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Velcade (Bortezomib) Consolidation After Transplant

NCT01539083 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2025-02-04

Study results available
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Summary

The purpose of this study is to determine if bortezomib when added to consolidation treatment with thalidomide and prednisolone leads to an improved response in patients with multiple myeloma who have undergone autologous stem cell transplant and initial treatment with bortezomib, cyclophosphamide, and dexamethasone.

Conditions

Interventions

DRUG

Thalidomide

Thalidomide 100 mg tablet, orally.

DRUG

Bortezomib

Bortezomib 1.3 milligram per square meter (mg/m\^2) solution for injection subcutaneously (SC).

DRUG

Cyclophosphamide

Cyclophosphamide 300 mg/m\^2 orally.

DRUG

Dexamethasone

Dexamethasone 20 mg orally.

DRUG

Prednisolone

Prednisolone 50 mg orally.

Sponsors & Collaborators

  • Janssen Scientific Affairs, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Asia-Pacific Medical Affairs Clinical Trial · Janssen Asia-Pacific Medical Affairs

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-13
Primary Completion
2015-12-30
Completion
2018-01-09

Countries

  • Australia
  • China
  • South Korea

Study Locations

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Entities

Drugs
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 NCT01539083 on ClinicalTrials.gov