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

Multiple Myeloma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00440479
• Other study ID #: CR012361
• Secondary ID: 26866138MMY4013
• Status: Completed
• Phase: Phase 4
• First received: February 26, 2007
• Last updated: April 15, 2015
• Start date: September 2006
• Est. completion date: January 2011

Study information

• Verified date: April 2015
• Source: Janssen-Cilag B.V.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Netherlands Medicines Evaluation Board
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematological Neoplasms
• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Bortezomib
dose as determined (observational study) by treating physician

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag B.V.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to treatment		No timepoints have been defined, as this is an observational study; data will be collected until three years after latest bortezomib administration	No
Secondary	bortezomib treatment schedule, dosing and timing		each cycle	No
Secondary	combination therapies for multiple myeloma		from start of bortezomib treatment up to 30 days after last bortezomib administration	No
Secondary	adverse events		from start of bortezomib treatment up to 30 days after last bortezomib administration	No
Secondary	overall survival		from end of bortezomib treatment up to 3 years after last bortezomib administration	No