Panobinostat/Bortezomib/Dexamethasone in Relapsed or Relapsed-and-refractory Multiple Myeloma
NCT ID: NCT02654990
Last Updated: 2024-07-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
248 participants
INTERVENTIONAL
2016-04-27
2022-08-15
Brief Summary
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The purpose of this study is to investigate the safety and efficacy of 3 different regimens of panobinostat (20 milligrams \[mg\] thrice a week \[TIW\], 20 mg twice a week \[BIW\], and 10 mg TIW) in combination with subcutaneous bortezomib and dexamethasone and to provide exposure, safety and efficacy data to identify the optimal regimen of panobinostat in a randomized, 3-arm parallel design. This study will also assess the impact of administering subcutaneous bortezomib (in combination with panobinostat and dexamethasone) twice weekly for 4 cycles, and then weekly starting from Cycle 5 until disease progression in participants ≤ 75 years of age. Participants \> 75 years of age will receive subcutaneous bortezomib weekly for the entire treatment period (in combination with panobinostat and dexamethasone) until disease progression.
Participants will be treated until disease progression or until they discontinue earlier due to unacceptable toxicity or for other reasons.
Participants who discontinued study treatment for reasons other than disease progression will be followed for efficacy every 6 weeks.
All participants will be followed for survival until the last participant entering long-term follow-up has completed a 3-year survival follow-up or discontinued earlier.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Panobinostat Capsules
20 mg, 10 mg or 15 mg (for dose reductions only)
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.
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.
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
Panobinostat Capsules
20 mg, 10 mg or 15 mg (for dose reductions only)
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.
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.
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
Panobinostat Capsules
20 mg, 10 mg or 15 mg (for dose reductions only)
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.
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.
Interventions
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Panobinostat Capsules
20 mg, 10 mg or 15 mg (for dose reductions only)
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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pharmaand GmbH
INDUSTRY
Responsible Party
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Locations
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Novartis Investigative Site
Fayetteville, Arkansas, United States
Novartis Investigative Site
Los Angeles, California, United States
Novartis Investigative Site
Fort Collins, Colorado, United States
Novartis Investigative Site
Gainesville, Florida, United States
Novartis Investigative Site
Atlanta, Georgia, United States
Novartis Investigative Site
Louisville, Kentucky, United States
Novartis Investigative Site
Boston, Massachusetts, United States
Novartis Investigative Site
Lake Success, New York, United States
Novartis Investigative Site
Morgantown, West Virginia, United States
Novartis Investigative Site
Prahran, Victoria, Australia
Novartis Investigative Site
Hasselt, , Belgium
Novartis Investigative Site
Barretos, São Paulo, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
São Paulo, , Brazil
Novartis Investigative Site
Edmonton, Alberta, Canada
Novartis Investigative Site
Kitchener, Ontario, Canada
Novartis Investigative Site
Ostrava Poruba, Czech Republic, Czechia
Novartis Investigative Site
Prague, , Czechia
Novartis Investigative Site
Bayonne, Bayonne Cedex, France
Novartis Investigative Site
Avignon, , France
Novartis Investigative Site
Grenoble, , France
Novartis Investigative Site
La Roche-sur-Yon, , France
Novartis Investigative Site
Lille, , France
Novartis Investigative Site
Metz, , France
Novartis Investigative Site
Nantes, , France
Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Pessac, , France
Novartis Investigative Site
Bad Saarow, , Germany
Novartis Investigative Site
Bayreuth, , Germany
Novartis Investigative Site
Darmstadt, , Germany
Novartis Investigative Site
Dresden, , Germany
Novartis Investigative Site
Halle, , Germany
Novartis Investigative Site
Hamburg, , Germany
Novartis Investigative Site
Kiel, , Germany
Novartis Investigative Site
Leipzig, , Germany
Novartis Investigative Site
Athens, , Greece
Novartis Investigative Site
Athens, , Greece
Novartis Investigative Site
Pátrai, , Greece
Novartis Investigative Site
Debrecen, HUN, Hungary
Novartis Investigative Site
Budapest, , Hungary
Novartis Investigative Site
Kaposvár, , Hungary
Novartis Investigative Site
Nyíregyháza, , Hungary
Novartis Investigative Site
Roma, RM, Italy
Novartis Investigative Site
Rimini, RN, Italy
Novartis Investigative Site
Beirut, , Lebanon
Novartis Investigative Site
Beirut, , Lebanon
Novartis Investigative Site
Sidon, , Lebanon
VUmc, Hematology, PK2 BR012
Amsterdam, , Netherlands
Albert Schweitzer ziekenhuis, Hematology
Dordrecht, , Netherlands
Novartis Investigative Site
Oslo, , Norway
Novartis Investigative Site
Lublin, , Poland
Novartis Investigative Site
Torun, , Poland
Novartis Investigative Site
Warsaw, , Poland
Novartis Investigative Site
Warsaw, , Poland
Novartis Investigative Site
Wroclaw, , Poland
Novartis Investigative Site
Braga, , Portugal
Novartis Investigative Site
Porto, , Portugal
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Saratov, , Russia
Novartis Investigative Site
Hwasun, , South Korea
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Málaga, Andalusia, Spain
Novartis Investigative Site
Salamanca, Castille and León, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
L'Hospitalet de Llobregat, Catalonia, Spain
Novartis Investigative Site
San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Zaragoza, , Spain
Novartis Investigative Site
Luleå, , Sweden
Novartis Investigative Site
Lund, , Sweden
Novartis Investigative Site
Uppsala, , Sweden
Novartis Investigative Site
Nonthaburi, Muang, Thailand
Novartis Investigative Site
Bangkok, , Thailand
Novartis Investigative Site
Chiang Mai, , Thailand
Novartis Investigative Site
Ankara, , Turkey (Türkiye)
Novartis Investigative Site
Istanbul, , Turkey (Türkiye)
Novartis Investigative Site
Izmir, , Turkey (Türkiye)
Countries
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References
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Laubach JP, Schjesvold F, Mariz M, Dimopoulos MA, Lech-Maranda E, Spicka I, Hungria VTM, Shelekhova T, Abdo A, Jacobasch L, Polprasert C, Hajek R, Illes A, Wrobel T, Sureda A, Beksac M, Goncalves IZ, Blade J, Rajkumar SV, Chari A, Lonial S, Spencer A, Maison-Blanche P, Moreau P, San-Miguel JF, Richardson PG. Efficacy and safety of oral panobinostat plus subcutaneous bortezomib and oral dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma (PANORAMA 3): an open-label, randomised, phase 2 study. Lancet Oncol. 2021 Jan;22(1):142-154. doi: 10.1016/S1470-2045(20)30680-X. Epub 2020 Dec 7.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-001564-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLBH589D2222
Identifier Type: -
Identifier Source: org_study_id
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