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A Japan Phase I/II Study of Bortezomib in Relapsed or Refractory Multiple Myeloma Patients

NCT00752518 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2011-05-17

No results posted yet for this study

Summary

The purpose of this study is to assess the safety/tolerability and determine the Japanese recommended dose (RD) of bortezomib administered as a once-daily intravenous bolus twice weekly for 2 consecutive weeks(Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 to 21) in Japanese patients with relapsed or refractory multiple myeloma.

Conditions

Interventions

DRUG

bortezomib

Sponsors & Collaborators

  • Janssen Pharmaceutical K.K.

    lead INDUSTRY

Principal Investigators

  • Janssen Pharmaceutical K.K. Clinical Trial · Janssen Pharmaceutical K.K.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31
Completion
2006-01-31

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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 NCT00752518 on ClinicalTrials.gov