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Bortezomib and Dexamethasone as Treatment and Maintenance for Multiple Myeloma Relapse

NCT00335348 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2013-01-09

No results posted yet for this study

Summary

This study has two main aims. The first is to assess whether Dexamethasone can increase the number of patients with who respond to Velcade.

The second aim of this study is to see whether treating patients with relapsed multiple myeloma with Velcade and Dexamethasone for a longer period of time extends the time that the myeloma is under control.

Conditions

Interventions

DRUG

Bortezomib

Induction- 1.3mg/m2 IV days 1,4,8,11 every 3 weeks up to 8 cycles Consolidation- 1.3mg/m2 IV days 1,8,15,22 every 5 weeks up to 3 cycles Maintenance- 1.3mg/m2 IV days 1,15 every 4 weeks

DRUG

Dexamethasone

Induction- 20mg orally days 1,2,4,5,8,9,11,12 every 3 weeks up to 8 cycles Consolidation- 20mg orally days 1,2,8,9,15,16,22,23 every 5 weeks up to 3 cycles Maintenance- 20mg orally days 1,2,15,16 every 4 weeks

Sponsors & Collaborators

  • Janssen-Cilag Ltd.

    collaborator INDUSTRY

  • Peter MacCallum Cancer Centre, Australia

    lead OTHER

Principal Investigators

  • Miles Prince, MD · Peter MacCallum Cancer Centre, Melbourne, Australia.

  • Simon Harrison, MB, BS., PhD · Peter MacCallum Cancer Centre, Australia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • Australia

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 NCT00335348 on ClinicalTrials.gov