MMVAR - Velcade: Study of Velcade for the Treatment of Myeloma Patients After Autologous Transplantation
NCT ID: NCT00256776
Last Updated: 2021-10-18
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
269 participants
INTERVENTIONAL
2005-07-31
2015-12-31
Brief Summary
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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.
Detailed Description
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\* 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 Dexamethasone in subjects with relapsed or progressive myeloma after autologous transplantation.
Secondary Objectives:
\* Compare the treatment groups for: overall survival; response rate (complete \& partial \& minimal) using standard criteria and treatment related complications.
Study design and methodology:
This is a prospective, randomized, parallel-group, open-label phase III, on an intention to treat, multicenter study. The main endpoint is time-to-failure (TTP=time to progression). The power is based on an initial assumption of a median TTP of 1.5 years in the experimental (Velcade) group and 1 year in the control group. The design of the study is group sequential. There will be 4 interim analyses and one final analysis. The study is designed to have a priori 90% power to detect the clinically relevant difference at completion of the study at 0.025 level. Patients with multiple myeloma whose disease has either progressed or relapsed at least one year after one or two autologous transplantations will be enrolled. Prior to random assignment, subjects will be stratified on center and number of autologous transplants.Subjects will be randomly assigned to treatment in a 1: 1 allocation within each stratum to Velcade plus Thalidomide plus Dexamethasone (VTD) or Thalidomide plus Dexamethasone. Velcade 1.3 mg/m2 will be given as an i.v. bolus on Days 1, 4, 8 and 11 followed by a 10-day rest period (Days 12 to 21) for 8 cycles (6 months) and then on Days 1, 8, 15, and 22 followed by a 20-day rest period (Days 23 to 42) for 4 cycles (6 months). In both arms, Thalidomide will be given at 200 mg/day per os for one year and Dexamethasone 40 mg/day per os four days every three weeks for one year.Treatment will continue until disease progression, or the occurrence of unacceptable treatment-related toxicity, or up to a total of 12 cycles of Velcade except for those subjects who have a continuing decrease in the levels of paraprotein after 12 cycles. These subjects may continue for as long as treatment is tolerated, and they continue to respond. If a subject has a CR, then treatment should continue at least 2 cycles after the objective response is confirmed. For subjects with a PR or stable disease, treatment may continue after a maximum objective response is confirmed unless the subject experiences unacceptable treatment-related toxicity or the subject has completed 12 cycles of treatment. Disease assessment will occur at the start of each cycle. If a subject discontinues treatment without disease progression, disease assessment will be performed every 3 weeks for 48-weeks from the start of the first dose of study entry drug. Subjects who have not progressed at the end of 48-week follow up period will be assessed every 6 weeks until disease progression is documented
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Thal + Dex + Velcade
Velcade (Bortezomib)
Thalidomide
Dexamethasone
Thal + Dex
Standard treatment
Thalidomide
Dexamethasone
Interventions
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Velcade (Bortezomib)
Thalidomide
Dexamethasone
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
INDUSTRY
Celgene Corporation
INDUSTRY
European Society for Blood and Marrow Transplantation
NETWORK
Responsible Party
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Principal Investigators
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Laurent Garderet, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpial Saint Antoine, Paris, France - <[email protected]>
Locations
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Karl-Franzens
Graz, , Austria
Universitatsklinik
Innsbruck, , Austria
Medizinische Universitaet Wien
Vienna, , Austria
Wilhelminenspital
Vienna, , Austria
St Joseph
Arlon, , Belgium
RHMS
Baudour, , Belgium
AZ St Jan
Bruges, , Belgium
Bordet
Brussels, , Belgium
Erasme CHU
Brussels, , Belgium
Saint Luc
Brussels, , Belgium
University Hospital
Brussels, , Belgium
Saint Joseph
Gilly, , Belgium
CH Jolimont
Haine-Saint-Paul, , Belgium
Clinique Saint-Pierre
Ottignies, , Belgium
UCL Mont-Godinne
Yvoir, , Belgium
University Hospital
Brno, , Czechia
Faculty Hospital
Olomouc, , Czechia
CHU Amiens
Amiens, , France
CHU Angers
Angers, , France
Centre Hospitalier d'Antibes
Antibes, , France
CHU Jean Minjoz
Besançon, , France
Avicenne
Bobigny, , France
Polyclinique Bordeaux Nord
Bordeaux, , France
Morvan CHU
Brest, , France
Hotel Dieu
Clermont-Ferrand, , France
ARC CHU Dijon
Dijon, , France
Hospitalier de Dunkerque
Dunkirk, , France
Hopital Michallon
Grenoble, , France
La Roche-sur-Yon, , France
Centre Hospitalier du Havre
Le Havre, , France
CHRU de Lille
Lille, , France
Edouard Herriot
Lyon, , France
Pierre Benite
Lyon, , France
Metz, , France
Centre Hospitalier de Mulhouse
Mulhouse, , France
CHU Nancy
Nancy, , France
Hotel Dieu
Nantes, , France
Archet
Nice, , France
Hopital Cochin
Paris, , France
Hotel Dieu
Paris, , France
Saint Antoine
Paris, , France
Hopital Jean Bernard
Poitiers, , France
Robert Debre
Reims, , France
CHU Hopital Sud
Rennes, , France
Henri Becquerel
Rouen, , France
CHRU Tours
Tours, , France
Klinikum Bremen
Bremen, , Germany
University of Cologne
Cologne, , Germany
University Hospital
Dresden, , Germany
University Hospital
Hamburg, , Germany
Medizinische Hochschule
Hanover, , Germany
Uniklinik Leipzig
Leipzig, , Germany
Universitatsklinikum Schleswig-Hostein
Lübeck, , Germany
DKD Wiesbaden
Wiesbaden, , Germany
Medizinische und Poliklinik II
Würzburg, , Germany
St Laszlo Hospital
Budapest, , Hungary
University of Debrecen
Debrecen, , Hungary
Rambam MC
Haifa, , Israel
Sheba MC
Tel Litwinsky, , Israel
Ospedale SS. Antonio e Biagio e Cesare Arrigo
Alessandria, , Italy
Ospedale Riuniti
Bergamo, , Italy
AO Spedali Civili di Brescia
Brescia, , Italy
Ospedale Maggiore
Catania, , Italy
Ospedale Maggiore
Milan, , Italy
Federico II
Naples, , Italy
V. Cervello
Palermo, , Italy
Azienda Ospedale BMM
Reggio Calabria, , Italy
A.O.S. Andrea
Rome, , Italy
Kantonsspital Aarau
Aarau, , Switzerland
Kantonsspital Baden
Baden, , Switzerland
Kantonsspital
Basel, , Switzerland
IOSI, Ospedale Civico
Bellinzona, , Switzerland
Inselspital
Bern, , Switzerland
Hopital Cantonal Universitaire
Geneva, , Switzerland
CHUV
Lausanne, , Switzerland
LA Onkologie/Medizin
Thun, , Switzerland
Stadtdpital Triemli
Zurich, , Switzerland
UniversitatsSpital
Zurich, , Switzerland
Heartlands Hospital
Birmingham, , United Kingdom
Addenbrookes
Cambridge, , United Kingdom
Great Western Hospital
Swindon, , United Kingdom
Countries
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Related Links
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Sponsor's website
Other Identifiers
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EBMT-CLWP: 42206611
Identifier Type: -
Identifier Source: secondary_id
EudraCT: 2005-001628-35
Identifier Type: -
Identifier Source: org_study_id