Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
10/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT 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

Not provided at time of registration.

Study design

Randomised controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial 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

Phase

Not Specified

Drug names

clodronate

Primary outcome measures

Not provided at time of registration.

Secondary outcome measures

Not provided at time of registration.

Overall trial start date

01/06/1986

Overall trial end date

01/06/1991

Reason abandoned

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

Patient

Age group

Not Specified

Gender

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

United Kingdom

Trial 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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11442499

Publication citations

  1. Results

    McCloskey EV, Dunn JA, Kanis JA, MacLennan IC, Drayson MT, Long-term follow-up of a prospective, double-blind, placebo-controlled randomized trial of clodronate in multiple myeloma., Br. J. Haematol., 2001, 113, 4, 1035-1043.

Additional files

Editorial Notes