Trial Outcomes & Findings for A Study to Compare CNTO 328 (Anti-IL-6 Monoclonal Antibody) and VELCADE-Melphalan-Prednisone (VMP) With VMP Alone in Previously Untreated Multiple Myeloma Patients (NCT NCT00911859)

NCT ID: NCT00911859

Last Updated: 2014-11-18

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 118 participants
• Primary outcome timeframe: Up to disease progression, approximately 3 years
• Results posted on: 2014-11-18

Participant Flow

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.

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.

Participant milestones

Measure	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.	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.	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.
Treatment Period STARTED	12	54	52
Treatment Period Received Treatment	12	53	52
Treatment Period COMPLETED	4	33	27
Treatment Period NOT COMPLETED	8	21	25
Maintainance Period STARTED	0	0	21
Maintainance Period COMPLETED	0	0	0
Maintainance Period NOT COMPLETED	0	0	21
Follow-up Period STARTED	12	53	52
Follow-up Period COMPLETED	1	7	11
Follow-up Period NOT COMPLETED	11	46	41

Reasons for withdrawal

Measure	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.	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.	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.
Treatment Period Adverse Event	3	3	7
Treatment Period Death	1	3	5
Treatment Period Lack of Efficacy	1	7	5
Treatment Period Physician Decision	3	3	3
Treatment Period Withdrawal by Subject	0	4	5
Treatment Period Did not receive study treatment	0	1	0
Maintainance Period Lack of Efficacy	0	0	9
Maintainance Period Physician Decision	0	0	9
Maintainance Period Withdrawal by Subject	0	0	3
Follow-up Period Death	5	8	10
Follow-up Period Lost to Follow-up	1	1	0
Follow-up Period Withdrawal by Subject	0	4	4
Follow-up Period Study terminated by sponsor	5	33	27

Baseline Characteristics

A Study to Compare CNTO 328 (Anti-IL-6 Monoclonal Antibody) and VELCADE-Melphalan-Prednisone (VMP) With VMP Alone in Previously Untreated Multiple Myeloma Patients

Baseline characteristics by cohort

Measure	Part 1: VMP (Velcade+Melphalan+Prednisone) + Siltuximab n=12 Participants 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.	Part 2: VMP (Velcade+Melphalan+Prednisone) n=54 Participants 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.	Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab n=52 Participants 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.	Total n=118 Participants Total of all reporting groups
Age, Continuous	73.6 years STANDARD_DEVIATION 6.3 • n=5 Participants	70.3 years STANDARD_DEVIATION 7.27 • n=7 Participants	71.6 years STANDARD_DEVIATION 4.76 • n=5 Participants	71.2 years STANDARD_DEVIATION 6.21 • n=4 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	30 Participants n=7 Participants	29 Participants n=5 Participants	66 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	24 Participants n=7 Participants	23 Participants n=5 Participants	52 Participants n=4 Participants
Region of Enrollment AUSTRALIA	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants	4 participants n=4 Participants
Region of Enrollment FRANCE	0 participants n=5 Participants	5 participants n=7 Participants	2 participants n=5 Participants	7 participants n=4 Participants
Region of Enrollment INDIA	0 participants n=5 Participants	3 participants n=7 Participants	1 participants n=5 Participants	4 participants n=4 Participants
Region of Enrollment ISRAEL	0 participants n=5 Participants	7 participants n=7 Participants	5 participants n=5 Participants	12 participants n=4 Participants
Region of Enrollment ITALY	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants	4 participants n=4 Participants
Region of Enrollment POLAND	0 participants n=5 Participants	5 participants n=7 Participants	11 participants n=5 Participants	16 participants n=4 Participants
Region of Enrollment ROMANIA	0 participants n=5 Participants	2 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants
Region of Enrollment RUSSIAN FEDERATION	0 participants n=5 Participants	10 participants n=7 Participants	10 participants n=5 Participants	20 participants n=4 Participants
Region of Enrollment SINGAPORE	0 participants n=5 Participants	3 participants n=7 Participants	2 participants n=5 Participants	5 participants n=4 Participants
Region of Enrollment SOUTH KOREA	0 participants n=5 Participants	7 participants n=7 Participants	8 participants n=5 Participants	15 participants n=4 Participants
Region of Enrollment SPAIN	12 participants n=5 Participants	5 participants n=7 Participants	7 participants n=5 Participants	24 participants n=4 Participants
Region of Enrollment UNITED STATES	0 participants n=5 Participants	3 participants n=7 Participants	2 participants n=5 Participants	5 participants n=4 Participants

PRIMARY outcome

Timeframe: Up to disease progression, approximately 3 years

Population: 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.

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.

Outcome measures

Measure	Part 2: VMP (Velcade+Melphalan+Prednisone) n=49 Participants 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.	Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab n=49 Participants 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.
Percentage of Participants Who Achieved Complete Response (CR) - European Group for Blood and Marrow Transplantation (EBMT) Criteria	22.4 Percentage of participants	26.5 Percentage of participants

SECONDARY outcome

Timeframe: Up to disease progression, approximately 3 years

Population: 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.

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

Outcome measures

Measure	Part 2: VMP (Velcade+Melphalan+Prednisone) n=49 Participants 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.	Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab n=49 Participants 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.
Percentage of Participants Who Achieved Overall Response ie, Complete Response (CR) or Partial Response (PR) - European Group for Blood and Marrow Transplantation (EBMT) Criteria	79.6 Percentage of participants	87.8 Percentage of participants

SECONDARY outcome

Timeframe: Up to disease progression, approximately 3 years

Population: 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.

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

Outcome measures

Measure	Part 2: VMP (Velcade+Melphalan+Prednisone) n=49 Participants 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.	Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab n=49 Participants 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.
Percentage of Participants Who Achieved Stringent Complete Response (sCR) - International Myeloma Working Group (IMWG) Criteria	6.1 Percentage of participants	4.1 Percentage of participants

SECONDARY outcome

Timeframe: 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)

Population: Intent-to-treat (ITT) population: all randomized participants.

PFS was defined as the time between randomization and either disease progression or death, whichever occurred first.

Outcome measures

Measure	Part 2: VMP (Velcade+Melphalan+Prednisone) n=54 Participants 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.	Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab n=52 Participants 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.
Progression-Free Survival (PFS)	518 Days Interval 460.0 to 582.0	519 Days Interval 443.0 to 673.0

SECONDARY outcome

Timeframe: 1 year

Population: Intent-to-treat (ITT) population: all randomized participants

The 1-year PFS rate was defined as the percentage of participants surviving 1 year after randomization without disease progression or death.

Outcome measures

Measure	Part 2: VMP (Velcade+Melphalan+Prednisone) n=54 Participants 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.	Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab n=52 Participants 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.
1-year Progression-Free Survival (PFS) Rate	77.5 Percentage of participants	72.1 Percentage of participants

SECONDARY outcome

Timeframe: 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

Population: Included participants in the randomized population who achieved CR or PR.

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.

Outcome measures

Measure	Part 2: VMP (Velcade+Melphalan+Prednisone) n=39 Participants 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.	Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab n=43 Participants 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.
Duration of Response (DOR)	497 Days Interval 457.0 to 637.0	583 Days Interval 449.0 to Insufficient number of participants with events; therefore, upper limit of 95% CI not reached.

SECONDARY outcome

Timeframe: 1 year

Population: Intent-to-treat (ITT) population: all randomized participants

Percentage of participants who are alive at the end of year 1 after randomization

Outcome measures

Measure	Part 2: VMP (Velcade+Melphalan+Prednisone) n=54 Participants 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.	Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab n=52 Participants 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.
1-year Survival Rate	87.8 Percentage of participants	87.5 Percentage of participants

SECONDARY outcome

Timeframe: From the date of randomization till the date of death, as assessed up to the end of study (approximately 3 years)

Population: Intent-to-treat (ITT) population: all randomized participants.

Overall survival is defined as the time interval in days between the date of randomization and the participant's death from any cause.

Outcome measures

Measure	Part 2: VMP (Velcade+Melphalan+Prednisone) n=54 Participants 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.	Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab n=52 Participants 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.
Overall Survival	NA Days Insufficient number of participants with events; therefore, median and 95% CI not reached.	NA Days Interval 783.0 to Insufficient number of participants with events; therefore, median and upper limit of 95% CI not reached.

SECONDARY outcome

Timeframe: Baseline (Day 1 predose) and Cycle 9 (Week 54)

Population: Intent-to-treat (ITT) population: all randomized participants with evaluable data during baseline and Cycle 9

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.

Outcome measures

Measure	Part 2: VMP (Velcade+Melphalan+Prednisone) n=31 Participants 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.	Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab n=25 Participants 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.
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)	14.78 Scores on a scale Standard Deviation 25.250	8.33 Scores on a scale Standard Deviation 31.088

Adverse Events

Part 1: VMP (Velcade+Melphalan+Prednisone) + Siltuximab

Serious events: 8 serious events

Other events: 12 other events

Deaths: 0 deaths

Part 2: VMP (Velcade+Melphalan+Prednisone)

Serious events: 27 serious events

Other events: 51 other events

Deaths: 0 deaths

Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab

Serious events: 30 serious events

Other events: 51 other events

Deaths: 0 deaths

Part 2, Maintenance Period: Siltuximab

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Measure	Part 1: VMP (Velcade+Melphalan+Prednisone) + Siltuximab n=12 participants at risk 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.	Part 2: VMP (Velcade+Melphalan+Prednisone) n=53 participants at risk 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.	Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab n=52 participants at risk 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.	Part 2, Maintenance Period: Siltuximab n=21 participants at risk Siltuximab 8.3 mg/kg or 11 mg/kg as a 1-hour intravenous infusion every 3 weeks, during the maintenance period
Blood and lymphatic system disorders Anaemia	0.00% 0/12 • 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)	1.9% 1/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Blood and lymphatic system disorders Neutropenia	0.00% 0/12 • 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)	0.00% 0/53 • 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)	5.8% 3/52 • 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)	0.00% 0/21 • 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)
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/12 • 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)	3.8% 2/53 • 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)	3.8% 2/52 • 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)	0.00% 0/21 • 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)
Cardiac disorders Atrial Fibrillation	0.00% 0/12 • 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)	1.9% 1/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Cardiac disorders Cardiac Arrest	0.00% 0/12 • 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)	1.9% 1/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Cardiac disorders Cardiac Failure	8.3% 1/12 • 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)	0.00% 0/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Cardiac disorders Cardiac Failure Acute	0.00% 0/12 • 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)	0.00% 0/53 • 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)	1.9% 1/52 • 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)	0.00% 0/21 • 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)
Cardiac disorders Cardio-Respiratory Arrest	0.00% 0/12 • 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)	1.9% 1/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Cardiac disorders Myocardial Infarction	0.00% 0/12 • 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)	0.00% 0/53 • 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)	1.9% 1/52 • 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)	0.00% 0/21 • 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)
Endocrine disorders Steroid Withdrawal Syndrome	0.00% 0/12 • 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)	0.00% 0/53 • 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)	1.9% 1/52 • 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)	0.00% 0/21 • 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)
Gastrointestinal disorders Abdominal Pain	0.00% 0/12 • 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)	1.9% 1/53 • 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)	3.8% 2/52 • 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)	0.00% 0/21 • 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)
Gastrointestinal disorders Diarrhoea	0.00% 0/12 • 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)	7.5% 4/53 • 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)	1.9% 1/52 • 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)	0.00% 0/21 • 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)
Gastrointestinal disorders Gastritis	0.00% 0/12 • 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)	0.00% 0/53 • 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)	1.9% 1/52 • 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)	0.00% 0/21 • 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)
Gastrointestinal disorders Haemorrhoidal Haemorrhage	0.00% 0/12 • 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)	0.00% 0/53 • 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)	1.9% 1/52 • 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)	0.00% 0/21 • 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)
Gastrointestinal disorders Ileus	0.00% 0/12 • 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)	0.00% 0/53 • 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)	1.9% 1/52 • 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)	0.00% 0/21 • 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)
Gastrointestinal disorders Ileus Paralytic	0.00% 0/12 • 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)	1.9% 1/53 • 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)	1.9% 1/52 • 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)	0.00% 0/21 • 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)
Gastrointestinal disorders Rectal Haemorrhage	0.00% 0/12 • 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)	1.9% 1/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Gastrointestinal disorders Upper Gastrointestinal Haemorrhage	0.00% 0/12 • 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)	1.9% 1/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Gastrointestinal disorders Vomiting	0.00% 0/12 • 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)	1.9% 1/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
General disorders Adverse Drug Reaction	0.00% 0/12 • 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)	1.9% 1/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
General disorders Asthenia	0.00% 0/12 • 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)	0.00% 0/53 • 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)	1.9% 1/52 • 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)	0.00% 0/21 • 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)
General disorders Pyrexia	8.3% 1/12 • 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)	0.00% 0/53 • 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)	1.9% 1/52 • 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)	0.00% 0/21 • 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)
Hepatobiliary disorders Hepatotoxicity	8.3% 1/12 • 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)	0.00% 0/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Infections and infestations Bronchitis	0.00% 0/12 • 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)	1.9% 1/53 • 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)	1.9% 1/52 • 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)	0.00% 0/21 • 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)
Infections and infestations Bronchopneumonia	0.00% 0/12 • 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)	5.7% 3/53 • 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)	3.8% 2/52 • 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)	0.00% 0/21 • 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)
Infections and infestations Gastroenteritis	0.00% 0/12 • 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)	0.00% 0/53 • 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)	1.9% 1/52 • 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)	0.00% 0/21 • 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)
Infections and infestations Gastroenteritis Escherichia Coli	0.00% 0/12 • 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)	1.9% 1/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Infections and infestations H1n1 Influenza	8.3% 1/12 • 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)	0.00% 0/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Infections and infestations Hepatitis B	8.3% 1/12 • 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)	0.00% 0/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Infections and infestations Lobar Pneumonia	0.00% 0/12 • 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)	0.00% 0/53 • 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)	1.9% 1/52 • 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)	0.00% 0/21 • 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)
Infections and infestations Parotitis	0.00% 0/12 • 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)	0.00% 0/53 • 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)	1.9% 1/52 • 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)	0.00% 0/21 • 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)
Infections and infestations Pneumonia	25.0% 3/12 • 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)	9.4% 5/53 • 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)	13.5% 7/52 • 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)	0.00% 0/21 • 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)
Infections and infestations Pneumonia Pneumococcal	8.3% 1/12 • 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)	0.00% 0/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Infections and infestations Respiratory Tract Infection	8.3% 1/12 • 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)	0.00% 0/53 • 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)	1.9% 1/52 • 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)	0.00% 0/21 • 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)
Infections and infestations Septic Shock	8.3% 1/12 • 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)	1.9% 1/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Injury, poisoning and procedural complications Femur Fracture	0.00% 0/12 • 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)	0.00% 0/53 • 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)	3.8% 2/52 • 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)	0.00% 0/21 • 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)
Injury, poisoning and procedural complications Hip Fracture	0.00% 0/12 • 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)	0.00% 0/53 • 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)	1.9% 1/52 • 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)	0.00% 0/21 • 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)
Injury, poisoning and procedural complications Radius Fracture	0.00% 0/12 • 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)	0.00% 0/53 • 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)	0.00% 0/52 • 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)	4.8% 1/21 • 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)
Injury, poisoning and procedural complications Spinal Compression Fracture	0.00% 0/12 • 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)	0.00% 0/53 • 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)	1.9% 1/52 • 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)	0.00% 0/21 • 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)
Injury, poisoning and procedural complications Spinal Fracture	0.00% 0/12 • 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)	0.00% 0/53 • 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)	1.9% 1/52 • 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)	0.00% 0/21 • 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)
Investigations Weight Decreased	0.00% 0/12 • 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)	0.00% 0/53 • 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)	1.9% 1/52 • 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)	0.00% 0/21 • 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)
Metabolism and nutrition disorders Dehydration	0.00% 0/12 • 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)	1.9% 1/53 • 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)	1.9% 1/52 • 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)	0.00% 0/21 • 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)
Metabolism and nutrition disorders Hypercalcaemia	8.3% 1/12 • 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)	1.9% 1/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/12 • 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)	1.9% 1/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/12 • 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)	1.9% 1/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Metabolism and nutrition disorders Hyperuricaemia	8.3% 1/12 • 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)	0.00% 0/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/12 • 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)	0.00% 0/53 • 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)	1.9% 1/52 • 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)	0.00% 0/21 • 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)
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/12 • 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)	0.00% 0/53 • 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)	3.8% 2/52 • 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)	0.00% 0/21 • 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)
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/12 • 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)	3.8% 2/53 • 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)	3.8% 2/52 • 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)	0.00% 0/21 • 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)
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/12 • 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)	1.9% 1/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Musculoskeletal and connective tissue disorders Back Pain	8.3% 1/12 • 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)	1.9% 1/53 • 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)	1.9% 1/52 • 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)	0.00% 0/21 • 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)
Musculoskeletal and connective tissue disorders Bone Lesion	0.00% 0/12 • 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)	1.9% 1/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Musculoskeletal and connective tissue disorders Pathological Fracture	0.00% 0/12 • 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)	1.9% 1/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma Pancreas	8.3% 1/12 • 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)	0.00% 0/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Multiple Myeloma	0.00% 0/12 • 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)	1.9% 1/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic Syndrome	0.00% 0/12 • 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)	1.9% 1/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Cancer	0.00% 0/12 • 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)	0.00% 0/53 • 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)	1.9% 1/52 • 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)	0.00% 0/21 • 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)
Nervous system disorders Cerebral Ischaemia	0.00% 0/12 • 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)	1.9% 1/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Nervous system disorders Cerebrovascular Accident	0.00% 0/12 • 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)	1.9% 1/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Nervous system disorders Dizziness	0.00% 0/12 • 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)	0.00% 0/53 • 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)	1.9% 1/52 • 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)	0.00% 0/21 • 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)
Nervous system disorders Encephalopathy	0.00% 0/12 • 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)	0.00% 0/53 • 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)	1.9% 1/52 • 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)	0.00% 0/21 • 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)
Nervous system disorders Hypoglycaemic Encephalopathy	0.00% 0/12 • 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)	1.9% 1/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Nervous system disorders Lacunar Infarction	0.00% 0/12 • 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)	1.9% 1/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Nervous system disorders Metabolic Encephalopathy	8.3% 1/12 • 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)	0.00% 0/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Nervous system disorders Syncope	0.00% 0/12 • 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)	0.00% 0/53 • 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)	3.8% 2/52 • 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)	0.00% 0/21 • 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)
Psychiatric disorders Completed Suicide	0.00% 0/12 • 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)	0.00% 0/53 • 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)	1.9% 1/52 • 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)	0.00% 0/21 • 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)
Psychiatric disorders Depression	0.00% 0/12 • 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)	0.00% 0/53 • 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)	1.9% 1/52 • 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)	0.00% 0/21 • 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)
Renal and urinary disorders Hydronephrosis	0.00% 0/12 • 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)	0.00% 0/53 • 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)	1.9% 1/52 • 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)	0.00% 0/21 • 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)
Renal and urinary disorders Renal Failure	0.00% 0/12 • 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)	1.9% 1/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Renal and urinary disorders Renal Failure Acute	0.00% 0/12 • 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)	1.9% 1/53 • 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)	5.8% 3/52 • 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)	0.00% 0/21 • 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)
Renal and urinary disorders Renal Impairment	8.3% 1/12 • 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)	1.9% 1/53 • 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)	1.9% 1/52 • 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)	0.00% 0/21 • 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)
Renal and urinary disorders Urinary Retention	0.00% 0/12 • 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)	3.8% 2/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.00% 0/12 • 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)	1.9% 1/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/12 • 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)	0.00% 0/53 • 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)	1.9% 1/52 • 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)	0.00% 0/21 • 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)
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.00% 0/12 • 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)	1.9% 1/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/12 • 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)	0.00% 0/53 • 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)	1.9% 1/52 • 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)	0.00% 0/21 • 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)
Respiratory, thoracic and mediastinal disorders Pleural Effusion	8.3% 1/12 • 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)	0.00% 0/53 • 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)	1.9% 1/52 • 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)	0.00% 0/21 • 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)
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	8.3% 1/12 • 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)	0.00% 0/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Respiratory, thoracic and mediastinal disorders Pulmonary Oedema	0.00% 0/12 • 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)	0.00% 0/53 • 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)	1.9% 1/52 • 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)	0.00% 0/21 • 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)
Respiratory, thoracic and mediastinal disorders Respiratory Failure	8.3% 1/12 • 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)	0.00% 0/53 • 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)	1.9% 1/52 • 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)	0.00% 0/21 • 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)
Respiratory, thoracic and mediastinal disorders Status Asthmaticus	0.00% 0/12 • 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)	1.9% 1/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Skin and subcutaneous tissue disorders Leukocytoclastic Vasculitis	0.00% 0/12 • 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)	0.00% 0/53 • 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)	1.9% 1/52 • 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)	0.00% 0/21 • 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)
Vascular disorders Hypotension	0.00% 0/12 • 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)	3.8% 2/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Vascular disorders Hypovolaemic Shock	0.00% 0/12 • 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)	1.9% 1/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)

Other adverse events

Measure	Part 1: VMP (Velcade+Melphalan+Prednisone) + Siltuximab n=12 participants at risk 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.	Part 2: VMP (Velcade+Melphalan+Prednisone) n=53 participants at risk 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.	Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab n=52 participants at risk 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.	Part 2, Maintenance Period: Siltuximab n=21 participants at risk Siltuximab 8.3 mg/kg or 11 mg/kg as a 1-hour intravenous infusion every 3 weeks, during the maintenance period
Skin and subcutaneous tissue disorders Dermatitis	8.3% 1/12 • 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)	0.00% 0/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Blood and lymphatic system disorders Anaemia	41.7% 5/12 • 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)	35.8% 19/53 • 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)	23.1% 12/52 • 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)	9.5% 2/21 • 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)
Blood and lymphatic system disorders Leukopenia	0.00% 0/12 • 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)	9.4% 5/53 • 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)	11.5% 6/52 • 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)	0.00% 0/21 • 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)
Blood and lymphatic system disorders Lymphopenia	0.00% 0/12 • 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)	5.7% 3/53 • 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)	7.7% 4/52 • 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)	0.00% 0/21 • 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)
Blood and lymphatic system disorders Neutropenia	91.7% 11/12 • 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)	47.2% 25/53 • 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)	65.4% 34/52 • 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)	14.3% 3/21 • 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)
Blood and lymphatic system disorders Thrombocytopenia	66.7% 8/12 • 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)	39.6% 21/53 • 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)	57.7% 30/52 • 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)	23.8% 5/21 • 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)
Cardiac disorders Atrial Fibrillation	8.3% 1/12 • 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)	3.8% 2/53 • 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)	3.8% 2/52 • 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)	0.00% 0/21 • 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)
Eye disorders Conjunctivitis	0.00% 0/12 • 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)	3.8% 2/53 • 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)	7.7% 4/52 • 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)	0.00% 0/21 • 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)
Eye disorders Dry Eye	0.00% 0/12 • 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)	7.5% 4/53 • 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)	1.9% 1/52 • 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)	0.00% 0/21 • 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)
Gastrointestinal disorders Abdominal Discomfort	0.00% 0/12 • 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)	5.7% 3/53 • 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)	3.8% 2/52 • 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)	0.00% 0/21 • 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)
Gastrointestinal disorders Abdominal Distension	0.00% 0/12 • 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)	3.8% 2/53 • 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)	5.8% 3/52 • 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)	0.00% 0/21 • 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)
Gastrointestinal disorders Abdominal Pain	8.3% 1/12 • 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)	11.3% 6/53 • 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)	7.7% 4/52 • 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)	0.00% 0/21 • 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)
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/12 • 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)	7.5% 4/53 • 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)	7.7% 4/52 • 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)	0.00% 0/21 • 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)
Gastrointestinal disorders Constipation	66.7% 8/12 • 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)	30.2% 16/53 • 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)	34.6% 18/52 • 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)	9.5% 2/21 • 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)
Gastrointestinal disorders Diarrhoea	58.3% 7/12 • 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)	39.6% 21/53 • 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)	34.6% 18/52 • 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)	9.5% 2/21 • 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)
Gastrointestinal disorders Dry Mouth	0.00% 0/12 • 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)	0.00% 0/53 • 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)	7.7% 4/52 • 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)	0.00% 0/21 • 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)
Gastrointestinal disorders Dyspepsia	0.00% 0/12 • 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)	11.3% 6/53 • 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)	5.8% 3/52 • 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)	4.8% 1/21 • 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)
Gastrointestinal disorders Gastritis	0.00% 0/12 • 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)	5.7% 3/53 • 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)	1.9% 1/52 • 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)	4.8% 1/21 • 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)
Gastrointestinal disorders Haemorrhoids	8.3% 1/12 • 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)	3.8% 2/53 • 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)	7.7% 4/52 • 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)	0.00% 0/21 • 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)
Gastrointestinal disorders Mouth Ulceration	8.3% 1/12 • 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)	0.00% 0/53 • 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)	3.8% 2/52 • 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)	0.00% 0/21 • 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)
Gastrointestinal disorders Nausea	33.3% 4/12 • 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)	39.6% 21/53 • 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)	30.8% 16/52 • 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)	0.00% 0/21 • 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)
Gastrointestinal disorders Stomatitis	8.3% 1/12 • 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)	3.8% 2/53 • 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)	1.9% 1/52 • 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)	0.00% 0/21 • 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)
Gastrointestinal disorders Vomiting	16.7% 2/12 • 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)	28.3% 15/53 • 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)	23.1% 12/52 • 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)	4.8% 1/21 • 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)
General disorders Asthenia	83.3% 10/12 • 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)	34.0% 18/53 • 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)	19.2% 10/52 • 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)	0.00% 0/21 • 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)
General disorders Chest Pain	0.00% 0/12 • 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)	9.4% 5/53 • 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)	11.5% 6/52 • 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)	4.8% 1/21 • 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)
General disorders Chills	8.3% 1/12 • 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)	5.7% 3/53 • 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)	5.8% 3/52 • 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)	0.00% 0/21 • 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)
General disorders Fatigue	0.00% 0/12 • 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)	15.1% 8/53 • 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)	23.1% 12/52 • 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)	9.5% 2/21 • 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)
General disorders Malaise	8.3% 1/12 • 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)	5.7% 3/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
General disorders Mucosal Discolouration	8.3% 1/12 • 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)	0.00% 0/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
General disorders Oedema	16.7% 2/12 • 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)	7.5% 4/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
General disorders Oedema Peripheral	25.0% 3/12 • 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)	7.5% 4/53 • 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)	30.8% 16/52 • 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)	0.00% 0/21 • 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)
General disorders Pain	0.00% 0/12 • 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)	3.8% 2/53 • 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)	5.8% 3/52 • 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)	4.8% 1/21 • 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)
General disorders Pyrexia	8.3% 1/12 • 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)	28.3% 15/53 • 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)	17.3% 9/52 • 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)	0.00% 0/21 • 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)
General disorders Spinal Pain	8.3% 1/12 • 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)	0.00% 0/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Hepatobiliary disorders Hepatic Function Abnormal	8.3% 1/12 • 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)	3.8% 2/53 • 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)	11.5% 6/52 • 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)	0.00% 0/21 • 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)
Hepatobiliary disorders Hepatotoxicity	8.3% 1/12 • 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)	1.9% 1/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Hepatobiliary disorders Jaundice	8.3% 1/12 • 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)	0.00% 0/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Infections and infestations Bronchitis	0.00% 0/12 • 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)	9.4% 5/53 • 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)	11.5% 6/52 • 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)	0.00% 0/21 • 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)
Infections and infestations H1n1 Influenza	8.3% 1/12 • 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)	0.00% 0/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Infections and infestations Hordeolum	8.3% 1/12 • 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)	5.7% 3/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Infections and infestations Nasopharyngitis	25.0% 3/12 • 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)	9.4% 5/53 • 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)	7.7% 4/52 • 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)	9.5% 2/21 • 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)
Infections and infestations Nipple Infection	8.3% 1/12 • 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)	0.00% 0/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Infections and infestations Onychomycosis	8.3% 1/12 • 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)	0.00% 0/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Infections and infestations Oral Candidiasis	25.0% 3/12 • 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)	5.7% 3/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Infections and infestations Pharyngitis	8.3% 1/12 • 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)	1.9% 1/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Infections and infestations Respiratory Tract Infection	16.7% 2/12 • 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)	1.9% 1/53 • 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)	5.8% 3/52 • 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)	0.00% 0/21 • 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)
Infections and infestations Respiratory Tract Infection Viral	0.00% 0/12 • 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)	5.7% 3/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Infections and infestations Sinusitis	0.00% 0/12 • 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)	0.00% 0/53 • 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)	5.8% 3/52 • 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)	0.00% 0/21 • 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)
Infections and infestations Upper Respiratory Tract Infection	25.0% 3/12 • 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)	11.3% 6/53 • 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)	9.6% 5/52 • 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)	9.5% 2/21 • 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)
Infections and infestations Urinary Tract Infection	8.3% 1/12 • 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)	3.8% 2/53 • 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)	9.6% 5/52 • 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)	0.00% 0/21 • 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)
Injury, poisoning and procedural complications Limb Injury	0.00% 0/12 • 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)	0.00% 0/53 • 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)	0.00% 0/52 • 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)	9.5% 2/21 • 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)
Investigations Weight Decreased	0.00% 0/12 • 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)	11.3% 6/53 • 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)	11.5% 6/52 • 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)	9.5% 2/21 • 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)
Metabolism and nutrition disorders Decreased Appetite	33.3% 4/12 • 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)	34.0% 18/53 • 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)	17.3% 9/52 • 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)	4.8% 1/21 • 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)
Metabolism and nutrition disorders Enzyme Abnormality	0.00% 0/12 • 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)	1.9% 1/53 • 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)	7.7% 4/52 • 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)	0.00% 0/21 • 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)
Metabolism and nutrition disorders Fluid Retention	16.7% 2/12 • 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)	0.00% 0/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Metabolism and nutrition disorders Hyperamylasaemia	0.00% 0/12 • 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)	0.00% 0/53 • 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)	5.8% 3/52 • 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)	0.00% 0/21 • 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)
Metabolism and nutrition disorders Hypercholesterolaemia	8.3% 1/12 • 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)	3.8% 2/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Metabolism and nutrition disorders Hyperglycaemia	8.3% 1/12 • 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)	5.7% 3/53 • 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)	3.8% 2/52 • 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)	0.00% 0/21 • 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)
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/12 • 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)	1.9% 1/53 • 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)	5.8% 3/52 • 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)	0.00% 0/21 • 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)
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/12 • 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)	0.00% 0/53 • 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)	5.8% 3/52 • 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)	0.00% 0/21 • 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)
Metabolism and nutrition disorders Hypocalcaemia	16.7% 2/12 • 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)	3.8% 2/53 • 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)	5.8% 3/52 • 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)	0.00% 0/21 • 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)
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/12 • 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)	0.00% 0/53 • 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)	7.7% 4/52 • 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)	0.00% 0/21 • 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)
Metabolism and nutrition disorders Hypokalaemia	33.3% 4/12 • 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)	3.8% 2/53 • 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)	13.5% 7/52 • 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)	4.8% 1/21 • 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)
Metabolism and nutrition disorders Hypomagnesaemia	8.3% 1/12 • 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)	0.00% 0/53 • 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)	7.7% 4/52 • 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)	0.00% 0/21 • 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)
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/12 • 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)	7.5% 4/53 • 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)	7.7% 4/52 • 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)	0.00% 0/21 • 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)
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/12 • 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)	11.3% 6/53 • 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)	11.5% 6/52 • 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)	0.00% 0/21 • 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)
Musculoskeletal and connective tissue disorders Back Pain	16.7% 2/12 • 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)	13.2% 7/53 • 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)	17.3% 9/52 • 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)	0.00% 0/21 • 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)
Musculoskeletal and connective tissue disorders Bone Pain	8.3% 1/12 • 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)	5.7% 3/53 • 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)	11.5% 6/52 • 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)	0.00% 0/21 • 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)
Musculoskeletal and connective tissue disorders Muscular Weakness	8.3% 1/12 • 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)	7.5% 4/53 • 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)	5.8% 3/52 • 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)	0.00% 0/21 • 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)
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	0.00% 0/12 • 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)	3.8% 2/53 • 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)	7.7% 4/52 • 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)	0.00% 0/21 • 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)
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.00% 0/12 • 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)	5.7% 3/53 • 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)	1.9% 1/52 • 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)	14.3% 3/21 • 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)
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/12 • 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)	7.5% 4/53 • 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)	3.8% 2/52 • 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)	0.00% 0/21 • 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)
Musculoskeletal and connective tissue disorders Neck Pain	8.3% 1/12 • 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)	0.00% 0/53 • 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)	1.9% 1/52 • 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)	9.5% 2/21 • 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)
Musculoskeletal and connective tissue disorders Pain in Extremity	16.7% 2/12 • 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)	13.2% 7/53 • 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)	19.2% 10/52 • 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)	14.3% 3/21 • 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)
Nervous system disorders Dizziness	16.7% 2/12 • 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)	17.0% 9/53 • 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)	21.2% 11/52 • 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)	4.8% 1/21 • 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)
Nervous system disorders Essential Tremor	8.3% 1/12 • 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)	0.00% 0/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Nervous system disorders Headache	0.00% 0/12 • 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)	5.7% 3/53 • 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)	7.7% 4/52 • 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)	4.8% 1/21 • 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)
Nervous system disorders Monoparesis	8.3% 1/12 • 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)	0.00% 0/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Nervous system disorders Neuralgia	41.7% 5/12 • 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)	30.2% 16/53 • 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)	19.2% 10/52 • 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)	0.00% 0/21 • 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)
Nervous system disorders Paraesthesia	0.00% 0/12 • 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)	7.5% 4/53 • 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)	7.7% 4/52 • 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)	0.00% 0/21 • 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)
Nervous system disorders Peripheral Sensory Neuropathy	75.0% 9/12 • 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)	64.2% 34/53 • 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)	59.6% 31/52 • 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)	4.8% 1/21 • 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)
Nervous system disorders Somnolence	8.3% 1/12 • 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)	3.8% 2/53 • 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)	1.9% 1/52 • 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)	0.00% 0/21 • 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)
Nervous system disorders Syncope	0.00% 0/12 • 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)	5.7% 3/53 • 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)	3.8% 2/52 • 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)	0.00% 0/21 • 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)
Nervous system disorders Tremor	8.3% 1/12 • 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)	1.9% 1/53 • 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)	1.9% 1/52 • 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)	0.00% 0/21 • 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)
Psychiatric disorders Agitation	8.3% 1/12 • 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)	1.9% 1/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Psychiatric disorders Anxiety	16.7% 2/12 • 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)	9.4% 5/53 • 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)	7.7% 4/52 • 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)	0.00% 0/21 • 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)
Psychiatric disorders Confusional State	0.00% 0/12 • 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)	5.7% 3/53 • 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)	1.9% 1/52 • 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)	0.00% 0/21 • 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)
Psychiatric disorders Depression	16.7% 2/12 • 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)	5.7% 3/53 • 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)	5.8% 3/52 • 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)	0.00% 0/21 • 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)
Psychiatric disorders Hallucination	8.3% 1/12 • 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)	0.00% 0/53 • 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)	1.9% 1/52 • 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)	4.8% 1/21 • 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)
Psychiatric disorders Insomnia	25.0% 3/12 • 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)	24.5% 13/53 • 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)	19.2% 10/52 • 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)	4.8% 1/21 • 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)
Renal and urinary disorders Dysuria	0.00% 0/12 • 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)	3.8% 2/53 • 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)	7.7% 4/52 • 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)	0.00% 0/21 • 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)
Renal and urinary disorders Renal Impairment	0.00% 0/12 • 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)	1.9% 1/53 • 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)	11.5% 6/52 • 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)	0.00% 0/21 • 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)
Reproductive system and breast disorders Pelvic Pain	0.00% 0/12 • 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)	0.00% 0/53 • 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)	5.8% 3/52 • 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)	0.00% 0/21 • 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)
Respiratory, thoracic and mediastinal disorders Cough	16.7% 2/12 • 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)	18.9% 10/53 • 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)	21.2% 11/52 • 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)	4.8% 1/21 • 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)
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.3% 1/12 • 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)	15.1% 8/53 • 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)	11.5% 6/52 • 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)	0.00% 0/21 • 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)
Respiratory, thoracic and mediastinal disorders Epistaxis	8.3% 1/12 • 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)	0.00% 0/53 • 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)	5.8% 3/52 • 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)	0.00% 0/21 • 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)
Respiratory, thoracic and mediastinal disorders Nasal Congestion	0.00% 0/12 • 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)	5.7% 3/53 • 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)	3.8% 2/52 • 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)	0.00% 0/21 • 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)
Respiratory, thoracic and mediastinal disorders Productive Cough	0.00% 0/12 • 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)	5.7% 3/53 • 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)	7.7% 4/52 • 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)	0.00% 0/21 • 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)
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/12 • 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)	5.7% 3/53 • 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)	3.8% 2/52 • 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)	0.00% 0/21 • 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)
Skin and subcutaneous tissue disorders Erythema	0.00% 0/12 • 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)	5.7% 3/53 • 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)	3.8% 2/52 • 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)	0.00% 0/21 • 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)
Skin and subcutaneous tissue disorders Pruritus	8.3% 1/12 • 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)	9.4% 5/53 • 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)	9.6% 5/52 • 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)	0.00% 0/21 • 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)
Skin and subcutaneous tissue disorders Rash	8.3% 1/12 • 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)	7.5% 4/53 • 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)	13.5% 7/52 • 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)	0.00% 0/21 • 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)
Skin and subcutaneous tissue disorders Scar	8.3% 1/12 • 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)	0.00% 0/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Vascular disorders Haematoma	8.3% 1/12 • 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)	0.00% 0/53 • 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)	0.00% 0/52 • 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)	0.00% 0/21 • 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)
Vascular disorders Hypertension	8.3% 1/12 • 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)	13.2% 7/53 • 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)	7.7% 4/52 • 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)	0.00% 0/21 • 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)
Vascular disorders Hypotension	8.3% 1/12 • 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)	3.8% 2/53 • 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)	13.5% 7/52 • 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)	4.8% 1/21 • 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)
Vascular disorders Orthostatic Hypotension	16.7% 2/12 • 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)	3.8% 2/53 • 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)	5.8% 3/52 • 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)	0.00% 0/21 • 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)

Additional Information

Senior Director

Janssen R&D BE

Email: ClinicalTrialDisclosure@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60