Multiple Myeloma
Conditions
Keywords
Myeloma, Autologous transplantation, Maintenance therapy, Thalidomide
Brief summary
Principal objective is to evaluate the impact of Thalidomide to prolong the duration of response after autologous transplantation for myeloma
Interventions
DRUGThalidomide
Per os thalidomide
DRUGBiphosphonates
Biphosphonates
Sponsors
University Hospital, Toulouse
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of response | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Survival | 3 years |
| Toxicity | 3 years |
Countries
France
Outcome results
None listed