| ID | Type | Description | Link |
|---|---|---|---|
| CNTO328MMY2001 | Other Identifier | Janssen Research & Development, LLC | |
| 2008-007157-12 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate safety and effectiveness of CNTO 328 (siltuximab) when it is administered together with velcade-melphalan-prednisone (VMP) in comparison with VMP alone in participants with multiple myeloma (a type of cancer that affects the blood and bone marrow).
The study will be conducted in 2 parts (Part 1 and Part 2) and will consist of screening period up to 2 weeks; treatment period; maintenance period (CNTO 328 hereafter referred to as siltuximab) for a maximum of 18 months and follow up period until the study ends. Part 1 is an open-label (all people know the identity of the intervention), single group safety lead-in part to evaluate the safety of siltuximab. Approximately 12 patients will be treated with siltuximab in combination with VMP. If the safety profile of the combination is acceptable, the study will proceed to Part 2. Part 2 is a randomized (the study medication is assigned by chance), open-label, 2-arm (Arm A: siltuximab + VMP; Arm B: VMP alone) study. Approximately 104 patients will be equally randomized, followed by a maintenance period with siltuximab in particiants in Arm A who achieve a partial response (PR) or better. Particiants in both parts of the study will be treated up to a maximum of nine 6-week cycles provided there is no evidence of disease progression, unacceptable toxicity, or withdrawal from treatment. Study medication will be continued for at least 2 additional cycles after confirmation of complete response, and preferably for the full 9 cycles of the treatment period. Participants who will be receiving maintenance treatment after the 12-month effectiveness analysis may continue to receive treatment with siltuximab only after careful consideration by the treating physician and on evidence of clinical benefit and in the absence of unwarranted toxicities. Safety assessments will include evaluation of adverse events, clinical laboratory tests, eastern cooperative oncology group performance status, electrocardiogram, vital signs, and physical examination which will be monitored throughout the study.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: VMP+Siltuximab 11 mg/kg | Experimental | Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP (Velcade+Melphalan+Prednisone). Velcade 1.3 mg/m2 will be administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 will be taken orally (by mouth). |
|
| Part 2, Arm A: VMP+Siltuximab 8.3 mg/kg or 11 mg/kg | Experimental | Siltuximab 8.3 mg/kg or 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. Velcade 1.3 mg/m2 will be administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 will be taken orally |
|
| Part 2, Arm B: VMP | Active Comparator | Velcade 1.3 mg/m2 will be administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 will be taken orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Siltuximab11 mg/kg | Drug | Participants will receive siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks in Part 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Complete Response (CR) - European Group for Blood and Marrow Transplantation (EBMT) Criteria | CR was assessed using EMBT criteria: disappearance of the original monoclonal paraprotein from the blood and urine on at least 2 determinations for a minimum of 6 weeks by immunofixation studies, <5% plasma cells in the bone marrow on at least 1 determination, if skeletal survey is available: no increase in the size or number of lytic bone lesions (development of a compression fracture does not exclude response), disappearance of soft tissue plasmacytomas for at least 6 weeks. | Up to disease progression, approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Overall Response ie, Complete Response (CR) or Partial Response (PR) - European Group for Blood and Marrow Transplantation (EBMT) Criteria | CR or PR was assessed using EBMT criteria. CR: disappearance of the original monoclonal paraprotein from the blood and urine on at least 2 determinations for a minimum of 6 weeks by immunofixation studies, <5% plasma cells in the bone marrow on at least 1 determination, if skeletal survey is available: no increase in the size or number of lytic bone lesions (development of a compression fracture does not exclude response), disappearance of soft tissue plasmacytomas for at least 6 weeks; PR: >=50% reduction in the level of serum monoclonal paraprotein for at least 2 determinations 6 weeks apart, if present, reduction in 24-hour urinary light chain excretion by either >=90% or to <200 mg for at least 2 determinations 6 weeks apart, >=50% reduction in the size of soft tissue plasmacytomas (by clinical or radiographic examination) for at least 6 weeks, if skeletal survey is available: no increase in size or number of lytic bone lesions |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development L.L.C Clinical Trial | Janssen Research & Development L.L.C | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston | Massachusetts | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24833354 | Derived | San-Miguel J, Blade J, Shpilberg O, Grosicki S, Maloisel F, Min CK, Polo Zarzuela M, Robak T, Prasad SV, Tee Goh Y, Laubach J, Spencer A, Mateos MV, Palumbo A, Puchalski T, Reddy M, Uhlar C, Qin X, van de Velde H, Xie H, Orlowski RZ. Phase 2 randomized study of bortezomib-melphalan-prednisone with or without siltuximab (anti-IL-6) in multiple myeloma. Blood. 2014 Jun 26;123(26):4136-42. doi: 10.1182/blood-2013-12-546374. Epub 2014 May 15. |
Not provided
Not provided
In Part 2, 105 participants received treatment (VMP: 53 and VMP+Siltuximab: 52). In the VMP+Siltuximab arm, 21 participants who achieved partial response or better entered the maintenance period and received only Siltuximab for 18 months, or until disease progression, unacceptable toxicity, or withdrawal from treatment, whichever occurred first.
The study was conducted at 40 centers in 12 countries: Australia; France; India; Israel; Italy; Poland; Romania; Russian Federation; Singapore; South Korea; Spain; and the United States.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: VMP + Siltuximab | Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Siltuximab 8.3 mg/kg or 11 mg/kg | Drug | Participants will receive siltuximab 8.3 mg/kg or 11 mg/kg as a 1-hour intravenous infusion every 3 weeks for 9 cycles of treatment in Part 2, Arm A and in maintenance period. |
|
|
| Velcade (bortezomib) | Drug | Participants will receive Velcade 1.3 mg/m2 as an intravenous bolus injection according to the current approved package insert in Part 1. |
|
|
| Velcade (bortezomib) | Drug | Participants will receive Velcade 1.3 mg/m2 as an intravenous bolus injection for 9 cycles of the treatment period in Part 2. It will be administered twice weekly for first 4 cycles (on Days 1, 4, 8, 11, 22, 25, 29, and 32, followed by a 10-day rest period) and once weekly for next 5 cycles (on Days 1, 8, 22, and 29, followed by a 13-day rest period) |
|
|
| Melphalan | Drug | Participants will take melphalan 9 mg/m2 will be administered orally on Days 1 to 4, followed by a 38-day rest period in Part 1. |
|
| Melphalan | Drug | Participants will receive melphalan according to currently approved package inserts. Melphalan 9 mg/m2 will be administered orally for 9 cycles of treatment period in Part 2, Arm A. |
|
| Prednisone | Drug | Participants will take prednisone 60 mg/m2 will be administered orally on Days 1 to 4, followed by a 38-day rest period in Part 1. |
|
| Prednisone | Drug | Participants will take prednisone 60 mg/m2 orally for 9 cycles of treatment period in Part 2, Arm A. |
|
| Velcade (bortezomib) | Drug | Participants will receive Velcade 1.3 mg/m2 as an intravenous bolus injection according to the current approved package insert. |
|
|
| Melphalan | Drug | Participants will take melphalan 9 mg/m2 orally according to currently approved package insert. |
|
| Prednisone | Drug | Participants will take prednisone 60 mg/m2 orally according to the package insert. |
|
| Up to disease progression, approximately 3 years |
| Percentage of Participants Who Achieved Stringent Complete Response (sCR) - International Myeloma Working Group (IMWG) Criteria | sCR was assesses by IMWG Criteria: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, <=5% plasma cells in bone marrow, normal free light chain ratio, absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. sCR is a CR that has been confirmed by immunofixation + free light chain assay + either bone marrow immunohistochemistry or immunofluorescence | Up to disease progression, approximately 3 years |
| Progression-Free Survival (PFS) | PFS was defined as the time between randomization and either disease progression or death, whichever occurred first. | From the date of randomization until disease progression or death, whichever occurred first, as assessed up to the last efficacy assessment for disease progression (approximately 3 years) |
| 1-year Progression-Free Survival (PFS) Rate | The 1-year PFS rate was defined as the percentage of participants surviving 1 year after randomization without disease progression or death. | 1 year |
| Duration of Response (DOR) | DOR was defined as length from the earliest date a participant achieved a complete response (CR) or partial response (PR) to either date for disease progression (including relapse from CR) or the censoring date for progressive disease. Responders without disease progression were censored at the last efficacy assessment for disease progression. | From the date participants achieved CR or PR to either date for disease progression (including relapse from CR) or the censoring date for progressive disease, as assessed Up to 30 days after last dose of study medication |
| 1-year Survival Rate | Percentage of participants who are alive at the end of year 1 after randomization | 1 year |
| Overall Survival | Overall survival is defined as the time interval in days between the date of randomization and the participant's death from any cause. | From the date of randomization till the date of death, as assessed up to the end of study (approximately 3 years) |
| Change From Baseline to Cycle 9 in Global Health Status/Quality of Life Subscale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30) | Global health status/quality of life is a subscale of the EORTC QOL C30, which comprises two questions related to overall health/quality of life during the past week. The raw score to each question ranged from 1 (very poor) to 7 (excellent). The raw mean score of health status/quality of life subscale is calculated for each participant and a linear transformation applied to standardize the raw score, so that scores range from 0 to 100; a higher score represents a higher ("better") health and quality of life. | Baseline (Day 1 predose) and Cycle 9 (Week 54) |
| Chapel Hill |
| North Carolina |
| United States |
| Philadelphia | Pennsylvania | United States |
| Houston | Texas | United States |
| Adelaide | Australia |
| Melbourne | Australia |
| Bordeaux | France |
| Montpellier | France |
| Strasbourg | France |
| Ahmedabad | India |
| Calicut | India |
| Hyderabad | India |
| Jaipur | India |
| Mumbai | India |
| Afula | Israel |
| Haifa | Israel |
| Jerusalem | Israel |
| Petah Tikva | Israel |
| Ramat Gan | Israel |
| Bialystok | Poland |
| Chorzów | Poland |
| Gdynia | Poland |
| Lodz | Poland |
| Wroclaw | Poland |
| Baia Mare | Romania |
| Brasov | Romania |
| Iași | Romania |
| Arkhangelsk | Russia |
| Moscow | Russia |
| Nizhny Novgorod | Russia |
| Saint Petersburg | Russia |
| Singapore | Singapore |
| Seoul | South Korea |
| Barcelona | Spain |
| Madrid | Spain |
| Murcia | Spain |
| Salamanca | Spain |
| Part 2: VMP |
Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally. |
| FG002 | Part 2: VMP + Siltuximab | Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally. |
| Received Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Maintainance Period |
|
|
| Follow-up Period |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: VMP (Velcade+Melphalan+Prednisone) + Siltuximab | Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally. |
| BG001 | Part 2: VMP (Velcade+Melphalan+Prednisone) | Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally. |
| BG002 | Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab | Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally. |
| 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 |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Percentage of Participants Who Achieved Complete Response (CR) - European Group for Blood and Marrow Transplantation (EBMT) Criteria | CR was assessed using EMBT criteria: disappearance of the original monoclonal paraprotein from the blood and urine on at least 2 determinations for a minimum of 6 weeks by immunofixation studies, <5% plasma cells in the bone marrow on at least 1 determination, if skeletal survey is available: no increase in the size or number of lytic bone lesions (development of a compression fracture does not exclude response), disappearance of soft tissue plasmacytomas for at least 6 weeks. | Response-evaluable population: Participants who had a confirmed diagnosis of multiple myeloma and measurable disease according to the EBMT criteria were evaluated for disease response. Also, participants must have received at least 1 administration of study medication and have at least 1 post-baseline disease assessment. | Posted | Number | Percentage of participants | Up to disease progression, approximately 3 years |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved Overall Response ie, Complete Response (CR) or Partial Response (PR) - European Group for Blood and Marrow Transplantation (EBMT) Criteria | CR or PR was assessed using EBMT criteria. CR: disappearance of the original monoclonal paraprotein from the blood and urine on at least 2 determinations for a minimum of 6 weeks by immunofixation studies, <5% plasma cells in the bone marrow on at least 1 determination, if skeletal survey is available: no increase in the size or number of lytic bone lesions (development of a compression fracture does not exclude response), disappearance of soft tissue plasmacytomas for at least 6 weeks; PR: >=50% reduction in the level of serum monoclonal paraprotein for at least 2 determinations 6 weeks apart, if present, reduction in 24-hour urinary light chain excretion by either >=90% or to <200 mg for at least 2 determinations 6 weeks apart, >=50% reduction in the size of soft tissue plasmacytomas (by clinical or radiographic examination) for at least 6 weeks, if skeletal survey is available: no increase in size or number of lytic bone lesions | Response-evaluable population: Participants who had a confirmed diagnosis of multiple myeloma and measurable disease according to the EBMT criteria were evaluated for disease response. Also, participants must have received at least 1 administration of study medication and have at least 1 post-baseline disease assessment. | Posted | Number | Percentage of participants | Up to disease progression, approximately 3 years |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved Stringent Complete Response (sCR) - International Myeloma Working Group (IMWG) Criteria | sCR was assesses by IMWG Criteria: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, <=5% plasma cells in bone marrow, normal free light chain ratio, absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. sCR is a CR that has been confirmed by immunofixation + free light chain assay + either bone marrow immunohistochemistry or immunofluorescence | Response-evaluable population: Participants who had a confirmed diagnosis of multiple myeloma and measurable disease according to the EBMT criteria were evaluated for disease response. Also, participants must have received at least 1 administration of study medication and have at least 1 post-baseline disease assessment. | Posted | Number | Percentage of participants | Up to disease progression, approximately 3 years |
| |||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) | PFS was defined as the time between randomization and either disease progression or death, whichever occurred first. | Intent-to-treat (ITT) population: all randomized participants. | Posted | Median | 95% Confidence Interval | Days | From the date of randomization until disease progression or death, whichever occurred first, as assessed up to the last efficacy assessment for disease progression (approximately 3 years) |
|
| |||||||||||||||||||||||||||||
| Secondary | 1-year Progression-Free Survival (PFS) Rate | The 1-year PFS rate was defined as the percentage of participants surviving 1 year after randomization without disease progression or death. | Intent-to-treat (ITT) population: all randomized participants | Posted | Number | Percentage of participants | 1 year |
|
| ||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | DOR was defined as length from the earliest date a participant achieved a complete response (CR) or partial response (PR) to either date for disease progression (including relapse from CR) or the censoring date for progressive disease. Responders without disease progression were censored at the last efficacy assessment for disease progression. | Included participants in the randomized population who achieved CR or PR. | Posted | Median | 95% Confidence Interval | Days | From the date participants achieved CR or PR to either date for disease progression (including relapse from CR) or the censoring date for progressive disease, as assessed Up to 30 days after last dose of study medication |
| ||||||||||||||||||||||||||||||
| Secondary | 1-year Survival Rate | Percentage of participants who are alive at the end of year 1 after randomization | Intent-to-treat (ITT) population: all randomized participants | Posted | Number | Percentage of participants | 1 year |
|
| ||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival is defined as the time interval in days between the date of randomization and the participant's death from any cause. | Intent-to-treat (ITT) population: all randomized participants. | Posted | Median | 95% Confidence Interval | Days | From the date of randomization till the date of death, as assessed up to the end of study (approximately 3 years) |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Cycle 9 in Global Health Status/Quality of Life Subscale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30) | Global health status/quality of life is a subscale of the EORTC QOL C30, which comprises two questions related to overall health/quality of life during the past week. The raw score to each question ranged from 1 (very poor) to 7 (excellent). The raw mean score of health status/quality of life subscale is calculated for each participant and a linear transformation applied to standardize the raw score, so that scores range from 0 to 100; a higher score represents a higher ("better") health and quality of life. | Intent-to-treat (ITT) population: all randomized participants with evaluable data during baseline and Cycle 9 | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Day 1 predose) and Cycle 9 (Week 54) |
|
Up to 30 days after the last dose of study medication
For Safety analyses all randomized participants who received at least 1 dose of study agents were analyzed. Data are presented for 117 participants in the treatment period (Part 1 and Part 2) and 21 participants who entered maintenance period (after achieving partial response or better in the Part 2 treatment period while receiving VPM+siltuximab)
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 | Part 1: VMP (Velcade+Melphalan+Prednisone) + Siltuximab | Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally. | 8 | 12 | 12 | 12 | ||
| EG001 | Part 2: VMP (Velcade+Melphalan+Prednisone) | Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally. | 27 | 53 | 51 | 53 | ||
| EG002 | Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab | Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally. | 30 | 52 | 51 | 52 | ||
| EG003 | Part 2, Maintenance Period: Siltuximab | Siltuximab 8.3 mg/kg or 11 mg/kg as a 1-hour intravenous infusion every 3 weeks, during the maintenance period | 1 | 21 | 15 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Cardiac Failure Acute | Cardiac disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Cardio-Respiratory Arrest | Cardiac disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Steroid Withdrawal Syndrome | Endocrine disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Haemorrhoidal Haemorrhage | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Ileus Paralytic | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Upper Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Adverse Drug Reaction | General disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Gastroenteritis Escherichia Coli | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| H1n1 Influenza | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Hepatitis B | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Lobar Pneumonia | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Parotitis | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Pneumonia Pneumococcal | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Radius Fracture | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Spinal Compression Fracture | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Spinal Fracture | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Bone Lesion | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Pathological Fracture | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Adenocarcinoma Pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Multiple Myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Myelodysplastic Syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Rectal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Cerebral Ischaemia | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Hypoglycaemic Encephalopathy | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Lacunar Infarction | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Metabolic Encephalopathy | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Completed Suicide | Psychiatric disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Renal Failure Acute | Renal and urinary disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Renal Impairment | Renal and urinary disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Status Asthmaticus | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Leukocytoclastic Vasculitis | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Hypovolaemic Shock | Vascular disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Dry Eye | Eye disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Mouth Ulceration | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Mucosal Discolouration | General disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Spinal Pain | General disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Hepatic Function Abnormal | Hepatobiliary disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| H1n1 Influenza | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Nipple Infection | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Oral Candidiasis | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Respiratory Tract Infection Viral | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Limb Injury | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Enzyme Abnormality | Metabolism and nutrition disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Fluid Retention | Metabolism and nutrition disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Hyperamylasaemia | Metabolism and nutrition disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Essential Tremor | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Monoparesis | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Renal Impairment | Renal and urinary disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Pelvic Pain | Reproductive system and breast disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Scar | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Orthostatic Hypotension | Vascular disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director | Janssen R&D BE | 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 |
| D008558 | Melphalan |
| D011241 | Prednisone |
| 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 |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Withdrawal by Subject |
|
| Withdrawal by Subject |
|
| Study terminated by sponsor |
|
| Male |
|
| FRANCE |
|
| INDIA |
|
| ISRAEL |
|
| ITALY |
|
| POLAND |
|
| ROMANIA |
|
| RUSSIAN FEDERATION |
|
| SINGAPORE |
|
| SOUTH KOREA |
|
| SPAIN |
|
| UNITED STATES |
|
| OG001 | Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab | Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally. |
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|