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| ID | Type | Description | Link |
|---|---|---|---|
| C0328T06 | Other Identifier | Janssen Research & Development, LLC | |
| 2006-001904-36 | EudraCT Number |
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The purpose of Part 1 of the study is to determine the safety of the combination of Siltuximab (CNTO 328) and bortezomib (Velcade). The purpose of Part 2 of the study is to compare the length of progression free survival for those patients given CNTO 328 and bortezomib to those patients given bortezomib alone.
The purpose of this study is to see what effects CNTO 328 has on relapsed or refractory multiple myeloma. The study drug, CNTO 328, is a chimeric (part mouse) antibody (small protein that is important for fighting infection).CNTO 328 blocks a small protein called Interleukin 6 (IL-6). IL-6 is made naturally by your body, and at normal levels is important for inflammatory response. High levels of IL-6 can help cancer cells grow and interfere with chemotherapy drugs killing cancer cells. Cancer-related sickness such as cachexia (weight loss), bone resorption (weakening of your bones), and depression have been linked to high levels of IL-6. CNTO 328 has been shown to slow down tumor growth or shrink tumors when tested in animals. In other clinical trials, over 100 patients have received CNTO 328. There are studies ongoing in participants with kidney cancer, hematologic malignancies (blood cancers such as multiple myeloma), and prostate cancer, to see if CNTO 328 is safe and to see what effects it has on these types of cancer. At this time, it is unknown what effect CNTO 328 has had on the participants' cancer. Bortezomib is a type of drug known as a "proteasome inhibitor." A proteasome is a substance that is found in every cell and it is there to help to break down other substances ('proteins') and has a role in the way cells divide. If the proteasome is inhibited, it cannot perform its function in the cell, and if a cell cannot divide it dies. Over 8000 patients with multiple myeloma and other types of cancer have been treated with bortezomib. Bortezomib has been extensively studied in patients with previously treated multiple myeloma. Based on its established activity in pretreated multiple myeloma, bortezomib is registered in the United States and in Europe for the treatment of multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. Bortezomib is currently also being studied in several other cancer types.This study consists of two parts. The purpose of Part 1 is to determine the safety of CNTO 328 and bortezomib when given together as a treatment. The purpose of Part 2 is to compare the safety and effects (good and bad) of the combination of CNTO 328 and bortezomib to the safety and effects of bortezomib alone. About 20 patients will take part in the first part of the study. About 270 patients will take part in the second part of the study at approximately 70 sites in the US, Canada, and Europe. Patients will be in the study for about 12 months, with a follow-up period of around 9 months. The study is divided into four different phases: Screening phase-which lasts up to 4 weeks. During this phase the study doctor will perform tests to see if the patient can participate in the study.Treatment phase-which may last up to 4 cycles of 42 days each during which the patient will be treated with CNTO 328 and bortezomib. Maintenance phase-If the patient benefits from the therapy in the treatment phase, the patient will continue to receive CNTO 328 and bortezomib, but now in cycles of 35 days each. Follow up phase, this includes an end of treatment visit 4 weeks after the patient's last infusion and follow up visits every three months until the patient starts a new anti-cancer treatment. CNTO 328 6mg/kg ( 6 milligrams per kilogram of body weight) will be given intravenously (into the vein) over 2 hours once every 2 weeks. Patients who respond with stable disease or better may receive additional doses. Bortezomib will be given IV (into the vein) at 1.3 mg/m2 over 3-5 seconds twice a week for 2 weeks followed by 1 week of rest.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Siltuximab Plus Bortezomib | Experimental | Siltuximab 6 milligram per kilogram (mg/kg) will be administered as intravenous infusion once every 2 weeks along with bortezomib 1.3 milligram per square meter (mg/m^2) during cycle 1. |
|
| Part 2: Bortezomib + Placebo | Experimental | Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10-day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles. |
|
| Part 2: Bortezomib + Siltuximab | Experimental | Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10-day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Siltuximab | Biological | Siltuximab 6 mg/kg will be administered as intravenous infusion once every 2 weeks during cycle 1 in Part 1. Siltuximab 6 mg/kg will be administered as intravenous infusion once every 2 weeks during 42-day Treatment Phase and 35-day Maintenance Phase in Part 2. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Progression-free survival was defined as the time interval between randomization and the first documented sign of disease progression (including relapse from complete response [CR]) by the European Bone Marrow Transplant (EBMT) criteria or death, whichever occurred first. Relapse from CR requires at least 1 of the following: Reappearance of serum or urinary M-protein on immunofixation or routine electrophoresis, confirmed by at least 1 further investigation and excluding oligoclonal immune reconstitution; Greater than or equal to (>=) 5 percent (%) plasma cells either in a bone marrow aspirate or on trephine bone biopsy; Development of new lytic bone lesions or soft tissue plasmacytomas or definite increase in the size of residual bone lesions (development of a compression fracture does not exclude continued response and may not indicate progression); Development of hypercalcemia not attributable to any other cause. | Randomization until disease progression or death, which ever occured first (maximum up to 5 years) |
| Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Best Confirmed Response of Complete Response (CR) or Partial Response (PR) (Overall Response Rate) | Overall response rate was defined as best response (CR/PR confirmed) for a participant recorded from first administration of study agent or randomization (Part 2) until disease progression/recurrence and before dexamethasone was added. CR: Absence of original M-protein in serum/urine by immunofixation,maintained for minimum of 6 weeks. The presence of oligoclonal bands consistent with oligoclonal immune reconstitution does not exclude CR; Less than 5 percent (%) plasma cells in bone marrow aspirate and also on trephine bone biopsy if biopsy is performed; No increase in size/number of lytic bone lesions; Disappearance of soft tissue plasmacytomas. PR: Greater than or equal to (>=) 50% reduction in level of serum M-protein, maintained for minimum of 6 weeks. Reduction in 24 hour urinary light chain excretion either by >= 90% or to < 200 mg, maintained for minimum of 6 weeks; >= 50% reduction in size of soft tissue plasmacytomas; No increase in size/number of lytic bone lesions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Greenbrae | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25294016 | Derived | Orlowski RZ, Gercheva L, Williams C, Sutherland H, Robak T, Masszi T, Goranova-Marinova V, Dimopoulos MA, Cavenagh JD, Spicka I, Maiolino A, Suvorov A, Blade J, Samoylova O, Puchalski TA, Reddy M, Bandekar R, van de Velde H, Xie H, Rossi JF. A phase 2, randomized, double-blind, placebo-controlled study of siltuximab (anti-IL-6 mAb) and bortezomib versus bortezomib alone in patients with relapsed or refractory multiple myeloma. Am J Hematol. 2015 Jan;90(1):42-9. doi: 10.1002/ajh.23868. |
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144 participants were randomized to bortezomib plus placebo group; of which, 3 participants received incorrect treatment (bortezomib plus siltuximab).
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1 - Bortezomib + Siltuximab | Siltuximab 6 milligram per kilogram (mg/kg) will be administered as intravenous infusion once every 2 weeks along with bortezomib 1.3 milligram per square meter (mg/m^2) during cycle 1. |
| FG001 | Part 2 - Bortezomib + Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
|
| Bortezomib | Drug | Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus once every 2 weeks during cycle 1 in Part 1. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10-day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period during 42-day treatment phase in Part 2. Bortezomib 1.3 mg/m2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) during 35-day Maintenance Phase in Part 2. |
|
|
| Placebo | Drug | Matching placebo will be administered as intravenous infusion once every 2 weeks during 42-day treatment phase and 35-day maintenance phase in Part 2. |
|
| Dexamethasone | Drug | Dexamethasone tablet will be administered in this study at the first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles in treatment phase and maintenance phase of Part 2. |
|
| Randomization until disease progression (maximum up to 5 years) |
| Percentage of Participants With Confirmed Complete Response (CR Rate) | CR rate was defined as the percentage of participants who achieved a confirmed CR before dexamethasone was added. CR: Absence of original M-protein in serum/urine by immunofixation,maintained for minimum of 6 weeks. The presence of oligoclonal bands consistent with oligoclonal immune reconstitution does not exclude CR; Less than 5 percent (%) plasma cells in bone marrow aspirate and also on trephine bone biopsy if biopsy is performed; No increase in size/number of lytic bone lesions; Disappearance of soft tissue plasmacytomas. | Randomization until disease progression (maximum up to 5 years) |
| Overall Survival | Overall survival was defined as the interval between the first administration of study agent or randomization (Part 2) and the participant's death from any cause. For participants with unknown survival status as of the data cut-off date, overall survival was censored at the last date known to be alive. | up to 5 years |
| Los Angeles |
| California |
| United States |
| Indianapolis | Indiana | United States |
| Albuquerque | New Mexico | United States |
| New York | New York | United States |
| Syracuse | New York | United States |
| Chapel Hill | North Carolina | United States |
| North Charleston | South Carolina | United States |
| Dallas | Texas | United States |
| Houston | Texas | United States |
| Madison | Wisconsin | United States |
| Antwerp | Belgium |
| B-8000 Brugge | Belgium |
| Brussels | Belgium |
| Edegem | Belgium |
| Leuven | Belgium |
| Rio de Janeiro | Brazil |
| Bulgaria | Bulgaria |
| Pleven | Bulgaria |
| Plovdiv | Bulgaria |
| Vancouver | British Columbia | Canada |
| Québec | Quebec | Canada |
| Calgary | Canada |
| Brno | Czechia |
| Hradec Králové | Czechia |
| Prague | Czechia |
| Grenoble | France |
| Lille Cedex N/a | France |
| Montpellier | France |
| Pierre-Bénite | France |
| Vandœuvre-lès-Nancy | France |
| Aschaffenburg | Germany |
| Essen | Germany |
| Mainz | Germany |
| Münster | Germany |
| Stuttgart | Germany |
| Ulm | Germany |
| Athens | Greece |
| Budapest | Hungary |
| Debrecen | Hungary |
| Gyõr | Hungary |
| NyÃregyháza | Hungary |
| Szeged | Hungary |
| Amersfoort | Netherlands |
| Amsterdam | Netherlands |
| Rotterdam | Netherlands |
| The Hague | Netherlands |
| Bialystok | Poland |
| Gdansk | Poland |
| Katowice | Poland |
| Lodz | Poland |
| Lublin | Poland |
| Poznan | Poland |
| Wroclaw | Poland |
| Coimbra | Portugal |
| Lisbon | Portugal |
| Porto | Portugal |
| Baia Mare | Romania |
| Brasov | Romania |
| Bucharest | Romania |
| Iași | Romania |
| Tg Mures | Romania |
| Arkhangelsk | Russia |
| Izhevsk | Russia |
| Moscow | Russia |
| Nizhny Novgorod | Russia |
| Novosibirsk | Russia |
| Saint Petersburg | Russia |
| Ufa | Russia |
| Bratislava | Slovakia |
| Martin | Slovakia |
| Badalona | Spain |
| Barcelona | Spain |
| Madrid | Spain |
| Salamanca | Spain |
| Valencia | Spain |
| London | United Kingdom |
| Nottingham | United Kingdom |
| Plymouth | United Kingdom |
| Sutton | United Kingdom |
Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles. |
| FG002 | Part 2 - Bortezomib + Siltuximab | Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles. |
| Treated |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1 - Bortezomib + Siltuximab | Siltuximab 6 milligram per kilogram (mg/kg) will be administered as intravenous infusion once every 2 weeks along with bortezomib 1.3 milligram per square meter (mg/m^2) during cycle 1. |
| BG001 | Part 2 - Bortezomib + Placebo | Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles. |
| BG002 | Part 2 - Bortezomib + Siltuximab | Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | 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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-free Survival | Progression-free survival was defined as the time interval between randomization and the first documented sign of disease progression (including relapse from complete response [CR]) by the European Bone Marrow Transplant (EBMT) criteria or death, whichever occurred first. Relapse from CR requires at least 1 of the following: Reappearance of serum or urinary M-protein on immunofixation or routine electrophoresis, confirmed by at least 1 further investigation and excluding oligoclonal immune reconstitution; Greater than or equal to (>=) 5 percent (%) plasma cells either in a bone marrow aspirate or on trephine bone biopsy; Development of new lytic bone lesions or soft tissue plasmacytomas or definite increase in the size of residual bone lesions (development of a compression fracture does not exclude continued response and may not indicate progression); Development of hypercalcemia not attributable to any other cause. | Intent-to-treat (ITT) population included all participants randomized in Part 2. Participants were analyzed as per initial randomization. | Posted | Median | 95% Confidence Interval | days | Randomization until disease progression or death, which ever occured first (maximum up to 5 years) |
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| Secondary | Percentage of Participants With Best Confirmed Response of Complete Response (CR) or Partial Response (PR) (Overall Response Rate) | Overall response rate was defined as best response (CR/PR confirmed) for a participant recorded from first administration of study agent or randomization (Part 2) until disease progression/recurrence and before dexamethasone was added. CR: Absence of original M-protein in serum/urine by immunofixation,maintained for minimum of 6 weeks. The presence of oligoclonal bands consistent with oligoclonal immune reconstitution does not exclude CR; Less than 5 percent (%) plasma cells in bone marrow aspirate and also on trephine bone biopsy if biopsy is performed; No increase in size/number of lytic bone lesions; Disappearance of soft tissue plasmacytomas. PR: Greater than or equal to (>=) 50% reduction in level of serum M-protein, maintained for minimum of 6 weeks. Reduction in 24 hour urinary light chain excretion either by >= 90% or to < 200 mg, maintained for minimum of 6 weeks; >= 50% reduction in size of soft tissue plasmacytomas; No increase in size/number of lytic bone lesions. | Response-evaluable population:all participants in Part 2 with confirmed diagnosis of multiple myeloma and measurable,secretory disease:either serum M-protein 1 >= gram per deciliter(g/dL)/urine M-protein >200 mg per 24 hours,at study entry;had at least 1 study agent administration;at least 1 post-baseline disease assessment before dexamethasone. | Posted | Number | percentage of participants | Randomization until disease progression (maximum up to 5 years) |
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| Secondary | Percentage of Participants With Confirmed Complete Response (CR Rate) | CR rate was defined as the percentage of participants who achieved a confirmed CR before dexamethasone was added. CR: Absence of original M-protein in serum/urine by immunofixation,maintained for minimum of 6 weeks. The presence of oligoclonal bands consistent with oligoclonal immune reconstitution does not exclude CR; Less than 5 percent (%) plasma cells in bone marrow aspirate and also on trephine bone biopsy if biopsy is performed; No increase in size/number of lytic bone lesions; Disappearance of soft tissue plasmacytomas. | Response-evaluable population:all participants in Part 2 with confirmed diagnosis of multiple myeloma and measurable,secretory disease:either serum M-protein 1 >= gram per deciliter(g/dL)/urine M-protein >200 mg per 24 hours,at study entry;had at least 1 study agent administration;at least 1 post-baseline disease assessment before dexamethasone. | Posted | Number | percentage of participants | Randomization until disease progression (maximum up to 5 years) |
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| Secondary | Overall Survival | Overall survival was defined as the interval between the first administration of study agent or randomization (Part 2) and the participant's death from any cause. For participants with unknown survival status as of the data cut-off date, overall survival was censored at the last date known to be alive. | ITT population included all participants randomized in Part 2. Participants were analyzed as per initial randomization. | Posted | Median | 95% Confidence Interval | days | up to 5 years |
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| Primary | Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | The safety population included all participants who received at least 1 dose of study treatment in Part 1 or Part 2. Participants were analyzed as per actual treatment received. | Posted | Number | participants | up to 5 years |
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The safety population included all participants who received at least 1 dose of study treatment in Part 1 or Part 2. Participants were analyzed as per actual treatment received.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1 - Bortezomib + Siltuximab | Siltuximab 6 milligram per kilogram (mg/kg) will be administered as intravenous infusion once every 2 weeks along with bortezomib 1.3 milligram per square meter (mg/m^2) during cycle 1. | 10 | 21 | 21 | 21 | ||
| EG001 | Part 2 - Bortezomib + Placebo | Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles. | 44 | 139 | 135 | 139 | ||
| EG002 | Part 2 - Bortezomib + Siltuximab | Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles. | 47 | 142 | 140 | 142 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA Version 16.0 | Non-systematic Assessment |
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| Cardiac Disorder | Cardiac disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Cardiogenic Shock | Cardiac disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Cardiopulmonary Failure | Cardiac disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Left Ventricular Dysfunction | Cardiac disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Ventricular Fibrillation | Cardiac disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Eye Swelling | Eye disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Retinal Detachment | Eye disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Haemorrhoidal Haemorrhage | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Mouth Ulceration | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Retroperitoneal Haemorrhage | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Chronic Fatigue Syndrome | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Face Oedema | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Mass | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Performance Status Decreased | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Sudden Cardiac Death | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Sudden Death | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hepatic Function Abnormal | Hepatobiliary disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Acute Hepatitis B | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Enterobacter Bacteraemia | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Kidney Infection | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Lobar Pneumonia | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Meningitis Bacterial | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Meningitis Pneumococcal | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Pneumonia Pneumococcal | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Pneumonia Streptococcal | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Streptococcal Bacteraemia | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Humerus Fracture | Injury, poisoning and procedural complications | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Spinal Compression Fracture | Injury, poisoning and procedural complications | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Ulna Fracture | Injury, poisoning and procedural complications | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Upper Limb Fracture | Injury, poisoning and procedural complications | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Tumour Lysis Syndrome | Metabolism and nutrition disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Bone Lesion | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Muscle Haemorrhage | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Bladder Transitional Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Colon Adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Pancreatic Carcinoma Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Plasma Cell Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Plasma Cell Myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Plasmacytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Cognitive Disorder | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Haemorrhagic Stroke | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Mononeuritis | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Spinal Cord Compression | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Subarachnoid Haemorrhage | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Viith Nerve Paralysis | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Vocal Cord Paresis | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Obstructive Uropathy | Renal and urinary disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Renal Failure Acute | Renal and urinary disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Renal Impairment | Renal and urinary disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Acute Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Interstitial Lung Disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Mediastinal Shift | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Respiratory Arrest | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Drug Eruption | Skin and subcutaneous tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hypovolaemic Shock | Vascular disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Jugular Vein Thrombosis | Vascular disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Orthostatic Hypotension | Vascular disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Chalazion | Eye disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Lacrimation Increased | Eye disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Aphthous Stomatitis | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Gait Disturbance | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Influenza Like Illness | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hepatic Function Abnormal | Hepatobiliary disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Ear Infection | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Herpes Simplex | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Weight Increased | Investigations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Enzyme Abnormality | Metabolism and nutrition disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hyperamylasaemia | Metabolism and nutrition disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hyperlipasaemia | Metabolism and nutrition disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Balance Disorder | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Peripheral Motor Neuropathy | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Renal Impairment | Renal and urinary disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Project Physician | Janssen R&D UK | ClinicalTrialDisclosure@its.jnj.com |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C504234 | siltuximab |
| D000069286 | Bortezomib |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
Not provided
Not provided
| Male |
|
| Brazil |
|
| Bulgaria |
|
| Canada |
|
| Czech Republic |
|
| France |
|
| Germany |
|
| Greece |
|
| Hungary |
|
| Netherlands |
|
| Poland |
|
| Portugal |
|
| Romania |
|
| Russian Federation |
|
| Spain |
|
| United Kingdom |
|
| United States |
|
| OG001 | Part 2 - Bortezomib + Siltuximab | Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles. |
|
|
| OG001 | Part 2 - Bortezomib + Siltuximab | Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles. |
|
|
Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
|
|
| OG002 | Part 2 - Bortezomib + Siltuximab | Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles. |
|
|