MyEloma Renal Impairment Trial: adjunctive plasma exchange in patients with newly diagnosed multiple myeloma and acute renal failure
Not Applicable
Completed
- Conditions
- MyelomaCancerMultiple myeloma and malignant plasma cell neoplasms
- Registration Number
- ISRCTN37161699
- Lead Sponsor
- Imperial College London (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 280
Inclusion Criteria
Patients with newly diagnosed myeloma and acute renal failure, aged 18 years or over
Added as of 10/12/2009:
1. Newly diagnosed myeloma
2. Acute renal failure (creatinine greater than 500 mmol/l, urine output less than 400 ml/d or requiring dialysis)
3. Aged 18 years or over, either sex
4. Written informed consent
5. No previous chemotherapy for myeloma
6. No significant intrinsic renal disease unrelated to myeloma
Exclusion Criteria
Does not comply with above inclusion criteria
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Added as of 10/12/2009:<br> Proportion of patients alive and dialysis-independent at 100 days.<br>
- Secondary Outcome Measures
Name Time Method <br> Added as of 10/12/2009:<br> 1. To determine whether addition of plasma exchange to chemotherapy affects overall survival<br> 2. To assess the impact of the addition of plasma exchange to chemotherapy on patients' quality of life<br> 3. To assess the value of renal histology in predicting recovery of renal function<br> 4. To assess the value of serum free light chain assay in determining response of the myeloma to chemotherapy and recovery of renal function in patients with renal failure<br>