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

This study has been terminated.
(Recruitment too slow. Number of eligible patients probably to low. Patients enrolled and/or in follow-up will be followed up in the Valeo study.)
Sponsor:
Information provided by:
Janssen-Cilag B.V.
ClinicalTrials.gov Identifier:
NCT00440479
First received: February 26, 2007
Last updated: November 4, 2010
Last verified: November 2010

February 26, 2007
November 4, 2010
September 2006
Not Provided
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 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00440479 on ClinicalTrials.gov Archive Site
  • bortezomib treatment schedule, dosing and timing [ Time Frame: each cycle ] [ Designated as safety issue: No ]
  • combination therapies for multiple myeloma [ Time Frame: from start of bortezomib treatment up to 30 days after last bortezomib administration ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: from start of bortezomib treatment up to 30 days after last bortezomib administration ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: from end of bortezomib treatment up to 3 years after last bortezomib administration ] [ Designated as safety issue: No ]
Not Provided
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ADVANCE: An Observational Study To Determine Bortezomib Safety and Effectiveness at First Relapse After Participation In First Line HOVON-49/50 Clinical Studies.
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.

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

Observational
Observational Model: Case-Only
Not Provided
Not Provided
Non-Probability Sample

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

  • Multiple Myeloma
  • Hematological Neoplasms
Drug: Bortezomib
dose as determined (observational study) by treating physician
001
Bortezomib dose as determined (observational study) by treating physician
Intervention: Drug: Bortezomib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
11
July 2011
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00440479
CR012361, 26866138MMY4013
No
Medical Affairs Manager, Janssen-Cilag B.V., Netherlands
Janssen-Cilag B.V.
Not Provided
Study Director: Janssen-Cilag B.V. Clinical Trial Janssen-Cilag B.V.
Janssen-Cilag B.V.
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP