MMVAR - Velcade: Study of Velcade for the Treatment of Myeloma Patients After Autologous Transplantation
A Randomized Controlled Study of Velcade (Bortezomib) Plus Thalidomide Plus Dexamethasone Compared to Thalidomide Plus Dexamethasone for the Treatment of Myeloma Patients Progressing or Relapsing After Autologous Transplantation
2 other identifiers
interventional
269
10 countries
81
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, 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 multiple-myeloma
Started Jul 2005
Longer than P75 for phase_3 multiple-myeloma
81 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 21, 2005
CompletedFirst Posted
Study publicly available on registry
November 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedResults Posted
Study results publicly available
October 18, 2021
CompletedOctober 18, 2021
September 1, 2021
8.4 years
November 21, 2005
September 21, 2021
September 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Median Time to Progression (TTP)
3 year
Secondary Outcomes (3)
Progression Free Survival
3 year
Overall Survival (Interval Between Date of Randomization and Death From Any Cause
1 year
Response Rate (Proportion of Subjects Who Achieve Complete, Partial, or Minimal Response)
1 year
Study Arms (2)
Thal + Dex + Velcade
EXPERIMENTALThal + Dex
ACTIVE COMPARATORStandard treatment
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (81)
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
Unknown Facility
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
Unknown Facility
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Study Unit
- Organization
- EBMT
Study Officials
- PRINCIPAL INVESTIGATOR
Laurent Garderet, MD
Hôpial Saint Antoine, Paris, France - <laurent.garderet@sat.aphp.fr>
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2005
First Posted
November 22, 2005
Study Start
July 1, 2005
Primary Completion
December 1, 2013
Study Completion
December 1, 2015
Last Updated
October 18, 2021
Results First Posted
October 18, 2021
Record last verified: 2021-09