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

Study Overview
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Brief Summary
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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.

Official Title
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REal Life, Retrospective Study of BOrtezomib Use as secoND Treatment for Myeloma Patients Previously Exposed to Bortezomib-based Therapies as First Line

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: Bortezomib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bortezomib|Re-challenge with bortezomib as second line therapy in myeloma patients relapsed after a previous bortezomib-based treatment|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | International Myeloma Study Group Criteria | March, 31, 2016 | 
| Adverse events | Types (haematological and non hematological) and degree (Common terminology criteria adverse criteria) | March,31, 2016 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival 1 and 2 |  | March, 31, 2016 | 
| Time to next treatment |  | March, 31, 2016 | 
| Overall survival |  | March, 31, 2016 | 
| Secondary primary malignancies | Types and incidence | March, 31, 2016 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rechallenge, Multiple myeloma, Bortezomib, Relapsed multiple myeloma