Trial · NCT01484275
A Study of Siltuximab (Anti- IL 6 Monoclonal Antibody) in Patients With High-risk Smoldering Multiple Myeloma
NCT01484275, Phase 2, Completed, Janssen Research & Development, LLC; results first posted 2020-01-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Siltuximab (Anti- IL 6 Monoclonal Antibody) in Patients With High-risk Smoldering Multiple Myeloma. Trials, record NCT01484275. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01484275
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Siltuximab (Anti- IL 6 Monoclonal Antibody) in Patients With High-risk Smoldering Multiple Myeloma
- NCT number
- NCT01484275
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 85 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- High-risk Smoldering Multiple Myeloma
- Interventions
- Siltuximab, Placebo
- First posted
- 2011-12-02
- Last updated
- 2020-01-27
- Other registries' IDs
- eudract:2011-001735-22
- Results first posted
- 2020-01-27
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | One-Year Progression-Free Survival (PFS) Rate | Up to 1 Year | 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). |
| Secondary | Progressive Disease Indicator Rate (PDIR) at 6 Months | At 6 Months | 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). |
| Secondary | Progression-Free Survival | Up to 4.7 Years | 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). |
| Secondary | Percentage of Participants With Serum M-protein Response | Up to 4.7 Years | 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. |
| Secondary | Time to Worsening in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Core 30 (EORTC-QLQ-C30) Scale Score | Up to 4.7 Years | 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. |
| Secondary | Time to Worsening in the Brief Pain Inventory (BPI) Worst Item Scores | Up to 4.7 Years | 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. |
| Secondary | Number of Participants With Symptomatic Multiple Myeloma With Adverse Prognostic Features | Up to 4.7 Years | 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. |
| Secondary | Number of Participants With Best Response to First Subsequent Multiple Myeloma Treatment | Up to 4.7 Years | 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. |
| Secondary | Overall Survival (OS) | Up to 4.7 Years | OS is defined as the time between randomization and death due to any cause. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | One-Year Progression-Free Survival (PFS) Rate | Up to 1 Year | 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). | Percentage of participants | NUMBER |
| SECONDARY | Progressive Disease Indicator Rate (PDIR) at 6 Months | At 6 Months | 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. | Percentage of participants | NUMBER |
| SECONDARY | Progression-Free Survival | Up to 4.7 Years | ITT population included participants who were randomly assigned to siltuximab or placebo treatment group based on an IVRS. | Days | MEDIAN |
| SECONDARY | Percentage of Participants With Serum M-protein Response | Up to 4.7 Years | ITT population included participants who were randomly assigned to siltuximab or placebo treatment group based on an IVRS. | Percentage of participants | NUMBER |
| SECONDARY | Time to Worsening in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Core 30 (EORTC-QLQ-C30) Scale Score | Up to 4.7 Years | 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. | Days | MEDIAN |
| SECONDARY | Time to Worsening in the Brief Pain Inventory (BPI) Worst Item Scores | Up to 4.7 Years | ITT population included participants who were randomly assigned to siltuximab or placebo treatment group based on an IVRS. | Days | MEDIAN |
| SECONDARY | Number of Participants With Symptomatic Multiple Myeloma With Adverse Prognostic Features | Up to 4.7 Years | The data was not collected and analyzed for this outcome measure as per the change in planned analysis. | ||
| SECONDARY | Number of Participants With Best Response to First Subsequent Multiple Myeloma Treatment | Up to 4.7 Years | The data was not collected and analyzed for this outcome measure as per the change in planned analysis. | ||
| SECONDARY | Overall Survival (OS) | Up to 4.7 Years | ITT population included participants who were randomly assigned to siltuximab or placebo treatment group based on an IVRS. | Days | MEDIAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| One-Year Progression-Free Survival (PFS) Rate | Siltuximab | 84.5 | 95% Confidence Interval 68.6 to 92.8 | Percentage of participants | |
| One-Year Progression-Free Survival (PFS) Rate | Placebo | 74.4 | 95% Confidence Interval 57.3 to 85.5 | Percentage of participants | |
| Progressive Disease Indicator Rate (PDIR) at 6 Months | Siltuximab | 30.2 | 95% Confidence Interval 17.2 to 46.1 | Percentage of participants | |
| Progressive Disease Indicator Rate (PDIR) at 6 Months | Placebo | 42.9 | 95% Confidence Interval 27.7 to 59.0 | Percentage of participants | |
| Progression-Free Survival | Siltuximab | NA | 95% Confidence Interval 703 to NA | Days | |
| Progression-Free Survival | Placebo | 715.0 | 95% Confidence Interval 490 to 1232 | Days | |
| Percentage of Participants With Serum M-protein Response | Siltuximab | 2.3 | 95% Confidence Interval 0.1 to 12.3 | Percentage of participants | |
| Percentage of Participants With Serum M-protein Response | Placebo | 0.0 | 95% Confidence Interval 0.0 to 8.4 | Percentage of participants | |
| Time to Worsening in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Core 30 (EORTC-QLQ-C30) Scale Score | Siltuximab | 125.50 | Full Range 56.0 to 1021.0 | Days | |
| Time to Worsening in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Core 30 (EORTC-QLQ-C30) Scale Score | Placebo | 118.00 | Full Range 56.0 to 565.0 | Days |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Siltuximab | 43 | |
| Overall Study | STARTED | Placebo | 42 | |
| Overall Study | COMPLETED | Siltuximab | 0 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Siltuximab | 43 | |
| Overall Study | NOT COMPLETED | Placebo | 42 |
Source ClinicalTrials.gov
Adverse events174
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Siltuximab | 6 | 43 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 6 | 42 | |
| other | Neutropenia | Blood and lymphatic system disorders | Siltuximab | 8 | 43 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo | 1 | 42 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Siltuximab | 5 | 43 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo | 0 | 42 | |
| other | Palpitations | Cardiac disorders | Siltuximab | 1 | 43 | |
| other | Palpitations | Cardiac disorders | Placebo | 4 | 42 | |
| other | Abdominal Distension | Gastrointestinal disorders | Siltuximab | 0 | 43 | |
| other | Abdominal Distension | Gastrointestinal disorders | Placebo | 4 | 42 |
1 to 10 of 174Source ClinicalTrials.gov
See all 174 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Siltuximab | 3 | 43 |
| Total, all-cause mortality | Placebo | 4 | 42 |
| Total, other adverse events | Siltuximab | 41 | 43 |
| Total, other adverse events | Placebo | 42 | 42 |
| Total, serious adverse events | Siltuximab | 13 | 43 |
| Total, serious adverse events | Placebo | 13 | 42 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30890552 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Siltuximab vs Placebo: deaths from any cause | Trial comparisons |
| Siltuximab vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01484275
GET https://conductscience.org/api/trials/v1/NCT01484275/events?page=2