Condition category
Cancer
Date applied
25/10/2000
Date assigned
25/10/2000
Last edited
11/01/2011
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 ICM MacLennan

ORCID ID

Contact details

University of Birmingham
MRC Centre for Immune Regulation
Room 435 the IBR
Birmingham
B15 2TT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G8223452

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

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

Myelomatosis

Intervention

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.

Intervention type

Drug

Phase

Not Specified

Drug names

Adriamycin, carmustine, melphan and cyclophosphamide (ABCM)

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/11/1993

Overall trial end date

31/12/2002

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/11/1993

Recruitment end date

31/12/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Birmingham
Birmingham
B15 2TT
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

1. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16275935
2. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16728700

Publication citations

  1. Results

    Augustson BM, Begum G, Dunn JA, Barth NJ, Davies F, Morgan G, Behrens J, Smith A, Child JA, Drayson MT, Early mortality after diagnosis of multiple myeloma: analysis of patients entered onto the United kingdom Medical Research Council trials between 1980 and 2002--Medical Research Council Adult Leukaemia Working Party., J. Clin. Oncol., 2005, 23, 36, 9219-9226, doi: 10.1200/JCO.2005.03.2086.

  2. Results

    Drayson M, Begum G, Basu S, Makkuni S, Dunn J, Barth N, Child JA, Effects of paraprotein heavy and light chain types and free light chain load on survival in myeloma: an analysis of patients receiving conventional-dose chemotherapy in Medical Research Council UK multiple myeloma trials., Blood, 2006, 108, 6, 2013-2019, doi: 10.1182/blood-2006-03-008953.

Additional files

Editorial Notes