Contact information
Type
Scientific
Primary contact
Dr Mark Drayson
ORCID ID
Contact details
Department of Immunology
Medical School
University of Birmingham
Vincent Drive
Birmingham
B15 2TT
United Kingdom
-
m.t.drayson@bham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G8003737 expired Oct 99
Study information
Scientific title
MYELOMA VIIIth trial
Acronym
MYELOMA VIIIth trial
Study hypothesis
To compare, for survival, the induction of first plateau phase in previously untreated patients with multiple myeloma, the efficacy of the above two treatments
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
Other
Trial type
Treatment
Patient information sheet
Condition
Leukaemia
Intervention
All patients receive three courses of ABCM. They are then randomised to continue with ABCM or to change to oral weekly cyclophosphamide.
Intervention type
Drug
Phase
Not Specified
Drug names
Cyclophosphamide and ABCM
Primary outcome measures
1. Survival
2. Obtaining plateau (stable disease with no more than minimal symptoms)
3. Quality of life
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/11/1993
Overall trial end date
01/11/2000
Reason abandoned
Eligibility
Participant inclusion criteria
1. Greater than 65 years old and less than 75 years old
2. Myeloma
3. No previous cytotoxic therapy
4. Netrophil count greater than or equal to 1.3 x 10^9/l
5. Platelet count greater than or equal to 75 x 10^9/L
6. Able to tolerate 3 l of fluid per day
7. Apyrexial
8. Free from infection
9. Informed consent
Participant type
Patient
Age group
Senior
Gender
Not Specified
Target number of participants
1000
Participant exclusion criteria
Patients with equivocal myelomatosis
Recruitment start date
01/11/1993
Recruitment end date
01/11/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Immunology
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