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| Name | Class |
|---|---|
| Fondazione EMN Italy Onlus | OTHER |
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This is a multicenter, randomized, open label study designed to evaluate the efficacy and safety of prolonged treatment with bortezomib twice monthly and dexamethasone after a salvage treatment containing bortezomib for relapsed or refractory multiple myeloma patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No prolonged therapy is scheduled | No Intervention | ||
| Bortezomib Dexamethasone (Biochemical relapse) | Experimental | Patients randomized in this group will be observed. At the occurrence of biochemical relapse, 4 VD cycles will be administered: Bortezomib (SC) and Dexamethasone (PO) weekly. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bortezomib | Drug |
| ||
| Dexamethasone |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Progression | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | Overall Survival Progression Free Survival | 5 years |
| Response | Objective overall response rate (ORR) | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Irccs Crob | Rionero in Vulture | Potenza | Italy |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
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| Drug |
|
| Response | Duration of response | 5 years |
| Response | Time to response | 5 years |
| Response | Time to the next anti-myeloma therapy (TNT) | 5 years |
| Response | TTP measured from the beginning of the salvage treatment | 5 years |
| Response | Role of the type of salvage treatment | 5 years |
| Response | Role of previous treatments | 5 years |
| Response | Incidence of grade 3 and 4 hematological and non-hematological adverse events (AEs) | 5 years |
| Response | Exploratory assessment on prognosis (ISS, age and FISH abnormalities) | 5 years |
| 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 |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001896 |
| Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |