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

Official Title

A Multicentre, 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


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.

Trial Description

Primary Outcome:

  • Overall response rate (ORR) up to 8 cycles
Secondary Outcome:
  • ORR throughout study
  • individual immunophenotypic complete response (CR) rate
  • Progression-free survival
  • Maximum plasma concentration (Cmax) for panobinostat (PAN) and bortezomib (BTZ)
  • Time to progression
  • Time to response
  • Duration of response (DOR)
  • European Organization of Research and Treatment of Cancer Quality of Life core 30-item questionnaire scores over time compared
  • individual stringent CR rate
  • individual CR rate
  • overall survival
  • individual Very Good Partial Response rate
  • Functional Assessment of Cancer Therapy / Gynecologic Oncology Group - Neurotoxicity scale scores over time
  • Time to reach Cmax for PAN and BTZ
  • Minimum observed plasma concentration (Cmin) for PAN and BTZ
  • Observed plasma concentration 24 hours after single and multiple dose administration of PAN and BTZ

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