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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:
ClinicalTrials.gov Identifier:
NCT00532675
First Posted: September 20, 2007
Last Update Posted: October 16, 2017
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.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  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: Intervention Model: Single Group Assignment
Masking: None (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 ( Novartis Pharmaceuticals ):

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 ]

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) ]

Enrollment: 46
Actual Study Start Date: April 22, 2008
Estimated Study Completion Date: December 31, 2018
Estimated Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Panobinostat Drug: LBH589

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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
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

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00532675     History of Changes
Other Study ID Numbers: CLBH589B2206
2006-007030-35 ( EudraCT Number )
First Submitted: September 18, 2007
First Posted: September 20, 2007
Last Update Posted: October 16, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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
Lenalidomide
Panobinostat
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents