Panobinostat in Combination With Bortezomib and Dexamethasone in Japanese Patients With Relapsed/Refractory Multiple Myeloma
Conditions
Relapse/Refractory Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
LBH589,, panobinostat,, bortezomib,, dexamethasone,, Phase II
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: LBH589 (panobinostat) Type: Drug
Name: bortezomib Type: Drug
Name: dexamethasone Type: Drug
Overall Status
Recruiting
Summary
The purpose of this study is to evaluate the efficacy and safety of panobinostat in combination with bortezomib and dexamethasone in Japanese patients with relapsed/refractory multiple myeloma.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Patient has a previous diagnosis of multiple myeloma

- Patient requires retreatment for multiple myeloma

- Patient has measurable M component in serum or urine at study screening

Exclusion Criteria:

- Primary refractory disease (patients that never reached at least an minor response for over 60 days under any prior therapy)

- Patient who has been treated by bortezomib before, and did not reach at least a minor response under this therapy, or progressed under it or within 60 days of last dose

- Patient received prior treatment with DAC inhibitors including panobinostat

- Patient has impaired cardiac function, or a prolonged QTc interval at screening ECG

Other protocol-defined inclusion/exclusion criteria may apply.
Locations
Novartis Investigative Site
Nagoya-city, Aichi, Japan
Status: Recruiting
Novartis Investigative Site
Matsuyama, Ehime, Japan
Status: Recruiting
Novartis Investigative Site
Fukuoka-city, Fukuoka, Japan
Status: Recruiting
Novartis Investigative Site
Maebashi-city, Gunma, Japan
Status: Recruiting
Novartis Investigative Site
Shibukawa, Gunma, Japan
Status: Recruiting
Novartis Investigative Site
Kobe-city, Hyogo, Japan
Status: Recruiting
Novartis Investigative Site
Okayama-city, Okayama, Japan
Status: Recruiting
Novartis Investigative Site
Suita-city, Osaka, Japan
Status: Recruiting
Novartis Investigative Site
Tokushima-city, Tokushima, Japan
Status: Recruiting
Novartis Investigative Site
Koto, Tokyo, Japan
Status: Recruiting
Novartis Investigative Site
Shibuya, Tokyo, Japan
Status: Recruiting
Novartis Investigative Site
Tachikawa, Tokyo, Japan
Status: Recruiting
Novartis Investigative Site
Kyoto, Japan
Status: Recruiting
Novartis Investigative Site
Niigata, Japan
Status: Recruiting
Novartis Investigative Site
Tokyo, Japan
Status: Recruiting
Start Date
December 2014
Completion Date
December 2017
Sponsors
Novartis Pharmaceuticals
Source
Novartis
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page