Efficacy and Safety of LBH589B in Adult Patients With Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00445068
Recruitment Status : Terminated
First Posted : March 8, 2007
Last Update Posted : May 10, 2013
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This study will evaluate the efficacy and safety of LBH589B in adult patients with multiple myeloma who have received at least two prior therapies and are refractory to their last therapy. Patients must have received in prior therapy either bortezomib or lenalidomide

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: LBH589 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: Panobinostat Drug: LBH589
Other Name: Panobinostat

Primary Outcome Measures :
  1. Response rate (complete response(CR) / partial response (PR))
    rate assessed by Bladé criteria 1998

  2. Efficacy responses assessments [ Time Frame: Baseline, every 3 weeks ]
    Change from baseline for the following parameters will be measured: Serum M-protein, Serum FreeLiteTM, Bence Jones protein by a 24-hour urine collection for urine light chain.

Secondary Outcome Measures :
  1. Overall response rate
    Per Bladé criteria

  2. Clinical benefit rate
    Per Bladé criteria

  3. Duration of response
    Per Bladé criteria

  4. Time to response
    Per Bladé criteria

  5. Progression free survival (PFS
    Per Bladé criteria

  6. Safety and tolerability
    This includes adverse and serious adverse events, pharmacokinetics per Bladé criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00445068

  Show 29 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals Identifier: NCT00445068     History of Changes
Other Study ID Numbers: CLBH589B2203
First Posted: March 8, 2007    Key Record Dates
Last Update Posted: May 10, 2013
Last Verified: May 2013

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action