Efficacy and Safety of LBH589B in Adult Patients With Multiple Myeloma

NCT00445068 | Terminated Phase 2 Results

• 1 other identifier: CLBH589B2203
• Study Type: interventional
• Target: 38
• Locations: 2 countries
• Sites: 29

Brief Summary

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

Conditions

Multiple Myeloma

Keywords

Multiple myeloma; adults; LBH589; refractory

Outcome Measures

Primary Outcomes (1)

• Response Rate (Complete Response(CR) / Partial Response (PR))

  The response (complete response (CR) / partial response (PR)) rate as per Bladé criteria was assessed by the investigator. Response to treatment was evaluated in participants with multiple myeloma (MM) who have received at least two prior lines of therapy and whose disease was refractory to the most recent line of therapy.

  From Start of the Study up to 57 Weeks approximately.

Secondary Outcomes (11)

• Overall Response Rate

  From Start of the Study up to 57 Weeks approximately.

• Clinical Benefit Rate

  From Start of the Study up to 57 Weeks approximately.

• Duration of Response

  From Start of the Study up to 57 Weeks approximately.

• Time to Response

  From Start of the Study up to 57 Weeks approximately.

• Progression Free Survival (PFS)

  From Start of the Study up to 57 Weeks approximately.

Study Arms (1)

Panobinostat

EXPERIMENTAL

Participants received panobinostat 20 milligrams (mg) orally once daily (OD), three times a week on days: 1, 3 and 5, then 8, 10 and 12, then 15, 17 and 19 of each cycle, as part of a 3-week (21 days) treatment cycle. Participants could continue treatment until disease progression or unacceptable toxicity.

Drug: LBH589

Interventions

LBH589 DRUG

Also known as: Panobinostat

Panobinostat

Eligibility Criteria

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

You may qualify if:

• Adults ≥ 18 years old
• Subjects must have signed the consent form before undergoing any study specific screening procedures and before participation in this study. The subject must be fully informed by the investigator of the nature and potential risks of participation in this study.
• Patients must have had a diagnosis of symptomatic multiple myeloma (from IMWG see (Kyle et al,2003) meeting all three of the following criteria:
• Monoclonal immunoglobulin (spike on electrophoresis, or band on immunofixation) on serum or on 24 hour urine.
• Bone marrow (clonal) plasma cells or plasmacytoma

You may not qualify if:

• Subjects must have received at least two prior lines of therapy and be refractory to the most recent line of therapy according to the following definitions: Refractory to most recent line of therapy Defined by disease progression during treatment or within 60 - 100 days after the completion of the most recent line of therapy. This includes the development of disease progression during maintenance or consolidation therapy with high dose glucocorticoids, or any other specific MM therapy Sixty days is counted from the point in time when the first response assessment is performed after completion of the last line of therapy. At a maximum, disease progression should be documented within 100 days after the last day of the last dose of any anti-MM therapy, including if last regimen of the most recent line of therapy was Autologous Stem Cell Transplant (ASCT). Stable disease patients also part of the IMWG definition are not eligible for this trial. At study screening, Progressive Disease (PD) will be assessed by comparing screening values or symptoms in reference to the baseline (values or symptoms) of their last line of therapy. Should a patient have experienced an initial response on their last line of therapy, PD should be assessed in reference to the lowest values of the initial confirmed response Minimal Response(MR) / Partial Response (PR) / Complete Response (CR).
• Disease progression is defined by having one or more of the following:
• \>25% increase in the level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation.
• \>25% increase in 24-hour urinary light chain excretion, which must also be an absolute increase of at least 200 mg/24 h and confirmed on a repeat investigation.
• \>25% increase in plasma cells in a bone marrow aspirate or on bone marrow biopsy, which must also be an absolute increase of at least 10%
• Definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas.
• Development of new bone lesions or soft tissue plasmacytomas (not including compression fracture).
• Development of hypercalcemia (corrected serum calcium \> 11.5 mg/dL or 2.8 mmol/L not attributable to any other cause).
• Subjects must have previously been treated with bortezomib and at least one of the following: lenalidomide or thalidomide
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2
• Patients must have the following hematological laboratory values:
• Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L (or ≥1.0 x 109/L if the neutropenia is clinically related to progressive myeloma with bone marrow infiltration of \> 50% involvement
• Hemoglobin ≥ 8.0 g/dl
• Platelets ≥ 75.0 x 109/L (or ≥ 50.0 x 109/L x if the thrombocytopenia is clinically related to progressive myeloma with bone marrow infiltration \> 50% involvement
• Patients must have the following renal function as shown by :

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (29)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

Aptium Oncology

Berkeley, California, 94704, United States

Location

City of Hope

Duarte, California, 91010, United States

Location

UCSF

San Francisco, California, 94143, United States

Location

Stanford

Stanford, California, 94305, United States

Location

Rocky Mountain Cancer Center

Denver, Colorado, 80218, United States

Location

Christiana Care

Newark, Delaware, 19718, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Rush University

Chicago, Illinois, 60612, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Indiana University

Indianapolis, Indiana, 46203, United States

Location

University of Iowa

Iowa City, Iowa, 52240-1515, United States

Location

Dana Farber

Boston, Massachusetts, 02115, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Hackensack University

Hackensack, New Jersey, 07456, United States

Location

Duke

Durham, North Carolina, 27710, United States

Location

Wake Forest

Winston-Salem, North Carolina, 27157, United States

Location

Metrohealth

Cleveland, Ohio, 44109, United States

Location

Sarah Canon Research Center

Nashville, Tennessee, 37203, United States

Location

Vanderbilt

Nashville, Tennessee, 37212, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390-9179, United States

Location

CTRC

San Antonio, Texas, 78258, United States

Location

Novartis investigative Site

Berlin, Germany

Location

Novartis Investigative Site

Heidelberg, Germany

Location

Novartis Investigative Site

Kiel, Germany

Location

Novartis Investigative Site

Starnberg, Germany

Location

Novartis Investigative Site

Würzburg, Germany

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Panobinostat

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; 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

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2007
• First Posted: March 8, 2007
• Study Start: April 16, 2007
• Primary Completion: May 19, 2008
• Study Completion: December 25, 2009
• Last Updated: July 14, 2021
• Results First Posted: July 14, 2021

Record last verified: 2021-06

Locations

DE (5); US (24)