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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02654990




Registration number
NCT02654990
Ethics application status
Date submitted
16/12/2015
Date registered
13/01/2016
Date last updated
12/07/2024

Titles & IDs
Public title
Panobinostat/Bortezomib/Dexamethasone in Relapsed or Relapsed-and-refractory Multiple Myeloma
Scientific title
A Multicenter, Randomized, Open-label Phase 2 Study Evaluating the Safety and Efficacy of Three Different Regimens of Oral Panobinostat in Combination With Subcutaneous Bortezomib and Oral Dexamethasone in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma Who Have Been Previously Exposed to Immunomodulatory Agents
Secondary ID [1] 0 0
2015-001564-19
Secondary ID [2] 0 0
CLBH589D2222
Universal Trial Number (UTN)
Trial acronym
PANORAMA_3
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 Capsules
Treatment: Drugs - Bortezomib Injection
Treatment: Drugs - Dexamethasone tablets

Experimental: Arm A - 20 mg Panobinostat TIW - 20 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and per oral dexamethasone

Experimental: Arm B - 20 mg Panobinostat BIW - 20 mg panobinostat BIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and per oral dexamethasone

Experimental: Arm C - 10 mg Panobinostat TIW - 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and per oral dexamethasone


Treatment: Drugs: Panobinostat Capsules
20 mg, 10 mg or 15 mg (for dose reductions only)

Treatment: Drugs: Bortezomib Injection
1.3 mg/square meter subcutaneous administration. Cycle 1-4: 2 weeks on/1 week off, BIW for participants = 75 years at time of screening; once a week for participants \> 75 years. Cycle 5+: once a week for all participants.

Treatment: Drugs: Dexamethasone tablets
Pre and 24 hours after bortezomib administration. Participants = 75 years at time of screening: 20 mg/dose participants; \> 75 years: 10 mg/dose.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Response Rate (ORR)
Timepoint [1] 0 0
Up to 168 days
Secondary outcome [1] 0 0
ORR Throughout the Study
Timepoint [1] 0 0
Up to 5.2 years
Secondary outcome [2] 0 0
iCR Rate
Timepoint [2] 0 0
Up to 5.2 years
Secondary outcome [3] 0 0
sCR Rate
Timepoint [3] 0 0
Up to 5.2 years
Secondary outcome [4] 0 0
CR Rate
Timepoint [4] 0 0
Up to 5.2 years
Secondary outcome [5] 0 0
VGPR Rate
Timepoint [5] 0 0
Up to 5.2 years
Secondary outcome [6] 0 0
Progression-free Survival (PFS)
Timepoint [6] 0 0
Up to 5.2 years
Secondary outcome [7] 0 0
Overall Survival (OS)
Timepoint [7] 0 0
Up to 5.2 years
Secondary outcome [8] 0 0
Maximum Plasma Concentration (Cmax): Panobinostat
Timepoint [8] 0 0
Cycle 1 Day 1 (Pre-dose, up to 8 hours post dose)
Secondary outcome [9] 0 0
Cmax: Bortezomib
Timepoint [9] 0 0
Cycle 1 Day 1 (Pre-dose, up to 8 hours post dose)
Secondary outcome [10] 0 0
Time to Reach Cmax (Tmax): Panobinostat
Timepoint [10] 0 0
Cycle 1 Day 1 (Pre-dose, up to 8 hours post dose)
Secondary outcome [11] 0 0
Tmax: Bortezomib
Timepoint [11] 0 0
Cycle 1 Day 1 (Pre-dose, up to 8 hours post dose)
Secondary outcome [12] 0 0
Exposure Response: Cmax for Panobinostat
Timepoint [12] 0 0
Up to 5.2 Years
Secondary outcome [13] 0 0
Change From Baseline in European Organization of Research and Treatment of Cancer (EORTC) Quality of Life Core 30-item Questionnaire (QLQ-C30) Global Health Status (GHS) Score
Timepoint [13] 0 0
Cycle 15 Day 1, at approximately 295 days
Secondary outcome [14] 0 0
Change From Baseline in the Functional Assessment of Cancer Therapy (FACT)/Gynecologic Oncology Group-Neurotoxicity (GOG-Ntx) Neurotoxicity Subscale Score
Timepoint [14] 0 0
Cycle 15 Day 1, at approximately 295 days
Secondary outcome [15] 0 0
Time to Progression (TTP)
Timepoint [15] 0 0
Up to 5.2 years
Secondary outcome [16] 0 0
Time to Response (TTR)
Timepoint [16] 0 0
Up to 5.2 years
Secondary outcome [17] 0 0
Duration of Response (DOR)
Timepoint [17] 0 0
Up to 5.2 years

Eligibility
Key inclusion criteria
* multiple myeloma per International Myeloma Working Group 2014 definition
* requiring treatment for relapsed or relapsed/refractory disease
* measurable disease based on central protein assessment
* received 1 to 4 prior lines of therapy
* prior immunomodulatory agent(s) exposure
* acceptable lab values prior to randomization
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* primary refractory myeloma
* refractory to bortezomib
* concomitant anti-cancer therapy (other than bortezomib/dexamethasone and bisphosphonates)
* prior treatment with pan-deacetylase inhibitors
* clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months prior to randomization)
* unresolved diarrhea = Common Terminology Criteria for adverse events grade 2 or presence of medical condition associated with chronic diarrhea (such as irritable bowel syndrome and inflammatory bowel disease)

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
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
27/04/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/08/2022
Sample size
Target
Accrual to date
Final
248
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Prahran
Recruitment postcode(s) [1] 0 0
3181 - Prahran
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
West Virginia
Country [10] 0 0
Belgium
State/province [10] 0 0
Hasselt
Country [11] 0 0
Brazil
State/province [11] 0 0
Sao Paulo
Country [12] 0 0
Brazil
State/province [12] 0 0
SP
Country [13] 0 0
Canada
State/province [13] 0 0
Alberta
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Czechia
State/province [15] 0 0
Czech Republic
Country [16] 0 0
Czechia
State/province [16] 0 0
Praha
Country [17] 0 0
France
State/province [17] 0 0
Bayonne Cedex
Country [18] 0 0
France
State/province [18] 0 0
Avignon Cedex 9
Country [19] 0 0
France
State/province [19] 0 0
Grenoble
Country [20] 0 0
France
State/province [20] 0 0
La Roche sur Yon Cedex
Country [21] 0 0
France
State/province [21] 0 0
Lille
Country [22] 0 0
France
State/province [22] 0 0
Metz
Country [23] 0 0
France
State/province [23] 0 0
Nantes Cedex 1
Country [24] 0 0
France
State/province [24] 0 0
Paris
Country [25] 0 0
France
State/province [25] 0 0
Pessac
Country [26] 0 0
Germany
State/province [26] 0 0
Bad Saarow
Country [27] 0 0
Germany
State/province [27] 0 0
Bayreuth
Country [28] 0 0
Germany
State/province [28] 0 0
Darmstadt
Country [29] 0 0
Germany
State/province [29] 0 0
Dresden
Country [30] 0 0
Germany
State/province [30] 0 0
Halle Saale
Country [31] 0 0
Germany
State/province [31] 0 0
Hamburg
Country [32] 0 0
Germany
State/province [32] 0 0
Kiel
Country [33] 0 0
Germany
State/province [33] 0 0
Leipzig
Country [34] 0 0
Greece
State/province [34] 0 0
Athens
Country [35] 0 0
Greece
State/province [35] 0 0
Patras
Country [36] 0 0
Hungary
State/province [36] 0 0
HUN
Country [37] 0 0
Hungary
State/province [37] 0 0
Budapest
Country [38] 0 0
Hungary
State/province [38] 0 0
Kaposvar
Country [39] 0 0
Hungary
State/province [39] 0 0
Nyiregyhaza
Country [40] 0 0
Italy
State/province [40] 0 0
RM
Country [41] 0 0
Italy
State/province [41] 0 0
RN
Country [42] 0 0
Korea, Republic of
State/province [42] 0 0
Hwasun
Country [43] 0 0
Korea, Republic of
State/province [43] 0 0
Seoul
Country [44] 0 0
Lebanon
State/province [44] 0 0
Beirut
Country [45] 0 0
Lebanon
State/province [45] 0 0
Sidon
Country [46] 0 0
Netherlands
State/province [46] 0 0
Amsterdam
Country [47] 0 0
Netherlands
State/province [47] 0 0
Dordrecht
Country [48] 0 0
Norway
State/province [48] 0 0
Oslo
Country [49] 0 0
Poland
State/province [49] 0 0
Lublin
Country [50] 0 0
Poland
State/province [50] 0 0
Torun
Country [51] 0 0
Poland
State/province [51] 0 0
Warszawa
Country [52] 0 0
Poland
State/province [52] 0 0
Wroclaw
Country [53] 0 0
Portugal
State/province [53] 0 0
Braga
Country [54] 0 0
Portugal
State/province [54] 0 0
Porto
Country [55] 0 0
Russian Federation
State/province [55] 0 0
Saint Petersburg
Country [56] 0 0
Russian Federation
State/province [56] 0 0
Saratov
Country [57] 0 0
Spain
State/province [57] 0 0
Andalucia
Country [58] 0 0
Spain
State/province [58] 0 0
Castilla Y Leon
Country [59] 0 0
Spain
State/province [59] 0 0
Catalunya
Country [60] 0 0
Spain
State/province [60] 0 0
Santa Cruz De Tenerife
Country [61] 0 0
Spain
State/province [61] 0 0
Madrid
Country [62] 0 0
Spain
State/province [62] 0 0
Zaragoza
Country [63] 0 0
Sweden
State/province [63] 0 0
Lulea
Country [64] 0 0
Sweden
State/province [64] 0 0
Lund
Country [65] 0 0
Sweden
State/province [65] 0 0
Uppsala
Country [66] 0 0
Thailand
State/province [66] 0 0
Muang
Country [67] 0 0
Thailand
State/province [67] 0 0
Bangkok
Country [68] 0 0
Thailand
State/province [68] 0 0
Chiang Mai
Country [69] 0 0
Turkey
State/province [69] 0 0
Ankara
Country [70] 0 0
Turkey
State/province [70] 0 0
Istanbul
Country [71] 0 0
Turkey
State/province [71] 0 0
Izmir

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
pharmaand GmbH
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02654990