Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma
Public ClinicalTrials.gov record NCT01023308. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01023308
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 767 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 21, 2009 (Actual)
- Primary completion
- Jul 30, 2015 (Actual)
- Completion
- Jul 30, 2015 (Actual)
- Last update posted
- Mar 17, 2020
2009 – 2015
United States locations
- U.S. sites
- 38
- U.S. states
- 22
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novartis Investigative Site | Phoenix | Arizona | — | — |
| Novartis Investigative Site | Anaheim | California | 92801 | — |
| Novartis Investigative Site | Concord | California | 94520 | — |
| Novartis Investigative Site | Los Angeles | California | 90027 | — |
| Novartis Investigative Site | San Diego | California | 92120 | — |
| Novartis Investigative Site | Stanford | California | 94304 | — |
| Novartis Investigative Site | Boca Raton | Florida | 33486 | — |
| Novartis Investigative Site | Lake Worth | Florida | 33467 | — |
| Novartis Investigative Site | Miami Shores | Florida | 33138 | — |
| Novartis Investigative Site | Athens | Georgia | 30607 | — |
| Novartis Investigative Site | Atlanta | Georgia | 30322 | — |
| Novartis Investigative Site | Marietta | Georgia | 30060 | — |
| Novartis Investigative Site | Marywood | Illinois | 60153 | — |
| Novartis Investigative Site | Quincy | Illinois | 62301 | — |
| Novartis Investigative Site | New Orleans | Louisiana | 70115 | — |
| Novartis Investigative Site | Baltimore | Maryland | 21229 | — |
| Novartis Investigative Site | Rockville | Maryland | 20850 | — |
| Novartis Investigative Site | Boston | Massachusetts | 02215 | — |
| Novartis Investigative Site | Southfield | Michigan | — | — |
| Novartis Investigative Site | Edina | Minnesota | 55435 | — |
| Novartis Investigative Site | Minneapolis | Minnesota | 55404 | — |
| Novartis Investigative Site | Columbia | Missouri | 65201 | — |
| Novartis Investigative Site | East Orange | New Jersey | 07018-1095 | — |
| Novartis Investigative Site | Mount Kisco | New York | 10549 | — |
| Novartis Investigative Site | Durham | North Carolina | 27710 | — |
| Novartis Investigative Site | Bismarck | North Dakota | 58501 | — |
| Novartis Investigative Site | Dayton | Ohio | 45429 | — |
| Novartis Investigative Site | Middletown | Ohio | 45042 | — |
| Novartis Investigative Site | Pittsburgh | Pennsylvania | 15224 | — |
| Novartis Investigative Site | East Providence | Rhode Island | 02915 | — |
| Novartis Investigative Site | Nashville | Tennessee | 37203 | — |
| Novartis Investigative Site | Nashville | Tennessee | 37232 | — |
| Novartis Investigative Site | Amarillo | Texas | 79106 | — |
| Novartis Investigative Site | Houston | Texas | 77030 | — |
| Novartis Investigative Site | Kennewick | Washington | 99336 | — |
| Novartis Investigative Site | Seattle | Washington | 98104 | — |
| Novartis Investigative Site | Walla Walla | Washington | 33962 | — |
| Novartis Investigative Site | Morgantown | West Virginia | 26506 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 172 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01023308, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 17, 2020 · Synced Oct 29, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01023308 live on ClinicalTrials.gov.