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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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
Secondary ID [1] 0 0
2009-015507-52
Secondary ID [2] 0 0
CLBH589D2308
Universal Trial Number (UTN)
Trial acronym
PANORAMA-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
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)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

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.
Timepoint [1] 0 0
45 months
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.
Timepoint [2] 0 0
45 months
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
Timepoint [1] 0 0
45 months
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
Timepoint [2] 0 0
45 months
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.
Timepoint [3] 0 0
45 months
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.
Timepoint [4] 0 0
45 months
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.
Timepoint [5] 0 0
45 months
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.
Timepoint [6] 0 0
45 months
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
Timepoint [7] 0 0
12, 24 and 48 weeks
Secondary outcome [8] 0 0
European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group
Timepoint [8] 0 0
12, 24 and 48 weeks
Secondary outcome [9] 0 0
Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group
Timepoint [9] 0 0
12, 24 and 48 weeks

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/12/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/07/2015
Sample size
Target
Accrual to date
Final
767
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Novartis Investigative Site - St Leonards
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Novartis Investigative Site - Herston
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Novartis Investigative Site - Woolloongabba
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Novartis Investigative Site - Franston
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Novartis Investigative Site - Nedlands
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Novartis Investigative Site - Perth
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2065 - St Leonards
Recruitment postcode(s) [2] 0 0
4029 - Herston
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4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
3199 - Franston
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment postcode(s) [6] 0 0
6000 - Perth
Recruitment outside Australia
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Barcelona
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Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01023308
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01023308