Status:
COMPLETED
IFM 99-02 Thalidomide in Myeloma
Lead Sponsor:
University Hospital, Toulouse
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Principal objective is to evaluate the impact of Thalidomide to prolong the duration of response after autologous transplantation for myeloma
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT00222053
Start Date
April 1 2000
End Date
December 1 2009
Last Update
April 2 2010
Active Locations (5)
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1
Médecine Interne, CHU Purpan
Toulouse, France
2
Médecine Interne, Hôpital Rangueil
Toulouse, France
3
Rhumatologie, CHU Purpan
Toulouse, France
4
Rhumatologie, CHU Rangueil
Toulouse, France