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

NCT00120263 | Completed

• 2 other identifiers: CIHR uop14875CIHR uop 14875
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma; Acute Renal Failure

Keywords

Plasma Exchange; Myeloma; Acute renal failure; Light Chains; Bence Jones Proteins; Kidney Function

Outcome Measures

Primary Outcomes (1)

• Composite Outcome: Death, Dialysis, MDRD GFR < 30 ml/min/1.73 meter squared

Secondary Outcomes (7)

• Cumulative survival

• Death or on dialysis at 6 months

• GFR at 6 months

• GFR change, entry to 6 months

• Dialysis Dependence at 6 months

Interventions

Plasma Exchange PROCEDURE

Eligibility Criteria

• Age: 18 Years - 81 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \<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

Sponsors & Collaborators

• London Health Sciences Centre: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• The Kidney Foundation of Canada: collaborator

Study Sites (1)

Dr W F Clark

London, Ontario, N6A 4G5, Canada

Location

Related Publications (1)

• Clark WF, Stewart AK, Rock GA, Sternbach M, Sutton DM, Barrett BJ, Heidenheim AP, Garg AX, Churchill DN; Canadian Apheresis Group. Plasma exchange when myeloma presents as acute renal failure: a randomized, controlled trial. Ann Intern Med. 2005 Dec 6;143(11):777-84. doi: 10.7326/0003-4819-143-11-200512060-00005.

  PMID: 16330788 RESULT

MeSH Terms

Conditions

Multiple Myeloma; Acute Kidney Injury; Neoplasms, Plasma Cell

Interventions

Plasma Exchange

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Blood Transfusion; Biological Therapy; Therapeutics; Plasmapheresis; Blood Component Removal; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• William F Clark, MD

  Western University, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 8, 2005
• First Posted: July 15, 2005
• Study Start: September 1, 1998
• Study Completion: April 1, 2004
• Last Updated: March 25, 2025

Record last verified: 2005-07

Locations

CA (1)