ADVANCE: An Observational Study To Determine Bortezomib Safety and Effectiveness at First Relapse After Participation In First Line HOVON-49/50 Clinical Studies.

April 15, 2015 updated by: Janssen-Cilag B.V.

An Observational Study To Determine Velcade (Bortezomib) Safety and Effectiveness at First Relapse After Participation In First Line HOVON-49/50 Clinical Studies (ADVANCE)

The primary aim of this observational study is to collect safety and effectiveness data for bortezomib used at first relapse in a group of multiple myeloma patients who received specific and well defined first line treatments within previous clinical studies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There is a need by physicians to evaluate the results of bortezomib treatment in a homogenous patient population with regard to the multiple myeloma treatments in first line. For that reason the current study, ADVANCE, is designed to structurally collect data on the daily practice use of bortezomib as treatment after first relapse in patients with specific and well defined first line treatments (i.e. patients who participated in the HOVON-49 or HOVON-50 study). In both HOVON studies patients were randomized to either receiving thalidomide or not, as a part of the first line treatment. Therefore, the effect of pre-treatment with thalidomide on duration, effectiveness and safety of the bortezomib treatment after first relapse can be studied specifically. The analysis of this particular type of data will, however, be descriptive. All adverse events, regardless of seriousness, severity, or presumed relationship to bortezomib therapy will be recorded on the case report form, i.e., a form for each patient in the study on which all needed data are recorded, and reported to the sponsor within current timelines. The sponsor assumes responsibility for appropriate reporting of adverse events to the regulatory authorities. This project is a 'post authorization study (PAS)'. This means that only routinely available medical data are collected, with the patients' permission, and no additional interventions or diagnostic procedures should be done specifically for this study. Because the study is observational, dosage, administration and duration of treatment is at discretion of the treating physician

Study Type

Observational

Enrollment (Actual)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Bergen Op Zoom, Netherlands
      • Breda, Netherlands
      • Ede Gld, Netherlands
      • Nijmegen, Netherlands
      • Rotterdam, Netherlands
      • Terneuzen, Netherlands
      • Tilburg, Netherlands
      • Utrecht, Netherlands
      • Vlissingen, Netherlands

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Multiple Myeloma patients treated with bortezomib at first relapse after participation in first line HOVON 49 or 50 clinical studies

Description

Inclusion Criteria:

  • Patients have to sign a statement that they agree with collection of their clinical data for this project
  • patients had a first relapse or progressive disease after treatment in the HOVON-49 or HOVON-50 study and will be treated with bortezomib.

Exclusion Criteria:

  • Prior enrollment in HOVON-54 study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
001
Bortezomib dose as determined (observational study) by treating physician
Drug: Bortezomib
dose as determined (observational study) by treating physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response to treatment
Time Frame: No timepoints have been defined, as this is an observational study; data will be collected until three years after latest bortezomib administration
No timepoints have been defined, as this is an observational study; data will be collected until three years after latest bortezomib administration

Secondary Outcome Measures

Outcome Measure
Time Frame
bortezomib treatment schedule, dosing and timing
Time Frame: each cycle
each cycle
combination therapies for multiple myeloma
Time Frame: from start of bortezomib treatment up to 30 days after last bortezomib administration
from start of bortezomib treatment up to 30 days after last bortezomib administration
adverse events
Time Frame: from start of bortezomib treatment up to 30 days after last bortezomib administration
from start of bortezomib treatment up to 30 days after last bortezomib administration
overall survival
Time Frame: from end of bortezomib treatment up to 3 years after last bortezomib administration
from end of bortezomib treatment up to 3 years after last bortezomib administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen-Cilag B.V.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

February 26, 2007

First Submitted That Met QC Criteria

February 26, 2007

First Posted (Estimate)

February 27, 2007

Study Record Updates

Last Update Posted (Estimate)

April 16, 2015

Last Update Submitted That Met QC Criteria

April 15, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR012361
  • 26866138MMY4013

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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