NCT00222053CompletedPhase 3
IFM 99-02 Thalidomide in Myeloma
University Hospital, Toulouse5 sites in 1 country800 target enrollmentStarted: April 2000Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 800
- Locations
- 5
- Primary Endpoint
- Duration of response
Study Overview
Brief Summary
Principal objective is to evaluate the impact of Thalidomide to prolong the duration of response after autologous transplantation for myeloma
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •Patient who refused to use an acceptable barrier method for contraception
Arms & Interventions
2
Active Comparator
Biphosphonates
Intervention: Biphosphonates (Drug)
3
Experimental
Thalidomide
Intervention: Thalidomide (Drug)
Outcomes
Primary Outcomes
Duration of response
Time Frame: 3 years
Secondary Outcomes
- Survival(3 years)
- Toxicity(3 years)
Investigators
Study Sites (5)
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