IFM 99-02 Thalidomide in Myeloma
- Registration Number
- NCT00222053
- Lead Sponsor
- University Hospital, Toulouse
- Brief Summary
Principal objective is to evaluate the impact of Thalidomide to prolong the duration of response after autologous transplantation for myeloma
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 800
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Biphosphonates Biphosphonates 3 Thalidomide Thalidomide
- Primary Outcome Measures
Name Time Method Duration of response 3 years
- Secondary Outcome Measures
Name Time Method Survival 3 years Toxicity 3 years
Trial Locations
- Locations (5)
Médecine Interne, CHU Purpan
🇫🇷Toulouse, France
Médecine Interne, Hôpital Rangueil
🇫🇷Toulouse, France
Rhumatologie, CHU Rangueil
🇫🇷Toulouse, France
Rhumatologie, CHU Purpan
🇫🇷Toulouse, France
Service d'hématologie, CHU Purpan
🇫🇷Toulouse, France