Safety Study of LBH589 When Given in Combination With Lenalidomide and Dexamethasone in Adult Patients With Multiple Myeloma.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00532675
First received: September 18, 2007
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

This study will evaluate the safety of LBH589 given in combination with lenalidomide and dexamethasone in adult patients with multiple myeloma


Condition Intervention Phase
Multiple Myeloma
Drug: LBH589
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • To determine the highest and safest dose of LBH589 when it is administered in combination with lenalidomide & dexamethasone [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety and tolerability assessed by monitoring of adverse events, serious adverse events and laboratory parameters To characterize the pharmacokinetic profile of the study treatment To characterize the pharmacodynamic profile of the study treatment [ Time Frame: Da1 to Day 3 (week 1 of first cycle) ] [ Designated as safety issue: Yes ]

Enrollment: 46
Study Start Date: April 2008
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Panobinostat Drug: LBH589

  Eligibility

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

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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

  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: NCT00532675

Locations
United States, California
University of California San Francisco UCSF MC at Parnassus (SC)
San Francisco, California, United States, 94101
United States, Georgia
Emory University School of Medicine/Winship Cancer Institute Dept. of Winship Cancer Inst.
Atlanta, Georgia, United States, 30322
United States, New York
St. Vincent's Comprehensive Cancer Center
New York, New York, United States, 10011
Australia, Queensland
Novartis Investigative Site
South Brisbane, Queensland, Australia, 4101
Novartis Investigative Site
Wooloongabba, Queensland, Australia, 4102
Australia, Victoria
Novartis Investigative Site
Prahran, Victoria, Australia, 3181
France
Novartis Investigative Site
Lille, France, 59037
Novartis Investigative Site
Montpellier cedex 5, France, 34295
Novartis Investigative Site
Nantes, France, 44035
Spain
Novartis Investigative Site
Salamanca, Castilla y Leon, Spain, 37007
Novartis Investigative Site
Valencia, Comunidad Valenciana, Spain, 46026
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00532675     History of Changes
Other Study ID Numbers: CLBH589B2206, 2006-007030-35
Study First Received: September 18, 2007
Last Updated: April 3, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: Ministry of Health
Spain: Spanish Agency of Medicines

Keywords provided by Novartis:
Myeloma
Multiple Myeloma
Lenalidomide
Revlimid
Dexamethasone
LBH589
Combination

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Lenalidomide
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on July 28, 2014