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A Phase II Study Of Oral LBH589 In Adult Patients With Multiple Myeloma Who Have Received At Least Two Prior Lines Of Therapy And Whose Disease Is Refractory To The Most Recent Line Of Therapy


Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

A Phase II Study Of Oral LBH589 In Adult Patients With Multiple Myeloma Who Have Received At Least Two Prior Lines Of Therapy And Whose Disease Is Refractory To The Most Recent Line Of Therapy

Inclusion Criteria


Inclusion criteria:

1. Adults ≥ 18 years old

2. Diagnosis of symptomatic multiple myeloma (per IMWG see Kyle et al 2003)

3. Subjects must have received at least two prior lines of therapy and be refractory to
the most recent line of therapy

4. Subjects must have previously been treated with : bortezomib or lenalidomide

5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2

6. Patients must have adequate laboratory values

7. Baseline left ventricular ejection fraction LVEF ≥ the lower limit of the
institutional normal

Exclusion criteria:

1. Prior therapy with a histone deacetylase inhibitor (HDAC)

2. Impaired cardiac function or clinically significant cardiac diseases

3. Impairment of gastrointestinal function (GI) function or GI disease that may
significantly alter the absorption of LBH589

4. Patients with unresolved diarrhea > Common Terminology Criteria for Adverse Events
(CTCAE) grade 1

5. Concomitant use of certain medications

6. Patients who have received chemotherapy, radiation therapy or any investigational
drugs, bortezomib or other immunomodulatory therapy or immunotherapy ≤ 3 weeks prior
to starting study drug or who have not recovered from side effects of such therapy

7. Patients who have received steroids ≤ 2 weeks prior to starting study treatment or
who have not recovered from side effects of such therapy.

8. Patients who have received high-dose corticosteroids as the only component of their
most recent line of therapy

9. Patients who have undergone major surgery ≤ 4 weeks prior to starting study drug or
who have not recovered from side effects of such therapy

10. Women who are pregnant or breast feeding or women of childbearing potential not using
an effective method of birth control.

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate (complete response(CR) / partial response (PR))

Outcome Description:

rate assessed by Bladé criteria 1998

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CLBH589B2203

NCT ID:

NCT00445068

Start Date:

April 2007

Completion Date:

December 2009

Related Keywords:

  • Multiple Myeloma
  • Multiple myeloma
  • adults
  • LBH589
  • refractory
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

University of IowaIowa City, Iowa  52242
University of MichiganAnn Arbor, Michigan  48109-0624
UCSFSan Francisco, California  941430324
Rocky Mountain Cancer CenterDenver, Colorado  80218
City of HopeDuarte, California  91010
Emory UniversityAtlanta, Georgia  30322
University of ChicagoChicago, Illinois  60637
Washington UniversitySt. Louis, Missouri  63110
Mayo ClinicScottsdale, Arizona  
Hackensack UniversityHackensack, New Jersey  07601
Moffitt Cancer CenterTampa, Florida  33612
Indiana UniversityIndianapolis, Indiana  46202
CTRCSan Antonio, Texas  78229
Dana FarberBoston, Massachusetts  02115-6084
Rush UniversityChicago, Illinois  60612
University of Texas SouthwesternDallas, Texas  75390
Aptium OncologyBerkeley, California  94704
StanfordStanford, California  94305
Christiana CareNewark, Delaware  19718
DukeDurham, North Carolina  27710
Wake ForestWinston-Salem, North Carolina  27157
MetrohealthCleveland, Ohio  44109
VanderbiltNashville, Tennessee  37212
Sarah Canon Research CenterNashville, Tennessee  37203