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Trial record 85 of 138 for:    lbh-589

Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma (PANORAMA-1)

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ClinicalTrials.gov Identifier: NCT01023308
Recruitment Status : Completed
First Posted : December 2, 2009
Results First Posted : October 23, 2015
Last Update Posted : December 29, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: Panobinostat
Drug: Bortezomib
Drug: Placebo
Enrollment 768
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Panobinostat + Bortezomib Placebo + Bortezomib
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 387 381
Completed 102 [1] 102 [1]
Not Completed 285 279
Reason Not Completed
Abnormal test proceedure results             3             8
Administrative problems             2             1
Adverse Event             130             66
Death             21             17
Disease progression             82             153
New Cancer therapy             4             7
Protocol Violation             3             4
Untreated             5             5
Lost to Follow-up             1             0
Withdrawal by Subject             34             18
[1]
completed all planned cycles of study treatment as per protocol
Arm/Group Title Panobinostat + Bortezomib Placebo + Bortezomib Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 387 381 768
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 387 participants 381 participants 768 participants
62.4  (9.34) 61.8  (9.43) 62.1  (9.38)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 387 participants 381 participants 768 participants
Female
185
  47.8%
176
  46.2%
361
  47.0%
Male
202
  52.2%
205
  53.8%
407
  53.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 387 participants 381 participants 768 participants
Caucasian 249 250 499
Asian 128 104 232
Black 5 17 22
Other 5 10 15
1.Primary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame 45 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Panobinostat + Bortezomib Placebo + Bortezomib
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 387 381
Measure Type: Number
Unit of Measure: number of events
207 260
2.Primary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame 45 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Panobinostat + Bortezomib Placebo + Bortezomib
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 387 381
Median (95% Confidence Interval)
Unit of Measure: months
11.99
(10.32 to 12.94)
8.80
(7.56 to 9.23)
3.Secondary Outcome
Title Overall Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone
Hide Description Number of OS events
Time Frame 45 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Panobinostat + Bortezomib Placebo + Bortezomib
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 387 381
Measure Type: Number
Unit of Measure: Number of OS events
134 152
4.Secondary Outcome
Title Overall Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone
Hide Description survival time in months
Time Frame 45 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Panobinostat + Bortezomib Placebo + Bortezomib
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 387 381
Median (95% Confidence Interval)
Unit of Measure: months
40.28
(35.02 to 44.81)
35.78
(28.98 to 40.64)
5.Secondary Outcome
Title 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.
Hide Description Best overall response based on mEBMT criteria per investigator assessment
Time Frame 45 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Panobinostat + Bortezomib Placebo + Bortezomib
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 387 381
Measure Type: Number
Unit of Measure: % participants with response
60.7 54.6
6.Secondary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame 45 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Panobinostat + Bortezomib Placebo + Bortezomib
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 387 381
Median (95% Confidence Interval)
Unit of Measure: time to response in months
1.51
(1.41 to 1.64)
2.00
(1.61 to 2.79)
7.Secondary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame 45 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Panobinostat + Bortezomib Placebo + Bortezomib
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 387 381
Median (95% Confidence Interval)
Unit of Measure: duration of response in months
13.14
(11.76 to 14.92)
10.87
(9.23 to 11.76)
8.Secondary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame 45 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Panobinostat + Bortezomib Placebo + Bortezomib
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 387 381
Median (95% Confidence Interval)
Unit of Measure: months
12.71
(11.30 to 14.06)
8.54
(7.66 to 9.72)
9.Secondary Outcome
Title European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group
Hide Description 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.
Time Frame 12, 24 and 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Panobinostat + Bortezomib Placebo + Bortezomib
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 387 381
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
Disease Symptom wk 12 change baseline (n=215,243)
-4.795
(-6.76 to -2.83)
-4.865
(-6.75 to -2.98)
Disease Symptom wk 24 change baseline (n=148,177)
-4.401
(-6.53 to -2.27)
-6.797
(-8.79 to -4.81)
Disease Symptom wk 48 change baseline (n=37,26)
-2.836
(-6.76 to -1.084)
-6.626
(-11.1 to -2.12)
Side effects of treatment wk 12 chge (n=213,242)
8.162
(6.510 to 9.814)
5.524
(3.933 to 7.115)
Side effects of treatment wk 24 chge (n=148,175)
9.016
(6.955 to 11.08)
7.731
(5.795 to 9.668)
Side effects of treatment wk 48 chge (n=37,26)
3.357
(0.442 to 6.273)
3.654
(0.352 to 6.956)
Future perspective wk 12 chge (n=214,242)
5.319
(2.893 to 7.744)
6.194
(3.854 to 8.533)
Future perspective wk 24 chge (n=148,176)
3.877
(0.977 to 6.778)
5.839
(3.103 to 8.575)
Future perspective wk 48 chge (n=37,26)
4.331
(-.142 to 8.804)
6.951
(1.807 to 12.10)
Body image wk 12 chge (n=213,240)
-7.178
(-10.5 to -3.87)
-6.22
(-9.41 to -3.03)
Body image wk 24 chge (n=147,175)
-11.463
(-15.3 to -7.66)
-7.358
(-10.9 to -3.81)
Body image wk 48 chge (n=37,26)
-2.161
(-7.73 to 3.410)
-4.666
(-11.1 to 1.729)
10.Secondary Outcome
Title European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group
Hide Description 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.
Time Frame 12, 24 and 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Panobinostat + Bortezomib Placebo + Bortezomib
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 387 381
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
Global health wk 12 change baseline (n=216,239)
-9.853
(-12.50 to -7.20)
-4.044
(-6.60 to -1.49)
Global health wk 24 change baseline (n=150,176)
-7.867
(-10.7 to -5.08)
-1.518
(-4.11 to -1.075)
Global health wk 48 change baseline (n=38,26)
-2.986
(-7.21 to 1.237)
4.345
(-0.416 to 9.106)
Physical functioning wk 12 chge (n=217,242)
-9.67
(-12.00 to -7.38)
-5.393
(-76.3 to -3.16)
Physical functioning wk 24 chge (n=151,177)
-9.516
(-12.20 to -7.38)
-6.456
(-8.98 to -3.93)
Physical functioning wk 48 chge (n=38,26)
-2.88
(-6.41 to 0.651)
2.037
(-2.07 to 6.147)
Role functioning wk 12 chge (n=215,237)
-11.159
(-14.6 to -7.74)
-6.762
(-10.1 to -3.45)
Role functioning wk 24 chge (n=150,176)
-11.875
(-15.7 to -8.01)
-11.263
(-14.9 to -7.61)
Role functioning wk 48 chge (n=38,26)
-5.927
(-11.4 to -0.424)
-0.401
(-6.73 to 5.924)
Cognitive functioning wk 12 chge (n=216,240)
-4.464
(-6.89 to -2.04)
-1.023
(-3.36 to 1.318)
Cognitive functioning wk 24 chge (n=149,176)
-6.053
(-8.87 to -3.24)
-3.542
(-6.22 to -0.865)
Cognitive functioning wk 48 chge (n=38,26)
-5.568
(-9.79 to -1.34)
-4.042
(-8.99 to 0.902)
Social functioning wk 12 chge (n=216,240)
-8.502
(-11.6 to -5.44)
-3.991
(-6.97 to 1.02)
Social functioning wk 24 chge (n=148,171)
-8.925
(-12.4 to -5.42)
-6.338
(-9.66 to -3.02)
Social functioning wk 48 chge (n=37,26)
-6.104
(-11.0 to -1.22)
4.617
(-0.930 to 10.16)
Fatigue wk 12 chge (n=217,241)
15.122
(12.27 to 17.98)
7.939
(5.174 to 10.70)
Fatigue wk 24 chge (n=151,176)
12.677
(9.419 to 15.94)
9.203
(6.136 to 12.27)
Fatigue wk 48 chge(n=38,26)
4.646
(0.086 to 9.206)
-2.625
(-7.88 to 2.628)
Dyspnea wk 12 chge (n=217,240)
13.964
(10.60 to 17.33)
6.266
(3.012 to 9.521)
Dyspnea wk 24 chge (n=151,177)
7.939
(4.639 to 11.24)
5.308
(2.221 to 8.394)
Dyspnea wk 48 chge (n=38,26)
4.118
(-1.58 to 9.813)
2.82
(-3.88 to 9.523)
Insomnia wk 12 chge (n=216,239)
6.283
(2.851 to 9.715)
7.625
(4.331 to 10.92)
Insomnia wk 24 chge (n=149,176)
10.023
(6.038 to 14.01)
6.104
(2.381 to 9.827)
Insomnia wk 48 chge (n=38,26)
-2.464
(-8.74 to 3.811)
-3.442
(-10.9 to 4.017)
Appetite loss wk 12 chge (n=217,239)
15.167
(11.60 to 18.74)
5.383
(1.925 to 8.841)
Appetite loss wk 24 chge (n=151,176)
16.574
(12.39 to 20.76)
5.861
(1.918 to 9.804)
Appetite loss wk 48 chge (n=38,26)
3.999
(-2.08 to 10.07)
-2.963
(-9.99 to 4.061)
Constipation wk 12 chge (n=215,240)
4.135
(0.667 to 7.603)
6.42
(3.104 to 9.735)
Constipation wk 24 chge (n=151,177)
-0.153
(-3.64 to 3.337)
0.524
(-2.73 to 5.782)
Constipation wk 48 chge (n=38,25)
-0.358
(-5.57 to 4.851)
-0.946
(-7.26 to 5.373)
Diarrhea wk 12 chge (n=217,241)
18.888
(15.04 to 22.74)
10.206
(6.452 to 13.96)
Diarrhea wk 24 chge (n=150,177)
23.163
(18.46 to 27.87)
16.406
(11.98 to 20.83)
Diarrhea wk 48 chge (n=38,26)
20.48
(14.02 to 26.94)
10.996
(3.422 to 18.57)
11.Secondary Outcome
Title Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group
Hide Description 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.
Time Frame 12, 24 and 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Panobinostat + Bortezomib Placebo + Bortezomib
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 387 381
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
Neurotoxicity wk 12 change baseline (n=212,240)
-4.481
(-5.33 to -3.63)
-3.337
(-4.17 to -2.50)
Neurotoxicity wk 24 change baseline (n=148,174)
-4.564
(-5.49 to -3.64)
-4.739
(-5.61 to -3.86)
Neurotoxicity wk 48 change baseline (n=35,26)
-3.158
(-4.52 to -1.79)
-2.133
(-3.64 to -0.627)
Physical wellbeing wk 12 chge (n=215,240)
-3.29
(-3.94 to -2.64)
-1.952
(-2.58 to -1.32)
Physical wellbeingwk 24 chge (n=150,176)
-3.044
(-3.74 to -2.35)
-2.259
(-2.92 to -1.60)
Physical wellbeing wk 48 chge (n=38,26)
-2.037
(-3.08 to -0.992)
0.203
(-1.03 to 1.439)
Trial Outcomes wk 12 chge (n=209,236)
-10.573
(-12.2 to -8.86)
-6.874
(-8.55 to -5.19)
Trial Outcomes wk 24 chge (n=148,173)
-9.84
(-11.7 to -7.98)
-8.894
(-10.7 to -7.13)
Trial Outcomes wk 48 chge (n=35,26)
-6.633
(-9.28 to -3.98)
-2.821
(-5.76 to 0.122)
FACT-G Total wk 12 chge (n=213,240)
-6.658
(-8.23 to -5.09)
-4.106
(-5.64 to -2.57)
FACT-G Totalwk 24 chge (n=147,175)
-6.076
(-7.84 to -4.31)
-4.609
(-6.30 to -2.92)
FACT-G Total wk 48 chge (n=37,26)
-2.704
(-5.29 to -0.118)
-1.435
(-4.42 to 1.547)
FACT/GOGNTX Total wk 12 chge (n=206,230)
-11.176
(-13.3 to -9.03)
-7.524
(-9.64 to -5.41)
FACT/GOGNTX Total wk 24 chge (n=146,172)
-10.581
(-12.9 to -8.23)
-9.179
(-9.64 to -5.41)
FACT/GOGNTX Total wk 48 chge (n=35,26)
-5.871
(-9.24 to -2.50)
-3.151
(-6.92 to 0.614)
Time Frame Safety Set consists of all patients who received at least one dose of any component of the study treatment. 10 patients were randomized but did not receive treatment. 6 patients from PAN+BTZ+Dex and 4 patients from PBO+BTZ+Dex
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PAN+BTZ PBO+BTZ
Hide Arm/Group Description 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. 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..
All-Cause Mortality
PAN+BTZ PBO+BTZ
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PAN+BTZ PBO+BTZ
Affected / at Risk (%) Affected / at Risk (%)
Total   228/381 (59.84%)   157/377 (41.64%) 
Blood and lymphatic system disorders     
Anaemia  1  14/381 (3.67%)  3/377 (0.80%) 
Febrile neutropenia  1  3/381 (0.79%)  1/377 (0.27%) 
Hyperviscosity syndrome  1  0/381 (0.00%)  1/377 (0.27%) 
Leukocytosis  1  1/381 (0.26%)  0/377 (0.00%) 
Leukopenia  1  2/381 (0.52%)  0/377 (0.00%) 
Monocytosis  1  1/381 (0.26%)  0/377 (0.00%) 
Neutropenia  1  2/381 (0.52%)  1/377 (0.27%) 
Pancytopenia  1  1/381 (0.26%)  1/377 (0.27%) 
Thrombocytopenia  1  28/381 (7.35%)  8/377 (2.12%) 
Cardiac disorders     
Acute coronary syndrome  1  1/381 (0.26%)  0/377 (0.00%) 
Acute myocardial infarction  1  1/381 (0.26%)  0/377 (0.00%) 
Angina pectoris  1  2/381 (0.52%)  2/377 (0.53%) 
Atrial fibrillation  1  4/381 (1.05%)  2/377 (0.53%) 
Atrial flutter  1  0/381 (0.00%)  1/377 (0.27%) 
Bradycardia  1  2/381 (0.52%)  0/377 (0.00%) 
Cardiac arrest  1  2/381 (0.52%)  2/377 (0.53%) 
Cardiac failure  1  1/381 (0.26%)  1/377 (0.27%) 
Cardiac failure acute  1  1/381 (0.26%)  0/377 (0.00%) 
Cardiac failure congestive  1  0/381 (0.00%)  1/377 (0.27%) 
Cardio-respiratory arrest  1  0/381 (0.00%)  1/377 (0.27%) 
Cardiopulmonary failure  1  0/381 (0.00%)  1/377 (0.27%) 
Left ventricular dysfunction  1  0/381 (0.00%)  1/377 (0.27%) 
Myocardial infarction  1  2/381 (0.52%)  0/377 (0.00%) 
Myocardial ischaemia  1  2/381 (0.52%)  0/377 (0.00%) 
Pericardial effusion  1  0/381 (0.00%)  1/377 (0.27%) 
Sinus tachycardia  1  1/381 (0.26%)  0/377 (0.00%) 
Tachycardia  1  2/381 (0.52%)  0/377 (0.00%) 
Ventricular tachycardia  1  1/381 (0.26%)  0/377 (0.00%) 
Ear and labyrinth disorders     
Vertigo  1  1/381 (0.26%)  0/377 (0.00%) 
Eye disorders     
Conjunctivitis  1  1/381 (0.26%)  0/377 (0.00%) 
Exophthalmos  1  1/381 (0.26%)  0/377 (0.00%) 
Optic ischaemic neuropathy  1  1/381 (0.26%)  0/377 (0.00%) 
Gastrointestinal disorders     
Abdominal discomfort  1  1/381 (0.26%)  0/377 (0.00%) 
Abdominal distension  1  1/381 (0.26%)  0/377 (0.00%) 
Abdominal pain  1  3/381 (0.79%)  3/377 (0.80%) 
Abdominal pain upper  1  1/381 (0.26%)  0/377 (0.00%) 
Colitis  1  3/381 (0.79%)  0/377 (0.00%) 
Constipation  1  3/381 (0.79%)  3/377 (0.80%) 
Diarrhoea  1  43/381 (11.29%)  9/377 (2.39%) 
Dysphagia  1  1/381 (0.26%)  0/377 (0.00%) 
Faecaloma  1  1/381 (0.26%)  0/377 (0.00%) 
Gastric haemorrhage  1  2/381 (0.52%)  0/377 (0.00%) 
Gastritis  1  2/381 (0.52%)  0/377 (0.00%) 
Gastrointestinal haemorrhage  1  2/381 (0.52%)  3/377 (0.80%) 
Gastrooesophageal reflux disease  1  1/381 (0.26%)  0/377 (0.00%) 
Haematemesis  1  1/381 (0.26%)  0/377 (0.00%) 
Haematochezia  1  2/381 (0.52%)  0/377 (0.00%) 
Haemorrhoids  1  0/381 (0.00%)  1/377 (0.27%) 
Ileus  1  5/381 (1.31%)  3/377 (0.80%) 
Ileus paralytic  1  0/381 (0.00%)  1/377 (0.27%) 
Inguinal hernia  1  2/381 (0.52%)  1/377 (0.27%) 
Intestinal ischaemia  1  1/381 (0.26%)  0/377 (0.00%) 
Large intestine perforation  1  1/381 (0.26%)  0/377 (0.00%) 
Nausea  1  7/381 (1.84%)  0/377 (0.00%) 
Necrotising oesophagitis  1  1/381 (0.26%)  0/377 (0.00%) 
Pancreatitis  1  1/381 (0.26%)  0/377 (0.00%) 
Pancreatitis acute  1  2/381 (0.52%)  1/377 (0.27%) 
Peritoneal necrosis  1  1/381 (0.26%)  0/377 (0.00%) 
Rectal haemorrhage  1  1/381 (0.26%)  0/377 (0.00%) 
Subileus  1  1/381 (0.26%)  1/377 (0.27%) 
Upper gastrointestinal haemorrhage  1  2/381 (0.52%)  0/377 (0.00%) 
Vomiting  1  12/381 (3.15%)  3/377 (0.80%) 
General disorders     
Asthenia  1  15/381 (3.94%)  6/377 (1.59%) 
Chest discomfort  1  1/381 (0.26%)  1/377 (0.27%) 
Chills  1  1/381 (0.26%)  0/377 (0.00%) 
Fatigue  1  11/381 (2.89%)  2/377 (0.53%) 
General physical health deterioration  1  2/381 (0.52%)  0/377 (0.00%) 
Generalised oedema  1  1/381 (0.26%)  0/377 (0.00%) 
Hypothermia  1  0/381 (0.00%)  2/377 (0.53%) 
Multi-organ failure  1  1/381 (0.26%)  1/377 (0.27%) 
Non-cardiac chest pain  1  1/381 (0.26%)  3/377 (0.80%) 
Oedema peripheral  1  1/381 (0.26%)  0/377 (0.00%) 
Pyrexia  1  16/381 (4.20%)  11/377 (2.92%) 
Spinal pain  1  0/381 (0.00%)  1/377 (0.27%) 
Sudden death  1  1/381 (0.26%)  1/377 (0.27%) 
Hepatobiliary disorders     
Biliary dyskinesia  1  0/381 (0.00%)  1/377 (0.27%) 
Cholecystitis  1  1/381 (0.26%)  1/377 (0.27%) 
Hepatic cirrhosis  1  1/381 (0.26%)  0/377 (0.00%) 
Hepatic failure  1  1/381 (0.26%)  0/377 (0.00%) 
Hepatomegaly  1  1/381 (0.26%)  1/377 (0.27%) 
Hyperbilirubinaemia  1  0/381 (0.00%)  1/377 (0.27%) 
Jaundice  1  0/381 (0.00%)  1/377 (0.27%) 
Infections and infestations     
Acute tonsillitis  1  1/381 (0.26%)  0/377 (0.00%) 
Appendicitis  1  1/381 (0.26%)  0/377 (0.00%) 
Aspergillosis  1  1/381 (0.26%)  0/377 (0.00%) 
Atypical pneumonia  1  1/381 (0.26%)  0/377 (0.00%) 
Bacteraemia  1  0/381 (0.00%)  1/377 (0.27%) 
Bacteriuria  1  1/381 (0.26%)  0/377 (0.00%) 
Bronchitis  1  3/381 (0.79%)  2/377 (0.53%) 
Bronchopneumonia  1  1/381 (0.26%)  1/377 (0.27%) 
Bronchopulmonary aspergillosis  1  1/381 (0.26%)  0/377 (0.00%) 
Cellulitis  1  2/381 (0.52%)  1/377 (0.27%) 
Clostridium difficile colitis  1  2/381 (0.52%)  0/377 (0.00%) 
Cytomegalovirus colitis  1  1/381 (0.26%)  0/377 (0.00%) 
Device related infection  1  0/381 (0.00%)  1/377 (0.27%) 
Device related sepsis  1  1/381 (0.26%)  0/377 (0.00%) 
Disseminated tuberculosis  1  1/381 (0.26%)  0/377 (0.00%) 
Diverticulitis  1  1/381 (0.26%)  0/377 (0.00%) 
Enteritis infectious  1  1/381 (0.26%)  0/377 (0.00%) 
Erysipelas  1  0/381 (0.00%)  1/377 (0.27%) 
Escherichia urinary tract infection  1  0/381 (0.00%)  1/377 (0.27%) 
Gastroenteritis  1  7/381 (1.84%)  2/377 (0.53%) 
Gastroenteritis salmonella  1  2/381 (0.52%)  0/377 (0.00%) 
Gastrointestinal infection  1  1/381 (0.26%)  0/377 (0.00%) 
Haemophilus sepsis  1  0/381 (0.00%)  1/377 (0.27%) 
Hepatitis B  1  3/381 (0.79%)  1/377 (0.27%) 
Herpes zoster  1  4/381 (1.05%)  5/377 (1.33%) 
Infection  1  5/381 (1.31%)  2/377 (0.53%) 
Influenza  1  1/381 (0.26%)  1/377 (0.27%) 
Lobar pneumonia  1  2/381 (0.52%)  0/377 (0.00%) 
Lower respiratory tract infection  1  3/381 (0.79%)  3/377 (0.80%) 
Lung infection  1  2/381 (0.52%)  2/377 (0.53%) 
Nasopharyngitis  1  0/381 (0.00%)  1/377 (0.27%) 
Necrotising fasciitis  1  0/381 (0.00%)  2/377 (0.53%) 
Neutropenic sepsis  1  2/381 (0.52%)  1/377 (0.27%) 
Oral candidiasis  1  0/381 (0.00%)  1/377 (0.27%) 
Parotitis  1  1/381 (0.26%)  0/377 (0.00%) 
Periodontitis  1  1/381 (0.26%)  0/377 (0.00%) 
Pharyngitis  1  2/381 (0.52%)  1/377 (0.27%) 
Pneumococcal sepsis  1  1/381 (0.26%)  0/377 (0.00%) 
Pneumonia  1  56/381 (14.70%)  40/377 (10.61%) 
Pneumonia bacterial  1  0/381 (0.00%)  2/377 (0.53%) 
Pneumonia fungal  1  2/381 (0.52%)  0/377 (0.00%) 
Pneumonia haemophilus  1  0/381 (0.00%)  1/377 (0.27%) 
Pneumonia influenzal  1  2/381 (0.52%)  1/377 (0.27%) 
Pneumonia pneumococcal  1  0/381 (0.00%)  1/377 (0.27%) 
Pneumonia respiratory syncytial viral  1  0/381 (0.00%)  1/377 (0.27%) 
Pseudomonal bacteraemia  1  1/381 (0.26%)  0/377 (0.00%) 
Pulmonary tuberculosis  1  1/381 (0.26%)  1/377 (0.27%) 
Respiratory tract infection  1  4/381 (1.05%)  2/377 (0.53%) 
Salmonellosis  1  0/381 (0.00%)  1/377 (0.27%) 
Sepsis  1  9/381 (2.36%)  7/377 (1.86%) 
Septic shock  1  9/381 (2.36%)  2/377 (0.53%) 
Sinusitis  1  1/381 (0.26%)  1/377 (0.27%) 
Skin infection  1  1/381 (0.26%)  0/377 (0.00%) 
Staphylococcal sepsis  1  0/381 (0.00%)  1/377 (0.27%) 
Streptococcal sepsis  1  0/381 (0.00%)  1/377 (0.27%) 
Upper respiratory tract infection  1  4/381 (1.05%)  3/377 (0.80%) 
Urinary tract infection  1  8/381 (2.10%)  4/377 (1.06%) 
Varicella  1  1/381 (0.26%)  0/377 (0.00%) 
Viral haemorrhagic cystitis  1  0/381 (0.00%)  1/377 (0.27%) 
Viral infection  1  1/381 (0.26%)  0/377 (0.00%) 
Injury, poisoning and procedural complications     
Ankle fracture  1  1/381 (0.26%)  0/377 (0.00%) 
Contusion  1  0/381 (0.00%)  1/377 (0.27%) 
Fall  1  2/381 (0.52%)  0/377 (0.00%) 
Femoral neck fracture  1  1/381 (0.26%)  1/377 (0.27%) 
Femur fracture  1  0/381 (0.00%)  1/377 (0.27%) 
Hand fracture  1  1/381 (0.26%)  0/377 (0.00%) 
Humerus fracture  1  0/381 (0.00%)  1/377 (0.27%) 
Intentional overdose  1  1/381 (0.26%)  0/377 (0.00%) 
Laceration  1  1/381 (0.26%)  0/377 (0.00%) 
Overdose  1  3/381 (0.79%)  0/377 (0.00%) 
Pelvic fracture  1  1/381 (0.26%)  0/377 (0.00%) 
Rib fracture  1  0/381 (0.00%)  1/377 (0.27%) 
Tibia fracture  1  1/381 (0.26%)  0/377 (0.00%) 
Transfusion reaction  1  1/381 (0.26%)  0/377 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  1/381 (0.26%)  1/377 (0.27%) 
Aspartate aminotransferase increased  1  1/381 (0.26%)  1/377 (0.27%) 
Blood creatinine increased  1  1/381 (0.26%)  2/377 (0.53%) 
Blood lactate dehydrogenase increased  1  0/381 (0.00%)  1/377 (0.27%) 
Blood potassium decreased  1  0/381 (0.00%)  1/377 (0.27%) 
Blood pressure decreased  1  0/381 (0.00%)  1/377 (0.27%) 
C-reactive protein increased  1  2/381 (0.52%)  0/377 (0.00%) 
Gamma-glutamyltransferase increased  1  0/381 (0.00%)  2/377 (0.53%) 
General physical condition abnormal  1  1/381 (0.26%)  0/377 (0.00%) 
Platelet count decreased  1  4/381 (1.05%)  0/377 (0.00%) 
Weight decreased  1  0/381 (0.00%)  1/377 (0.27%) 
White blood cell count decreased  1  1/381 (0.26%)  0/377 (0.00%) 
Metabolism and nutrition disorders     
Acidosis  1  0/381 (0.00%)  1/377 (0.27%) 
Decreased appetite  1  4/381 (1.05%)  2/377 (0.53%) 
Dehydration  1  11/381 (2.89%)  5/377 (1.33%) 
Diabetes mellitus  1  0/381 (0.00%)  1/377 (0.27%) 
Diabetes mellitus inadequate control  1  1/381 (0.26%)  0/377 (0.00%) 
Electrolyte imbalance  1  1/381 (0.26%)  0/377 (0.00%) 
Hypercalcaemia  1  1/381 (0.26%)  3/377 (0.80%) 
Hyperglycaemia  1  2/381 (0.52%)  3/377 (0.80%) 
Hypocalcaemia  1  1/381 (0.26%)  0/377 (0.00%) 
Hypochloraemia  1  1/381 (0.26%)  0/377 (0.00%) 
Hypoglycaemia  1  1/381 (0.26%)  2/377 (0.53%) 
Hypokalaemia  1  8/381 (2.10%)  4/377 (1.06%) 
Hyponatraemia  1  4/381 (1.05%)  1/377 (0.27%) 
Hypophagia  1  2/381 (0.52%)  0/377 (0.00%) 
Hypophosphataemia  1  1/381 (0.26%)  0/377 (0.00%) 
Metabolic acidosis  1  0/381 (0.00%)  1/377 (0.27%) 
Tumour lysis syndrome  1  1/381 (0.26%)  0/377 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/381 (0.52%)  0/377 (0.00%) 
Back pain  1  3/381 (0.79%)  2/377 (0.53%) 
Bone pain  1  1/381 (0.26%)  1/377 (0.27%) 
Bursitis  1  1/381 (0.26%)  0/377 (0.00%) 
Flank pain  1  1/381 (0.26%)  0/377 (0.00%) 
Joint swelling  1  1/381 (0.26%)  0/377 (0.00%) 
Muscular weakness  1  0/381 (0.00%)  1/377 (0.27%) 
Musculoskeletal pain  1  1/381 (0.26%)  1/377 (0.27%) 
Myalgia  1  2/381 (0.52%)  0/377 (0.00%) 
Myopathy  1  1/381 (0.26%)  0/377 (0.00%) 
Osteonecrosis of jaw  1  1/381 (0.26%)  0/377 (0.00%) 
Pain in extremity  1  1/381 (0.26%)  1/377 (0.27%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer pain  1  0/381 (0.00%)  1/377 (0.27%) 
Endometrial cancer  1  1/381 (0.26%)  0/377 (0.00%) 
Prostate cancer  1  0/381 (0.00%)  1/377 (0.27%) 
Rectal cancer  1  0/381 (0.00%)  1/377 (0.27%) 
Small cell lung cancer  1  0/381 (0.00%)  2/377 (0.53%) 
Nervous system disorders     
Altered state of consciousness  1  1/381 (0.26%)  0/377 (0.00%) 
Autonomic neuropathy  1  1/381 (0.26%)  0/377 (0.00%) 
Brain compression  1  0/381 (0.00%)  1/377 (0.27%) 
Brain injury  1  0/381 (0.00%)  1/377 (0.27%) 
Brain oedema  1  1/381 (0.26%)  0/377 (0.00%) 
Central nervous system haemorrhage  1  0/381 (0.00%)  1/377 (0.27%) 
Central nervous system necrosis  1  1/381 (0.26%)  0/377 (0.00%) 
Cerebral haemorrhage  1  1/381 (0.26%)  2/377 (0.53%) 
Cerebrovascular accident  1  3/381 (0.79%)  0/377 (0.00%) 
Coma  1  1/381 (0.26%)  0/377 (0.00%) 
Convulsion  1  1/381 (0.26%)  0/377 (0.00%) 
Cranial nerve paralysis  1  0/381 (0.00%)  1/377 (0.27%) 
Depressed level of consciousness  1  1/381 (0.26%)  0/377 (0.00%) 
Dizziness  1  5/381 (1.31%)  2/377 (0.53%) 
Haemorrhage intracranial  1  1/381 (0.26%)  0/377 (0.00%) 
Headache  1  1/381 (0.26%)  0/377 (0.00%) 
Hemiparesis  1  1/381 (0.26%)  1/377 (0.27%) 
Hyperreflexia  1  0/381 (0.00%)  1/377 (0.27%) 
Lacunar infarction  1  1/381 (0.26%)  1/377 (0.27%) 
Loss of consciousness  1  5/381 (1.31%)  1/377 (0.27%) 
Neuralgia  1  1/381 (0.26%)  1/377 (0.27%) 
Neuropathy peripheral  1  3/381 (0.79%)  1/377 (0.27%) 
Paraparesis  1  1/381 (0.26%)  0/377 (0.00%) 
Paraplegia  1  0/381 (0.00%)  1/377 (0.27%) 
Polyneuropathy  1  0/381 (0.00%)  1/377 (0.27%) 
Post herpetic neuralgia  1  0/381 (0.00%)  1/377 (0.27%) 
Sciatica  1  0/381 (0.00%)  1/377 (0.27%) 
Sensory loss  1  0/381 (0.00%)  1/377 (0.27%) 
Somnolence  1  1/381 (0.26%)  0/377 (0.00%) 
Speech disorder  1  0/381 (0.00%)  1/377 (0.27%) 
Syncope  1  5/381 (1.31%)  2/377 (0.53%) 
Transient ischaemic attack  1  1/381 (0.26%)  0/377 (0.00%) 
VIIth nerve paralysis  1  0/381 (0.00%)  1/377 (0.27%) 
Psychiatric disorders     
Confusional state  1  1/381 (0.26%)  1/377 (0.27%) 
Delirium  1  1/381 (0.26%)  0/377 (0.00%) 
Hypomania  1  1/381 (0.26%)  0/377 (0.00%) 
Mental disorder  1  0/381 (0.00%)  1/377 (0.27%) 
Mental status changes  1  1/381 (0.26%)  0/377 (0.00%) 
Renal and urinary disorders     
Anuria  1  0/381 (0.00%)  1/377 (0.27%) 
Azotaemia  1  0/381 (0.00%)  1/377 (0.27%) 
Oliguria  1  1/381 (0.26%)  0/377 (0.00%) 
Renal failure  1  4/381 (1.05%)  4/377 (1.06%) 
Renal failure acute  1  7/381 (1.84%)  9/377 (2.39%) 
Renal impairment  1  1/381 (0.26%)  1/377 (0.27%) 
Ureteric obstruction  1  1/381 (0.26%)  0/377 (0.00%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  1/381 (0.26%)  0/377 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome  1  0/381 (0.00%)  2/377 (0.53%) 
Acute respiratory failure  1  3/381 (0.79%)  1/377 (0.27%) 
Aspiration  1  0/381 (0.00%)  1/377 (0.27%) 
Asthma  1  0/381 (0.00%)  1/377 (0.27%) 
Chronic obstructive pulmonary disease  1  0/381 (0.00%)  1/377 (0.27%) 
Cough  1  1/381 (0.26%)  0/377 (0.00%) 
Dyspnoea  1  4/381 (1.05%)  7/377 (1.86%) 
Epistaxis  1  2/381 (0.52%)  1/377 (0.27%) 
Hypoventilation  1  0/381 (0.00%)  1/377 (0.27%) 
Hypoxia  1  1/381 (0.26%)  0/377 (0.00%) 
Lung disorder  1  1/381 (0.26%)  1/377 (0.27%) 
Lung infiltration  1  1/381 (0.26%)  0/377 (0.00%) 
Orthopnoea  1  1/381 (0.26%)  1/377 (0.27%) 
Pleural effusion  1  4/381 (1.05%)  0/377 (0.00%) 
Pneumonitis  1  1/381 (0.26%)  3/377 (0.80%) 
Pneumothorax  1  1/381 (0.26%)  0/377 (0.00%) 
Pulmonary embolism  1  4/381 (1.05%)  4/377 (1.06%) 
Pulmonary haemorrhage  1  1/381 (0.26%)  0/377 (0.00%) 
Pulmonary hypertension  1  1/381 (0.26%)  0/377 (0.00%) 
Pulmonary oedema  1  1/381 (0.26%)  1/377 (0.27%) 
Respiratory distress  1  1/381 (0.26%)  0/377 (0.00%) 
Respiratory failure  1  5/381 (1.31%)  0/377 (0.00%) 
Tachypnoea  1  0/381 (0.00%)  1/377 (0.27%) 
Skin and subcutaneous tissue disorders     
Acute febrile neutrophilic dermatosis  1  1/381 (0.26%)  1/377 (0.27%) 
Dermatitis allergic  1  0/381 (0.00%)  1/377 (0.27%) 
Rash  1  2/381 (0.52%)  1/377 (0.27%) 
Swelling face  1  1/381 (0.26%)  0/377 (0.00%) 
Vascular disorders     
Aortic stenosis  1  1/381 (0.26%)  0/377 (0.00%) 
Circulatory collapse  1  2/381 (0.52%)  0/377 (0.00%) 
Deep vein thrombosis  1  2/381 (0.52%)  3/377 (0.80%) 
Embolism  1  1/381 (0.26%)  0/377 (0.00%) 
Haematoma  1  1/381 (0.26%)  0/377 (0.00%) 
Hypotension  1  5/381 (1.31%)  2/377 (0.53%) 
Hypovolaemic shock  1  3/381 (0.79%)  0/377 (0.00%) 
Lymphoedema  1  0/381 (0.00%)  1/377 (0.27%) 
Orthostatic hypotension  1  9/381 (2.36%)  1/377 (0.27%) 
Shock haemorrhagic  1  1/381 (0.26%)  0/377 (0.00%) 
Venous thrombosis limb  1  1/381 (0.26%)  1/377 (0.27%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PAN+BTZ PBO+BTZ
Affected / at Risk (%) Affected / at Risk (%)
Total   379/381 (99.48%)   366/377 (97.08%) 
Blood and lymphatic system disorders     
Anaemia  1  154/381 (40.42%)  125/377 (33.16%) 
Leukopenia  1  61/381 (16.01%)  31/377 (8.22%) 
Lymphopenia  1  52/381 (13.65%)  35/377 (9.28%) 
Neutropenia  1  112/381 (29.40%)  40/377 (10.61%) 
Thrombocytopenia  1  238/381 (62.47%)  150/377 (39.79%) 
Eye disorders     
Conjunctivitis  1  28/381 (7.35%)  31/377 (8.22%) 
Gastrointestinal disorders     
Abdominal distension  1  30/381 (7.87%)  25/377 (6.63%) 
Abdominal pain  1  50/381 (13.12%)  38/377 (10.08%) 
Abdominal pain upper  1  43/381 (11.29%)  36/377 (9.55%) 
Constipation  1  101/381 (26.51%)  122/377 (32.36%) 
Diarrhoea  1  254/381 (66.67%)  155/377 (41.11%) 
Dyspepsia  1  47/381 (12.34%)  43/377 (11.41%) 
Nausea  1  137/381 (35.96%)  78/377 (20.69%) 
Vomiting  1  91/381 (23.88%)  47/377 (12.47%) 
General disorders     
Asthenia  1  77/381 (20.21%)  51/377 (13.53%) 
Fatigue  1  155/381 (40.68%)  109/377 (28.91%) 
Oedema peripheral  1  108/381 (28.35%)  72/377 (19.10%) 
Pyrexia  1  90/381 (23.62%)  48/377 (12.73%) 
Infections and infestations     
Bronchitis  1  20/381 (5.25%)  25/377 (6.63%) 
Herpes zoster  1  15/381 (3.94%)  36/377 (9.55%) 
Nasopharyngitis  1  49/381 (12.86%)  46/377 (12.20%) 
Respiratory tract infection  1  17/381 (4.46%)  20/377 (5.31%) 
Upper respiratory tract infection  1  65/381 (17.06%)  53/377 (14.06%) 
Urinary tract infection  1  23/381 (6.04%)  15/377 (3.98%) 
Investigations     
Alanine aminotransferase increased  1  22/381 (5.77%)  19/377 (5.04%) 
Blood creatinine increased  1  37/381 (9.71%)  21/377 (5.57%) 
Blood urea increased  1  20/381 (5.25%)  10/377 (2.65%) 
Platelet count decreased  1  43/381 (11.29%)  17/377 (4.51%) 
Weight decreased  1  44/381 (11.55%)  17/377 (4.51%) 
Metabolism and nutrition disorders     
Decreased appetite  1  106/381 (27.82%)  46/377 (12.20%) 
Hyperglycaemia  1  30/381 (7.87%)  25/377 (6.63%) 
Hypoalbuminaemia  1  21/381 (5.51%)  8/377 (2.12%) 
Hypocalcaemia  1  35/381 (9.19%)  32/377 (8.49%) 
Hypokalaemia  1  100/381 (26.25%)  52/377 (13.79%) 
Hyponatraemia  1  48/381 (12.60%)  18/377 (4.77%) 
Hypophosphataemia  1  42/381 (11.02%)  32/377 (8.49%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  25/381 (6.56%)  26/377 (6.90%) 
Back pain  1  45/381 (11.81%)  46/377 (12.20%) 
Bone pain  1  21/381 (5.51%)  31/377 (8.22%) 
Muscle spasms  1  23/381 (6.04%)  21/377 (5.57%) 
Muscular weakness  1  24/381 (6.30%)  20/377 (5.31%) 
Myalgia  1  24/381 (6.30%)  24/377 (6.37%) 
Pain in extremity  1  40/381 (10.50%)  54/377 (14.32%) 
Nervous system disorders     
Dizziness  1  67/381 (17.59%)  61/377 (16.18%) 
Dysgeusia  1  36/381 (9.45%)  26/377 (6.90%) 
Headache  1  51/381 (13.39%)  40/377 (10.61%) 
Hypoaesthesia  1  28/381 (7.35%)  34/377 (9.02%) 
Neuralgia  1  38/381 (9.97%)  44/377 (11.67%) 
Neuropathy peripheral  1  117/381 (30.71%)  133/377 (35.28%) 
Paraesthesia  1  24/381 (6.30%)  27/377 (7.16%) 
Peripheral sensory neuropathy  1  42/381 (11.02%)  46/377 (12.20%) 
Polyneuropathy  1  28/381 (7.35%)  28/377 (7.43%) 
Psychiatric disorders     
Insomnia  1  73/381 (19.16%)  61/377 (16.18%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  81/381 (21.26%)  70/377 (18.57%) 
Dyspnoea  1  53/381 (13.91%)  40/377 (10.61%) 
Skin and subcutaneous tissue disorders     
Rash  1  33/381 (8.66%)  23/377 (6.10%) 
Vascular disorders     
Hypertension  1  27/381 (7.09%)  23/377 (6.10%) 
Hypotension  1  49/381 (12.86%)  34/377 (9.02%) 
Orthostatic hypotension  1  22/381 (5.77%)  11/377 (2.92%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
San-Miguel JF, Hungria VT, Yoon SS, Beksac M, Dimopoulos MA, Elghandour A, Jedrzejczak WW, Günther A, Nakorn TN, Siritanaratkul N, Corradini P, Chuncharunee S, Lee JJ, Schlossman RL, Shelekhova T, Yong K, Tan D, Numbenjapon T, Cavenagh JD, Hou J, LeBlanc R, Nahi H, Qiu L, Salwender H, Pulini S, Moreau P, Warzocha K, White D, Bladé J, Chen W, de la Rubia J, Gimsing P, Lonial S, Kaufman JL, Ocio EM, Veskovski L, Sohn SK, Wang MC, Lee JH, Einsele H, Sopala M, Corrado C, Bengoudifa BR, Binlich F, Richardson PG. Panobinostat plus bortezomib and dexamethasone versus placebo plus bortezomib and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma: a multicentre, randomised, double-blind phase 3 trial. Lancet Oncol. 2014 Oct;15(11):1195-206. doi: 10.1016/S1470-2045(14)70440-1. Epub 2014 Sep 18. Erratum in: Lancet Oncol. 2015 Jan;16(1):e6.
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01023308     History of Changes
Other Study ID Numbers: CLBH589D2308
2009-015507-52 ( EudraCT Number )
First Submitted: November 30, 2009
First Posted: December 2, 2009
Results First Submitted: March 23, 2015
Results First Posted: October 23, 2015
Last Update Posted: December 29, 2016