For Healthcare Professionals

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

clipboard-pencil

About the study

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.
user-3

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. multiple myeloma as per IMWG 2014 definition
  2. requiring treatment for relapsed or relapsed/refractory disease
  3. measurable disease based on central protein assessment
  4. 1 to 4 prior lines of therapy
  5. prior IMiD exposure
  6. acceptable lab values prior to randomization

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 months prior to randomization)
  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.
pin location

Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-888-669-6682Email iconEmail Study Center

Study’s details


Contition

Multiple Myeloma

Age

18+

Phase

Phase 2

Participants needed

249

Est. Completion Date

May 2024

Treatment type

Interventional


Sponsor

SecuraBio

ClinicalTrials.gov identifier

NCT02654990

Study number

CLBH589D2222

Understanding Clinical Trials


Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?
Vector

Interested?

Sign up to save your favorites, 
receive newsletters, resources, and alerts 
about clinical trials related to your conditions of interest.