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

Use our guide to learn which trials are right for you!

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
11
sites
Gainesville, Florida 32610
Principal Investigator: Jan S. Moreb
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Jacob Laubach
Phone: 617-632-3352
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
?
mi
from
Boston, MA
Click here to add this to my saved trials
1717 13
Everett, Washington 98201
Principal Investigator: Jason Lukas
Phone: 425-297-5500
?
mi
from
Everett, WA
Click here to add this to my saved trials
Fayetteville, Arkansas 72703
Principal Investigator: J. Thaddeus Beck
Phone: 479-936-9900
?
mi
from
Fayetteville, AR
Click here to add this to my saved trials
Fort Collins, Colorado 80528
Principal Investigator: Steven R. Schuster
?
mi
from
Fort Collins, CO
Click here to add this to my saved trials
Lake Success, New York 11042
Principal Investigator: Morton Coleman
Phone: 516-488-2918
?
mi
from
Lake Success, NY
Click here to add this to my saved trials
Los Angeles, California 90017
Principal Investigator: Boris Bagdasarian
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
500 S Preston St
Louisville, Kentucky
(502) 852-5555
Principal Investigator: Maxwell Krem
Phone: 502-217-8273
University of Louisville The University of Louisville is a state supported research university located in...
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Morgantown, West Virginia 26506
Principal Investigator: Abraham Kanate
?
mi
from
Morgantown, WV
Click here to add this to my saved trials
Prahran, Victoria
?
mi
from
Prahran,
Click here to add this to my saved trials