IFM 99-02 Thalidomide in Myeloma

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Principal objective is to evaluate the impact of Thalidomide to prolong the duration of response after autologous transplantation for myeloma

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Toulouse
• Treatments: Diphosphonates; Thalidomide

Criteria

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