Phase 3
18 Years
65 Years
18 Years
65 Years
Not Enrolling
Both
Multiple Myeloma
Both
Multiple Myeloma
Trial Information
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Duration of response
Outcome Time Frame:
3 years
Safety Issue:
No
Principal Investigator
ATTAL Michel, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
CHU Toulouse
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
PHRC 98-45-N
NCT ID:
NCT00222053
Start Date:
April 2000
Completion Date:
December 2009
Related Keywords:
- Multiple Myeloma
- Myeloma
- Autologous transplantation
- Maintenance therapy
- Thalidomide
- Multiple Myeloma
- Neoplasms, Plasma Cell
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