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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
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 Dexamethasone acetate Panobinostat 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, United States
  • St. Vincent's Comprehensive Cancer Center
    New York, New York, 10011, United States
  • 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
  • Novartis Investigative Site
    South Brisbane, Queensland, 4101, Australia
  • Novartis Investigative Site
    Prahran, Victoria, 3181, Australia

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 1, 2017