Efficacy and Safety of LBH589B in Adult Patients With Multiple Myeloma

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00445068
First received: March 7, 2007
Last updated: May 8, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Multiple Myeloma
Drug: LBH589
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Response rate (complete response(CR) / partial response (PR)) [ Designated as safety issue: No ]
    rate assessed by Bladé criteria 1998

  • Efficacy responses assessments [ Time Frame: Baseline, every 3 weeks ] [ Designated as safety issue: No ]
    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:
  • Overall response rate [ Designated as safety issue: No ]
    Per Bladé criteria

  • Clinical benefit rate [ Designated as safety issue: No ]
    Per Bladé criteria

  • Duration of response [ Designated as safety issue: No ]
    Per Bladé criteria

  • Time to response [ Designated as safety issue: No ]
    Per Bladé criteria

  • Progression free survival (PFS [ Designated as safety issue: No ]
    Per Bladé criteria

  • Safety and tolerability [ Designated as safety issue: Yes ]
    This includes adverse and serious adverse events, pharmacokinetics per Bladé criteria


Enrollment: 38
Study Start Date: April 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Panobinostat Drug: LBH589
Other Name: Panobinostat

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445068

  Show 29 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00445068     History of Changes
Other Study ID Numbers: CLBH589B2203
Study First Received: March 7, 2007
Last Updated: May 8, 2013
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Australia: Department of Health and Ageing Therapeutic Goods Administration
Spain: Spanish Agency of Medicines
Netherlands: Medicines Evaluation Board (MEB)
Italy: Ministry of Health
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Novartis:
Multiple myeloma
adults
LBH589
refractory

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

ClinicalTrials.gov processed this record on October 23, 2014