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:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00532675
First received: September 18, 2007
Last updated: March 25, 2013
Last verified: March 2013
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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:
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Dexamethasone sodium phosphate
Lenalidomide
U.S. FDA Resources
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: | 55 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (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
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, 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: | March 25, 2013 |
| 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 June 18, 2013