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ISRCTN
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ISRCTN66518389
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DOI
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10.1186/ISRCTN66518389
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Myeloma VII - myelomatosis therapy 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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To compare ABCM for plateau induction with alpha IFN maintenance vs. a three-phase regimen of C-VAMP, high dose melphalan (with autologous bone marrow/peripheral blood stem cell support as appropriate) and alpha IFN maintenance. To compare toxicity profiles in the two arms, to address the issue of quality of life, to address the issue of health economics, to investigate cellular changes by means of linked studies of morphology, phenotyping and cytogenetics before and after treatment and at relapse.
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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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Leukaemia
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Participants - inclusion criteria
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1. They have definite myelomatosis requiring chemotherapy 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 blood and/or urine
2. They have definite lytic bone lesions
3. They are aged under 65 years
4. They are able to tolerate a daily fluid intake of not less than 3 litres
5. The physician is satisfied it would be appropriate to receive any of specified treatments
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Participants - exclusion criteria
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1. Patients have equivocal myelomatosis (these should be registered but will not receive treatment - if disease progresses then they may be entered into the main trial)
2. They have previous malignancies except non-melanoma skin tumours or in situ carcinomas
3. Had previous treatment except minimal local radiotherapy to relieve bone pain
4. If have a life threatening disease unrelated to myelomastosis.
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Anticipated start date
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01/09/1993
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Anticipated end date
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20/10/2000
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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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750
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Interventions
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ABCM for plateau induction with alpha Interferon (IFN) maintenance/a three-phase regimen of C-VAMP, high dose melphalan (with autologous bone marrow/peripheral blood stem cell support as appropriate) and alpha IFN maintenance
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Primary outcome measure(s)
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Overall survival
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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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2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12736280
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Contact name
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Dr
JA
Child
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Address
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Department of Haematology
Leeds General Infirmary
Great George Street
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City/town
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Leeds
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Zip/Postcode
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LS1 3EX
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Country
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United Kingdom
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Tel
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+44 (0)113 392 5153
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Email
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tony.child@leedsth.nhs.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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19/08/2009
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Date ISRCTN assigned
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25/10/2000
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