| Source of record | UK Trials |
| ISRCTN | ISRCTN47723344 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | MRC MYEL VIA |
| Public title | Medical Research Council sixth myelomatosis trial for previously untreated patients: ABCM with or without clodronate |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Plasma cell neoplasms |
| Study hypothesis | Not provided at time of registration. |
| Design/methodology | Randomised controlled trial. |
| Research ethics review | Not provided at time of registration. |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - exclusion criteria | Not provided at time of registration. |
| Patient information material |
|
| Anticipated start date | 01/06/1986 |
| Anticipated end date | 01/06/1991 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration. |
| Interventions | 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. |
| Primary outcome measure(s) | Not provided at time of registration. |
| Secondary outcome measure(s) | Not provided at time of registration. |
| Sources of funding | UK Medical Research Council |
| Sponsor name | Medical Research Council (UK) |
| Sponsor details | 20 Park Crescent
London
United Kingdom
W1B 1AL |
| Sponsor telephone | +44 (0)20 7636 5422 |
| Sponsor fax | +44 (0)20 7436 6179 |
| Sponsor email | clinical.trial@headoffice.mrc.ac.uk |
| Sponsor website | http://www.mrc.ac.uk |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN47723344 |
| Date last extracted from ISRCTN register | 17/04/2008 |
