Trial intelligence / Profile preview

Subcutaneous Velcade Combinations in Elderly MM

NCT01190787Phase 2

Key facts

Status
Completed
Start
Jul 2010
Primary completion
May 2012
Countries
1
Modality
Small Molecules, Modified Peptides
Conditions
multiple myeloma (MM)
01

Overview

Phase 2, randomised, open-label trial of bortezomib in multiple myeloma (MM) (3 arms). Primary endpoint: Very Good Partial Response, Complete response rate, Partial response rate at 5 years. Started Jul 2010; status: completed.

02

Design

3 arms
Study design
RandomizedOpen-label
  • VMP

    Bortezomib (SC) + Melphalan (PO) + Prednisone (PO)

  • VCP

    Bortezomib (SC) + Cyclophosphamide (PO) + Prednisone (PO)

  • VP

    Bortezomib (SC) + Prednisone (PO)

03

Endpoints

Primary

  • Very Good Partial Response, Complete response rate, Partial response rate

Secondary

  • Progression free survival

  • Time to progression

  • Time to Next Therapy

  • Overall survival

  • Time to response

  • Duration of response

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