Efficacy Study Comparing Velcade Dexamethasone Thalidomide Versus Velcade Cyclophosphamide Dexamethasone as Induction Treatment in the Initial Management of Multiple Myeloma (IFM2013-04) (IFM2013-04)
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple myeloma, Newly Diagnosed
Eligibility Criteria
Inclusion Criteria:
Patients newly diagnosed with symptomatic Multiple Myeloma (MM) patient
- - 18 ≤ age < 66 years
- - Eastern Cooperative Oncology Group Performance Status of 0, 1 or 2
- - Patients must be eligible for Autologous Stem Cell Transplantation
- - Patients must have measurable disease by serum M-protein ≥ 10 g/L and/or urine M-protein ≥200mg/day
- Female patients of child-bearing potential (FCBP):
- Must agree to have medically supervised pregnancy tests prior to starting study and every 21 days, including 4 weeks after the end of study treatment. This applies even if the patient practices complete and continued sexual abstinence.
- Must agree to use and be able to comply with effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including during periods of dose interruptions), and for 28 days after discontinuation of study therapy.
- Male Patients:
- Must agree to use a condom during sexual contact with a FCBP, throughout study drug therapy, during any dose interruption and for one week after discontinuation of study therapy
- Must agree to not donate semen during study drug therapy and for one week after discontinuation of study therapy
- All patients must:
- Agree to abstain from donating blood while taking study drug therapy and for one week after discontinuation of study drug therapy
- Agree not to share study medication with another person.
- - Patients must be capable of giving informed consent
- - Patients must be affiliated with French social security system
Exclusion Criteria:
- - Asymptomatic Multiple myeloma
- - Non-secretory Multiple myeloma
- - Proven AL-amyloidosis
- - Age ≥ 66 years old
- - Prior or current systemic therapy for Multiple myeloma, including steroids (except for emergency use of a 4-day block of dexamethasone before randomization, maximum total dose allowed 160 mg)
- - Radiation therapy in the 2 weeks preceding randomization
- - National Cancer Institute grade ≥ 2 peripheral neuropathy
- - Haemoglobin < 8g/dL
- - Absolute neutrophil count < 1,000 cells / µL, platelet count < 50,000 cells / µL
- - Creatinine level > 170 µmol/L or requiring dialysis.
- - Bilirubin, transaminases or GamaGT > 3 UNL (upper normal limit)
- - Positive HIV serology, evidence of active Hepatitis B and C infection
- - Severe active infection
- - Inability to comply with an anti-thrombotic treatment regimen
- - A personal medical history of severe psychiatric disease
- - Uncontrolled diabetes contraindicating the use of high-dose dexamethasone
- - Non-controlled or severe cardiovascular disease (including a myocardial infarction in the 6 months prior to recruitment)
- - A personal medical history of cancer unless the patient has been without relapse after treatment discontinuation > or = 5 years (except for basocellular skin cancer or in situ cervical cancer)
- - Use of any investigational drug in the 30 days preceding randomization
22 - Pregnant or lactating women. 23 - Adults under juridical protection 24 - Known or suspected hypersensitivity to any of the study therapies or excipients 25 - Necessity of vaccination for yellow fever or with any other live vaccines
Sites / Locations
- Centre Hospitalier de la région d'Annecy
- CHRU Hôpital Sud
- CHU Angers
- Centre Hospitalier Argenteuil
- Centre Hospitalier H.Duffaut
- Centre Hospitalier de la Côte Basque
- CHRU de Besançon
- Hôpital Avicenne
- Polyclinique Bordeaux Nord Aquitaine
- Centre hospitalier Pierre Oudot
- Hôpital A.Morvan
- CHU Caen Côte de Nacre
- CH René Dubos
- Centre Hospitalier William Morey
- Hôpital d'instruction des armées Percy
- CHU d'Estaing
- Hôpitaux civils de Colmar
- Centre Hospitalier Sud Francilien
- CHU Henri Mondor
- CHRU Dijon
- Centre Hospitalier Général
- CHRU - Hôpital A.Michallon
- Centre hospitalier départemental Vendée
- Hôpital Louis Pasteur
- Centre Jean Bernard
- CH Le Mans
- Hopital Saint Vincent de Paul
- CHRU - Hôpital Claude Huriez
- CHU de Limoges
- Hôpital Du Scorff
- Centre Léon Bérard
- Institut Paoli Calmettes
- Centre Hospitalier de Meaux
- CHR Metz Thionville
- Centre Hospitalier intercommunale Meulan les mureaux
- Hopital E Muller
- Nantes University Hospital
- Hôpital de l'Archet 1
- Groupe Hospitalo-Universitaire Carémeau
- CHU - Hôpital St-Antoine
- Institut CURIE
- Hôpital Cochin
- CHU - Hôpital St-Antoine
- Hôpital Pitié-Salpétrière
- AP-HP Hôpital Necker
- Centre Hospitalier de PERIGUEUX
- CH Saint Jean
- CHRU - Hôpital du Haut Lévêque
- Centre Hospitalier Lyon sud
- CHRU - Hôpital Jean Bernard
- Hôpital R.Debré
- CHRU - Hôpital de Pontchaillou
- Centre Henri Becquerel
- Centre Hospitalier
- Centre Hospitalier Yves le Foll
- Centre René Huguenin
- Centre hospitalier
- Institut de Cancérologie de la Loire
- Hôpitaux Universitaires de Strasbourg
- CHRU - Hôpital Purpan
- CHRU - Hôpital Bretonneau
- CHRU - Hôpitaux de Brabois
- CH Bretagne Atlantique Vannes et Auray
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
VELCADE (BORTEZOMIB) THALIDOMIDE DEXAMETHASONE (VTD)
VELCADE (BORTEZOMIB) CYCLOPHOSPHAMIDE DEXAMETHASONE (VCD)
Arm A: Induction therapy 4 cycles of VTD (21 days) Thalidomide® 100 mg/day Per Os Day1 to Day21 Velcade® 1.3 mg/m²/day Subcutaneous Day1, 4, 8 and 11 Dexamethasone 40 mg/day Per Os Day 1 to 4 and Day 9 to 12 Systematic stem cell harvest after cycle 3 Mobilization: Cyclophosphamide and one week after the last dose of Thalidomide, stem cells have to be harvested
For arm B: Induction therapy : 4 cycles of VCD (21 days) Cyclophosphamide 500 mg/m²/day, Per Os Day 1, 8, 15 Velcade® and Dexamethasone identical treatment to Arm A Systematic stem cell harvest after cycle 3 Mobilization: Cyclophosphamide and two weeks after the last dose of Cyclophosphamide, stem cells have to be harvested