The purpose of this Phase 2 study is to evaluate the efficacy and safety of treatment with bortezomib, lenalidomide and dexamethasone in patients with untreated multiple myeloma. This study will evaluate whether the addition of lenalidomide to bortezomib and dexamethasone will increase the Complete Response (CR)/ very good partial response (VGPR) rate before and after High Dose Therapy (HDT) with ASCT.
Patients will receive 3 induction cycles of bortezomib, lenalidomide and dexamethasone (VRD) followed by high dose melphalan and autologous stem cell transplantation. Two months after haematological recovery, patients will receive 2 consolidation cycles of VRD and maintenance therapy for 1 year with lenalidomide
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Induction: 3 cycles of 21 days of Dexamethasone : 40 mg/j, days 1, 8 et 14 Bortezomib (Velcade®) : 1,3 mg/m2/d, days 1, 4, 8, et 11 Lenalidomide (Revlimid®) :25 mg/d, days 1 to 14 Consolidation (2 months After ASCT): 2 cycles of 21 days of Lenalidomide (Revlimid®) 25 mg/j, days 1 à 14 Bortezomib (Velcade®) 1,3 mg/m2/d, days 1, 4, 8, et 11 Dexamethasone 40 mg/j, days 1, 8 et 14 Maintenance Phase: 3 to 8 weeks after consolidation. Cycle length: 28 days Lenalidomide (Revlimid®) 10 mg/d until 12 months
Centre François Baclesse
Caen, France
University Hospital of Dijon, Hôpital des Enfants
Dijon, France
University Hospital of Grenoble, Hôpital A.Michallon, BP 217 X
Grenoble, France
University Hospital Of Lille, Hôpital Claude Huriez
Evaluation of the best response after consolidation
Evaluate the best response achieved , according to the IMWG uniform criteria, after consolidation treatment.
Time frame: 6 to 8 months after start of induction for each patient = after consolidation therapy for all patients
Response Evaluation after 3 cycles
Evaluate the complete and very good partial response rates of the combination of bortezomib, lenalidomide and dexamethasone in newly diagnosed multiple myeloma patients after 3 cycles.
Time frame: 6 to 8 months after start of induction for each patient = after consolidation therapy for all patients
Safety and tolerability : number and nature of Adverse Events
Determine the safety and tolerability of the drug combination in this patient populations.
Time frame: 6 to 8 months after start of induction for each patient = after consolidation therapy for all patients
Stem Cells Collection
Evaluate the faisability and quality of the peripheral stem cells collection.
Time frame: 6 to 8 months after start of induction for each patient = after consolidation therapy for all patients
Response After HDT-ASCT and 2 cycles
Evaluate the complete and very good partial response rates 2 months after HDT with ASCT and after 2 cycles of consolidation treatment.
Time frame: 6 to 8 months after start of induction for each patient = after consolidation therapy for all patients
Progression Free Survival
Evaluate the progression free survival, the overall survival, time to progression and duration of response.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Lille, France
Institut Paoli Calmette
Marseille, France
University Hospital of Bordeaux, "Hôpital du Haut Lévêque "
Pessac, France
University Hospital of Toulouse, Purpan
Toulouse, France
Hôpital Bretonneau, Tours
Tours, France
Hôpitaux de Brabois Nancy
Vandœuvre-lès-Nancy, France
Time frame: 6 to 8 months after start of induction for each patient = after consolidation therapy for all patients