A Phase III Trial on the Effect of Elotuzumab in VRD Induction /Consolidation and Lenalidomide Maintenance in Patients With Newly Diagnosed Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      Trial in patients with newly diagnosed myeloma to evaluate the effect of elotuzumab in
      induction and consolidation therapy with bortezomib/lenalidomide/dexamethasone and in
      lenalidomide maintenance treatment
    

Detailed description: 
      Prospective, multicentre, randomised, parallel group, open, phase III clinical trial, for
      patients with confirmed diagnosis of untreated multiple myeloma requiring systemic therapy .

      Investigational Medicinal Products:Elotuzumab, lenalidomide

      Patients are randomized in one of 4 study arms (A1, A2, B1, B2). Patients randomized in arm
      A1 or A2 will receive 4 cycles VRD (Bortezomib (Velcade®), Lenalidomide (Revlimid®),
      Dexamethasone). Patients in arm B1 or B2 will additionally receive the monoclonal antibody
      Elotuzumab in the 4 cycles VRD. After induction therapy patients undergo intensifying therapy
      according to GMMG standard (usually mobilization therapy followed by stem cell collection and
      autologous stem cell transplantation). After intensification a consolidation therapy will be
      performed with two cycles VRD (A1 und B1) or VRD+ Elotuzumab (A2 und B2), followed by
      Lenalidomide maintenance therapy with (arm A2 and B2) or without (arm A1 and B1) additional
      Elotuzumab. Maintenance therapy will be performed for 2 years.

      Primary objective is the determination of the best of four treatment strategies regarding
      progression-free survival (PFS), defined as time from randomisation to progression or death
      from any cause whichever occurs first.

      The duration of the trial for each patients is expected to be 36-39 months (induction and
      intensification treatment: 7-10 months, 3 months rest between intensification and start of
      consolidation, consolidation 2 months, maintenance phase 24 months).
    

Intervention name(s): elotuzumab; Lenalidomide; Bortezomib; Dexamethasone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 10 mg/kg in the vein( i.v) on day 1,8 and 15 in induction cycle 1 and 2, on day 1 and 11 in induction cycle 3 and 4 (Arm B1 and B2). 10 mg/kg i.v. on day 1,8 and 15 in consolidation cycle 1 and 2 (Arm A2 and B2), 10 mg/kg i.v. on day 1 and15 in maintenance cycle 1-6, 10 mg/kg i.v. on day 1 in maintenance cycle 7-26 (Arm A2 and B2); 25 mg per os on day 1-14 in induction cycle 1-4, 25 mg p.o. on day 1-14 in consolidation cycle 1 and 2, 10 mg p.o. on day 1-28 in maintenance cycle 1-3, 15 mg p.o. on day 1-28 in maintenance cycle 4-26 (all arms); all arms: 1,3 mg/m^2 subcutaneous on day 1, 4, 8 and 11 in 4 induction cycles, 1,3 mg/m^2 subcutaneous on day 1, 8 and 15 in 2 cycles of consolidation; 20 mg per os on day 1,2 and 4,5 and 8,9 and 11,12 and 15 in induction cycles 1 and 2. 20 mg per os on day 1,2 and 4,5 and 8,9 and 11,12 in induction cycles 3 and 4 (Arms A1 and A2).
8 mg per os and 12 mg i.v. on day 1, 8 and 15 and 20 mg per os on days 2,4,5, 9, 11 and 12 in induction cycles 1 and 2. 8 mg per os and 12 mg i.v. on day 1, and 11, 20 mg per os on days 2,4,5,8, 9, and 12 in induction cycles 3 and 4 (Arms B1 and B2).
20 mg per os on days 1,2, 8,9, 15 and 16 in both cycles of consolidation (Arms A1 and B1). 8 mg per os and 12 mg i.v. on days 1, 8 and 15 and 20 mg per os on days 2, 9 and 16 in both consolidation cycles (Arms A2 and B2).
12 mg per os on day 1 and 15 in maintenance cycles 1-6, 12 mg per os on day 1 of maintenance cycles 7 and following (Arms A1 and B1). 4 mg per os and 8 mg i.v. on day 1 and 15 in maintenance cycles 1-6, 4 mg per os and 8 mg i.v. on day 1 of maintenance cycles 7 and following (Arms A2 and B2).
Other intervention name(s): Revlimid; Velcade
Intervention MeSH terms: Dexamethasone; Lenalidomide; Bortezomib; Elotuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment