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

18 Years
Not Enrolling
Multiple Myeloma, Hematological Neoplasms

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Trial Information

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

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

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

Type of Study:


Study Design:

Observational Model: Case-Only

Outcome Measure:

Response to treatment

Outcome Time Frame:

No timepoints have been defined, as this is an observational study; data will be collected until three years after latest bortezomib administration

Safety Issue:


Principal Investigator

Janssen-Cilag B.V. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen-Cilag B.V.


Netherlands: Netherlands Medicines Evaluation Board

Study ID:




Start Date:

September 2006

Completion Date:

July 2011

Related Keywords:

  • Multiple Myeloma
  • Hematological Neoplasms
  • Multiple Myeloma
  • hematological neoplasms
  • chemotherapy
  • efficacy
  • safety
  • bortezomib
  • proteasome inhibitor
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Hematologic Neoplasms