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Efficacy of Panobinostat in Patients With Relapsed and Bortezomib-refractory Multiple Myeloma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Efficacy of Panobinostat in Patients With Relapsed and Bortezomib-refractory Multiple Myeloma

A Phase II, Multi-center, Single Arm, Open Label Study of Panobinostat in Combination With Bortezomib and Dexamethasone in Patients With Relapsed and Bortezomib-refractory Multiple Myeloma

NCT01083602•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study is designed to assess the effectiveness of the combination of Panobinostat plus Bortezomib and Dexamethasone in patients with relapsed and bortezomib refractory Multiple Myeloma.

Detailed Description

This is a phase II, two stage, single arm, open label, multi-center study of oral PAN in combination with BTZ/Dex in patients with relapsed and refractory multiple myeloma, who are bortezomib-refractory and have received at least 2 prior lines of therapy. Patients must have been exposed to an iMID (lenalidomide or thalidomide) and progressed on or within 60 days of their last BTZ-containing line of therapy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patient has a previous diagnosis of multiple myeloma, based on IMWG 2003 definitions. All three of the following criteria must have been met:
•* Monoclonal immunoglobulin (M component) on electrophoresis, and on immunofixation on serum or on total 24 hour urine
•* Bone marrow (clonal) plasma cells ≥ 10% or biopsy proven plasmacytoma
•* Related organ or tissue impairment (CRAB symptoms: anemia, hypercalcemia, lytic bone lesions, renal insufficiency, hyperviscosity, amyloidosis or recurrent infections)
•2. Patient must have relapsed and refractory MM and must require treatment for the relapsed disease
•3. Patients must have received at least 2 prior lines of therapy which include an IMiD (thalidomide or lenalidomide)
•4. Patient must be refractory to the last bortezomib containing line of therapy given in the relapsed and refractory setting defined as:
•* having progressed on or within 60 days of the last bortezomib-containing line of therapy
•5. Patient has measurable disease on M protein at study screening defined by at least one of the following measurements as per thresholds clarified in IMWG 2003 disease definitions (Kyle, et al 2003):
•* Serum M-protein ≥ 1 g/dL (≥ 10 g/L)
+17 more criteria

Exclusion Criteria

•1. Primary refractory disease (patients that never reached at least an MR for over 60 days under any prior therapy)
•2. Patients who have a history of prior MM treatment with a DAC inhibitor including panobinostat
•3. Patients who have had prior allogeneic stem cell transplantation and show evidence of active graft-versus-host disease that requires immunosuppressive therapy
•4. Peripheral neuropathy ≥ CTCAE grade 2
•5. Patients who will need valproic acid for any medical condition during the study or within 5 days prior to the first administration of study drug / treatment or who cannot be switch to safely to alternative anti-epileptic medication
•6. Patients who have impaired cardiac function including any of the following:
•* Congenital long QT syndrome, complete left bundle branch block or use of a permanent cardiac pacemaker, history or presence of ventricular tachyarrhythmias, clinically significant resting bradycardia (\< 50 beats per minute). Right bundle branch block + left anterior hemiblock (bifascicular block)
•* QTcF \> 450 msec on screening ECG
•* Previous history of angina pectoris or acute MI within 6 months
•* Congestive heart failure (New York Heart Association functional classification III-IV)
+11 more criteria

Locations (13)

University of California at Los Angeles

Los Angeles, California, United States

Stanford University Medical Center Division of Hematology

Stanford, California, United States

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, United States

Emory University School of Medicine/Winship Cancer Institute Dept. of Winship Cancer Inst.

Atlanta, Georgia, United States

Georgia Regents University MedCollege of GA Cancer Ctr 2

Augusta, Georgia, United States

Hematology/Oncology of the North Shore Orchard Healthcare Res. Inc.

Skokie, Illinois, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Somerset Hematology Oncology Associates Somerset Hema Oncol Assoc (2)

Somerset, New Jersey, United States

Montefiore Medical Center

The Bronx, New York, United States

Duke University Medical Center Dept. of DUMC (4)

Durham, North Carolina, United States

Key Dates

Start Date

June 1, 2010

Primary Completion Date

February 1, 2014

Completion Date

February 1, 2014

Last Updated

December 21, 2017

Enrollment

ACTUAL participants

Conditions

Relapsed and Bortezomib Refractory Multiple MyelomaRefractory Multiple MyelomaMultiple Myeloma in Relapse

Interventions

panobinostat

DRUG

bortezomib

DRUG

dexamethasone

DRUG

A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma

NCT04973605

Relapsed/Refractory Multiple Myeloma

View study

RECRUITINGPHASE1

Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)

NCT05862012

Relapsed/Refractory Multiple Myeloma

View study

RECRUITINGPHASE2

Elranatamab in R/R Multiple Myeloma

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 21, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Efficacy of Panobinostat in Patients With Relapsed and Bortezomib-refractory Multiple Myeloma

Inclusion Criteria

Exclusion Criteria

A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma

Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)

Elranatamab in R/R Multiple Myeloma

A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

A Study of Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) Treated With T-cell Redirectors Outside of Clinical Trials

A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regimens in Participants With Relapsed Refractory Multiple Myeloma (DURGA-4)