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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001564-19 | EudraCT Number |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A - 20 mg Panobinostat TIW | Experimental | 20 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and per oral dexamethasone |
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| Arm B - 20 mg Panobinostat BIW | Experimental | 20 mg panobinostat BIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and per oral dexamethasone |
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| Arm C - 10 mg Panobinostat TIW | Experimental | 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and per oral dexamethasone |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Panobinostat Capsules | Drug | 20 mg, 10 mg or 15 mg (for dose reductions only) |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | 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. | Up to 168 days |
| Measure | Description | Time Frame |
|---|---|---|
| ORR Throughout the Study | 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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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Fayetteville | Arkansas | 72703 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33301738 | Derived | 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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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A - Panobinostat (20 mg, TIW) | Participants received 20 milligrams (mg) panobinostat thrice a week (TIW), 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone. |
| FG001 | Arm B - Panobinostat (20 mg, BIW) |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 30, 2019 | Sep 6, 2023 |
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| Bortezomib Injection | Drug | 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. |
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| Dexamethasone tablets | Drug | 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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| Up to 5.2 years |
| iCR Rate | 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. | Up to 5.2 years |
| sCR Rate | 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. | Up to 5.2 years |
| CR Rate | 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. | Up to 5.2 years |
| VGPR Rate | 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. | Up to 5.2 years |
| Progression-free Survival (PFS) | 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). | Up to 5.2 years |
| Overall Survival (OS) | OS is defined as the time from date of randomization to the date of death due to any cause. | Up to 5.2 years |
| Maximum Plasma Concentration (Cmax): Panobinostat | Serial blood samples were collected for panobinostat Cmax analysis. Results are reported in nanograms/milliliter (ng/mL). | Cycle 1 Day 1 (Pre-dose, up to 8 hours post dose) |
| Cmax: Bortezomib | Serial blood samples were collected for bortezomib Cmax analysis. Results are reported in ng/mL. | Cycle 1 Day 1 (Pre-dose, up to 8 hours post dose) |
| Time to Reach Cmax (Tmax): Panobinostat | Serial blood samples were collected for panobinostat Tmax analysis. Results are reported in hours. | Cycle 1 Day 1 (Pre-dose, up to 8 hours post dose) |
| Tmax: Bortezomib | Serial blood samples were collected for bortezomib Tmax analysis. Results are reported in hours. | Cycle 1 Day 1 (Pre-dose, up to 8 hours post dose) |
| Exposure Response: Cmax for Panobinostat | 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). | Up to 5.2 Years |
| 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 | 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. | Cycle 15 Day 1, at approximately 295 days |
| Change From Baseline in the Functional Assessment of Cancer Therapy (FACT)/Gynecologic Oncology Group-Neurotoxicity (GOG-Ntx) Neurotoxicity Subscale Score | 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. | Cycle 15 Day 1, at approximately 295 days |
| Time to Progression (TTP) | 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. | Up to 5.2 years |
| Time to Response (TTR) | 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). | Up to 5.2 years |
| Duration of Response (DOR) | 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. | Up to 5.2 years |
| Los Angeles |
| California |
| 90017 |
| United States |
| Novartis Investigative Site | Fort Collins | Colorado | 80528 | United States |
| Novartis Investigative Site | Gainesville | Florida | 32608 | United States |
| Novartis Investigative Site | Atlanta | Georgia | 30322 | United States |
| Novartis Investigative Site | Louisville | Kentucky | 40202 | United States |
| Novartis Investigative Site | Boston | Massachusetts | 02215 | United States |
| Novartis Investigative Site | Lake Success | New York | 11042 | United States |
| Novartis Investigative Site | Morgantown | West Virginia | 26506 | United States |
| Novartis Investigative Site | Prahran | Victoria | 3181 | Australia |
| Novartis Investigative Site | Hasselt | 3500 | Belgium |
| Novartis Investigative Site | Barretos | São Paulo | 14784 400 | Brazil |
| Novartis Investigative Site | São Paulo | São Paulo | 04537 081 | Brazil |
| Novartis Investigative Site | São Paulo | 05403-000 | Brazil |
| Novartis Investigative Site | Edmonton | Alberta | T6G 1Z2 | Canada |
| Novartis Investigative Site | Kitchener | Ontario | N2G 1G3 | Canada |
| Novartis Investigative Site | Ostrava Poruba | Czech Republic | 708 52 | Czechia |
| Novartis Investigative Site | Prague | 12808 | Czechia |
| Novartis Investigative Site | Bayonne | Bayonne Cedex | 64109 | France |
| Novartis Investigative Site | Avignon | 84902 | France |
| Novartis Investigative Site | Grenoble | 38043 | France |
| Novartis Investigative Site | La Roche-sur-Yon | 85295 | France |
| Novartis Investigative Site | Lille | 59037 | France |
| Novartis Investigative Site | Metz | 57000 | France |
| Novartis Investigative Site | Nantes | 44093 | France |
| Novartis Investigative Site | Paris | 75231 | France |
| Novartis Investigative Site | Pessac | 33604 | France |
| Novartis Investigative Site | Bad Saarow | 15526 | Germany |
| Novartis Investigative Site | Bayreuth | 95445 | Germany |
| Novartis Investigative Site | Darmstadt | 64287 | Germany |
| Novartis Investigative Site | Dresden | 01307 | Germany |
| Novartis Investigative Site | Halle | 06120 | Germany |
| Novartis Investigative Site | Hamburg | 22763 | Germany |
| Novartis Investigative Site | Kiel | 24105 | Germany |
| Novartis Investigative Site | Leipzig | 04103 | Germany |
| Novartis Investigative Site | Athens | 115 27 | Greece |
| Novartis Investigative Site | Athens | 115 28 | Greece |
| Novartis Investigative Site | Pátrai | 265 00 | Greece |
| Novartis Investigative Site | Debrecen | HUN | 4032 | Hungary |
| Novartis Investigative Site | Budapest | 1097 | Hungary |
| Novartis Investigative Site | Kaposvár | 7400 | Hungary |
| Novartis Investigative Site | Nyíregyháza | 4400 | Hungary |
| Novartis Investigative Site | Roma | RM | 00161 | Italy |
| Novartis Investigative Site | Rimini | RN | 47900 | Italy |
| Novartis Investigative Site | Beirut | 166830 | Lebanon |
| Novartis Investigative Site | Beirut | Lebanon |
| Novartis Investigative Site | Sidon | 652 | Lebanon |
| VUmc, Hematology, PK2 BR012 | Amsterdam | 1081 HV | Netherlands |
| Albert Schweitzer ziekenhuis, Hematology | Dordrecht | 3318 AT | Netherlands |
| Novartis Investigative Site | Oslo | NO 0450 | Norway |
| Novartis Investigative Site | Lublin | 20 090 | Poland |
| Novartis Investigative Site | Torun | 87 100 | Poland |
| Novartis Investigative Site | Warsaw | 02 106 | Poland |
| Novartis Investigative Site | Warsaw | 02 776 | Poland |
| Novartis Investigative Site | Wroclaw | 50 367 | Poland |
| Novartis Investigative Site | Braga | 4710243 | Portugal |
| Novartis Investigative Site | Porto | 4200-072 | Portugal |
| Novartis Investigative Site | Saint Petersburg | 191024 | Russia |
| Novartis Investigative Site | Saratov | 410012 | Russia |
| Novartis Investigative Site | Hwasun | 58128 | South Korea |
| Novartis Investigative Site | Seoul | 03080 | South Korea |
| Novartis Investigative Site | Málaga | Andalusia | 29010 | Spain |
| Novartis Investigative Site | Salamanca | Castille and León | 37007 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08036 | Spain |
| Novartis Investigative Site | L'Hospitalet de Llobregat | Catalonia | 08907 | Spain |
| Novartis Investigative Site | San Cristóbal de La Laguna | Santa Cruz De Tenerife | 38320 | Spain |
| Novartis Investigative Site | Madrid | 28006 | Spain |
| Novartis Investigative Site | Madrid | 28040 | Spain |
| Novartis Investigative Site | Madrid | 28041 | Spain |
| Novartis Investigative Site | Zaragoza | 50009 | Spain |
| Novartis Investigative Site | Luleå | SE 971 80 | Sweden |
| Novartis Investigative Site | Lund | SE-221 85 | Sweden |
| Novartis Investigative Site | Uppsala | SE-751 85 | Sweden |
| Novartis Investigative Site | Nonthaburi | Muang | 40002 | Thailand |
| Novartis Investigative Site | Bangkok | 10330 | Thailand |
| Novartis Investigative Site | Chiang Mai | 50200 | Thailand |
| Novartis Investigative Site | Ankara | 06100 | Turkey (Türkiye) |
| Novartis Investigative Site | Istanbul | 34899 | Turkey (Türkiye) |
| Novartis Investigative Site | Izmir | 35340 | Turkey (Türkiye) |
Participants received 20 mg panobinostat twice a week (BIW), 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone. |
| FG002 | Arm C - Panobinostat (10 mg, TIW) | Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone. |
|
| Received at Least 1 Dose of Study Drug | Safety Set: all participants who received any study treatment. |
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| COMPLETED |
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| NOT COMPLETED |
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Full analysis set (FAS): all participants to whom study treatment was assigned by randomization.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A - Panobinostat (20 mg, TIW) | Participants received 20 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone. |
| BG001 | Arm B - Panobinostat (20 mg, BIW) | Participants received 20 mg panobinostat BIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone. |
| BG002 | Arm C - Panobinostat (10 mg, TIW) | Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Eastern Cooperative Oncology Group Performance Status | Scale to assess disease progression and disease effects on daily living abilities, as well as determine appropriate treatment and prognosis. Status range includes: 0 (fully active); 1 (restricted physical activity); 2 (unable to carry out work activities); 3 (limited self-care); 4 (completely disabled). | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
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| Primary | Overall Response Rate (ORR) | 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. | Full analysis set (FAS): all participants to whom study treatment was assigned by randomization. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 168 days |
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| Secondary | ORR Throughout the Study | 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. | Full analysis set (FAS): all participants to whom study treatment was assigned by randomization. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 5.2 years |
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| Secondary | iCR Rate | 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. | Full analysis set (FAS): all participants to whom study treatment was assigned by randomization. | Posted | Number | percentage of participants | Up to 5.2 years |
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| Secondary | sCR Rate | 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. | Full analysis set (FAS): all participants to whom study treatment was assigned by randomization. | Posted | Number | percentage of participants | Up to 5.2 years |
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| Secondary | CR Rate | 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. | Full analysis set (FAS): all participants to whom study treatment was assigned by randomization. | Posted | Number | percentage of participants | Up to 5.2 years |
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| Secondary | VGPR Rate | 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. | Full analysis set (FAS): all participants to whom study treatment was assigned by randomization. | Posted | Number | percentage of participants | Up to 5.2 years |
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| Secondary | Progression-free Survival (PFS) | 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). | Full analysis set (FAS): all participants to whom study treatment was assigned by randomization. | Posted | Median | 95% Confidence Interval | months | Up to 5.2 years |
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| Secondary | Overall Survival (OS) | OS is defined as the time from date of randomization to the date of death due to any cause. | Full analysis set (FAS): all participants to whom study treatment was assigned by randomization. | Posted | Median | 95% Confidence Interval | months | Up to 5.2 years |
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| Secondary | Maximum Plasma Concentration (Cmax): Panobinostat | Serial blood samples were collected for panobinostat Cmax analysis. Results are reported in nanograms/milliliter (ng/mL). | Pharmacokinetics Analysis Set (PAS): all participants with at least 1 evaluable pharmacokinetics concentration of panobinostat after dosing on Day 1. Here, 'Overall Number of Participants Analyzed' refers to the number of evaluable participants analyzed. | Posted | Mean | Standard Deviation | ng/mL | Cycle 1 Day 1 (Pre-dose, up to 8 hours post dose) |
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| Secondary | Cmax: Bortezomib | Serial blood samples were collected for bortezomib Cmax analysis. Results are reported in ng/mL. | Pharmacokinetics Analysis Set (PAS): all participants with at least 1 evaluable pharmacokinetics concentration of bortezomib after dosing on Day 1. Here, 'Overall Number of Participants Analyzed' refers to the number of evaluable participants analyzed. | Posted | Mean | Standard Deviation | ng/mL | Cycle 1 Day 1 (Pre-dose, up to 8 hours post dose) |
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| Secondary | Time to Reach Cmax (Tmax): Panobinostat | Serial blood samples were collected for panobinostat Tmax analysis. Results are reported in hours. | Pharmacokinetics Analysis Set (PAS): all participants with at least 1 evaluable pharmacokinetics concentration of panobinostat after dosing on Day 1. Here, 'Overall Number of Participants Analyzed' refers to the number of evaluable participants analyzed. | Posted | Mean | Standard Deviation | hours | Cycle 1 Day 1 (Pre-dose, up to 8 hours post dose) |
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| Secondary | Tmax: Bortezomib | Serial blood samples were collected for bortezomib Tmax analysis. Results are reported in hours. | Pharmacokinetics Analysis Set (PAS): all participants with at least 1 evaluable pharmacokinetics concentration of bortezomib after dosing on Day 1. Here, 'Overall Number of Participants Analyzed' refers to the number of evaluable participants analyzed. | Posted | Mean | Standard Deviation | hours | Cycle 1 Day 1 (Pre-dose, up to 8 hours post dose) |
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| Secondary | Exposure Response: Cmax for Panobinostat | 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). | Full analysis set (FAS): all participants to whom study treatment was assigned by randomization. Here, 'Overall Number of Participants Analyzed' refers to the number of evaluable participants analyzed. | Posted | Number | 95% Confidence Interval | percent probability | Up to 5.2 Years |
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| Secondary | 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 | 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. | Full analysis set (FAS): all participants to whom study treatment was assigned by randomization and who had a valid baseline HRQoL assessment and at least 1 post-baseline assessment. Here, 'Overall Number of Participants Analyzed' refers to the number of evaluable participants analyzed. | Posted | Mean | Standard Deviation | score on a scale | Cycle 15 Day 1, at approximately 295 days |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Functional Assessment of Cancer Therapy (FACT)/Gynecologic Oncology Group-Neurotoxicity (GOG-Ntx) Neurotoxicity Subscale Score | 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. | Full analysis set (FAS): all participants to whom study treatment was assigned by randomization and who had a valid baseline HRQoL assessment and at least 1 post-baseline assessment. Here, 'Overall Number of Participants Analyzed' refers to the number of evaluable participants analyzed. | Posted | Mean | Standard Deviation | score on a scale | Cycle 15 Day 1, at approximately 295 days |
| |||||||||||||||||||||||||||||||||
| Secondary | Time to Progression (TTP) | 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. | Full analysis set (FAS): all participants to whom study treatment was assigned by randomization. | Posted | Median | 95% Confidence Interval | months | Up to 5.2 years |
| |||||||||||||||||||||||||||||||||
| Secondary | Time to Response (TTR) | 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). | Full analysis set (FAS): all participants to whom study treatment was assigned by randomization. | Posted | Median | 95% Confidence Interval | months | Up to 5.2 years |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | 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. | Full analysis set (FAS): all participants to whom study treatment was assigned by randomization. | Posted | Median | 95% Confidence Interval | months | Up to 5.2 years |
|
Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Safety Set: all participants who received any study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A - Panobinostat (20 mg, TIW) | Participants received 20 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone. | 34 | 78 | 44 | 78 | 78 | 78 |
| EG001 | Arm B - Panobinostat (20 mg, BIW) | Participants received 20 mg panobinostat BIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone. | 41 | 83 | 40 | 83 | 82 | 83 |
| EG002 | Arm C - Panobinostat (10 mg, TIW) | Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone. | 47 | 80 | 36 | 80 | 78 | 80 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Bicytopenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Methaemoglobinaemia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Atrial Flutter | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cardiac Failure Acute | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Gastrointestinal Motility Disorder | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Drug Withdrawal Syndrome | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Bacterial Pyelonephritis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Pneumonia Parainfluenza Viral | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Abscess Limb | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Bacterial Sepsis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Diarrhoea Infectious | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Haemophilus Sepsis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Parainfluenza Virus Infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Pneumonia Haemophilus | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Pneumonia Viral | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Pyelonephritis Acute | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Rhinovirus Infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Streptococcal Sepsis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Forearm Fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Subdural Haematoma | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Transfusion-related Acute Lung Injury | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Femoral Neck Fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Spinal Compression Fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Troponin Increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Blood Creatine Increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Blood Lactate Dehydrogenase Increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Myocardial Necrosis Marker Increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Platelet Count Decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Type 2 Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Diabetic Ketoacidosis | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Electrolyte Imbalance | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Gastrointestinal Tract Adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Haematological Malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Neuropathy Peripheral | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Spinal Cord Compression | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypomania | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Benign Prostatic Hyperplasia | Reproductive system and breast disorders | MedDRA 22.1 | Systematic Assessment | This adverse event only affected male participants. |
|
| Orchitis Noninfective | Reproductive system and breast disorders | MedDRA 22.1 | Systematic Assessment | This adverse event only affected male participants. |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Obstructive Airways Disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pneumonia Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pulmonary Haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Acute Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Skin Ulcer | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Circulatory Collapse | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Peripheral Ischaemia | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Orthostatic Hypotension | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Non-cardiac Chest Pain | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Respiratory Tract Infection Viral | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Platelet Count Decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| C-Reactive Protein Increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Neutrophil Count Decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| White Blood Cell Count Decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Weight Increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Neuropathy Peripheral | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Orthostatic Hypotension | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
|
Sponsor's agreements with investigators require proposed public disclosures of trial results to be submitted to Sponsor for review prior to publication. Sponsor may request deletion of confidential information or a delay in publication to address intellectual property concerns, but Sponsor may not suppress publication of the trial results indefinitely. Sponsor may request delay of a single-center publication until after the release of a multi-site publication or an agreed upon period of time.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information Department | pharmaand GmbH | +43/1/3560006 | medinfo@pharmaand.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 16, 2019 | Sep 6, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077767 | Panobinostat |
| D000069286 | Bortezomib |
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D006877 | Hydroxamic Acids |
| D006898 | Hydroxylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002264 | Carboxylic Acids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
Not provided
Not provided
| Male |
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| Southeast Asian |
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| Hispanic or Latino |
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| Other |
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| Unknown/Not Reported |
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| Asian |
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| Black or African American |
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| Other |
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| 1 |
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| 2 |
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| 3 |
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| 4 |
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Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone. |
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Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone. |
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| OG002 | Arm C - Panobinostat (10 mg, TIW) | Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone. |
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Participants received 20 mg panobinostat BIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone. |
| OG002 | Arm C - Panobinostat (10 mg, TIW) | Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone. |
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| OG001 | Arm B - Panobinostat (20 mg, BIW) | Participants received 20 mg panobinostat BIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone. |
| OG002 | Arm C - Panobinostat (10 mg, TIW) | Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone. |
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