NCT02654990

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 248 (actual)
• Sponsor: pharmaand GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 3 different regimens of panobinostat (20 milligrams \[mg\] thrice a week \[TIW\], 20 mg twice a week \[BIW\], and 10 mg TIW) in combination with subcutaneous bortezomib and dexamethasone and to provide exposure, safety and efficacy data to identify the optimal regimen of panobinostat in a randomized, 3-arm parallel design. This study will also assess the impact of administering subcutaneous bortezomib (in combination with panobinostat and dexamethasone) twice weekly for 4 cycles, and then weekly starting from Cycle 5 until disease progression in participants ≤ 75 years of age. Participants \> 75 years of age will receive subcutaneous bortezomib weekly for the entire treatment period (in combination with panobinostat and dexamethasone) until disease progression. Participants will be treated until disease progression or until they discontinue earlier due to unacceptable toxicity or for other reasons. Participants who discontinued study treatment for reasons other than disease progression will be followed for efficacy every 6 weeks. All participants will be followed for survival until the last participant entering long-term follow-up has completed a 3-year survival follow-up or discontinued earlier.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Panobinostat Capsules	20 mg, 10 mg or 15 mg (for dose reductions only)
DRUG	Bortezomib Injection	1.3 mg/square meter subcutaneous administration. Cycle 1-4: 2 weeks on/1 week off, BIW for participants ≤ 75 years at time of screening; once a week for participants \> 75 years. Cycle 5+: once a week for all participants.
DRUG	Dexamethasone tablets	Pre and 24 hours after bortezomib administration. Participants ≤ 75 years at time of screening: 20 mg/dose participants; \> 75 years: 10 mg/dose.

Timeline

• Start date: 2016-04-27
• Primary completion: 2019-10-18
• Completion: 2022-08-15
• First posted: 2016-01-13
• Last updated: 2024-07-12
• Results posted: 2024-07-12

Locations

80 sites across 22 countries: United States, Australia, Belgium, Brazil, Canada, Czechia, France, Germany, Greece, Hungary, Italy, Lebanon, Netherlands, Norway, Poland, Portugal, Russia, South Korea, Spain, Sweden, Thailand, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study