Condition category
Cancer
Date applied
25/10/2000
Date assigned
25/10/2000
Last edited
25/05/2016
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 Mark Drayson

ORCID ID

Contact details

Department of Immunology
Medical School
University of Birmingham
Vincent Drive
Birmingham
B15 2TT
United Kingdom
-
m.t.drayson@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G8003737 expired Oct 99

Study information

Scientific title

MYELOMA VIIIth trial

Acronym

MYELOMA VIIIth trial

Study hypothesis

To compare, for survival, the induction of first plateau phase in previously untreated patients with multiple myeloma, the efficacy of the above two treatments

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

Other

Trial type

Treatment

Patient information sheet

Condition

Leukaemia

Intervention

All patients receive three courses of ABCM. They are then randomised to continue with ABCM or to change to oral weekly cyclophosphamide.

Intervention type

Drug

Phase

Not Specified

Drug names

Cyclophosphamide and ABCM

Primary outcome measures

1. Survival
2. Obtaining plateau (stable disease with no more than minimal symptoms)
3. Quality of life

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/11/1993

Overall trial end date

01/11/2000

Reason abandoned

Eligibility

Participant inclusion criteria

1. Greater than 65 years old and less than 75 years old
2. Myeloma
3. No previous cytotoxic therapy
4. Netrophil count greater than or equal to 1.3 x 10^9/l
5. Platelet count greater than or equal to 75 x 10^9/L
6. Able to tolerate 3 l of fluid per day
7. Apyrexial
8. Free from infection
9. Informed consent

Participant type

Patient

Age group

Senior

Gender

Not Specified

Target number of participants

1000

Participant exclusion criteria

Patients with equivocal myelomatosis

Recruitment start date

01/11/1993

Recruitment end date

01/11/2000

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Immunology
Birmingham
B15 2TT
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

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

Publication citations

Additional files

Editorial Notes

25/05/2016: No publications found, verifying study status with principal investigator