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Study of Bortezomib and Dexamethasone With or Without Cyclophosphamide in Patients With Relapsed or Not Controllable Multiple Myeloma

NCT00813150 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2014-08-15

Study results available
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Summary

The purpose of this study is to compare bortezomib, dexamethasone and cyclophosphamide to bortezomib and dexamethasone alone for primary refractory or relapsed multiple myeloma.

Conditions

Interventions

DRUG

Dexamethasone

Type=exact number, number=20, unit=mg, form=tablet, route=oral. The patients will receive 20 mg of dexamethasone on days 1+2,4+5,8+9,11+12 for 21 days for 8 cycles.

DRUG

Bortezomib

Type=exact number, number=1.3, unit=mg, form=injection, route=intravenous. The patients will receive 1.3mg/m2 on days 1,4,8,11 for 21 days for 8 cycles.

DRUG

Cyclophosphamide

Type=exact number, number=50, unit=mg, form=tablet, route=oral. The patients will receive 50 mg of cyclophosphamide once daily continuously from cycle 1 to 8.

Sponsors & Collaborators

  • Janssen-Cilag G.m.b.H

    lead INDUSTRY

Principal Investigators

  • Janssen-Cilag G.m.b.H, Germany Clinical Trial · Janssen-Cilag G.m.b.H

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • Germany

Study Locations

More Related Trials

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 NCT00813150 on ClinicalTrials.gov