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ISRCTN
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ISRCTN37161699
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DOI
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10.1186/ISRCTN37161699
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ClinicalTrials.gov identifier
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NCT00416897
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EudraCT number
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Public title
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MyEloma Renal Impairment Trial: adjunctive plasma exchange in patients with newly diagnosed multiple myeloma and acute renal failure
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Scientific title
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A randomised controlled trial of adjunctive plasma exchange in patients with newly diagnosed multiple myeloma and acute renal failure
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Acronym
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MERIT
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Serial number at source
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C7625/A2879
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Study hypothesis
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As of 10/12/2009 this record was updated; all details can be found in the relevant fields under the above update date.
Added as of 10/12/2009:
Does the addition of plasma exchange (PE) to chemotherapy increase the likelihood of renal recovery in patients with acute renal failure associated with newly diagnosed myeloma?
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Myeloma
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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Does not comply with above inclusion criteria
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Anticipated start date
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01/01/2004
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Anticipated end date
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31/12/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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280 (added 10/09/2007)
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Interventions
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Plasma exchange in addition to standard chemotherapy versus standard chemotherapy alone.
Added as of 10/12/2009:
Chemotherapy (ALL patients): two 4-day courses of dexamethasone (d1-12), followed by four cycles of vincristine, Adriamycin and dexamethasone (VAD) (d17-83), with appropriate supportive therapy. Treatment after 100 days will be according to local preference.
Plasma exchange (patients randomised to PE): 7 plasma exchanges within the first two weeks of entry (at least 4 within the first week). Method of plasma exchange will be by either cytocentrifugation or plasma filtration, according to local practice.
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Primary outcome measure(s)
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Added as of 10/12/2009:
Proportion of patients alive and dialysis-independent at 100 days.
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Secondary outcome measure(s)
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Added as of 10/12/2009:
1. To determine whether addition of plasma exchange to chemotherapy affects overall survival
2. To assess the impact of the addition of plasma exchange to chemotherapy on patients' quality of life
3. To assess the value of renal histology in predicting recovery of renal function
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
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Sources of funding
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1. Leukaemia Research Fund (UK)
2. Cancer Research UK (CRUK) (UK)
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Trial website
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Publications
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Contact name
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Dr
G
Gaskin
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Address
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Renal Unit
Imperial College School of Medicine
Department of Medicine
Hammersmith Hospital
Du Cane Road
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City/town
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London
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Zip/Postcode
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W12 0HS
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Country
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United Kingdom
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Tel
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+44 (0)181 383 3152
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Email
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Sponsor
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Imperial College London (UK)
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Address
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c/o Clinical Trials Research Unit
University of Leeds
17 Springfield Mount
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City/town
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Leeds
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Zip/Postcode
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LS2 9NG
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Country
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United Kingdom
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Sponsor website:
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http://www3.imperial.ac.uk/
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Date applied
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21/09/2000
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Last edited
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11/02/2013
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Date ISRCTN assigned
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21/09/2000
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