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Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

Description

Summary

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

Official Title

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

Keywords

Multiple Myeloma Myeloma Lenalidomide Revlimid Dexamethasone LBH589 Combination Panobinostat Dexamethasone acetate Dexamethasone 21-phosphate BB 1101

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

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

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT00532675
Phase
Phase 1
Study Type
Interventional
Last Updated
February 2017