Condition category
Cancer
Date applied
25/10/2000
Date assigned
25/10/2000
Last edited
19/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

  1. 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.

Additional files

Editorial Notes