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Retrospective Evaluation of Re-Treatment With Bortezomib in Subjects With First Relapse After Bortezomib First-Line Therapy

Phase 4
18 Years
Not Enrolling
Hematological Cancer, Multiple Myeloma

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Trial Information

Retrospective Evaluation of Re-Treatment With Bortezomib in Subjects With First Relapse After Bortezomib First-Line Therapy

This is an international, multicenter, non-interventional, retrospective study to evaluate
the efficacy and safety of bortezomib in 100 adult patients diagnosed with multiple myeloma
(MM) who responded to bortezomib as first-line treatment, experienced partial response or
better, presented with relapsed disease, and were re-treated (second-line) with bortezomib
(for at least 3 cycles) after a treatment-free interruption of at least 6 months. As this is
a non-interventional study, no changes to the current treatment that the patient receives
will be required, and no additional treatment will be provided by the company. The decision
of the patients to take part in this study will not have any impact on the care they
receive. All the appropriate treatment-related decisions will have been made by the treating
physician(s), and only data available from clinical practice will be collected.
Retrospective data will be collected at a single time point for each patient (the data
collection visit). Each investigator should collect data from patients fulfilling all
inclusion and exclusion criteria. After receiving the signed informed consent form (ICF)
from the patient (if required by local regulations), the investigator will start documenting
the retrospective data for each patient using electronic data capture (eDC). After
confirmation of the patient's eligibility, the patient's last visit, patient
characteristics, predefined risk factors (if available), MM-related data, and first- and
second-line bortezomib-related data will be documented in the Case Report Form (CRF). The
patient's status after re-treatment with bortezomib, medical resource utilization data, as
well as (serious) adverse drug reactions ([S]ADRs) will be collected. No blood, urine, or
other biological samples will be taken, and no additional investigations will be performed.
the current therapy of the patient will be maintained with no changes

Inclusion Criteria:

- Has a current diagnosis/was diagnosed with MM or secretory MM

- Was previously treated with bortezomib-containing chemotherapy

- Responded to bortezomib as first-line treatment

- Has been re-treated with bortezomib (at least 3 cycles) due to relapse of the disease
(following the first bortezomib treatment), after a treatment-free interruption of at
least 6 months

- Completed bortezomib re-treatment at least 2 months ago Exclusion Criteria:

- Was a pregnant or breastfeeding woman while receiving either first-line or
second-line treatment with Velcade

Has received bortezomib-containing chemotherapy for the first time following a first
relapse or later

- Has participated in a clinical trial in which bortezomib was used as second-line
treatment following a relapse after response to Velcade as first-line chemotherapy,
and the study data are not publicly available at the time of inclusion in the current

- Has received bortezomib as first-line therapy and was re-treated with bortezomib
after first relapse in the VISTA clinical trial

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Retrospective

Outcome Measure:

overall response after retreatment

Outcome Description:

overall response after retreatment will be assessed from initial diagnosis to the time of data collection

Outcome Time Frame:

Day 1

Safety Issue:


Principal Investigator

Janssen Pharmaceutica N.V. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Pharmaceutica N.V.


Belgium: Ministry of Social Affairs, Public Health and the Environment

Study ID:




Start Date:

March 2011

Completion Date:

October 2011

Related Keywords:

  • Hematological Cancer
  • Multiple Myeloma
  • Bortezomib
  • Velcade
  • multiple myeloma
  • retrospective study, response rate, medical resource utilization
  • Multiple Myeloma
  • Neoplasms, Plasma Cell