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| Sponsor: | Novartis Pharmaceuticals |
|---|---|
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT01023308 |
Purpose
Panobinostat (LBH589) is a highly potent pan-deacetylase inhibitor (pan-DACi), inclusive of HDAC6, which disrupts aggresome function, promotes accumulation of cytotoxic misfolded protein aggregates and triggers myeloma cell death. Combination of pan-DAC and protease inhibition by co-treatment with panobinostat (PAN) and bortezomib (BTZ) has demonstrated synergistic cytotoxicity in vitro and in vivo in pre-clinical experiments. Furthermore, clinical experience in advanced multiple myeloma (MM) patients treated by oral panobinostat and i.v bortezomib ± dexamethasone showed very encouraging results for efficacy and manageable toxicity profile.
Given the medical need for improved treatment strategies for patients with previously treated and relapsed MM, the purpose of this prospective, multinational, randomized, double-blind, placebo-controlled, parallel group Phase III study is to compare the results in progression-free survival of 2 combination therapies, panobinostat with bortezomib and dexamethasone or placebo with bortezomib and dexamethasone, in patients with previously treated MM whose disease has recurred or progressed.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: Panobinostat Drug: Bortezomib Drug: Dexamethasone Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Double Blind, Placebo Controlled Phase III Study of Panobinostat in Combination With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma |
| Estimated Enrollment: | 676 |
| Study Start Date: | December 2009 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Panobinostat + Bortezomib + Dexamethasone |
Drug: Panobinostat
Other Name: LBH589
Drug: Bortezomib
Drug: Dexamethasone
|
| Placebo Comparator: Placebo + Bortezomib + Dexamethasone | Drug: Bortezomib Drug: Dexamethasone Drug: Placebo |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Contacts and Locations| Contact: Novartis Pharmaceuticals | +1-800 340 6843 |
Show 176 Study Locations| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
| Responsible Party: | external Affairs, Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01023308 History of Changes |
| Other Study ID Numbers: | CLBH589D2308, EUDRACT number: 2009-015507-52 |
| Study First Received: | November 30, 2009 |
| Last Updated: | April 18, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Myeloma DACi Bortezomib Combination, |
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Dexamethasone acetate |
Dexamethasone Dexamethasone 21-phosphate Bortezomib BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones |