Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01023308
Registration number
NCT01023308
Ethics application status
Date submitted
30/11/2009
Date registered
2/12/2009
Date last updated
17/03/2020
Titles & IDs
Public title
Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma
Query!
Scientific title
A Multicenter, Randomized, Double Blind, Placebo Controlled Phase III Study of Panobinostat in Combination With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma
Query!
Secondary ID [1]
0
0
2009-015507-52
Query!
Secondary ID [2]
0
0
CLBH589D2308
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
PANORAMA-1
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Other cancer types
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Panobinostat
Treatment: Drugs - Bortezomib
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Placebo
Experimental: Panobinostat + Bortezomib + Dexamethasone -
Placebo comparator: Placebo + Bortezomib + Dexamethasone -
Treatment: Drugs: Panobinostat
Panobinostat was administered 3x week ( 2 weeks on 1 week off)
Treatment: Drugs: Bortezomib
Bortezomib was administered 2 x week ( 2weeks on 1 week off)
Treatment: Drugs: Dexamethasone
Dexamethasone was adminstered on day of Bortezomib and the day after Bortezomib administration
Treatment: Drugs: Placebo
Placebo was administered 3x week ( 2 weeks on 1 week off)
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
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.
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
45 months
Query!
Primary outcome [2]
0
0
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.
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
45 months
Query!
Secondary outcome [1]
0
0
Overall Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone
Query!
Assessment method [1]
0
0
Number of OS events
Query!
Timepoint [1]
0
0
45 months
Query!
Secondary outcome [2]
0
0
Overall Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone
Query!
Assessment method [2]
0
0
survival time in months
Query!
Timepoint [2]
0
0
45 months
Query!
Secondary outcome [3]
0
0
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.
Query!
Assessment method [3]
0
0
Best overall response based on mEBMT criteria per investigator assessment
Query!
Timepoint [3]
0
0
45 months
Query!
Secondary outcome [4]
0
0
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.
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
45 months
Query!
Secondary outcome [5]
0
0
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.
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
45 months
Query!
Secondary outcome [6]
0
0
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.
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
45 months
Query!
Secondary outcome [7]
0
0
European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
12, 24 and 48 weeks
Query!
Secondary outcome [8]
0
0
European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group
Query!
Assessment method [8]
0
0
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.
Query!
Timepoint [8]
0
0
12, 24 and 48 weeks
Query!
Secondary outcome [9]
0
0
Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group
Query!
Assessment method [9]
0
0
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.
Query!
Timepoint [9]
0
0
12, 24 and 48 weeks
Query!
Eligibility
Key inclusion criteria
1. Patient has a previous diagnosis of multiple myeloma.
2. Patient requires retreatment for multiple myeloma
3. Patient has measurable M component in serum or urine at study screening
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1. Patient who has progressed under all prior lines of anti MM therapy
2. Patient who has been treated by bortezomib before, and did not reach at least a minor response under this therapy, or progressed under it or within 60 days of last dose
3. Patient has shown intolerance to bortezomib or to dexamethasone or components of these drugs or has any contraindication to one or the other drug , following locally applicable prescribing information
4. Patient received prior treatment with DAC inhibitors including panobinostat
5. Patient has impaired cardiac function, or a prolonged QTc interval at screening ECG
6. Patient taking medications with relative risk of prolonging the QT interval or inducing Torsade de pointes
7. Female patient who is pregnant or breast feeding or with childbearing potential and not willing to use a double method of contraception up to 3 months after the end of study treatment. Male patient who is not willing to use a barrier method of contraception up to 3 months after the end of study treatment.
Other protocol-defined inclusion/exclusion criteria may apply.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
21/12/2009
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
30/07/2015
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
767
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Query!
Recruitment hospital [1]
0
0
Novartis Investigative Site - St Leonards
Query!
Recruitment hospital [2]
0
0
Novartis Investigative Site - Herston
Query!
Recruitment hospital [3]
0
0
Novartis Investigative Site - Woolloongabba
Query!
Recruitment hospital [4]
0
0
Novartis Investigative Site - Franston
Query!
Recruitment hospital [5]
0
0
Novartis Investigative Site - Nedlands
Query!
Recruitment hospital [6]
0
0
Novartis Investigative Site - Perth
Query!
Recruitment postcode(s) [1]
0
0
2065 - St Leonards
Query!
Recruitment postcode(s) [2]
0
0
4029 - Herston
Query!
Recruitment postcode(s) [3]
0
0
4102 - Woolloongabba
Query!
Recruitment postcode(s) [4]
0
0
3199 - Franston
Query!
Recruitment postcode(s) [5]
0
0
6009 - Nedlands
Query!
Recruitment postcode(s) [6]
0
0
6000 - Perth
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Georgia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Illinois
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Louisiana
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Maryland
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Massachusetts
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Michigan
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Minnesota
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Missouri
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
New Jersey
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
New York
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
North Carolina
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
North Dakota
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Ohio
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Pennsylvania
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Rhode Island
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Tennessee
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Texas
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Washington
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
West Virginia
Query!
Country [23]
0
0
Argentina
Query!
State/province [23]
0
0
Buenos Aires
Query!
Country [24]
0
0
Argentina
Query!
State/province [24]
0
0
Cordoba
Query!
Country [25]
0
0
Austria
Query!
State/province [25]
0
0
Linz
Query!
Country [26]
0
0
Austria
Query!
State/province [26]
0
0
Wien
Query!
Country [27]
0
0
Belgium
Query!
State/province [27]
0
0
Brussel
Query!
Country [28]
0
0
Belgium
Query!
State/province [28]
0
0
Bruxelles
Query!
Country [29]
0
0
Belgium
Query!
State/province [29]
0
0
Hasselt
Query!
Country [30]
0
0
Brazil
Query!
State/province [30]
0
0
DF
Query!
Country [31]
0
0
Brazil
Query!
State/province [31]
0
0
RJ
Query!
Country [32]
0
0
Brazil
Query!
State/province [32]
0
0
SP
Query!
Country [33]
0
0
Canada
Query!
State/province [33]
0
0
Nova Scotia
Query!
Country [34]
0
0
Canada
Query!
State/province [34]
0
0
Ontario
Query!
Country [35]
0
0
Canada
Query!
State/province [35]
0
0
Quebec
Query!
Country [36]
0
0
China
Query!
State/province [36]
0
0
Beijing
Query!
Country [37]
0
0
China
Query!
State/province [37]
0
0
Guangxi
Query!
Country [38]
0
0
China
Query!
State/province [38]
0
0
Jiangsu
Query!
Country [39]
0
0
China
Query!
State/province [39]
0
0
Sichuan
Query!
Country [40]
0
0
China
Query!
State/province [40]
0
0
Tianjin
Query!
Country [41]
0
0
China
Query!
State/province [41]
0
0
Zhejiang
Query!
Country [42]
0
0
China
Query!
State/province [42]
0
0
Shanghai
Query!
Country [43]
0
0
Czechia
Query!
State/province [43]
0
0
Czech Republic
Query!
Country [44]
0
0
Czechia
Query!
State/province [44]
0
0
CZE
Query!
Country [45]
0
0
Denmark
Query!
State/province [45]
0
0
Copenhagen
Query!
Country [46]
0
0
Denmark
Query!
State/province [46]
0
0
Odense
Query!
Country [47]
0
0
Denmark
Query!
State/province [47]
0
0
Vejle
Query!
Country [48]
0
0
Denmark
Query!
State/province [48]
0
0
Ålborg
Query!
Country [49]
0
0
Denmark
Query!
State/province [49]
0
0
Århus
Query!
Country [50]
0
0
Egypt
Query!
State/province [50]
0
0
Alexandria
Query!
Country [51]
0
0
Egypt
Query!
State/province [51]
0
0
Giza
Query!
Country [52]
0
0
Finland
Query!
State/province [52]
0
0
HUS Helsinki
Query!
Country [53]
0
0
Finland
Query!
State/province [53]
0
0
Turku
Query!
Country [54]
0
0
France
Query!
State/province [54]
0
0
Blois Cedex
Query!
Country [55]
0
0
France
Query!
State/province [55]
0
0
Dijon
Query!
Country [56]
0
0
France
Query!
State/province [56]
0
0
Lille Cedex
Query!
Country [57]
0
0
France
Query!
State/province [57]
0
0
Limoges cedex
Query!
Country [58]
0
0
France
Query!
State/province [58]
0
0
Nantes
Query!
Country [59]
0
0
France
Query!
State/province [59]
0
0
Paris
Query!
Country [60]
0
0
France
Query!
State/province [60]
0
0
Pierre Benite
Query!
Country [61]
0
0
France
Query!
State/province [61]
0
0
Strasbourg cedex
Query!
Country [62]
0
0
France
Query!
State/province [62]
0
0
Vandoeuvre Les Nancy
Query!
Country [63]
0
0
Germany
Query!
State/province [63]
0
0
Aachen
Query!
Country [64]
0
0
Germany
Query!
State/province [64]
0
0
Bad Saarow
Query!
Country [65]
0
0
Germany
Query!
State/province [65]
0
0
Bamberg
Query!
Country [66]
0
0
Germany
Query!
State/province [66]
0
0
Berlin
Query!
Country [67]
0
0
Germany
Query!
State/province [67]
0
0
Bremen
Query!
Country [68]
0
0
Germany
Query!
State/province [68]
0
0
Dresden
Query!
Country [69]
0
0
Germany
Query!
State/province [69]
0
0
Duisburg
Query!
Country [70]
0
0
Germany
Query!
State/province [70]
0
0
Erlangen
Query!
Country [71]
0
0
Germany
Query!
State/province [71]
0
0
Frankfurt
Query!
Country [72]
0
0
Germany
Query!
State/province [72]
0
0
Hamburg
Query!
Country [73]
0
0
Germany
Query!
State/province [73]
0
0
Jena
Query!
Country [74]
0
0
Germany
Query!
State/province [74]
0
0
Kiel
Query!
Country [75]
0
0
Germany
Query!
State/province [75]
0
0
Magdeburg
Query!
Country [76]
0
0
Germany
Query!
State/province [76]
0
0
Muenchen
Query!
Country [77]
0
0
Germany
Query!
State/province [77]
0
0
Rostock
Query!
Country [78]
0
0
Germany
Query!
State/province [78]
0
0
Ulm
Query!
Country [79]
0
0
Germany
Query!
State/province [79]
0
0
Wuerzburg
Query!
Country [80]
0
0
Greece
Query!
State/province [80]
0
0
GR
Query!
Country [81]
0
0
Greece
Query!
State/province [81]
0
0
Athens
Query!
Country [82]
0
0
Hong Kong
Query!
State/province [82]
0
0
Hong Kong SAR
Query!
Country [83]
0
0
Hong Kong
Query!
State/province [83]
0
0
Hong Kong
Query!
Country [84]
0
0
Hong Kong
Query!
State/province [84]
0
0
New Territories
Query!
Country [85]
0
0
Israel
Query!
State/province [85]
0
0
Jerusalem
Query!
Country [86]
0
0
Israel
Query!
State/province [86]
0
0
Kfar Saba
Query!
Country [87]
0
0
Israel
Query!
State/province [87]
0
0
Petach Tikva
Query!
Country [88]
0
0
Israel
Query!
State/province [88]
0
0
Ramat Gan
Query!
Country [89]
0
0
Italy
Query!
State/province [89]
0
0
FG
Query!
Country [90]
0
0
Italy
Query!
State/province [90]
0
0
LE
Query!
Country [91]
0
0
Italy
Query!
State/province [91]
0
0
MI
Query!
Country [92]
0
0
Italy
Query!
State/province [92]
0
0
PE
Query!
Country [93]
0
0
Italy
Query!
State/province [93]
0
0
PI
Query!
Country [94]
0
0
Italy
Query!
State/province [94]
0
0
PV
Query!
Country [95]
0
0
Italy
Query!
State/province [95]
0
0
RC
Query!
Country [96]
0
0
Italy
Query!
State/province [96]
0
0
RM
Query!
Country [97]
0
0
Italy
Query!
State/province [97]
0
0
SA
Query!
Country [98]
0
0
Italy
Query!
State/province [98]
0
0
VR
Query!
Country [99]
0
0
Italy
Query!
State/province [99]
0
0
Napoli
Query!
Country [100]
0
0
Japan
Query!
State/province [100]
0
0
Aichi
Query!
Country [101]
0
0
Japan
Query!
State/province [101]
0
0
Ehime
Query!
Country [102]
0
0
Japan
Query!
State/province [102]
0
0
Fukuoka
Query!
Country [103]
0
0
Japan
Query!
State/province [103]
0
0
Gifu
Query!
Country [104]
0
0
Japan
Query!
State/province [104]
0
0
Gunma
Query!
Country [105]
0
0
Japan
Query!
State/province [105]
0
0
Hiroshima
Query!
Country [106]
0
0
Japan
Query!
State/province [106]
0
0
Ibaraki
Query!
Country [107]
0
0
Japan
Query!
State/province [107]
0
0
Okayama
Query!
Country [108]
0
0
Japan
Query!
State/province [108]
0
0
Osaka
Query!
Country [109]
0
0
Japan
Query!
State/province [109]
0
0
Tokyo
Query!
Country [110]
0
0
Japan
Query!
State/province [110]
0
0
Niigata
Query!
Country [111]
0
0
Korea, Republic of
Query!
State/province [111]
0
0
Gyeonggi Do
Query!
Country [112]
0
0
Korea, Republic of
Query!
State/province [112]
0
0
Seocho Gu
Query!
Country [113]
0
0
Korea, Republic of
Query!
State/province [113]
0
0
Busan
Query!
Country [114]
0
0
Korea, Republic of
Query!
State/province [114]
0
0
Incheon
Query!
Country [115]
0
0
Korea, Republic of
Query!
State/province [115]
0
0
Jeollanam-do
Query!
Country [116]
0
0
Korea, Republic of
Query!
State/province [116]
0
0
Seoul
Query!
Country [117]
0
0
Korea, Republic of
Query!
State/province [117]
0
0
Taegu
Query!
Country [118]
0
0
Lebanon
Query!
State/province [118]
0
0
Beirut
Query!
Country [119]
0
0
Mexico
Query!
State/province [119]
0
0
San Luis Potosí
Query!
Country [120]
0
0
Netherlands
Query!
State/province [120]
0
0
Rotterdam
Query!
Country [121]
0
0
Netherlands
Query!
State/province [121]
0
0
Utrecht
Query!
Country [122]
0
0
Norway
Query!
State/province [122]
0
0
Bergen
Query!
Country [123]
0
0
Norway
Query!
State/province [123]
0
0
Fredrikstad
Query!
Country [124]
0
0
Norway
Query!
State/province [124]
0
0
Kristiansand
Query!
Country [125]
0
0
Norway
Query!
State/province [125]
0
0
Oslo
Query!
Country [126]
0
0
Norway
Query!
State/province [126]
0
0
Skien
Query!
Country [127]
0
0
Norway
Query!
State/province [127]
0
0
Trondheim
Query!
Country [128]
0
0
Poland
Query!
State/province [128]
0
0
Warszawa
Query!
Country [129]
0
0
Russian Federation
Query!
State/province [129]
0
0
Saratov
Query!
Country [130]
0
0
Russian Federation
Query!
State/province [130]
0
0
St Petersburg
Query!
Country [131]
0
0
Singapore
Query!
State/province [131]
0
0
Singapore
Query!
Country [132]
0
0
South Africa
Query!
State/province [132]
0
0
Parktown
Query!
Country [133]
0
0
South Africa
Query!
State/province [133]
0
0
Pretoria
Query!
Country [134]
0
0
Spain
Query!
State/province [134]
0
0
Andalucia
Query!
Country [135]
0
0
Spain
Query!
State/province [135]
0
0
Castilla Y Leon
Query!
Country [136]
0
0
Spain
Query!
State/province [136]
0
0
Catalunya
Query!
Country [137]
0
0
Spain
Query!
State/province [137]
0
0
Comunidad Valenciana
Query!
Country [138]
0
0
Spain
Query!
State/province [138]
0
0
Galicia
Query!
Country [139]
0
0
Spain
Query!
State/province [139]
0
0
Navarra
Query!
Country [140]
0
0
Spain
Query!
State/province [140]
0
0
Pais Vasco
Query!
Country [141]
0
0
Spain
Query!
State/province [141]
0
0
Santa Cruz De Tenerife
Query!
Country [142]
0
0
Spain
Query!
State/province [142]
0
0
Barcelona
Query!
Country [143]
0
0
Sweden
Query!
State/province [143]
0
0
Göteborg
Query!
Country [144]
0
0
Sweden
Query!
State/province [144]
0
0
Linköping
Query!
Country [145]
0
0
Sweden
Query!
State/province [145]
0
0
Luleå
Query!
Country [146]
0
0
Sweden
Query!
State/province [146]
0
0
Stockholm
Query!
Country [147]
0
0
Sweden
Query!
State/province [147]
0
0
Uppsala
Query!
Country [148]
0
0
Taiwan
Query!
State/province [148]
0
0
Kaohsiung City
Query!
Country [149]
0
0
Taiwan
Query!
State/province [149]
0
0
Taichung
Query!
Country [150]
0
0
Taiwan
Query!
State/province [150]
0
0
Taipei
Query!
Country [151]
0
0
Taiwan
Query!
State/province [151]
0
0
Taoyuan
Query!
Country [152]
0
0
Thailand
Query!
State/province [152]
0
0
Bangkok
Query!
Country [153]
0
0
Turkey
Query!
State/province [153]
0
0
TUR
Query!
Country [154]
0
0
Turkey
Query!
State/province [154]
0
0
Adana
Query!
Country [155]
0
0
Turkey
Query!
State/province [155]
0
0
Ankara
Query!
Country [156]
0
0
United Kingdom
Query!
State/province [156]
0
0
Scotland
Query!
Country [157]
0
0
United Kingdom
Query!
State/province [157]
0
0
London
Query!
Country [158]
0
0
United Kingdom
Query!
State/province [158]
0
0
Manchester
Query!
Country [159]
0
0
United Kingdom
Query!
State/province [159]
0
0
Wolverhampton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Novartis Pharmaceuticals
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT01023308
Query!
Trial related presentations / publications
San-Miguel JF, Einsele H, Moreau P. The Role of Panobinostat Plus Bortezomib and Dexamethasone in Treating Relapsed or Relapsed and Refractory Multiple Myeloma: A European Perspective. Adv Ther. 2016 Nov;33(11):1896-1920. doi: 10.1007/s12325-016-0413-7. Epub 2016 Sep 27. San-Miguel JF, Hungria VT, Yoon SS, Beksac M, Dimopoulos MA, Elghandour A, Jedrzejczak WW, Gunther A, Nakorn TN, Siritanaratkul N, Schlossman RL, Hou J, Moreau P, Lonial S, Lee JH, Einsele H, Sopala M, Bengoudifa BR, Binlich F, Richardson PG. Overall survival of patients with relapsed multiple myeloma treated with panobinostat or placebo plus bortezomib and dexamethasone (the PANORAMA 1 trial): a randomised, placebo-controlled, phase 3 trial. Lancet Haematol. 2016 Nov;3(11):e506-e515. doi: 10.1016/S2352-3026(16)30147-8. Epub 2016 Oct 14. Richardson PG, Hungria VT, Yoon SS, Beksac M, Dimopoulos MA, Elghandour A, Jedrzejczak WW, Guenther A, Nakorn TN, Siritanaratkul N, Schlossman RL, Hou J, Moreau P, Lonial S, Lee JH, Einsele H, Sopala M, Bengoudifa BR, Corrado C, Binlich F, San-Miguel JF. Panobinostat plus bortezomib and dexamethasone in previously treated multiple myeloma: outcomes by prior treatment. Blood. 2016 Feb 11;127(6):713-21. doi: 10.1182/blood-2015-09-665018. Epub 2015 Dec 2. Erratum In: Blood. 2016 Jun 30;127(26):3460. doi: 10.1182/blood-2016-05-717777. San-Miguel JF, Hungria VT, Yoon SS, Beksac M, Dimopoulos MA, Elghandour A, Jedrzejczak WW, Gunther 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, Blade 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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Novartis Pharmaceuticals
Query!
Address
0
0
Novartis Pharmaceuticals
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01023308
Download to PDF