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Sponsor: European Society for Blood and Marrow Transplantation
Conditions: Multiple Myeloma
Interventions: Velcade (Bortezomib), Thalidomide, Dexamethasone
Countries: Austria, Belgium, Czechia, France, Germany, Hungary, Israel, Italy
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, or relapsed, at least one year after transplantation. Eligible patients will be randomly assigned to one of two treatments: either Velcade plus Thalidomide plus Dexamethasone or Thalidomide plus Dexamethasone. Thalidomide and Velcade are two new agents that have recently become available for the treatment of multiple myeloma, especially in relapsed patients. This study therefore aims to test the hypothesis that the combination treatment with Velcade plus Thalidomide plus Dexamethasone will result in a longer time to progression (measure of time after the disease is treated until it starts to get worse) than Thalidomide plus Dexamethasone alone.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * 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 Criteria: * 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
- Graz, Austria
- Innsbruck, Austria
- Vienna, Austria
- Vienna, Austria
- Arlon, Belgium
- Baudour, Belgium
- Bruges, Belgium
- Brussels, Belgium
- Brussels, Belgium
- Brussels, Belgium
- Brussels, Belgium
- Gilly, Belgium
- Haine-Saint-Paul, Belgium
- Ottignies, Belgium
- Yvoir, Belgium
- Brno, Czechia
- Olomouc, Czechia
- Amiens, France
- Angers, France
- Antibes, France
- Besançon, France
- Bobigny, France
- Bordeaux, France
- Brest, France
- Clermont-Ferrand, France
- Dijon, France
- Dunkirk, France
- Grenoble, France
- La Roche-sur-Yon, France
- Le Havre, France
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