Dexamethasone and Chemotherapy With or Without Plasma Exchange in Patients With Newly Diagnosed Multiple Myeloma and Acute Kidney Failure
NCT ID: NCT00416897
Last Updated: 2013-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
280 participants
INTERVENTIONAL
2003-03-31
2008-12-31
Brief Summary
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PURPOSE: This randomized phase III trial is studying dexamethasone, chemotherapy, and plasma exchange to see how well they work compared with dexamethasone and chemotherapy alone in treating patients with newly diagnosed multiple myeloma and acute kidney failure.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
NONE
Interventions
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chemotherapy
dexamethasone
plasmapheresis
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of Glasgow
OTHER
Principal Investigators
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Gill Gaskin, MD
Role: STUDY_CHAIR
Hammersmith Hospitals NHS Trust
Locations
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Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, England, United Kingdom
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, United Kingdom
Good Hope Hospital
Birmingham, England, United Kingdom
Birmingham Heartlands Hospital
Birmingham, England, United Kingdom
Bradford Royal Infirmary
Bradford, England, United Kingdom
Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, England, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom
Addenbrooke's Hospital
Cambridge, England, United Kingdom
Kent and Canterbury Hospital
Canterbury, England, United Kingdom
St. Helier Hospital
Carshalton, England, United Kingdom
Saint Richards Hospital
Chichester, England, United Kingdom
Walsgrave Hospital
Coventry, England, United Kingdom
Harrogate District Hospital
Harrogate, England, United Kingdom
Wycombe General Hospital
High Wycombe, England, United Kingdom
Hull Royal Infirmary
Hull, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Leicester General Hospital
Leicester, England, United Kingdom
Aintree University Hospital
Liverpool, England, United Kingdom
Saint Bartholomew's Hospital
London, England, United Kingdom
St. Georges, University of London
London, England, United Kingdom
Hammersmith Hospital
London, England, United Kingdom
Newcastle Upon Tyne Hospitals NHS Trust
Newcastle upon Tyne, England, United Kingdom
Nottingham City Hospital
Nottingham, England, United Kingdom
Oxford Radcliffe Hospital
Oxford, England, United Kingdom
Hope Hospital
Salford, England, United Kingdom
Staffordshire General Hospital
Stafford, England, United Kingdom
Sunderland Royal Hospital
Sunderland, England, United Kingdom
Royal Cornwall Hospital
Truro, Cornwall, England, United Kingdom
New Cross Hospital
Wolverhampton, England, United Kingdom
Cancer Care Centre at York Hospital
York, England, United Kingdom
Centre for Cancer Research and Cell Biology at Queen's University Belfast
Belfast, Northern Ireland, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom
Monklands General Hospital
Airdrie, Scotland, United Kingdom
Dumfries & Galloway Royal Infirmary
Dumfries, Scotland, United Kingdom
Ninewells Hospital
Dundee, Scotland, United Kingdom
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland, United Kingdom
Royal Infirmary - Castle
Glasgow, Scotland, United Kingdom
Morriston Hospital NHS Trust
West Glamorgen, Scotland, United Kingdom
Wrexham Maelor Hospital
Wrexham, Wales, United Kingdom
Countries
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Other Identifiers
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CRUK-MERIT
Identifier Type: -
Identifier Source: secondary_id
EU-20670
Identifier Type: -
Identifier Source: secondary_id
ISRCTN37161699
Identifier Type: -
Identifier Source: secondary_id
CDR0000523378
Identifier Type: -
Identifier Source: org_study_id