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
  Purpose

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.


Condition Intervention
Multiple Myeloma
Hematological Neoplasms
Drug: Bortezomib

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: An Observational Study To Determine Velcade (Bortezomib) Safety and Effectiveness at First Relapse After Participation In First Line HOVON-49/50 Clinical Studies (ADVANCE)

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag B.V.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 11
Study Start Date: September 2006
Estimated Study Completion Date: July 2011
Groups/Cohorts Assigned Interventions
001
Bortezomib dose as determined (observational study) by treating physician
Drug: Bortezomib
dose as determined (observational study) by treating physician

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00440479

Sponsors and Collaborators
Janssen-Cilag B.V.
Investigators
Study Director: Janssen-Cilag B.V. Clinical Trial Janssen-Cilag B.V.
  More Information

No publications provided

Responsible Party: Medical Affairs Manager, Janssen-Cilag B.V., Netherlands
ClinicalTrials.gov Identifier: NCT00440479     History of Changes
Other Study ID Numbers: CR012361, 26866138MMY4013
Study First Received: February 26, 2007
Last Updated: November 4, 2010
Health Authority: Netherlands: Netherlands Medicines Evaluation Board

Keywords provided by Janssen-Cilag B.V.:
Multiple Myeloma
hematological neoplasms
chemotherapy
efficacy
safety
bortezomib
proteasome inhibitor

Additional relevant MeSH terms:
Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Hematologic Neoplasms
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site
Bortezomib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 23, 2014