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

NCT00532675 | Completed Phase 1 FDA Drug

• 2 other identifiers: CLBH589B22062006-007030-35
• Study Type: interventional
• Target: 46
• Locations: 4 countries
• Sites: 10

Brief Summary

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

Conditions

Multiple Myeloma

Keywords

Myeloma; Multiple Myeloma; Lenalidomide; Revlimid; Dexamethasone; LBH589; Combination

Outcome Measures

Primary Outcomes (1)

• To determine the highest and safest dose of LBH589 when it is administered in combination with lenalidomide & dexamethasone

  24 weeks

Secondary Outcomes (1)

• 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

  Da1 to Day 3 (week 1 of first cycle)

Study Arms (4)

PAN 5 mg

EXPERIMENTAL

Panobinostat 5 mg

Drug: LBH589; Combination Product: Lenalidomide

PAN 10 mg

EXPERIMENTAL

Panobinostat 10 mg

Drug: LBH589; Combination Product: Lenalidomide

PAN 20 mg

EXPERIMENTAL

Panobinostat 20 mg

Drug: LBH589; Combination Product: Lenalidomide

PAN 25 mg

EXPERIMENTAL

Panobinostat 25 mg

Drug: LBH589; Combination Product: Lenalidomide

Interventions

LBH589 DRUG

PAN 5 mg and PAN 20 mg capsules

Also known as: Panobinostat, PAN

PAN 10 mg; PAN 20 mg; PAN 25 mg; PAN 5 mg

Lenalidomide COMBINATION_PRODUCT

Lenalidomide 5mg or 25 mg

PAN 10 mg; PAN 20 mg; PAN 25 mg; PAN 5 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (10)

UCSF Medical Center

San Francisco, California, 94143, United States

Location

Emory University School of Medicine/Winship Cancer Institute Dept. of Winship Cancer Inst.

Atlanta, Georgia, 30322, United States

Location

St. Vincent's Comprehensive Cancer Center

New York, New York, 10011, United States

Location

Novartis Investigative Site

South Brisbane, Queensland, 4101, Australia

Location

Novartis Investigative Site

Prahran, Victoria, 3181, Australia

Location

Novartis Investigative Site

Lille, 59037, France

Location

Novartis Investigative Site

Montpellier, 34295, France

Location

Novartis Investigative Site

Nantes, 44035, France

Location

Novartis Investigative Site

Salamanca, Castille and León, 37007, Spain

Location

Novartis Investigative Site

Valencia, Valencia, 46026, Spain

Location

Related Links

• Results for CLBH589B2206 can be found on the Novartis Clinical Trial Results Website

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Panobinostat; Lenalidomide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hydroxamic Acids; Hydroxylamines; Amines; Organic Chemicals; Hydroxy Acids; Carboxylic Acids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Isoindoles

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2007
• First Posted: September 20, 2007
• Study Start: April 22, 2008
• Primary Completion: November 8, 2017
• Study Completion: November 8, 2017
• Last Updated: December 19, 2020

Record last verified: 2020-02

Locations

FR (3); US (3); AU (2); ES (2)