MYELOMA VIIIth trial
| ISRCTN | ISRCTN52157196 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52157196 |
| Protocol serial number | G8003737 expired Oct 99 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council (MRC) (UK) |
- 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
Scientific
Department of Immunology
Medical School
University of Birmingham
Vincent Drive
Birmingham
B15 2TT
United Kingdom
| m.t.drayson@bham.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | MYELOMA VIIIth trial |
| Study acronym | MYELOMA VIIIth trial |
| Study objectives | 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(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Cyclophosphamide and ABCM |
| Primary outcome measure(s) | 1. Survival 2. Obtaining plateau (stable disease with no more than minimal symptoms) 3. Quality of life |
| Key secondary outcome measure(s) | Not provided at time of registration |
| Completion date | 01/11/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Not Specified |
| Target sample size at registration | 1000 |
| Key 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 |
| Key exclusion criteria | Patients with equivocal myelomatosis |
| Date of first enrolment | 01/11/1993 |
| Date of final enrolment | 01/11/2000 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Immunology
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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
