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

NCT01208766 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1503

Last updated 2026-01-06

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • European Myeloma Network B.V.

    collaborator NETWORK

  • Gruppo Italiano Malattie EMatologiche dell'Adulto

    collaborator OTHER

  • DSMM (Deutsche Studiengruppe Multiples Myelom)

    collaborator UNKNOWN

  • NMSG (Nordic Myeloma Study Group)

    collaborator UNKNOWN

  • Central European Myeloma Study Group

    collaborator OTHER

  • Stichting Hemato-Oncologie voor Volwassenen Nederland

    lead OTHER

Principal Investigators

  • Pieter Sonneveld, Prof. · Stichting Hemato-Oncologie voor Volwassenen Nederland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2020-12-31
Completion
2025-01-31

Countries

  • Australia
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Finland
  • Greece
  • Hungary
  • Italy
  • Luxembourg
  • Netherlands
  • Norway
  • Portugal
  • Sweden
  • Switzerland
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01208766 on ClinicalTrials.gov