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Subcutaneous Velcade Plus Oral Melphalan and Prednisone or Plus Cycloposphamide and Prednisone or Plus Prednisone

NCT01190787 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-01-23

No results posted yet for this study

Summary

This protocol is a single-arm, three-cohort, phase II multicenter study designed to assess the safety and the efficacy of three all-oral combinations: Velcade with continuous low-dose melphalan and prednisone (VMP) or with continuous low-dose cyclophosphamide and prednisone (VCP) or Velcade with low-dose prednisone could be effective and well tolerated (VP).

Conditions

Interventions

DRUG

velcade subcutaneous melphalan prednisone

INDUCTION Velcade will be given as subcutaneous (SC) injection. Each cycle will be repeated every 28 days. Melphalan will be given orally. Each cycle will be repeated every 28 days. Prednisone will be given orally.Each cycle will be repeated every 28 days. MAINTENANCE Velcade will be given a SC injection. Each cycle will be repeated every 28 days.

DRUG

velcade cyclophosphamide prednisone

INDUCTION Velcade will be given as subcutaneous (SC) injection. Each cycle will be repeated every 28 days. Cyclophosphamide will be given orally. Each cycle will be repeated every 28 days. Prednisone will be given orally.Each cycle will be repeated every 28 days. MAINTENANCE Velcade will be given a SC injection. Each cycle will be repeated every 28 days.

DRUG

velcade prednisone

INDUCTION Velcade will be given as subcutaneous (SC) injection. Each cycle will be repeated every 28 days. Prednisone will be given orally.Each cycle will be repeated every 28 days. MAINTENANCE Velcade will be given a SC injection. Each cycle will be repeated every 28 days.

Sponsors & Collaborators

  • Fondazione EMN Italy Onlus

    collaborator OTHER

  • European Myeloma Network B.V.

    lead NETWORK

Principal Investigators

  • Mario Boccadoro, MD · Fondazione EMN Italy Onlus

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2012-05-31
Completion
2024-01-18

Countries

  • Italy

Study Locations

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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 NCT01190787 on ClinicalTrials.gov