Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
G8223452
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study 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
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Adriamycin, carmustine, melphan and cyclophosphamide (ABCM)
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall study start date
01/11/1993
Overall study end date
31/12/2002
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Sex
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
England, United Kingdom
Study 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)
UK Medical Research Council, MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 20/12/2005 | Yes | No | |
| Results article | results | 15/09/2006 | Yes | No |