Contact information
Type
Scientific
Primary contact
Dr JA Child
ORCID ID
Contact details
Department of Haematology
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom
+44 (0)113 392 5153
tony.child@leedsth.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G8223452
Study information
Scientific title
Acronym
Study hypothesis
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Leukaemia
Intervention
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
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Overall survival
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/09/1993
Overall trial end date
20/10/2000
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
750
Participant exclusion criteria
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.
Recruitment start date
01/09/1993
Recruitment end date
20/10/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Haematology
Leeds
LS1 3EX
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12736280
Publication citations
-
Results
Child JA, Morgan GJ, Davies FE, Owen RG, Bell SE, Hawkins K, Brown J, Drayson MT, Selby PJ, , High-dose chemotherapy with hematopoietic stem-cell rescue for multiple myeloma., N. Engl. J. Med., 2003, 348, 19, 1875-1883, doi: 10.1056/NEJMoa022340.