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

Status:	Recruiting
Conditions:	Blood Cancer, Hematology, Hematology
Therapuetic Areas:	Hematology, Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	4/6/2019
Start Date:	April 27, 2016
End Date:	December 15, 2022
Contact:	Novartis Pharmaceuticals
Email:	novartis.email@novartis.com
Phone:	1-888-669-6682

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

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.

Inclusion Criteria:

- multiple myeloma as per IMWG 2014 definition

- requiring treatment for relapsed or relapsed/refractory disease

- measurable disease based on central protein assessment

- 1 to 4 prior lines of therapy

- prior IMiD exposure

- acceptable lab values prior to randomization

Exclusion Criteria:

- primary refractory myeloma

- refractory to bortezomib

- concomitant anti-cancer therapy (other then BTZ/Dex and bisphosphonates

- prior treatment with DAC inhibitors

- Clinically significant, uncontrolled heart disease and/or recent cardiac event (within
6 months prior to randomization)

- 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.

We found this trial at

sites

Highlands Oncology Group, P.A.

Fayetteville, Arkansas 72703

Principal Investigator: J. Thaddeus Beck

Phone: 479-936-9900

from

Fayetteville, AR