Posted : July 15, 2005
Last Update Posted : May 9, 2006
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:

Background:Plasma exchange has been suggested to be of theoretical benefit in the treatment of acute renal failure at the onset of multiple myeloma. Two small-randomized trials provide conflicting evidence.

Objective: To assess the effect of 5 to 7 plasma exchanges in the treatment of acute renal failure at the onset of multiple myeloma.

Design: Randomized controlled trial with 4 strata (chemotherapy and dialysis dependence) from 1998 to 2004.

Setting: Hospital plasma exchange units in 14 major Canadian medical centers.

Participants: 92 voluntary patients between the ages of 18 to 81 with acute renal failure at the onset of myeloma after volume repletion and hypercalcemia.

Intervention: 5 to 7 plasma exchanges of 50 ml/Kgm of 5% Human Serum Albumin in first 10 days plus conventional therapy versus conventional therapy alone.

Measurements: The primary outcome is a composite measure of death, dialysis dependence or Modification of Diet in Renal Disease Study glomerular filtration rate (MDRD GFR) < 30mg/min/1.73 meter squared at 6 months.


Condition or disease Intervention/treatment
Multiple Myeloma Acute Renal Failure Procedure: Plasma Exchange

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Plasma Exchange for Acute Renal Failure at the Onset of Myeloma
Study Start Date : September 1998
Estimated Study Completion Date : April 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Composite Outcome: Death, Dialysis, MDRD GFR < 30 ml/min/1.73 meter squared

Secondary Outcome Measures :
  1. Cumulative survival
  2. Death or on dialysis at 6 months
  3. GFR at 6 months
  4. GFR change, entry to 6 months
  5. Dialysis Dependence at 6 months
  6. Coming off dialysis by 6 months
  7. Dialysis initiation post plasma exchange intervention

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 81 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • New diagnosis of multiple myeloma and progressive acute kidney failure. The former is defined as a bone marrow aspirate with > 10% plasma cells and a monoclonal light chain in the urine, plasma or renal tissue. The latter is defined as a serum Creatinine > 200 umol/L with a rise > 50 umol/L in the preceding 2 weeks despite correction of hypercalcemia , hypovolemia and metabolic acidosis as required in a patient with a normal size kidney on ultrasound.

Exclusion Criteria:

  • <18 or > 81 years of age
  • Obstruction on renal ultrasound (examination required)
  • Use of intravenous contrast or non-steroidal anti-inflammatory drugs during the previous 2 weeks
  • Prior treatment for myeloma
  • Pregnancy
  • Inability to sign informed consent
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00120263


Locations
Canada, Ontario
Dr W F Clark
London, Ontario, Canada, N6A 4G5
Sponsors and Collaborators
London Health Sciences Centre
Canadian Institutes of Health Research (CIHR)
The Kidney Foundation of Canada
Investigators
Principal Investigator: William F Clark, MD University of Western Ontario, Canada
More Information

Publications:
ClinicalTrials.gov Identifier: NCT00120263     History of Changes
Other Study ID Numbers: CIHR uop14875
CIHR uop 14875
First Posted: July 15, 2005    Key Record Dates
Last Update Posted: May 9, 2006
Last Verified: July 2005

Keywords provided by London Health Sciences Centre:
Plasma Exchange
Myeloma
Acute renal failure
Light Chains
Bence Jones Proteins
Kidney Function

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Renal Insufficiency
Acute Kidney Injury
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Kidney Diseases
Urologic Diseases