Dexamethasone and Chemotherapy With or Without Plasma Exchange in Patients With Newly Diagnosed Multiple Myeloma and Acute Kidney Failure
- Conditions
- Multiple Myeloma and Plasma Cell NeoplasmRenal Failure
- Registration Number
- NCT00416897
- Lead Sponsor
- University of Glasgow
- Brief Summary
RATIONALE: Dexamethasone is used to treat multiple myeloma. Drugs used in chemotherapy may stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Plasma exchange is a process in which certain cells are separated from the plasma in the blood by a machine and then only the cells are returned to the patient. Dexamethasone and plasma exchange may be an effective treatment for acute kidney failure caused by multiple myeloma. It is not yet known whether giving dexamethasone and chemotherapy together with plasma exchange is more effective than giving dexamethasone and chemotherapy alone in treating patients with multiple myeloma and acute kidney failure.
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
OBJECTIVES:
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 280
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients alive and dialysis-independent at 100 days
- Secondary Outcome Measures
Name Time Method Proportion of patients alive and dialysis-independent at 6 and 12 months Overall survival Glomerular filtration rate (calculated or measured) at 15 and 100 days and at 6 and 12 months Change in serum free light chain levels between days 0 and 15 Response of myeloma to treatment at 100 days and at 6 and 12 months Quality of life
Trial Locations
- Locations (39)
Addenbrooke's Hospital
🇬🇧Cambridge, England, United Kingdom
Saint Richards Hospital
🇬🇧Chichester, England, United Kingdom
Walsgrave Hospital
🇬🇧Coventry, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
🇬🇧Leeds, England, United Kingdom
Monklands General Hospital
🇬🇧Airdrie, Scotland, United Kingdom
Ninewells Hospital
🇬🇧Dundee, Scotland, United Kingdom
Basingstoke and North Hampshire NHS Foundation Trust
🇬🇧Basingstoke, England, United Kingdom
Good Hope Hospital
🇬🇧Birmingham, England, United Kingdom
Birmingham Heartlands Hospital
🇬🇧Birmingham, England, United Kingdom
Bristol Haematology and Oncology Centre
🇬🇧Bristol, England, United Kingdom
Kent and Canterbury Hospital
🇬🇧Canterbury, England, United Kingdom
Hull Royal Infirmary
🇬🇧Hull, England, United Kingdom
Bradford Royal Infirmary
🇬🇧Bradford, England, United Kingdom
Harrogate District Hospital
🇬🇧Harrogate, England, United Kingdom
Wycombe General Hospital
🇬🇧High Wycombe, England, United Kingdom
Leicester General Hospital
🇬🇧Leicester, England, United Kingdom
Saint Bartholomew's Hospital
🇬🇧London, England, United Kingdom
Aintree University Hospital
🇬🇧Liverpool, England, United Kingdom
Newcastle Upon Tyne Hospitals NHS Trust
🇬🇧Newcastle-Upon-Tyne, England, United Kingdom
Nottingham City Hospital
🇬🇧Nottingham, England, United Kingdom
Cancer Care Centre at York Hospital
🇬🇧York, England, United Kingdom
Hammersmith Hospital
🇬🇧London, England, United Kingdom
St. Georges, University of London
🇬🇧London, 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
Centre for Cancer Research and Cell Biology at Queen's University Belfast
🇬🇧Belfast, Northern Ireland, United Kingdom
Aberdeen Royal Infirmary
🇬🇧Aberdeen, Scotland, United Kingdom
Dumfries & Galloway Royal Infirmary
🇬🇧Dumfries, 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
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
🇬🇧Birmingham, England, United Kingdom
St. Helier Hospital
🇬🇧Carshalton, England, United Kingdom
New Cross Hospital
🇬🇧Wolverhampton, England, United Kingdom
Sussex Cancer Centre at Royal Sussex County Hospital
🇬🇧Brighton, England, United Kingdom