Protocol Summary

Protocol No.: OCR15239

Sponsor Protocol No.: CLBH589D2222

Study 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

Principal Investigator(s)
Moreb, Jan

Objective
The purpose of this study is to investigate the safety and efficacy of three different regimens of Panobinostat 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 patients = 75 years of age will receive for the entire treatment period subcutaneous Bortezomib weekly (in combination with Panobinostat and Dexamethasone) until disease progression.

Phase: Phase II

Age Group: Adult

Scope: National

Treatment
Arm A - 20mg PAN TIW
20mg panobinostat three times a week, 2 weeks on/1week of in combination with s.c. bortezomib and p.o. dexamethasone

Arm B - 20mg PAN BIW
20mg panobinostat twice a week, 2 weeks on/1 week off in combination with s.c. bortezomib and p.o. dexamethasone

Arm C - 10mg PAN TIW
10mg panobinostat three times a week 2 weeks on/1 week off in combination with s.c. bortezomib and p.o. dexamethasone

Detailed Eligibility
INCLUSION CRITERIA:
1. Ages 18 years old and older
2. Multiple myeloma as per IMWG 2014 definition
3. Requiring treatment for relapsed or relapsed/refractory disease
4. Measurable disease based on central protein assessment
5. 1 to 3 prior lines of therapy
6. Prior IMiD exposure
7. Acceptable lab values prior to starting study treatment

EXCLUSION CRITERIA:
1. Primary refractory myeloma
2. Refractory to bortezomib
3. Concomitant anti-cancer therapy (other then BTZ/Dex and bisphosphonates
4. Prior treatment with DAC inhibitors
5. Clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 month prior to screening)
6. Unresolved diarrhea >= CTCAE grade 2 or presence of medical condition associated with chronic diarrhea (such as irritable bowel syndrome, inflammatory bowel disease)

**Other protocol-defined inclusion/exclusion criteria may apply.

Applicable Disease Sites
Multiple Myeloma

Participating Institutions
UF Gainesville : Diane Richardson

Contact
Diane Richardson
Phone: +1 352-273-6844

Email: drichardson@ufl.edu