Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
MRC MYEL VIA
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration.
Ethics approval(s)
Not provided at time of registration.
Study design
Randomised controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
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
Overall study end date
01/06/1991
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Not Specified
Sex
Not Specified
Target number of participants
Not provided at time of registration.
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
01/06/1986
Recruitment end date
01/06/1991
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Government
Funder name
UK Medical Research Council
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2001 | Yes | No |