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 (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
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
-
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.
-
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.