for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:



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


Multiple Myeloma Myeloma Lenalidomide Revlimid Dexamethasone LBH589 Combination Neoplasms, Plasma Cell Dexamethasone acetate Panobinostat BB 1101


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


  • University of California San Francisco UCSF MC at Parnassus (SC)
    San Francisco California 94101 United States
  • 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


in progress, not accepting new patients
Start Date
Completion Date
Novartis Pharmaceuticals
Phase 1
Study Type
Last Updated
October 13, 2017