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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
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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
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Secondary ID [1]
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2015-001564-19
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Secondary ID [2]
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CLBH589D2222
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Universal Trial Number (UTN)
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Trial acronym
PANORAMA_3
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma
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Condition category
Condition code
Cancer
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0
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Other cancer types
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Response Rate (ORR)
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Assessment method [1]
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ORR is defined as the percentage of participants with a confirmed partial response (PR) or better (immunophenotypic complete response \[iCR\] or stringent complete response \[sCR\] or complete response \[CR\] or very good partial response \[VGPR\]) as their best overall response after completion of up to 8 cycles of assigned study regimen. Each cycle was 21 days long. Best overall response was the best post-baseline confirmed overall response observed in a given participant and was determined based on overall responses observed at all post-baseline response assessments, recorded from randomization until progressive disease (PD), death, start of new therapy, withdrawal of consent, or end of study, whatever came first. ORR was assessed blindly per independent review committee (IRC) according to International Myeloma Working Group (IMWG) criteria.
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Timepoint [1]
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Up to 168 days
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Secondary outcome [1]
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ORR Throughout the Study
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Assessment method [1]
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ORR is defined as the percentage of participants with a confirmed PR or better (iCR or sCR or CR or VGPR) as their best overall response throughout the entire study. Best overall response was the best post-baseline confirmed overall response observed in a given participant and was determined based on overall responses observed at all post-baseline response assessments, recorded from randomization until PD, death, start of new therapy, withdrawal of consent or end of study, whatever came first. ORR was assessed blindly per IRC according to IMWG criteria.
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Timepoint [1]
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Up to 5.2 years
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Secondary outcome [2]
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iCR Rate
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Assessment method [2]
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iCR, based on IMWG criteria per blinded IRC assessment, is defined as: negative immunofixation of serum and urine; disappearance of any soft tissue plasmacytoma(s), in the case of any presence of soft tissue plasmacytoma(s) at baseline; less than 5% plasma cells in bone marrow; normal free light chain (FLC) ratio; absence of clonal plasma cells in bone marrow analyzed by immunohistochemistry or 2- to 4-color flow cytometry; absence of phenotypically aberrant plasma cells (clonal) in bone marrow (BM) with a minimum of 1 million total BM cells analyzed by multiparametric flow cytometry (\>4 colors). Results reported as percentage of participants achieving iCR.
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Timepoint [2]
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Up to 5.2 years
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Secondary outcome [3]
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sCR Rate
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Assessment method [3]
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sCR, based on IMWG criteria per blinded IRC assessment, is defined as: negative immunofixation of serum and urine; disappearance of any soft tissue plasmacytoma(s), in the case of any presence of soft tissue plasmacytoma(s) at baseline; less than 5% plasma cells in bone marrow; normal FLC ratio; absence of clonal plasma cells in bone marrow analyzed by immunohistochemistry or 2- to 4-color flow cytometry. Results reported as percentage of participants achieving sCR.
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Timepoint [3]
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Up to 5.2 years
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Secondary outcome [4]
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CR Rate
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Assessment method [4]
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CR, based on IMWG criteria per blinded IRC assessment, is defined as: negative immunofixation of serum and urine; disappearance of any soft tissue plasmacytoma(s), in the case of any presence of soft tissue plasmacytoma(s) at baseline; less than 5% plasma cells in bone marrow; in case the only measurable disease at baseline is the serum FLC assessment, a normal FLC ratio of 0.26 to 1.65 is required additionally to qualify for CR. Results reported as percentage of participants achieving CR.
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Timepoint [4]
0
0
Up to 5.2 years
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Secondary outcome [5]
0
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VGPR Rate
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Assessment method [5]
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VGPR, based on IMWG criteria per blinded IRC assessment, is defined as: serum and/or urine M protein detectable by immunofixation but not on protein electrophoresis, or =90% reduction from baseline in serum) and urine M protein \<100 milligrams/24 hours); in the case of the presence of any soft tissue plasmacytoma(s) at baseline, a reduction in the sum of the products of the cross-diameters by =50% from baseline is required; in case the only measurable disease in a participant at baseline is the serum FLC level (that is, no measurable disease in serum and urine PEP), a decrease of \>90% in the difference between involved and uninvolved FLC levels from baseline is required. Results reported as percentage of participants achieving VGPR.
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Timepoint [5]
0
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Up to 5.2 years
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Secondary outcome [6]
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Progression-free Survival (PFS)
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Assessment method [6]
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PFS, assessed based on IMWG criteria per blind IRC assessment, is defined as the time from date of randomization to date of first documented disease progression or death (regardless of cause of death).
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Timepoint [6]
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Up to 5.2 years
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Secondary outcome [7]
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Overall Survival (OS)
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Assessment method [7]
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OS is defined as the time from date of randomization to the date of death due to any cause.
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Timepoint [7]
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Up to 5.2 years
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Secondary outcome [8]
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Maximum Plasma Concentration (Cmax): Panobinostat
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Assessment method [8]
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Serial blood samples were collected for panobinostat Cmax analysis. Results are reported in nanograms/milliliter (ng/mL).
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Timepoint [8]
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Cycle 1 Day 1 (Pre-dose, up to 8 hours post dose)
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Secondary outcome [9]
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Cmax: Bortezomib
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Assessment method [9]
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Serial blood samples were collected for bortezomib Cmax analysis. Results are reported in ng/mL.
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Timepoint [9]
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Cycle 1 Day 1 (Pre-dose, up to 8 hours post dose)
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Secondary outcome [10]
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Time to Reach Cmax (Tmax): Panobinostat
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Assessment method [10]
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Serial blood samples were collected for panobinostat Tmax analysis. Results are reported in hours.
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Timepoint [10]
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Cycle 1 Day 1 (Pre-dose, up to 8 hours post dose)
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Secondary outcome [11]
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Tmax: Bortezomib
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Assessment method [11]
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Serial blood samples were collected for bortezomib Tmax analysis. Results are reported in hours.
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Timepoint [11]
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Cycle 1 Day 1 (Pre-dose, up to 8 hours post dose)
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Secondary outcome [12]
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Exposure Response: Cmax for Panobinostat
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Assessment method [12]
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The exposure-response relationship was assessed utilizing Cmax (Cycle 1 Day 1) for panobinostat versus the outcomes of ORR, grade 3/4 thrombocytopenia, and grade 3/4 diarrhea. Two statistical models were used: logistic regression models, in which these 3 outcomes were treated in a binary fashion according to their occurrence; Cox regression models, with the relevant outcomes being the time to occurrence of grade 3/4 thrombocytopenia and the time to occurrence of grade 3/4 diarrhea. Results are reported as model-based probability. An increase in the model-based probability indicates an increase in the occurrence of the outcomes (ORR, grade 3/4 thrombocytopenia, 3/4 diarrhea) with increasing values of Cmax (that is, with increasing dose of panobinostat).
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Timepoint [12]
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Up to 5.2 Years
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Secondary outcome [13]
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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
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Assessment method [13]
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Health-related quality of life (HRQoL) was assessed by the EORTC QLQ-C30, which is frequently employed in clinical oncology trials and is recognized as reliable and valid. The EORTC QLQ-C30 measures functional dimensions (physical, role, emotional, cognitive, and social), 3 symptom items (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea and financial impact), and a global health scale (GHS) and quality-of-life scale. For each domain and item, a linear transformation is applied to standardize the score between 0 and 100. Results are presented specifically for the GHS score. A higher GHS score indicates a higher HRQoL. Each cycle was 21 days long.
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Timepoint [13]
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Cycle 15 Day 1, at approximately 295 days
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Secondary outcome [14]
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Change From Baseline in the Functional Assessment of Cancer Therapy (FACT)/Gynecologic Oncology Group-Neurotoxicity (GOG-Ntx) Neurotoxicity Subscale Score
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Assessment method [14]
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HRQoL was assessed by the FACT/GOG-Ntx, a 38-item questionnaire designed to assess general quality of life and severity and impact of neurotoxicity from systemic chemotherapy. It is frequently employed in clinical oncology trials and is recognized as a reliable and valid measure to assess symptoms associated with neurotoxicity. It focuses on 4 general quality of life domains for physical well-being, functional well-being, social/family well-being, and emotional well-being, and includes the neurotoxicity subscale domain to characterize treatment-related neurotoxicity. Results are presented specifically for the 11-item neurotoxicity subscale, which uses a 5-point rating scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). Each item is scored from 0-4, with the severity of neurotoxicity measured as the sum of the 11 items, ranging from 0 to 44. Lower scores indicate lower neurotoxicity and higher HRQoL. Each cycle was 21 days long.
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Timepoint [14]
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Cycle 15 Day 1, at approximately 295 days
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Secondary outcome [15]
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Time to Progression (TTP)
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Assessment method [15]
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TTP, based on IMWG criteria per blinded IRC assessment, is defined as the time from the date of randomization to the date of the first documented disease progression or death due to multiple myeloma.
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Timepoint [15]
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Up to 5.2 years
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Secondary outcome [16]
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Time to Response (TTR)
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Assessment method [16]
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TTR, based on IMWG criteria per blinded IRC assessment, is the time between date of randomization to the date of first onset of PR or better response (iCR or sCR or CR or VGPR).
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Timepoint [16]
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Up to 5.2 years
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Secondary outcome [17]
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Duration of Response (DOR)
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Assessment method [17]
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DOR, based on IMWG criteria per blinded IRC assessment, is defined as the duration from the first documented onset of PR or better (iCR or sCR or CR or VGPR) to the date of first documented disease progression or death due to multiple myeloma.
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Timepoint [17]
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Up to 5.2 years
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/04/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
15/08/2022
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Sample size
Target
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Accrual to date
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Final
248
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Novartis Investigative Site - Prahran
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Recruitment postcode(s) [1]
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3181 - Prahran
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arkansas
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Kentucky
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United States of America
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Massachusetts
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United States of America
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New York
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United States of America
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West Virginia
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Belgium
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Hasselt
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Brazil
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Sao Paulo
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Brazil
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SP
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Canada
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Alberta
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Canada
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Ontario
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Czechia
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Czech Republic
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Czechia
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Praha
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France
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Bayonne Cedex
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France
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Avignon Cedex 9
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France
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Grenoble
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France
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La Roche sur Yon Cedex
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France
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Lille
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France
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Metz
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France
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Nantes Cedex 1
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France
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Paris
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France
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Pessac
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Germany
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Bad Saarow
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Germany
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Bayreuth
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Germany
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Darmstadt
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Germany
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Dresden
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Germany
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Halle Saale
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Germany
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Hamburg
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Germany
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Kiel
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Germany
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Leipzig
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Greece
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Athens
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Patras
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Budapest
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Hungary
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Kaposvar
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Hungary
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Nyiregyhaza
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Italy
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RM
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Italy
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RN
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Korea, Republic of
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Hwasun
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Seoul
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Lebanon
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Beirut
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Sidon
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Amsterdam
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Dordrecht
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Oslo
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Lublin
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Torun
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Braga
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Porto
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Russian Federation
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Saint Petersburg
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Russian Federation
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Saratov
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Andalucia
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Spain
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Castilla Y Leon
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Spain
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Catalunya
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Spain
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Santa Cruz De Tenerife
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Spain
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Madrid
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Spain
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Zaragoza
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Lulea
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Sweden
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Lund
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Sweden
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Uppsala
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Thailand
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Muang
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Thailand
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Bangkok
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Thailand
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Chiang Mai
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Turkey
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Ankara
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Turkey
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Istanbul
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Turkey
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Izmir
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
pharmaand GmbH
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
Note: The study data was transferred to zr pharma\& following the divestment of panobinostat to pharma\&. Prior to study completion under the sponsorship of Secura Bio, the study was initiated and conducted in part under the sponsorship of Novartis. 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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Trial website
https://clinicaltrials.gov/study/NCT02654990
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Trial related presentations / publications
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.
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Study protocol
https://cdn.clinicaltrials.gov/large-docs/90/NCT02654990/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/90/NCT02654990/SAP_001.pdf
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https://clinicaltrials.gov/study/NCT02654990
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