Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2006-007030-35 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the safety of LBH589 given in combination with lenalidomide and dexamethasone in adult patients with multiple myeloma
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PAN 5 mg | Experimental | Panobinostat 5 mg |
|
| PAN 10 mg | Experimental | Panobinostat 10 mg |
|
| PAN 20 mg | Experimental | Panobinostat 20 mg |
|
| PAN 25 mg | Experimental | Panobinostat 25 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LBH589 | Drug | PAN 5 mg and PAN 20 mg capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the highest and safest dose of LBH589 when it is administered in combination with lenalidomide & dexamethasone | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability assessed by monitoring of adverse events, serious adverse events and laboratory parameters To characterize the pharmacokinetic profile of the study treatment To characterize the pharmacodynamic profile of the study treatment | Da1 to Day 3 (week 1 of first cycle) |
Not provided
Inclusion criteria:
Exclusion criteria:
Other protocol defined inclusion/exclusion criteria may apply
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Medical Center | San Francisco | California | 94143 | United States | ||
| Emory University School of Medicine/Winship Cancer Institute Dept. of Winship Cancer Inst. |
Not provided
| Label | URL |
|---|---|
| Results for CLBH589B2206 can be found on the Novartis Clinical Trial Results Website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Lenalidomide | Combination Product | Lenalidomide 5mg or 25 mg |
|
| Atlanta |
| Georgia |
| 30322 |
| United States |
| St. Vincent's Comprehensive Cancer Center | New York | New York | 10011 | United States |
| Novartis Investigative Site | South Brisbane | Queensland | 4101 | Australia |
| Novartis Investigative Site | Prahran | Victoria | 3181 | Australia |
| Novartis Investigative Site | Lille | 59037 | France |
| Novartis Investigative Site | Montpellier | 34295 | France |
| Novartis Investigative Site | Nantes | 44035 | France |
| Novartis Investigative Site | Salamanca | Castille and León | 37007 | Spain |
| Novartis Investigative Site | Valencia | Valencia | 46026 | Spain |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D054219 | Neoplasms, Plasma Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077767 | Panobinostat |
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D006877 | Hydroxamic Acids |
| D006898 | Hydroxylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002264 | Carboxylic Acids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D054833 | Isoindoles |
Not provided
Not provided