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Completed

NCT Number: NCT01030302

A Retreatment Study With Bortezomib for Multiple Myeloma

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

bortezomib

Drug

bortezomib injection into a vein 1.3 mg/m2 twice a week for 21 days

Primary outcomes

  1. 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.

    Time frame: 6-12 months

Secondary outcomes

  1. Adverse events

    Time frame: at the end of every 3 week cycle

  2. Overall response rate

    Time frame: 6-12 months

Sponsors and collaborators

Lead sponsor

Janssen Korea, Ltd., Korea

Industry

Registry information

Official study title

An Observational, Prospective Analysis of Retreatment With Bortezomib for Multiple Myeloma

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 11, 2009
Registry last updated
Mar 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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