Myeloma VII - myelomatosis therapy trial
ISRCTN | ISRCTN66518389 |
---|---|
DOI | https://doi.org/10.1186/ISRCTN66518389 |
Secondary identifying numbers | G8223452 |
- Submission date
- 25/10/2000
- Registration date
- 25/10/2000
- Last edited
- 19/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr JA Child
Scientific
Scientific
Department of Haematology
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom
Phone | +44 (0)113 392 5153 |
---|---|
tony.child@leedsth.nhs.uk |
Study information
Study design | Randomised controlled trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
Scientific title | |
Study objectives | To compare ABCM for plateau induction with alpha IFN maintenance vs. a three-phase regimen of C-VAMP, high dose melphalan (with autologous bone marrow/peripheral blood stem cell support as appropriate) and alpha IFN maintenance. To compare toxicity profiles in the two arms, to address the issue of quality of life, to address the issue of health economics, to investigate cellular changes by means of linked studies of morphology, phenotyping and cytogenetics before and after treatment and at relapse. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Leukaemia |
Intervention | ABCM for plateau induction with alpha Interferon (IFN) maintenance/a three-phase regimen of C-VAMP, high dose melphalan (with autologous bone marrow/peripheral blood stem cell support as appropriate) and alpha IFN maintenance |
Intervention type | Other |
Primary outcome measure | Overall survival |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/09/1993 |
Completion date | 20/10/2000 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Sex | Not Specified |
Target number of participants | 750 |
Key inclusion criteria | 1. They have definite myelomatosis requiring chemotherapy 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 blood and/or urine 2. They have definite lytic bone lesions 3. They are aged under 65 years 4. They are able to tolerate a daily fluid intake of not less than 3 litres 5. The physician is satisfied it would be appropriate to receive any of specified treatments |
Key exclusion criteria | 1. Patients have equivocal myelomatosis (these should be registered but will not receive treatment - if disease progresses then they may be entered into the main trial) 2. They have previous malignancies except non-melanoma skin tumours or in situ carcinomas 3. Had previous treatment except minimal local radiotherapy to relieve bone pain 4. If have a life threatening disease unrelated to myelomastosis. |
Date of first enrolment | 01/09/1993 |
Date of final enrolment | 20/10/2000 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Haematology
Leeds
LS1 3EX
United Kingdom
LS1 3EX
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
Phone | +44 (0)20 7636 5422 |
---|---|
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
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 share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 08/05/2003 | Yes | No |