Study in Myeloma Patients Newly Diagnosed Treated as an Induction With Velcade-Dex or Velcade (Bortezomib) Thalidomide Dexamethasone (VTD)
A Phase 3 Study of Velcade (Bortezomib) Dexamethasone (VD) Versus Velcade (Bortezomib) Thalidomide Dexamethasone (VTD) as an Induction Treatment Prior to Autologous Stem Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma
2 other identifiers
interventional
205
2 countries
56
Brief Summary
Primary objective:
- Compare the complete remission (CR) rates (i.e., the true CR, with negative immunofixation) achieved with either four courses of VD or four courses of VTD. Secondary objectives:
- Compare the following parameters following 4 cycles of VD or VTD induction treatment:
- CR rate+ very good partial remission (VGPR) rate
- Overall remission rate (CR + VGPR + partial remission (PR) rate)
- K/l light chain ratio in patients in CR.
- Safety (quality of the sampled stem cells, extrahaematological and haematological toxicity: specially neurological toxicity, length of hospitalization).
- Compare the CR rate and the CR + VGPR rates after post-induction autologous stem cell transplantation (ASCT).
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
56 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
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 29, 2009
CompletedFirst Posted
Study publicly available on registry
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedJune 1, 2009
May 1, 2009
1.4 years
May 29, 2009
May 29, 2009
Conditions
Keywords
Study Arms (2)
Velcade-Dexamethasone
ACTIVE COMPARATORVelcade-Thalidomide-Dexamethasone
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Newly diagnosed symptomatic multiple myeloma (MM) patient
- Aged under 65
- Candidate for ASCT, with measurable levels of paraprotein in the serum (³ 10 g/L) or the urine (³ 200 mg/day)
- Using effective contraceptive methods (for fertile men, women of childbearing potential)
- Provision of informed consent
- No evidence of active infection
You may not qualify if:
- Asymptomatic MM
- Non-secretory MM
- Aged 66 years or over
- ECOG performance status over 2 (see Appendix 2)
- Proven amyloidosis
- A personal medical history of cancer (except for basocellular skin cancer or in situ cervical cancer)
- Positive HIV serology
- A personal medical history of severe psychiatric disease
- Severe diabetes contraindicating the use of high-dose dexamethasone
- NCI grade ³ 2 peripheral neuropathy
- Serum clinical chemistry:
- creatinine level \> 300 µmol/L or requiring dialysis
- bilirubin, transaminases or GamaGT \> 3 the upper normal limit (UNL)
- Prior or current systemic therapy for MM, including steroids (except for emergency use of a 4-day block of dexamethasone between the screening phase and randomization)
- Radiation therapy in the 2 weeks preceding randomization
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (56)
ANVERS Centrumziekenhuis
Antwerp, Belgium
Anvers Uza
Antwerp, Belgium
Bruxelles Erasme
Brussels, Belgium
Bruxelles I Bordet
Brussels, Belgium
BRUXELLES St LUC
Brussels, Belgium
GILLY
Gilly, Belgium
YVOIR MontGodinne
Yvoir, Belgium
Chu Angers
Angers, France
CH Annecy
Annecy, France
Ch Avignon
Avignon, France
CH Bayonne
Bayonne, France
Chu Besancon
Besançon, France
CH BLOIS
Blois, France
Bobigny Avicenne
Bobigny, France
Chu Bordeaux
Bordeaux, France
Chu Brest
Brest, France
Caen M Interne Baclèse
Caen, France
CH Chartres
Chartres, France
Clamart Percy
Clamart, France
CHU Clermont Ferrand
Clermont-Ferrand, France
Ch Colmar
Colmar, France
Chu Dijon
Dijon, France
Ch Dunkerque
Dunkirk, France
Chu Grenoble
Grenoble, France
CH La Roche Sur Yon
La Roche-sur-Yon, France
Le Mans Victor Hugo
Le Mans, France
Chru Lille
Lille, France
Ch Lorient
Lorient, France
CHU Lyon Edouard Herriot
Lyon, France
CHU Lyon Sud Pierre Benite
Lyon, France
Lyon Léon Berard
Lyon, France
Marseille IPC
Marseille, France
CHR Metz Bonsecours
Metz, France
Chu Nancy
Nancy, France
Chu Nantes
Nantes, France
Nantes Catherine De Sienne
Nantes, France
CHU Nice M Interne
Nice, France
CHR Orléans
Orléans, France
Paris Cochin
Paris, France
Paris Hôtel Dieu
Paris, France
Paris Necker
Paris, France
Paris St Antoine
Paris, France
Paris St Louis
Paris, France
CHU Poitiers hemato
Poitiers, France
CHU Reims
Reims, France
CHU Rennes Hemato
Rennes, France
CHU Rennes M interne
Rennes, France
CH Roanne
Roanne, France
Rouen Becquerel
Rouen, France
CH St Brieuc
Saint-Brieuc, France
St ETIENNE
Saint-Etienne, France
CHRU Strasbourg
Strasbourg, France
Chu Toulouse
Toulouse, France
CHU Tours
Tours, France
CH Valence
Valence, France
CH Vannes
Vannes, France
Related Publications (1)
Moreau P, Avet-Loiseau H, Facon T, Attal M, Tiab M, Hulin C, Doyen C, Garderet L, Randriamalala E, Araujo C, Lepeu G, Marit G, Caillot D, Escoffre M, Lioure B, Benboubker L, Pegourie B, Kolb B, Stoppa AM, Fuzibet JG, Decaux O, Dib M, Berthou C, Chaleteix C, Sebban C, Traulle C, Fontan J, Wetterwald M, Lenain P, Mathiot C, Harousseau JL. Bortezomib plus dexamethasone versus reduced-dose bortezomib, thalidomide plus dexamethasone as induction treatment before autologous stem cell transplantation in newly diagnosed multiple myeloma. Blood. 2011 Nov 24;118(22):5752-8; quiz 5982. doi: 10.1182/blood-2011-05-355081. Epub 2011 Aug 17.
PMID: 21849487DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
Study Record Dates
First Submitted
May 29, 2009
First Posted
June 1, 2009
Study Start
March 1, 2008
Primary Completion
August 1, 2009
Last Updated
June 1, 2009
Record last verified: 2009-05