NCT01208766

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

A Randomized Phase III Study to Compare Bortezomib, Melphalan, Prednisone (VMP) With High Dose Melphalan Followed by Bortezomib, Lenalidomide, Dexamethasone (VRD) Consolidation and Lenalidomide Maintenance in Patients With Newly Diagnosed Multiple Myeloma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,503 (actual)
• Sponsor: Stichting Hemato-Oncologie voor Volwassenen Nederland · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Bortezomib, Melphalan, Prednisone (VMP)	* Bortezomib \_ 1.3 mg/m2 \_ i.v. rapid infusion \_ days 1,4,8,11,22,25,29,32 * Melphalan \_ 9 mg/m² \_ p.o. \_ days 1-4 * Prednisone \_ 60 mg/m² \_ p.o. \_ days 1-4
DRUG	1 or 2 cycle(s) HDM (High Dose Melphalan)	\- Melphalan \_ 100 mg/m² \_ i.v. rapid infusion \_ -3, -2\* \*Patients with renal insufficiency 100 mg/m2 only at day -3 If a patient is randomized to receive 2 x HDM a second course of High Dose Melphalan may be administered between 2 and 3 months after the first course when the patient achieved at least PR.
DRUG	2 cycles of Bortezomib, Lenalidomide, Dexamethasone (VRD)	* Bortezomib \_ 1.3 mg/m2 \_ i.v. rapid infusion \_ days 1,4,8,11 * Lenalidomide \_ 25 mg \_ p.o. \_ days 1-21 * Dexamethasone \_ 20 mg \_ p.o. \_ days 1,2,4,5,8,9,11,12

Timeline

• Start date: 2011-01-01
• Primary completion: 2020-12-01
• Completion: 2025-01-01
• First posted: 2010-09-24
• Last updated: 2026-01-06

Locations

208 sites across 16 countries: Australia, Austria, Belgium, Czechia, Denmark, Finland, Greece, Hungary, Italy, Luxembourg, Netherlands, Norway, Portugal, Sweden, Switzerland, Turkey (Türkiye)