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Main
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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. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN32846751 |
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Date of registration:
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25/10/2000 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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VIIIth myelomatosis trial
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Scientific title:
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Date of first enrolment:
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01/11/1993 |
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Target sample size:
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0 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN32846751 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Not Specified)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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ICM
MacLennan |
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Address:
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University of Birmingham
MRC Centre for Immune Regulation
Room 435 the IBR
B15 2TT
Birmingham
United Kingdom |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Patients with definite myelomatosis requiring chemotherapy in the judgement of the physician 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 the blood and/or urine; Definite lytic bone lesions
2. Aged less than 65 years
3. Patients with equivocal myelomatosis are excluded
4. No previous cytotoxic chemotherapy, except prednisolone or other corticosteroids to relieve fluid-unresponsive hypercalcaemia or minimal local radiotherapy to relieve bone pain
5. No medical contraindications to protocol treatments
6. Patients must have a neutrophil count of at least 1.3 x 10E9/l and a platelet count of at least 75 x 10E9/l
7. Patients must be able to tolerate a daily fluid intake of not less than 3 litres, evidence of renal insufficiency following pre-treatment re-hydration does not necessarily exclude
8. Patients must be apyrexial and free from infection
Exclusion criteria: Not provided at time of registration
Age minimum:
Age maximum:
Gender:
Not Specified
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Health Condition(s) or Problem(s) studied
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Myelomatosis
Cancer
Multiple myeloma and malignant plasma cell neoplasms
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Intervention(s)
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All patients receive three courses of chemotherapy with adriamycin, carmustine, melphan and cyclophosphamide (ABCM), cycle to be repeated every 6 weeks. Patients who in whom there are no signs of disease progression and who fulfil all the entry criteria are randomised to one of two treatment regimens:
1. ABCM REGIMEN: Chemotherapy with ABCM, cycle to be repeated every 6 weeks. Treatment is stopped when the patient reaches plateau phase provided they have received at least four courses of ABCM.
2. ORAL C WEEKLY REGIMEN: Oral cyclophosphamide given as a single dose every 7 days plus prednisolone given on alternative days for 6 weeks. Weekly oral cyclophosphamide is continued until the patient reaches plateau phase and has received either three courses of ABCM and a minimum of 8 weeks of oral cyclophosphamide (if less than three courses of ABCM were given, 6 months chemotherapy), there is disease progression or the patient can no longer tolerate treatment.
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Primary Outcome(s)
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Not provided at time of registration
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Secondary Outcome(s)
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Not provided at time of registration
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Source(s) of Monetary Support
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Medical Research Council (MRC) (UK)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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