ISRCTN ISRCTN66518389
DOI https://doi.org/10.1186/ISRCTN66518389
Secondary identifying numbers G8223452
Submission date
25/10/2000
Registration date
25/10/2000
Last edited
19/08/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr JA Child
Scientific

Department of Haematology
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom

Phone +44 (0)113 392 5153
Email tony.child@leedsth.nhs.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesTo 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedLeukaemia
InterventionABCM 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 typeOther
Primary outcome measureOverall survival
Secondary outcome measuresNot provided at time of registration
Overall study start date01/09/1993
Completion date20/10/2000

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Target number of participants750
Key inclusion criteria1. 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
Key exclusion criteria1. 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.
Date of first enrolment01/09/1993
Date of final enrolment20/10/2000

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Haematology
Leeds
LS1 3EX
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone +44 (0)20 7636 5422
Email clinical.trial@headoffice.mrc.ac.uk
Website http://www.mrc.ac.uk

Funders

Funder type

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 08/05/2003 Yes No