Overview

Bortezomib as First Salvage Therapy for Myeloma Patients Previously Exposed to Bortezomib as Initial Treatment.

Status:
Unknown status
Trial end date:
2016-06-01
Target enrollment:
0
Participant gender:
All
Summary
This observational, non-interventional, retrospective, multicenter, national study focuses on collecting information about the effectiveness and safety of bortezomib re-use at first relapse in MM patients already treated in their first line with a bortezomib-based regimen, re-challenged with the same drug according to current clinical practice and/or Italian SIE/SIES/GITMO, IMWG and/or NCCN Guidelines/Treatment Recommendations. Data will be collected retrospectively from approximately 25 haematologic/oncologic sites in Italy. Approximately, data of up to 100 patients will be collected.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
IRCCS Centro di Riferimento Oncologico della Basilicata
Treatments:
Bortezomib
Criteria
Inclusion Criteria:

Patients satisfying all of the following criteria will be enclosed in the study:

- Age ≥ 18 years old

- Patients with documented multiple myeloma that received bortezomib-based regimens as
first line treatment (both in clinical practice or clinical trials) even if followed
by ASCT (Autologous stem cell transplantation) and that after their first line
treatment's clinical or biochemical relapse received again a bortezomib-based
treatment according to current clinical practice and/or Italian Societies of
Hematology (SIE), Experimental Hematology (SIES) and Transplantation (GITMO),
International Myeloma Working group (IMWG) and/or National Cancer Comprehensive Cancer
Network (NCCN) guidelines/treatment recommendations.

- Signed Informed Consent form if feasible

Exclusion Criteria:

- Patients not treated with bortezomib as first line therapy and/or second line therapy

- Patients with more than one relapse before bortezomib re-use

- Patients unable to understand and sign Informed Consent form (see exceptions listed in
section 8 "Informed consent")

- Patients who received bortezomib at relapse in combination with any investigational
drug not-approved.