Trial | NCT00222053  Report issue

Title

IFM 99-02 Thalidomide in Myeloma

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    800
Principal objective is to evaluate the impact of Thalidomide to prolong the duration of response after autologous transplantation for myeloma
Study Started
Apr 30
2000
Primary Completion
Sep 30
2009
Study Completion
Dec 31
2009
Last Update
Apr 02
2010
Estimate

Drug Thalidomide

Per os thalidomide

Drug Biphosphonates

Biphosphonates

1 No Intervention

No specific intervention

2 Active Comparator

Biphosphonates

3 Experimental

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
No Results Posted