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MyEloma Renal Impairment Trial: adjunctive plasma exchange in patients with newly diagnosed multiple myeloma and acute renal failure

Not Applicable
Completed
Conditions
Myeloma
Cancer
Multiple 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
NameTimeMethod
<br> Added as of 10/12/2009:<br> Proportion of patients alive and dialysis-independent at 100 days.<br>
Secondary Outcome Measures
NameTimeMethod
<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>
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