Clinical trial · Interventional
Trial of Plasma Exchange for Acute Renal Failure at the Onset of Myeloma
A Randomized Controlled Trial of Plasma Exchange for Acute Renal Failure at the Onset of Myeloma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Renal Failure | — | UNRESOLVED | — |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Plasma Exchange | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Composite Outcome: Death, Dialysis, MDRD GFR < 30 ml/min/1.73 meter squared
Secondary outcomes (7)
- measure
- Cumulative survival
- measure
- Death or on dialysis at 6 months
- measure
- GFR at 6 months
- measure
- GFR change, entry to 6 months
- measure
- Dialysis Dependence at 6 months
- measure
- Coming off dialysis by 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 81 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTClark 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