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Trial record 2 of 2 for:    smm2001

A Study of Siltuximab (Anti- IL 6 Monoclonal Antibody) in Patients With High-risk Smoldering Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01484275
Recruitment Status : Completed
First Posted : December 2, 2011
Results First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition High-risk Smoldering Multiple Myeloma
Interventions Drug: Siltuximab
Drug: Placebo
Enrollment 85
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Siltuximab Placebo
Hide Arm/Group Description Participants received 15 milligram per kilogram (mg/kg) of siltuximab as a 1-hour intravenous (IV) infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant). Participants received placebo as a 1-hour IV infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
Period Title: Overall Study
Started 43 42
Completed 0 0
Not Completed 43 42
Reason Not Completed
Study terminated by sponsor             28             32
Other             10             0
Death             3             4
Withdrawal by Subject             1             5
Lost to Follow-up             1             1
Arm/Group Title Siltuximab Placebo Total
Hide Arm/Group Description Participants received 15 milligram per kilogram (mg/kg) of siltuximab as a 1-hour intravenous (IV) infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant). Participants received placebo as a 1-hour IV infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant). Total of all reporting groups
Overall Number of Baseline Participants 43 42 85
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants 42 participants 85 participants
63.2  (10.95) 59.5  (12.03) 61.4  (11.57)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 42 participants 85 participants
Female
17
  39.5%
20
  47.6%
37
  43.5%
Male
26
  60.5%
22
  52.4%
48
  56.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 42 participants 85 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
4
   9.3%
2
   4.8%
6
   7.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   2.3%
2
   4.8%
3
   3.5%
White
35
  81.4%
37
  88.1%
72
  84.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   7.0%
1
   2.4%
4
   4.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 42 participants 85 participants
Australia
4
   9.3%
4
   9.5%
8
   9.4%
Belgium
1
   2.3%
1
   2.4%
2
   2.4%
France
5
  11.6%
1
   2.4%
6
   7.1%
Germany
5
  11.6%
14
  33.3%
19
  22.4%
Israel
7
  16.3%
3
   7.1%
10
  11.8%
Korea, Republic Of
3
   7.0%
2
   4.8%
5
   5.9%
Spain
9
  20.9%
6
  14.3%
15
  17.6%
United Kingdom
4
   9.3%
2
   4.8%
6
   7.1%
United States
5
  11.6%
9
  21.4%
14
  16.5%
1.Primary Outcome
Title One-Year Progression-Free Survival (PFS) Rate
Hide Description One-year PFS rate is defined as the percentage (%) of participants surviving 1 year after randomization without progression to multiple myeloma or death estimated by the Kaplan-Meier method and based on the International Myeloma Working Group (IMWG) calcium, renal, anemia, and bone lesions (CRAB) criteria. Progressive disease (PD) is defined as presence of an M- component in serum plus clonal plasma cells in the bone marrow plus 1 or more of the following: Calcium elevation (greater than [>] 11.5 milligram per deciliter [mg/dL] [> 2.88 millimoles per liter {mmol/L}]); Renal insufficiency (creatinine > 2 mg/dL [177 micromoles per liter or more]; Anemia (hemoglobin less than [<] 10 gram per deciliter [g/dL] or 2 g/dL lower than lower limit of normal [LLN] [hemoglobin < 6.5 mmol/L or 1.25 mmol/L lower than LLN]); Bone disease (lytic lesions or osteopenia).
Time Frame Up to 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population included participants who were randomly assigned to siltuximab or placebo treatment group based on an integrated voice response system (IVRS).
Arm/Group Title Siltuximab Placebo
Hide Arm/Group Description:
Participants received 15 milligram per kilogram (mg/kg) of siltuximab as a 1-hour intravenous (IV) infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
Participants received placebo as a 1-hour IV infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
Overall Number of Participants Analyzed 43 42
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
84.5
(68.6 to 92.8)
74.4
(57.3 to 85.5)
2.Secondary Outcome
Title Progressive Disease Indicator Rate (PDIR) at 6 Months
Hide Description PDIR is defined as percentage of participants who meet any of following criteria occurring within 6 months of start of treatment. a) CRAB criteria: true progression events, b) Serum M-protein: increase by 25 % compared with baseline at 2 consecutive assessments, c) Magnetic resonance imaging: unequivocal increase in focal bone lesions, d) Immunoparesis: decrease by 25% compared with baseline of 2 other non-affected immunoglobulin (Ig) (IgG, IgM, IgA) at 2 consecutive assessments, e) Hemoglobin: decrease of 1.5 g/dL (with at least 1 read below LLN) at 2 consecutive assessments, with no other identifiable cause. PD is defined as presence of M-component in serum plus clonal plasma cells in bone marrow plus 1 or more of following: Calcium elevation (> 11.5 mg/dL [> 2.88 mmol/L]); Renal insufficiency (creatinine >2 mg/dL [177 micro mol/L or more]); Anemia (hemoglobin <10 or 2 g/dL lower than LLN) [hemoglobin < 6.5 or 1.25 mmol/L lower than LLN]); Bone disease (lytic lesions or osteopenia).
Time Frame At 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Response evaluable population included participants who had a diagnosis of high-risk smoldering multiple myeloma (SMM) and received at least 1 dose of siltuximab/placebo treatment. In addition, participants were to have at least 1 post-baseline disease assessment.
Arm/Group Title Siltuximab Placebo
Hide Arm/Group Description:
Participants received 15 milligram per kilogram (mg/kg) of siltuximab as a 1-hour intravenous (IV) infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
Participants received placebo as a 1-hour IV infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
Overall Number of Participants Analyzed 43 42
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
30.2
(17.2 to 46.1)
42.9
(27.7 to 59.0)
3.Secondary Outcome
Title Progression-Free Survival
Hide Description PFS is defined as the time between randomization and initial documented PD according to the CRAB - International Myeloma Working Group (IMWG) criteria or date of death, whichever occurs first. PD is defined as presence of an M-component in serum plus clonal plasma cells in the bone marrow plus 1 or more of the following: Calcium elevation (> 11.5 mg/dL [> 2.88 mmol/L]); Renal insufficiency (creatinine > 2 mg/dL [177 [micro mol/L or more]); Anemia (<10 g/dL or 2 g/dL) lower than LLN) [hemoglobin < 6.5 mmol/L or 1.25 mmol/L lower than LLN]); Bone disease (lytic lesions or osteopenia).
Time Frame Up to 4.7 Years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included participants who were randomly assigned to siltuximab or placebo treatment group based on an IVRS.
Arm/Group Title Siltuximab Placebo
Hide Arm/Group Description:
Participants received 15 milligram per kilogram (mg/kg) of siltuximab as a 1-hour intravenous (IV) infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
Participants received placebo as a 1-hour IV infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
Overall Number of Participants Analyzed 43 42
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(703 to NA)
715.0
(490 to 1232)
[1]
Here, NA signifies that median and upper limit of confidence interval (CI) was not estimable due to less number of events.
4.Secondary Outcome
Title Percentage of Participants With Serum M-protein Response
Hide Description Serum M-protein response is defined as a decrease of greater than or equal to (>=) 50% in serum M-protein compared with baseline at 2 consecutive assessments.
Time Frame Up to 4.7 Years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included participants who were randomly assigned to siltuximab or placebo treatment group based on an IVRS.
Arm/Group Title Siltuximab Placebo
Hide Arm/Group Description:
Participants received 15 milligram per kilogram (mg/kg) of siltuximab as a 1-hour intravenous (IV) infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
Participants received placebo as a 1-hour IV infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
Overall Number of Participants Analyzed 43 42
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
2.3
(0.1 to 12.3)
0.0
(0.0 to 8.4)
5.Secondary Outcome
Title Time to Worsening in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Core 30 (EORTC-QLQ-C30) Scale Score
Hide Description Time to worsening in EORTC-QLQ-C30 (physical function scale) is defined as time between randomization and first documentation of a worsening in EORTC-QLQ-C-30. Worsening in the EORTC-QLQ-C30 is defined as 10 points decrease from baseline. It comprises module with 30 items. Questionnaire includes 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, nausea/vomiting), a global health and quality of life scale, and a number of single items assessing symptoms (dyspnea, loss of appetite, insomnia, constipation, diarrhoea). Instrument contains 28 items using a Likert scale with 4 response options: "Not at All," "A Little," "Quite a Bit," "Very Much" (scored 1-4). Two additional items use response options (1-7): 1=Very Poor, to 7=Excellent. All scale and item scores were linearly transformed to be in range from 0-100. A higher score represents a higher (better) level of functioning, or a higher (worse) level of symptoms.
Time Frame Up to 4.7 Years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included participants who were randomly assigned to siltuximab or placebo treatment group based on an IVRS who had 10 points decrease from baseline in the physical function scale.
Arm/Group Title Siltuximab Placebo
Hide Arm/Group Description:
Participants received 15 milligram per kilogram (mg/kg) of siltuximab as a 1-hour intravenous (IV) infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
Participants received placebo as a 1-hour IV infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
Overall Number of Participants Analyzed 22 21
Median (Full Range)
Unit of Measure: Days
125.50
(56.0 to 1021.0)
118.00
(56.0 to 565.0)
6.Secondary Outcome
Title Time to Worsening in the Brief Pain Inventory (BPI) Worst Item Scores
Hide Description Time to worsening in the BPI worst item is defined as the time between randomization and the first documentation of a worsening in the BPI worst item. It has 2 domains reflecting pain severity and pain interference with domains of functioning and well-being. The selected item refers to the "worst" pain the patient has experienced over the past 24 hours. This item has been found to be most responsive to interference with key domains of functioning and well-being and may be used as a single item. Responses are provided on an 11-point numeric rating scale ranging from 0 "no pain" to 10 "pain as bad as you can imagine". Responses are described as mild (1 to 4), moderate (5 to 6) and severe (7 to 10). Worsening in the BPI worst item is defined as 2 points increase from baseline.
Time Frame Up to 4.7 Years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included participants who were randomly assigned to siltuximab or placebo treatment group based on an IVRS.
Arm/Group Title Siltuximab Placebo
Hide Arm/Group Description:
Participants received 15 milligram per kilogram (mg/kg) of siltuximab as a 1-hour intravenous (IV) infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
Participants received placebo as a 1-hour IV infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
Overall Number of Participants Analyzed 43 42
Median (95% Confidence Interval)
Unit of Measure: Days
652.0 [1] 
(226 to NA)
453.0 [1] 
(277 to NA)
[1]
Here, NA signifies that upper limit of CI was not estimable due to an insufficient number of events.
7.Secondary Outcome
Title Number of Participants With Symptomatic Multiple Myeloma With Adverse Prognostic Features
Hide Description Number of participants who progressed to symptomatic multiple myeloma with stage III of International Staging System (ISS) or abnormal cytogenetic findings were assessed. The ISS system consists of stage I: beta2-microglobulin < 3.5 milligram per liter (mg/L) and albumin >= 3.5 gram (g)/100 ml; stage II: neither stage I nor stage III and stage III: beta2-microglobulin >= 5.5 mg/L.
Time Frame Up to 4.7 Years
Hide Outcome Measure Data
Hide Analysis Population Description
The data was not collected and analyzed for this outcome measure as per the change in planned analysis.
Arm/Group Title Siltuximab Placebo
Hide Arm/Group Description:
Participants received 15 milligram per kilogram (mg/kg) of siltuximab as a 1-hour intravenous (IV) infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
Participants received placebo as a 1-hour IV infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Number of Participants With Best Response to First Subsequent Multiple Myeloma Treatment
Hide Description Best response to first subsequent anti-myeloma therapy was assessed by physician report at 6-month intervals and classified as: complete response (CR) (negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and < 5% plasms cells (PCs) in bone marrow); stringent CR (CR plus a normal FLC ratio, absence of clonal cells in bone marrow); near CR (< 5% PCs in a bone marrow aspirate, no increase in lytic bone lesions); very good partial response (VGPR) (serum and urine component detectable by immunofixation but not on electrophoresis, or >= 90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hour); partial response (PR): >= 50 reduction of serum M-protein, reduction in 24-hour urinary M-protein by >=90 % or to < 200 mg/24 hours); minimal response (>=25% but <= 49% reduction of serum M-protein and reduction in urine M-protein by 50%-89%); stable disease (not meeting criteria for CR, VGPR, PR, or PD); PD; not evaluable and unknown.
Time Frame Up to 4.7 Years
Hide Outcome Measure Data
Hide Analysis Population Description
The data was not collected and analyzed for this outcome measure as per the change in planned analysis.
Arm/Group Title Siltuximab Placebo
Hide Arm/Group Description:
Participants received 15 milligram per kilogram (mg/kg) of siltuximab as a 1-hour intravenous (IV) infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
Participants received placebo as a 1-hour IV infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS is defined as the time between randomization and death due to any cause.
Time Frame Up to 4.7 Years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included participants who were randomly assigned to siltuximab or placebo treatment group based on an IVRS.
Arm/Group Title Siltuximab Placebo
Hide Arm/Group Description:
Participants received 15 milligram per kilogram (mg/kg) of siltuximab as a 1-hour intravenous (IV) infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
Participants received placebo as a 1-hour IV infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
Overall Number of Participants Analyzed 43 42
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Here, NA signifies that median and confidence interval was not estimable due to less number of events.
Time Frame Up to 4.7 Years
Adverse Event Reporting Description Safety analysis set included participants who have received at least 1 administration of any study agent (siltuximab or placebo).
 
Arm/Group Title Siltuximab Placebo
Hide Arm/Group Description Participants received 15 milligram per kilogram (mg/kg) of siltuximab as a 1-hour intravenous (IV) infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant). Participants received placebo as a 1-hour IV infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
All-Cause Mortality
Siltuximab Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   3/43 (6.98%)   4/42 (9.52%) 
Hide Serious Adverse Events
Siltuximab Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   13/43 (30.23%)   13/42 (30.95%) 
Blood and lymphatic system disorders     
Anaemia * 1  0/43 (0.00%)  1/42 (2.38%) 
Cardiac disorders     
Acute Coronary Syndrome * 1  1/43 (2.33%)  0/42 (0.00%) 
Cardiac Arrest * 1  0/43 (0.00%)  1/42 (2.38%) 
Ear and labyrinth disorders     
Eustachian Tube Disorder * 1  1/43 (2.33%)  0/42 (0.00%) 
Gastrointestinal disorders     
Gastric Disorder * 1  1/43 (2.33%)  0/42 (0.00%) 
General disorders     
Asthenia * 1  1/43 (2.33%)  0/42 (0.00%) 
Hepatobiliary disorders     
Cholecystitis Acute * 1  0/43 (0.00%)  1/42 (2.38%) 
Infections and infestations     
Diverticulitis * 1  1/43 (2.33%)  1/42 (2.38%) 
Influenza * 1  0/43 (0.00%)  1/42 (2.38%) 
Lower Respiratory Tract Infection * 1  0/43 (0.00%)  1/42 (2.38%) 
Mastoiditis * 1  1/43 (2.33%)  0/42 (0.00%) 
Otitis Media * 1  1/43 (2.33%)  0/42 (0.00%) 
Pharyngitis * 1  1/43 (2.33%)  0/42 (0.00%) 
Pneumonia * 1  2/43 (4.65%)  1/42 (2.38%) 
Pneumonia Streptococcal * 1  0/43 (0.00%)  1/42 (2.38%) 
Sepsis * 1  0/43 (0.00%)  1/42 (2.38%) 
Sinusitis * 1  1/43 (2.33%)  0/42 (0.00%) 
Urinary Tract Infection * 1  0/43 (0.00%)  1/42 (2.38%) 
Injury, poisoning and procedural complications     
Back Injury * 1  0/43 (0.00%)  1/42 (2.38%) 
Joint Dislocation * 1  1/43 (2.33%)  0/42 (0.00%) 
Lower Limb Fracture * 1  1/43 (2.33%)  0/42 (0.00%) 
Rib Fracture * 1  1/43 (2.33%)  0/42 (0.00%) 
Spinal Fracture * 1  1/43 (2.33%)  0/42 (0.00%) 
Metabolism and nutrition disorders     
Hypercalcaemia * 1  0/43 (0.00%)  1/42 (2.38%) 
Hypoglycaemia * 1  0/43 (0.00%)  1/42 (2.38%) 
Musculoskeletal and connective tissue disorders     
Back Pain * 1  2/43 (4.65%)  0/42 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colon Cancer * 1  1/43 (2.33%)  0/42 (0.00%) 
Nervous system disorders     
Facial Paresis * 1  0/43 (0.00%)  1/42 (2.38%) 
Transient Ischaemic Attack * 1  1/43 (2.33%)  0/42 (0.00%) 
Renal and urinary disorders     
Acute Kidney Injury * 1  0/43 (0.00%)  2/42 (4.76%) 
Oliguria * 1  1/43 (2.33%)  0/42 (0.00%) 
Renal Impairment * 1  0/43 (0.00%)  1/42 (2.38%) 
Respiratory, thoracic and mediastinal disorders     
Nasal Septum Deviation * 1  1/43 (2.33%)  0/42 (0.00%) 
Skin and subcutaneous tissue disorders     
Angioedema * 1  1/43 (2.33%)  0/42 (0.00%) 
Vascular disorders     
Ischaemia * 1  0/43 (0.00%)  1/42 (2.38%) 
Poor Venous Access * 1  0/43 (0.00%)  1/42 (2.38%) 
1
Term from vocabulary, MedDRA Version 19.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Siltuximab Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   41/43 (95.35%)   42/42 (100.00%) 
Blood and lymphatic system disorders     
Anaemia * 1  6/43 (13.95%)  6/42 (14.29%) 
Neutropenia * 1  8/43 (18.60%)  1/42 (2.38%) 
Thrombocytopenia * 1  5/43 (11.63%)  0/42 (0.00%) 
Cardiac disorders     
Palpitations * 1  1/43 (2.33%)  4/42 (9.52%) 
Gastrointestinal disorders     
Abdominal Distension * 1  0/43 (0.00%)  4/42 (9.52%) 
Abdominal Pain * 1  3/43 (6.98%)  6/42 (14.29%) 
Abdominal Pain Lower * 1  1/43 (2.33%)  3/42 (7.14%) 
Abdominal Pain Upper * 1  2/43 (4.65%)  4/42 (9.52%) 
Constipation * 1  5/43 (11.63%)  7/42 (16.67%) 
Diarrhoea * 1  6/43 (13.95%)  7/42 (16.67%) 
Nausea * 1  9/43 (20.93%)  10/42 (23.81%) 
Stomatitis * 1  2/43 (4.65%)  3/42 (7.14%) 
General disorders     
Asthenia * 1  8/43 (18.60%)  3/42 (7.14%) 
Chest Pain * 1  1/43 (2.33%)  5/42 (11.90%) 
Fatigue * 1  6/43 (13.95%)  14/42 (33.33%) 
Influenza Like Illness * 1  1/43 (2.33%)  5/42 (11.90%) 
Oedema Peripheral * 1  3/43 (6.98%)  3/42 (7.14%) 
Pyrexia * 1  3/43 (6.98%)  6/42 (14.29%) 
Infections and infestations     
Bronchitis * 1  3/43 (6.98%)  3/42 (7.14%) 
Gastroenteritis * 1  3/43 (6.98%)  1/42 (2.38%) 
Herpes Zoster * 1  1/43 (2.33%)  3/42 (7.14%) 
Nasopharyngitis * 1  9/43 (20.93%)  15/42 (35.71%) 
Oral Herpes * 1  0/43 (0.00%)  4/42 (9.52%) 
Pneumonia * 1  3/43 (6.98%)  1/42 (2.38%) 
Rhinitis * 1  1/43 (2.33%)  4/42 (9.52%) 
Sinusitis * 1  3/43 (6.98%)  3/42 (7.14%) 
Upper Respiratory Tract Infection * 1  5/43 (11.63%)  10/42 (23.81%) 
Urinary Tract Infection * 1  3/43 (6.98%)  3/42 (7.14%) 
Investigations     
Alanine Aminotransferase Increased * 1  4/43 (9.30%)  0/42 (0.00%) 
Aspartate Aminotransferase Increased * 1  3/43 (6.98%)  1/42 (2.38%) 
Metabolism and nutrition disorders     
Decreased Appetite * 1  3/43 (6.98%)  0/42 (0.00%) 
Hypertriglyceridaemia * 1  4/43 (9.30%)  0/42 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  5/43 (11.63%)  11/42 (26.19%) 
Back Pain * 1  10/43 (23.26%)  12/42 (28.57%) 
Muscle Spasms * 1  0/43 (0.00%)  5/42 (11.90%) 
Musculoskeletal Chest Pain * 1  5/43 (11.63%)  9/42 (21.43%) 
Myalgia * 1  2/43 (4.65%)  3/42 (7.14%) 
Pain in Extremity * 1  5/43 (11.63%)  8/42 (19.05%) 
Nervous system disorders     
Dizziness * 1  3/43 (6.98%)  6/42 (14.29%) 
Headache * 1  6/43 (13.95%)  9/42 (21.43%) 
Sciatica * 1  4/43 (9.30%)  2/42 (4.76%) 
Syncope * 1  3/43 (6.98%)  1/42 (2.38%) 
Psychiatric disorders     
Insomnia * 1  0/43 (0.00%)  4/42 (9.52%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  8/43 (18.60%)  8/42 (19.05%) 
Dyspnoea * 1  3/43 (6.98%)  3/42 (7.14%) 
Epistaxis * 1  0/43 (0.00%)  5/42 (11.90%) 
Oropharyngeal Pain * 1  2/43 (4.65%)  10/42 (23.81%) 
Rhinorrhoea * 1  0/43 (0.00%)  4/42 (9.52%) 
Skin and subcutaneous tissue disorders     
Night Sweats * 1  0/43 (0.00%)  3/42 (7.14%) 
Rash * 1  6/43 (13.95%)  0/42 (0.00%) 
Vascular disorders     
Hypertension * 1  1/43 (2.33%)  4/42 (9.52%) 
1
Term from vocabulary, MedDRA Version 19.0
*
Indicates events were collected by non-systematic assessment
Siltuximab demonstrated positive trending toward 1-year PFS only in high risk SMM-group. Sponsor and Steering Committee decided not to further pursue clinical development of siltuximab for SMM and terminated study, and was considered as completed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Director
Organization: Janssen Research & Development, LLC
Phone: 844-434-4210
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01484275    
Obsolete Identifiers: NCT01563666
Other Study ID Numbers: CR100755
CNTO328SMM2001 ( Other Identifier: Janssen Research & Development, LLC )
2011-001735-22 ( EudraCT Number )
First Submitted: December 1, 2011
First Posted: December 2, 2011
Results First Submitted: December 20, 2019
Results First Posted: January 27, 2020
Last Update Posted: January 27, 2020