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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bortezomib | Drug | Re-challenge with bortezomib as second line therapy in myeloma patients relapsed after a previous bortezomib-based treatment |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival 1 and 2 | March, 31, 2016 | |
| Time to next treatment | March, 31, 2016 | |
| Overall survival |
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Inclusion Criteria:
Patients satisfying all of the following criteria will be enclosed in the study:
Exclusion Criteria:
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Adult patients with documented multiple myeloma that received bortezomib-based regimens as first line treatment and that after their first line treatment's relapse received again a bortezomib-based treatment
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| Name | Affiliation | Role |
|---|---|---|
| Pellegrino Musto, MD | IRCCS Centro di Riferimento Oncologico della Basilicata, Rionero in Vulture (Pz), Italy | Principal Investigator |
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Central database of single patients
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
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| March, 31, 2016 |
| Secondary primary malignancies | Types and incidence | March, 31, 2016 |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001896 |
| Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |