|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ISRCTN |
|
Last refreshed on:
|
13 January 2015 |
|
Main ID: |
ISRCTN47723344 |
|
Date of registration:
|
19/08/2002 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Medical Research Council sixth myelomatosis trial for previously untreated patients: ABCM with or without clodronate
|
|
Scientific title:
|
|
|
Date of first enrolment:
|
01/06/1986 |
|
Target sample size:
|
0 |
|
Recruitment status: |
Completed |
|
URL:
|
http://isrctn.com/ISRCTN47723344 |
|
Study type:
|
Interventional |
|
Study design:
|
Randomised controlled trial. (Treatment)
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
United Kingdom
| | | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
-
- |
|
Address:
|
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
NW1 2DA
London
United Kingdom |
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
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
Exclusion criteria: Not provided at time of registration.
Age minimum:
Age maximum:
Gender:
Not Specified
|
|
Health Condition(s) or Problem(s) studied
|
Plasma cell neoplasms
Cancer
|
|
Intervention(s)
|
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(s)
|
|
Not provided at time of registration.
|
|
Secondary Outcome(s)
|
|
Not provided at time of registration.
|
|
Secondary ID(s)
|
|
MRC MYEL VIA
|
|
Source(s) of Monetary Support
|
|
UK Medical Research Council
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|