Medical Research Council sixth myelomatosis trial for previously untreated patients: ABCM with or without clodronate
| ISRCTN | ISRCTN47723344 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47723344 |
| Secondary identifying numbers | MRC MYEL VIA |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 10/10/2012
- 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 - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Study design | Randomised controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Not provided at time of registration. |
| Ethics approval(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | Plasma cell neoplasms |
| Intervention | Patients are randomised to one of two treatment regimens: 1. Regimen A: Induction chemotherapy with adriamycin, carmustine, melphan and cyclophosphamide (ABCM) repeated every 6 weeks plus daily oral placebo. 2. Regimen B: Induction chemotherapy with ABCM repeated every 6 weeks plus daily oral clodronate. All patients who have reached plateau phase on these regimens are randomised into part B of the trial. Maintenance therapy with alpha-2-interferon versus no maintenance therapy. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | clodronate |
| Primary outcome measure | Not provided at time of registration. |
| Secondary outcome measures | Not provided at time of registration. |
| Overall study start date | 01/06/1986 |
| Completion date | 01/06/1991 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration. |
| Key inclusion criteria | 1. Aged <75 years 2. Myelomatosis defined as having at least two of the following: a. Bone marrow smears or sections showing the presence of a neoplastic plasma cell infiltrate and/or microplasmacytomas b. A paraprotein present in the blood or urine c. Definite lytic bone lesions 2. Patients with equivocal myelomatosis are not eligible 3. No previous cytotoxic chemotherapy, except in the circumstances defined in the protocol 4. Able to tolerate a daily fluid intake of not less than 3 L 5. No contraindications to any of the treatment protocols |
| Key exclusion criteria | Not provided at time of registration. |
| Date of first enrolment | 01/06/1986 |
| Date of final enrolment | 01/06/1991 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
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
Government
UK Medical Research Council
No information available
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 | 01/06/2001 | Yes | No |
