Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Dexamethasone

Bortezomib

Dexamethasone acetate

Panobinostat

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Histone Deacetylase Inhibitors

Enzyme Inhibitors

Panobinostat was administered 3x week ( 2 weeks on 1 week off)

Bortezomib was administered 2 x week ( 2weeks on 1 week off)

Dexamethasone was adminstered on day of Bortezomib and the day after Bortezomib administration

Placebo was administered 3x week ( 2 weeks on 1 week off)

Placebo

Novartis Pharmaceuticals

Panobinostat (LBH589) is a highly potent pan-deacetylase inhibitor (pan-DACi), inclusive of HDAC6, which disrupts aggresome function, promotes accumulation of cytotoxic misfolded protein aggregates and triggers myeloma cell death. Combination of pan-DAC and protease inhibition by co-treatment with panobinostat (PAN) and bortezomib (BTZ) has demonstrated synergistic cytotoxicity in vitro and in vivo in pre-clinical experiments. Furthermore, clinical experience in advanced multiple myeloma (MM) patients treated by oral panobinostat and i.v bortezomib ± dexamethasone showed very encouraging results for efficacy and manageable toxicity profile.

Given the medical need for improved treatment strategies for patients with previously treated and relapsed MM, the purpose of this prospective, multinational, randomized, double-blind, placebo-controlled, parallel group Phase III study is to compare the results in progression-free survival of 2 combination therapies, panobinostat with bortezomib and dexamethasone or placebo with bortezomib and dexamethasone, in patients with previously treated MM whose disease has recurred or progressed.

Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma

A Multicenter, Randomized, Double Blind, Placebo Controlled Phase III Study of Panobinostat in Combination With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma

Best overall response based on mEBMT criteria per investigator assessment

Higher values in the disease symptoms and side effects of treatment scores indicate worsening. Higher scores in the future perspective and body image scores indicate improvement. LS Means and SEM are estimated from the repeated measures model. Following factors and covariates are included in the repeated measurement model: time, treatment, treatment by time interaction, number of prior lines of anti-MM therapy (1/ 2 and 3), prior use of BTZ (Yes/ No), baseline score.Disease Symptom is the sum of 20 questions, total score ranges from 0 (best possible outcome) to 100 (worst possible outcome)", All subscales of EORTC QLQ-MY20 have the same score range of 0 -100. Decrease in symptom scores from baseline indicate improvement in symptoms.

The EORTC QLQ-C30 measures functional dimensions (physical, role, emotional, cognitive, and social), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), six single-item symptom scales (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea and financial impact) and a global health status/QoL scale. Disease Symptom is the sum of 30 questions, total score ranges from 0 (best possible outcome) to 100 (worst possible outcome)", All subscales of EORTC QLQ-C30 have the same score range of 0 -100. For global health status and other functional scales,an increase from baseline indicates improvement of QoL. Whereas for symptoms scales, fatigue, dyspnea, insomnia, appetite loss, constipation and diarrhea, decrease in scores from baseline indicate improvement in symptoms.

Chronic Illness Therapy (FACIT) Measurement System and focuses on four general quality of life domains for physical well being, functional well-being, social/family well-being, and emotional well-being, and includes additional items to characterize treatment-related neurotoxicity. Higher subscales/total scores represent higher QOL. In the case of the neurotoxicity subscale, lower scores correspond to higher neurotoxicity. The recall period referenced in the questionnaire is the past 7 days.Ranges for FACT-G subscales are as follows:.PWB, scale 0 -28, , NtxS scale 0-44, FACT/GOG-Ntx trial outcome index scale is 0-100 and FACT-G scale is also scaled 0-100. An increase from baseline in these scores indicate improvement.

Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.

PAN+BTZ

Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day..

PBO+BTZ

Panobinostat + Bortezomib

Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.

Placebo + Bortezomib

Total

Age, Continuous

Sex: Female, Male

Caucasian

Asian

Black

Other

Race/Ethnicity, Customized

Study Director

Progression-free Survival Events in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.

Progression Free Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.

Overall Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone

Overall Response Rate in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.

Time to Response Per Investigator Assessment (mEBMT Criteria) of Response Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.

Duration of Response Per Investigator Assessment (mEBMT Criteria) Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.

Time to Progression/Relapse Per Investigator Assessment (mEBMT Criteria) Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.

Disease Symptom wk 12 change baseline (n=215,243)

Disease Symptom wk 24 change baseline (n=148,177)

Disease Symptom wk 48 change baseline (n=37,26)

Side effects of treatment wk 12 chge (n=213,242)

Side effects of treatment wk 24 chge (n=148,175)

Side effects of treatment wk 48 chge (n=37,26)

Future perspective wk 12 chge (n=214,242)

Future perspective wk 24 chge (n=148,176)

Future perspective wk 48 chge (n=37,26)

Body image wk 12 chge (n=213,240)

Body image wk 24 chge (n=147,175)

Body image wk 48 chge (n=37,26)

European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group

Global health wk 12 change baseline (n=216,239)

Global health wk 24 change baseline (n=150,176)

Global health wk 48 change baseline (n=38,26)

Physical functioning wk 12 chge (n=217,242)

Physical functioning wk 24 chge (n=151,177)

Physical functioning wk 48 chge (n=38,26)

Role functioning wk 12 chge (n=215,237)

Role functioning wk 24 chge (n=150,176)

Role functioning wk 48 chge (n=38,26)

Cognitive functioning wk 12 chge (n=216,240)

Cognitive functioning wk 24 chge (n=149,176)

Cognitive functioning wk 48 chge (n=38,26)

Social functioning wk 12 chge (n=216,240)

Social functioning wk 24 chge (n=148,171)

Social functioning wk 48 chge (n=37,26)

Fatigue wk 12 chge (n=217,241)

Fatigue wk 24 chge (n=151,176)

Fatigue wk 48 chge(n=38,26)

Dyspnea wk 12 chge (n=217,240)

Dyspnea wk 24 chge (n=151,177)

Dyspnea wk 48 chge (n=38,26)

Insomnia wk 12 chge (n=216,239)

Insomnia wk 24 chge (n=149,176)

Insomnia wk 48 chge (n=38,26)

Appetite loss wk 12 chge (n=217,239)

Appetite loss wk 24 chge (n=151,176)

Appetite loss wk 48 chge (n=38,26)

Constipation wk 12 chge (n=215,240)

Constipation wk 24 chge (n=151,177)

Constipation wk 48 chge (n=38,25)

Diarrhea wk 12 chge (n=217,241)

Diarrhea wk 24 chge (n=150,177)

Diarrhea wk 48 chge (n=38,26)

European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group

Neurotoxicity wk 12 change baseline (n=212,240)

Neurotoxicity wk 24 change baseline (n=148,174)

Neurotoxicity wk 48 change baseline (n=35,26)

Physical wellbeing wk 12 chge (n=215,240)

Physical wellbeingwk 24 chge (n=150,176)

Physical wellbeing wk 48 chge (n=38,26)

Trial Outcomes wk 12 chge (n=209,236)

Trial Outcomes wk 24 chge (n=148,173)

Trial Outcomes wk 48 chge (n=35,26)

FACT-G Total wk 12 chge (n=213,240)

FACT-G Totalwk 24 chge (n=147,175)

FACT-G Total wk 48 chge (n=37,26)

FACT/GOGNTX Total wk 12 chge (n=206,230)

FACT/GOGNTX Total wk 24 chge (n=146,172)

FACT/GOGNTX Total wk 48 chge (n=35,26)

Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma	NCT01023308	Multiple Myelom...	Panobinostat Bortezomib Dexamethasone Placebo	18 Years -	Novartis
Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma	NCT01023308	Multiple Myelom...	Panobinostat Bortezomib Dexamethasone Placebo	18 Years -	Novartis
Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma	NCT01023308	Multiple Myelom...	Panobinostat Bortezomib Dexamethasone Placebo	18 Years -	Novartis

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