Study to Compare VMP With HDM Followed by VRD Consolidation and Lenalidomide Maintenance in Patients With Newly Diagnosed Multiple Myeloma

• Status: Active, not recruiting
• Trial end date: 2023-04-01

Summary

Study phase: phase III

Study objective:

• Comparison of Bortezomib, Melphalan, Prednisone (VMP) with High Dose Melphalan followed autologous stem cell transplantation (ASCT)

• Comparison of Bortezomib, Lenalidomide, Dexamethasone(VRD) as consolidation versus no consolidation

• Comparison of single versus tandem high dose Melphalan with ASCT

Patient population: Patients with symptomatic multiple myeloma,previously untreated, ISS stages 1-3, age 18-65 years inclusive

Study design: Prospective, multicenter, intergroup, randomized

Duration of treatment: Expected duration of induction, stem cell collection and intensification is 6 - 9 months. Consolidation with VRD will last 2 months Maintenance therapy with Lenalidomide will be given until relapse. All patients will be followed until 10 years after registration.

• Phase: Phase 3

Details

• Lead Sponsor: Stichting Hemato-Oncologie voor Volwassenen Nederland
• Collaborators: Central European Myeloma Study Group; DSMM (Deutsche Studiengruppe Multiples Myelom); European Myeloma Network; GIMEMA (Italian Group for Adult Hematologic Diseases); Gruppo Italiano Malattie EMatologiche dell'Adulto; NMSG (Nordic Myeloma Study Group)
• Treatments: BB 1101; Bortezomib; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Lenalidomide; Melphalan; Prednisone; Thalidomide