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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-000646-32 |
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The Phase I of the study was completed, but Phase 2 has not been activated
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The purpose of this study is to determine whether the association of ZMP is safe and provides benefits in patients with relapsed/refractory MM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZMP | Experimental | Combination with Vorinostat, Melphalan and Prednisone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vorinostat | Drug | Patients will start induction treatment with a standard dose of MP and escalating doses of Vorinostat:
Level -1 Vorinostat = 100 mg daily on days 1-21 Melphalan = 0.18 mg/kg on days 1 - 4 Prednisone = 1.5 mg/kg on days 1 - 4 Level 0 Vorinostat = 200 mg daily on days 1-21 Melphalan = 0.18 mg/kg on days 1 - 4 Prednisone = 1.5 mg/kg on days 1 - 4 Level +1 Vorinostat = 300 mg daily on days 1-21 Melphalan = 0.18 mg/kg on days 1 - 4 Prednisone = 1.5 mg/kg on days 1 - 4 Level +2 Vorinostat = 400 mg daily on days 1-21 Melphalan = 0.18 mg/kg on days 1 - 4 Prednisone = 1.5 mg/kg on days 1 - 4 |
| Measure | Description | Time Frame |
|---|---|---|
| The dose limiting toxicity (DLT)of Vorinostat with MP | one year | |
| The maximum tolerated dose (MTD) of Vorinostat in association with MP | 1 year | |
| A significant number of PR or higher (>40%) following the proposed ZMP therapy | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Progression Free Survival | 5 Years | |
| Duration of Overall Survival | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mario Boccadoro, MD | University of Turin, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dipartimento Medicina Clinica e Sperimentale | Padova | 35128 | Italy | |||
| A.O.U. S. Giovanni Battista |
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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 |
|---|---|
| D000077337 | Vorinostat |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
| Torino |
| 10126 |
| Italy |
| Policlinico Universitario di Udine | Udine | 33100 | Italy |
| Azienda Ospedaliera di Verona - Policlinico G.B. Rossi | Verona | 37134 | Italy |
| 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 |
| D000588 |
| Amines |
| D006877 | Hydroxamic Acids |
| D006898 | Hydroxylamines |
| D006880 | Hydroxy Acids |
| D002264 | Carboxylic Acids |