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ISRCTN
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ISRCTN32846751
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DOI
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10.1186/ISRCTN32846751
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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VIIIth myelomatosis trial
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Scientific title
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Acronym
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N/A
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Serial number at source
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G8223452
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Study hypothesis
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Not provided at time of registration
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Lay summary
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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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Myelomatosis
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Participants - inclusion criteria
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1. Patients with definite myelomatosis requiring chemotherapy in the judgement of the physician and fulfilling at least two of the three following criteria: Bone marrow aspirate and/or trephine showing the presence of a neoplastic plasma cell infiltrate and/or microplasmacytomas; A paraprotein present in the blood and/or urine; Definite lytic bone lesions
2. Aged less than 65 years
3. Patients with equivocal myelomatosis are excluded
4. No previous cytotoxic chemotherapy, except prednisolone or other corticosteroids to relieve fluid-unresponsive hypercalcaemia or minimal local radiotherapy to relieve bone pain
5. No medical contraindications to protocol treatments
6. Patients must have a neutrophil count of at least 1.3 x 10E9/l and a platelet count of at least 75 x 10E9/l
7. Patients must be able to tolerate a daily fluid intake of not less than 3 litres, evidence of renal insufficiency following pre-treatment re-hydration does not necessarily exclude
8. Patients must be apyrexial and free from infection
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Participants - exclusion criteria
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Not provided at time of registration
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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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31/12/2002
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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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Not provided at time of registration
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Interventions
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All patients receive three courses of chemotherapy with adriamycin, carmustine, melphan and cyclophosphamide (ABCM), cycle to be repeated every 6 weeks. Patients who in whom there are no signs of disease progression and who fulfil all the entry criteria are randomised to one of two treatment regimens:
1. ABCM REGIMEN: Chemotherapy with ABCM, cycle to be repeated every 6 weeks. Treatment is stopped when the patient reaches plateau phase provided they have received at least four courses of ABCM.
2. ORAL C WEEKLY REGIMEN: Oral cyclophosphamide given as a single dose every 7 days plus prednisolone given on alternative days for 6 weeks. Weekly oral cyclophosphamide is continued until the patient reaches plateau phase and has received either three courses of ABCM and a minimum of 8 weeks of oral cyclophosphamide (if less than three courses of ABCM were given, 6 months chemotherapy), there is disease progression or the patient can no longer tolerate treatment.
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Primary outcome measure(s)
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Not provided at time of registration
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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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1. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16275935
2. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16728700
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Contact name
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Dr
ICM
MacLennan
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Address
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University of Birmingham
MRC Centre for Immune Regulation
Room 435 the IBR
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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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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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11/01/2011
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Date ISRCTN assigned
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25/10/2000
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