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

• Conditions: Multiple Myeloma

• Registration Number: NCT02797041
• Lead Sponsor: IRCCS Centro di Riferimento Oncologico della Basilicata

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Primary Completion: 2016-03
• Status Verified: 2016-06
• Study Completion: 2016-06
• Study First Submitted: 2016-06-02
• Study First Submitted QC: 2016-06-10
• Study First Posted: 2016-06-13
• Last Update Submitted: 2016-06-13
• Last Update Posted: 2016-06-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events	March,31, 2016	Types (haematological and non hematological) and degree (Common terminology criteria adverse criteria)
Response rate	March, 31, 2016	International Myeloma Study Group Criteria

Secondary Outcome Measures

Name	Time	Method
Secondary primary malignancies	March, 31, 2016	Types and incidence
Overall survival	March, 31, 2016
Progression free survival 1 and 2	March, 31, 2016
Time to next treatment	March, 31, 2016