Safety Study of LBH589 When Given in Combination With Lenalidomide and Dexamethasone in Adult Patients With Multiple Myeloma.

December 16, 2020 updated by: Novartis Pharmaceuticals

A Phase Ib, Multi-center, Open-label, Dose-escalation Study of Oral LBH589 When Administered in Combination With Oral Lenalidomide & Dexamethasone in Adult Patients With Multiple Myeloma

This study will evaluate the safety of LBH589 given in combination with lenalidomide and dexamethasone in adult patients with multiple myeloma

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Novartis Investigative Site
    • Victoria
      • Prahran, Victoria, Australia, 3181
        • Novartis Investigative Site
  • France
      • Lille, France, 59037
        • Novartis Investigative Site
      • Montpellier cedex 5, France, 34295
        • Novartis Investigative Site
      • Nantes, France, 44035
        • Novartis Investigative Site
  • Spain
    • Castilla Y Leon
      • Salamanca, Castilla Y Leon, Spain, 37007
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spain, 46026
        • Novartis Investigative Site
  • United States
    • California
      • San Francisco, California, United States, 94143
        • UCSF Medical Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University School of Medicine/Winship Cancer Institute Dept. of Winship Cancer Inst.
    • New York
      • New York, New York, United States, 10011
        • St. Vincent's Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Patients must have a diagnosis of active multiple myeloma
  • Patients must have received at least one prior line of therapy and their disease has relapsed..
  • Patients must be suitable for treatment with lenalidomide & dexamethasone.
  • Adults ≥ 18 years old
  • ECOG Performance Status ≤ 2
  • Life expectancy > 12 weeks
  • Patients must have acceptable neutrophil and platelet counts as well as adequate kidney and liver function.
  • Able to sign informed consent and to comply with the protocol

Exclusion criteria:

  • Primary refractory MM
  • Peripheral neuropathy ≥ CTCAE grade 2
  • Impaired cardiac function or clinically significant cardiac diseases
  • Impairment of GI function or GI disease that may significantly alter the absorption of LBH589
  • Patients with diarrhea > CTCAE grade 1
  • Patients using medications that have a relative risk of prolonging the QT interval
  • Concomitant use of CYP3A4 inhibitors
  • Patients with a history of deep vein thrombosis or thromboembolism within < 6 months prior to starting study treatment
  • Patients who have undergone major surgery ≤ 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy
  • Women who are pregnant or breast feeding or women of childbearing potential (WOCBP) not using 2 reliable forms of birth control
  • Male patients whose sexual partners are WOCBP and who are unable to use a latex condom during sexual contact (even if they have undergone a vasectomy)
  • Patients with any significant history of non-compliance to medical regimens or unwilling or unable to comply with the instructions given to him/her by the study staff.

Other protocol defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PAN 5 mg
Panobinostat 5 mg
Drug: LBH589
PAN 5 mg and PAN 20 mg capsules
Other Names:
  • Panobinostat, PAN
Combination product: Lenalidomide
Lenalidomide 5mg or 25 mg
Experimental: PAN 10 mg
Panobinostat 10 mg
Drug: LBH589
PAN 5 mg and PAN 20 mg capsules
Other Names:
  • Panobinostat, PAN
Combination product: Lenalidomide
Lenalidomide 5mg or 25 mg
Experimental: PAN 20 mg
Panobinostat 20 mg
Drug: LBH589
PAN 5 mg and PAN 20 mg capsules
Other Names:
  • Panobinostat, PAN
Combination product: Lenalidomide
Lenalidomide 5mg or 25 mg
Experimental: PAN 25 mg
Panobinostat 25 mg
Drug: LBH589
PAN 5 mg and PAN 20 mg capsules
Other Names:
  • Panobinostat, PAN
Combination product: Lenalidomide
Lenalidomide 5mg or 25 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the highest and safest dose of LBH589 when it is administered in combination with lenalidomide & dexamethasone
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability assessed by monitoring of adverse events, serious adverse events and laboratory parameters To characterize the pharmacokinetic profile of the study treatment To characterize the pharmacodynamic profile of the study treatment
Time Frame: Da1 to Day 3 (week 1 of first cycle)
Da1 to Day 3 (week 1 of first cycle)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2008

Primary Completion (Actual)

November 8, 2017

Study Completion (Actual)

November 8, 2017

Study Registration Dates

First Submitted

September 18, 2007

First Submitted That Met QC Criteria

September 18, 2007

First Posted (Estimate)

September 20, 2007

Study Record Updates

Last Update Posted (Actual)

December 19, 2020

Last Update Submitted That Met QC Criteria

December 16, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLBH589B2206
  • 2006-007030-35 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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