IFM 99-02 Thalidomide in Myeloma

Toulouse University Hospital

Status and phase: Completed; Phase 3

Conditions: Multiple Myeloma

Treatments: Drug: Biphosphonates; Drug: Thalidomide

Study type: Interventional

Funder types: Other

Identifiers

NCT00222053

PHRC 98-45-N

Details and patient eligibility

About

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

Enrollment: 800 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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800 participants in 3 patient groups

1

No Intervention group

Description:

No specific intervention

2

Active Comparator group

Description:

Biphosphonates

Treatment:

Drug: Biphosphonates

3

Experimental group

Description:

Thalidomide

Treatment:

Drug: Thalidomide