ISRCTN ISRCTN52157196
DOI https://doi.org/10.1186/ISRCTN52157196
Secondary identifying numbers G8003737 expired Oct 99
Submission date
25/10/2000
Registration date
25/10/2000
Last edited
27/09/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Mark Drayson
Scientific

Department of Immunology
Medical School
University of Birmingham
Vincent Drive
Birmingham
B15 2TT
United Kingdom

Email m.t.drayson@bham.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific titleMYELOMA VIIIth trial
Study acronymMYELOMA VIIIth trial
Study objectivesTo 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(s)Not provided at time of registration.
Health condition(s) or problem(s) studiedLeukaemia
InterventionAll patients receive three courses of ABCM. They are then randomised to continue with ABCM or to change to oral weekly cyclophosphamide.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Cyclophosphamide and ABCM
Primary outcome measure1. Survival
2. Obtaining plateau (stable disease with no more than minimal symptoms)
3. Quality of life
Secondary outcome measuresNot provided at time of registration
Overall study start date01/11/1993
Completion date01/11/2000

Eligibility

Participant type(s)Patient
Age groupSenior
SexNot Specified
Target number of participants1000
Key inclusion criteria1. 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
Key exclusion criteriaPatients with equivocal myelomatosis
Date of first enrolment01/11/1993
Date of final enrolment01/11/2000

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Immunology
Birmingham
B15 2TT
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone +44 (0)20 7636 5422
Email clinical.trial@headoffice.mrc.ac.uk
Website http://www.mrc.ac.uk

Funders

Funder type

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

27/09/2019: No publications found, verifying study status with principal investigator.
25/05/2016: No publications found, verifying study status with principal investigator