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ISRCTN
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ISRCTN52157196
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DOI
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10.1186/ISRCTN52157196
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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MYELOMA VIIIth trial
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Scientific title
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Acronym
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MYELOMA VIIIth trial
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Serial number at source
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G8003737 expired Oct 99
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Study hypothesis
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To compare, for survival, the induction of first plateau phase in previously untreated patients with multiple myeloma, the efficacy of the above two treatments
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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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Leukaemia
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Participants - inclusion criteria
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1. Greater than 65 years old and less than 75 years old
2. Myeloma
3. No previous cytotoxic therapy
4. Netrophil count greater than or equal to 1.3 x 10^9/l
5. Platelet count greater than or equal to 75 x 10^9/L
6. Able to tolerate 3 l of fluid per day
7. Apyrexial
8. Free from infection
9. Informed consent
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Participants - exclusion criteria
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Patients with equivocal myelomatosis
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Anticipated start date
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01/11/1993
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Anticipated end date
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01/11/2000
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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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1000
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Interventions
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All patients receive three courses of ABCM. They are then randomised to continue with ABCM or to change to oral weekly cyclophosphamide.
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Primary outcome measure(s)
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1. Survival
2. Obtaining plateau (stable disease with no more than minimal symptoms)
3. Quality of life
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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Publications
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Contact name
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Dr
Mark
Drayson
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Address
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Department of Immunology
Medical School
University of Birmingham
Vincent Drive
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City/town
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Birmingham
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Zip/Postcode
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B15 2TT
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Country
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United Kingdom
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Email
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m.t.drayson@bham.ac.uk
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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25/10/2000
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Last edited
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07/02/2013
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Date ISRCTN assigned
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25/10/2000
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