Efficacy and Safety of LBH589B in Adult Patients With Multiple Myeloma
- Registration Number
- NCT00445068
- Lead Sponsor
- Novartis Pharmaceuticals
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 38
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Panobinostat LBH589 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.
- Primary Outcome Measures
Name Time Method Response Rate (Complete Response(CR) / Partial Response (PR)) From Start of the Study up to 57 Weeks approximately. 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.
- Secondary Outcome Measures
Name Time Method Overall Response Rate From Start of the Study up to 57 Weeks approximately. Overall response rate is the proportion of patients with a best overall response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria (Overall Response (OR) = CR + PR).
Complete Response (CR): Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm Partial Response (PR): At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.Duration of Response From Start of the Study up to 57 Weeks approximately. Duration of response is defined as time between time to first documented response (CR/PR) and time to first documented disease progression or death.
Time to Response From Start of the Study up to 57 Weeks approximately. Time to response is defined as time between Day 1 cycle 1 and time to first documented response (CR/PR).
Progression Free Survival (PFS) From Start of the Study up to 57 Weeks approximately. Progressions free survival is defined as time between Day 1 cycle 1 and time to first documented disease progression or death. Disease progression will be determined as per response criteria.
Time to Peak Concentration (Tmax) of Panobinostat Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8 Tmax is defined as the time at which the Cmax occurs. It will be obtained from the Tmax parameter calculated by WinNonlin®. If there is no measurable Cmax in the subject's pharmacokinetic (PK) profile, then Tmax will be missing for that subject. Tmax will be reported in units of h.
Clinical Benefit Rate From Start of the Study up to 57 Weeks approximately. Clinical benefit rate is defined by the percentage of participants achieving either a confirmed tumor response or stable disease (SD) for at least 24 weeks. Response Criteria in Solid Tumors (RECIST) is a system for measuring tumor shrinkage or progression in terms of the longest dimensions of the tumor on imaging scans such as computerized tomography (CT). A "partial response" requires a decrease of 30% or more, "Progression" requires an increase of at least 20%, and "Stable disease" falls in between these two. All responses have a repeat assessment to confirm the response
Safety and Tolerability From Start of the Study up to 57 Weeks approximately. Adverse Event (AE) are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
Last Observed Plasma Concentration (Clast) of Panobinostat Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8 Clast is defined as the Last observed (quantifiable) plasma concentration (Clast), in units of ng/mL. Blood samples were collected to assess Clast.
Maximum Plasma Concentration (Cmax) of Panobinostat Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8 Cmax is defined as the maximum observed drug concentration observed in plasma over all PK sample concentrations. It will be obtained from the Cmax parameter calculated by WinNonlin®. If there is no measurable concentration in the subject's PK profile, then Cmax will be missing for that subject. Cmax will be reported in units of ng/mL.
Area Under the Plasma Concentration (AUC0-24) of Panobinostat Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8 Area under the curve (AUC) is defined as the area under concentration-time curve as a measure of drug exposure. The area under the plasma concentration-time curve from time zero to 24 hours.
Time of Clast (Tlast) of Panobinostat Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8 Time of Clast (Tlast) will be obtained from the Tlast parameter calculated by WinNonlin®. If there is no measurable concentration in the subject's PK profile, then Tlast will be missing for that participants. Tlast will be reported in units of h.
Trial Locations
- Locations (26)
Aptium Oncology
🇺🇸Berkeley, California, United States
Emory University
🇺🇸Atlanta, Georgia, United States
City of Hope
🇺🇸Duarte, California, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Christiana Care
🇺🇸Newark, Delaware, United States
Stanford
🇺🇸Stanford, California, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Hackensack University
🇺🇸Hackensack, New Jersey, United States
University of Texas Southwestern
🇺🇸Dallas, Texas, United States
Wake Forest
🇺🇸Winston-Salem, North Carolina, United States
Novartis investigative Site
🇩🇪Berlin, Germany
Dana Farber
🇺🇸Boston, Massachusetts, United States
CTRC
🇺🇸San Antonio, Texas, United States
Rush University
🇺🇸Chicago, Illinois, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Duke
🇺🇸Durham, North Carolina, United States
Metrohealth
🇺🇸Cleveland, Ohio, United States
UCSF
🇺🇸San Francisco, California, United States
Sarah Canon Research Center
🇺🇸Nashville, Tennessee, United States
Vanderbilt
🇺🇸Nashville, Tennessee, United States
Mayo Clinic
🇺🇸Scottsdale, Arizona, United States
Rocky Mountain Cancer Center
🇺🇸Denver, Colorado, United States
Novartis Investigative Site
🇩🇪Wuerzburg, Germany