Status:
TERMINATED
MMVAR - Velcade: Study of Velcade for the Treatment of Myeloma Patients After Autologous Transplantation
Lead Sponsor:
European Society for Blood and Marrow Transplantation
Collaborating Sponsors:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Celgene Corporation
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is an international study in adult patients diagnosed with multiple myeloma who have already received at least one autologous stem cell transplantation and who have responded but later progressed...
Detailed Description
Primary Objectives: \* Test the hypothesis that treatment with Velcade plus Thalidomide plus Dexamethasone in combination, will result in a longer time to progression (TTP) than Thalidomide plus Dexa...
Eligibility Criteria
Inclusion
- Male or female ≥18 years-of-age
- Multiple myeloma with evaluable disease
- Relapsing or having a progressive disease
- Karnofsky performance status \> 50 %
- Life expectancy of at least 3 months
- Female of child-bearing potential must have a method of birth control and a negative serum or urine beta--human chorionic gonadotropin (β-HCG) pregnancy test at screening and all through the study
- Male must use contraception
- Voluntary written informed consent
Exclusion
- Non-secretory multiple myeloma
- Platelet count \< 40,000 X 10\^9/L
- Absolute neutrophil count \<1.0 X 10\^9/L
- Creatinine clearance \<30 mL/minute
- Peripheral neuropathy \>= Grade 2
- Seropositive for HIV, or active hepatitis A, B or C infection
- Pregnant or breastfeeding female
- Patient has hypersensitivity to bortezomib, boron or mannitol
- Other investigational drugs
- Serious medical or psychiatric illness
- Previous or concurrent malignancies at other sites
- Poorly controlled hypertension, uncontrolled or severe cardiovascular disease or uncontrolled diabetes mellitus
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
269 Patients enrolled
Trial Details
Trial ID
NCT00256776
Start Date
July 1 2005
End Date
December 1 2015
Last Update
October 18 2021
Active Locations (81)
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1
Karl-Franzens
Graz, Austria
2
Universitatsklinik
Innsbruck, Austria
3
Medizinische Universitaet Wien
Vienna, Austria
4
Wilhelminenspital
Vienna, Austria