Myeloma VII - myelomatosis therapy trial

ISRCTN	ISRCTN66518389
DOI	https://doi.org/10.1186/ISRCTN66518389
Protocol serial number	G8223452
Sponsor	Medical Research Council (MRC) (UK)
Funder	Medical Research Council (MRC) (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr JA Child
Scientific

Department of Haematology
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom

Phone	+44 (0)113 392 5153
Email	tony.child@leedsth.nhs.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To compare ABCM for plateau induction with alpha IFN maintenance vs. a three-phase regimen of C-VAMP, high dose melphalan (with autologous bone marrow/peripheral blood stem cell support as appropriate) and alpha IFN maintenance. To compare toxicity profiles in the two arms, to address the issue of quality of life, to address the issue of health economics, to investigate cellular changes by means of linked studies of morphology, phenotyping and cytogenetics before and after treatment and at relapse.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Leukaemia
Intervention	ABCM for plateau induction with alpha Interferon (IFN) maintenance/a three-phase regimen of C-VAMP, high dose melphalan (with autologous bone marrow/peripheral blood stem cell support as appropriate) and alpha IFN maintenance
Intervention type	Other
Primary outcome measure(s)	Overall survival
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	20/10/2000

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	750
Key inclusion criteria	1. They have definite myelomatosis requiring chemotherapy and fulfilling at least two of the three following criteria: bone marrow aspirate and/or trephine showing the presence of a neoplastic plasma cell infiltrate and/or microplasmacytomas, a paraprotein present in blood and/or urine 2. They have definite lytic bone lesions 3. They are aged under 65 years 4. They are able to tolerate a daily fluid intake of not less than 3 litres 5. The physician is satisfied it would be appropriate to receive any of specified treatments
Key exclusion criteria	1. Patients have equivocal myelomatosis (these should be registered but will not receive treatment - if disease progresses then they may be entered into the main trial) 2. They have previous malignancies except non-melanoma skin tumours or in situ carcinomas 3. Had previous treatment except minimal local radiotherapy to relieve bone pain 4. If have a life threatening disease unrelated to myelomastosis.
Date of first enrolment	01/09/1993
Date of final enrolment	20/10/2000

Department of Haematology

Leeds
LS1 3EX
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	08/05/2003		Yes	No