Spots Global Cancer Trial Database for Frontline Therapy in de Novo Multiple Myeloma Patients Under 65

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Trial Identification

Brief Title: Frontline Therapy in de Novo Multiple Myeloma Patients Under 65

Official Title: IFM2008: Frontline Therapy in de Novo Multiple Myeloma Patients Under 65, (a Phase 2 Multicenter Trial)

Study ID: NCT01206205

Conditions

Multiple Myeloma

Interventions

Lenalidomide, Bortezomib

Study Description

Brief Summary: 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.

Detailed Description: 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