MMVAR - Velcade: Study of Velcade for the Treatment of Myeloma Patients After Autologous Transplantation
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Velcade, Autologous transplantation, Relapse, Disease progress
Eligibility Criteria
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
Sites / Locations
- Karl-Franzens
- Universitatsklinik
- Medizinische Universitaet Wien
- Wilhelminenspital
- St Joseph
- RHMS
- AZ St Jan
- Bordet
- Erasme CHU
- Saint Luc
- University Hospital
- Saint Joseph
- CH Jolimont
- Clinique Saint-Pierre
- UCL Mont-Godinne
- University Hospital
- Faculty Hospital
- CHU Amiens
- CHU Angers
- Centre Hospitalier d'Antibes
- CHU Jean Minjoz
- Avicenne
- Polyclinique Bordeaux Nord
- Morvan CHU
- Hotel Dieu
- ARC CHU Dijon
- Hospitalier de Dunkerque
- Hopital Michallon
- Centre Hospitalier du Havre
- CHRU de Lille
- Edouard Herriot
- Pierre Benite
- Centre Hospitalier de Mulhouse
- CHU Nancy
- Hotel Dieu
- Archet
- Hopital Cochin
- Hotel Dieu
- Saint Antoine
- Hopital Jean Bernard
- Robert Debre
- CHU Hopital Sud
- Henri Becquerel
- CHRU Tours
- Klinikum Bremen
- University of Cologne
- University Hospital
- University Hospital
- Medizinische Hochschule
- Uniklinik Leipzig
- Universitatsklinikum Schleswig-Hostein
- DKD Wiesbaden
- Medizinische und Poliklinik II
- St Laszlo Hospital
- University of Debrecen
- Rambam MC
- Sheba MC
- Ospedale SS. Antonio e Biagio e Cesare Arrigo
- Ospedale Riuniti
- AO Spedali Civili di Brescia
- Ospedale Maggiore
- Ospedale Maggiore
- Federico II
- V. Cervello
- Azienda Ospedale BMM
- A.O.S. Andrea
- Kantonsspital Aarau
- Kantonsspital Baden
- Kantonsspital
- IOSI, Ospedale Civico
- Inselspital
- Hopital Cantonal Universitaire
- CHUV
- LA Onkologie/Medizin
- Stadtdpital Triemli
- UniversitatsSpital
- Heartlands Hospital
- Addenbrookes
- Great Western Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Thal + Dex + Velcade
Thal + Dex
Standard treatment