A Retreatment Study With Bortezomib for Multiple Myeloma

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: bortezomib

• Registration Number: NCT01030302
• Lead Sponsor: Janssen Korea, Ltd., Korea

Brief Summary

The purpose of this study is to monitor such factors as a past history, a previous history of drug use, the degree of response to initial treatment, the frequency of previous therapies, age, Eastern Cooperative Oncology Group (ECOG) performance status, which is used by doctors and researchers to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis, before the bortezomib re-treatment, the concomitant drugs that are used for re-treatment and the pattern of treatment in patients with multiple myeloma who were re-treated with injectable bortezomib.

Detailed Description

It will be essential to obtain the Korean clinical data about the efficacy and safety of the re-treatment with bortezomib as well as to analyze its actual pattern. The current trial is a prospective, multi-center, Phase 4, observational study that will be conducted to collect such demographic data as a past history, a previous history of drug use, the degree of responses to initial treatment, the frequency of previous therapies, age, Eastern Cooperative Oncology Group (ECOG) performance status, the concomitant drugs that are used for re-treatment and the pattern of treatment for patients with multiple myeloma and who were re-treated with injectable bortezomib. Also safety data will be collected. Observational Study -No investigational drug administered

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-10-29
• Study First Submitted QC: 2009-12-10
• Study First Posted: 2009-12-11
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-07
• Last Update Posted: 2013-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Patients with multiple myeloma
• Patients who were treated with bortezomib monotherapy or bortezomib combination therapy
• Patients who relapsed after >= six months interval since last dose of bortezomib
• Patients who had a treatment response of higher than partial remission (PR) to the previous bortezomib therapy
• Patients who were fully aware of the objectives and essential procedures of the current trial and then submitted a written informed consent declaring that they will voluntarily participate in the current trial

Read More

Exclusion Criteria

• The current presence of or a past history of hypersensitivity to bortezomib or its constituents
• Severe hepatic dysfunction (AST or ALT at first use>= x 5 upper normal)
• Pregnant women

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
001	bortezomib	bortezomib injection into a vein 1.3 mg/m2 twice a week for 21 days

Primary Outcome Measures

Name	Time	Method
To monitor such factors as a past history, a previous history of drug use, the degree of responses to initial treatment, the frequency of previous therapies, age, the concomitant drugs that are used for re-treatment and the pattern of treatment.	6-12 months

Secondary Outcome Measures

Name	Time	Method
Overall response rate	6-12 months
Adverse events	at the end of every 3 week cycle