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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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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00222053 |
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Date of registration:
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15/09/2005 |
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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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IFM 99-02 Thalidomide in Myeloma
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Scientific title:
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Date of first enrolment:
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April 2000 |
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Target sample size:
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800 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00222053 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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ATTAL Michel, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHU Toulouse |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- de novo myeloma
- according to Durie and Salmon classification stage II, III and stage I with a lytic
bone lesion
- patients from 18 to 65 years old
- beta2microglobulin < 3 mg/l or del13 absent
- signed informed consent
- eligible for transplantation
Exclusion Criteria:
- peripheral neurological toxicities
- uncontrolled or severe cardiovascular disease
- other malignancy except basocellular carcinoma or FIGO stage I carcinoma of the
cervix
- patient who received biphosphonate during the last 60 days
- renal failure definited as creatinine > 150 µmol/l
- patient with obvious vascular cerebral medical history
- liver dysfunction definited as bilirubin > 35 µmol/l or ASAT, ALAT, PAL > 4N
- respiratory dysfunction
- HIV +
- Patient who refused to use an acceptable barrier method for contraception
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Multiple Myeloma
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Intervention(s)
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Drug: Biphosphonates
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Drug: Thalidomide
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Primary Outcome(s)
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Duration of response
[Time Frame: 3 years]
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Secondary Outcome(s)
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Toxicity
[Time Frame: 3 years]
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Survival
[Time Frame: 3 years]
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Secondary ID(s)
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PHRC 98-45-N
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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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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