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Panobinostat/Bortezomib/Dexamethasone in Relapsed or Relapsed-and-refractory Multiple Myeloma — PANORAMA_3  

Multiple Myeloma Clinical Trial

Official title:
A Multicenter, Randomized, Open-label Phase 2 Study Evaluating the Safety and Efficacy of Three Different Regimens of Oral Panobinostat in Combination With Subcutaneous Bortezomib and Oral Dexamethasone in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma Who Have Been Previously Exposed to Immunomodulatory Agents

Clinical Trial Summary

NOTE: The study data was transferred to zr pharma& following the divestment of Panobinostat to pharma&. Prior to study completion under the sponsorship of Secura Bio, the study was initiated and conducted in part under the sponsorship of Novartis. The purpose of this study is to investigate the safety and efficacy of three different regimens of PAN (20 mg TIW, 20 mg BIW, and 10 mg TIW) in combination with s.c. BTZ and Dex and to provide exposure, safety and efficacy data to identify the optimal regimen of PAN in a randomized, 3-arm parallel design. This study will also assess the impact of administering s.c. BTZ (in combination with PAN and Dex) twice weekly for 4 cycles, and then weekly starting from Cycle 5 until disease progression in patients ≤ 75 years of age. Patients > 75 years of age will receive for the entire treatment period s.c. BTZ weekly (in combination with PAN and Dex) until disease progression. Patients will be treated until disease progression or until they discontinue earlier due to unacceptable toxicity or for other reasons. Patients who discontinued study treatment for reasons other than disease progression will be followed for efficacy every 6 weeks. All patients will be followed for survival until the last patient entering long-term follow-up has completed a 3-year survival follow-up or discontinued earlier.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02654990
Study type Interventional
Source pharmaand GmbH
Contact
Status Completed
Phase Phase 2
Start date April 27, 2016
Completion date August 15, 2022
View Details
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