Status:
COMPLETED
Study of Panobinostat in Combination With Bortezomib and Dexamethasone in Japanese Patients With Relapsed/Refractory Multiple Myeloma
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Relapse/Refractory Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study was to evaluate the efficacy and safety of panobinostat in combination with bortezomib and dexamethasone in Japanese patients with relapsed/refractory multiple myeloma.
Eligibility Criteria
Inclusion
- Patient had a previous diagnosis of multiple myeloma
- Patient required retreatment for multiple myeloma
- Patient had measurable M component in serum or urine at study screening
Exclusion
- Primary refractory disease (patients that never reached at least an minor response for over 60 days under any prior therapy)
- Patient who had 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 had impaired cardiac function, or a prolonged QTc interval at screening ECG
Key Trial Info
Start Date :
December 16 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 25 2018
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT02290431
Start Date
December 16 2014
End Date
December 25 2018
Last Update
November 18 2019
Active Locations (20)
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1
Novartis Investigative Site
Nagoya, Aichi-ken, Japan, 467-8602
2
Novartis Investigative Site
Kashiwa, Chiba, Japan, 277-8567
3
Novartis Investigative Site
Matsuyama, Ehime, Japan, 790-8524
4
Novartis Investigative Site
Fukuoka, Fukuoka, Japan, 812-8582