Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Siltuximab · 4 trials · 5 indications
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).
An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Durable tumor and symptomatic response is complete response (CR) + partial response (PR). CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion) and resolution of baseline symptoms attributed to multicentric Castleman's disease, sustained for at least 18 weeks. PR: \>=50 percent decrease in sum of the product of the diameters of indicator lesion(s), with at least stable disease in all other evaluable disease in the absence of treatment failure sustained for at least 18 weeks. The statistical analysis shows difference in symptomatic response rate (siltuximab+best supportive care \[BSC\] minus Placebo+BSC).
| Arm | Type | Description |
|---|---|---|
| Siltuximab | EXPERIMENTAL | Type=exact, unit=mg/kg, number=15, form=intravenous infusion, route=intravenous use, every 4 weeks until progression to symptomatic multiple myeloma, unacceptable toxicity, withdrawal of consent, or the end of the study. |
| Placebo | PLACEBO_COMPARATOR | Form=intravenous infusion, route=intravenous use route=intravenous, use every 4 weeks until progression to symptomatic multiple myeloma, unacceptable toxicity, withdrawal of consent, or the end of the study. |
| Siltuximab+best supportive care (BSC) | EXPERIMENTAL | Siltuximab 11 mg/kg will be administered as a 1-hour intravenous infusion every 3 weeks + BSC. |
| Placebo+BSC | PLACEBO_COMPARATOR | Placebo will be administered as a 1-hour intravenous infusion every 3 weeks + BSC. Participants who do not respond to placebo during the blinded treatment period will have option to crossover and receive siltuximab 11 mg/kg which will be administered by 1-hour intravenous infusion every 3 weeks + BSC during the unblinded treatment period. |
| 001 | EXPERIMENTAL | Siltuximab 15mg/kg IV infusion every 3 weeks for 4 cycles. If applicable extended dosing of 15 mg/kg IV infusion every 4 weeks for up to 2 years. |
| Name | Type | Description |
|---|---|---|
| Siltuximab | DRUG | Type=exact, unit=mg/kg, number=15, form=intravenous infusion, route=intravenous use, every 4 weeks until progression to symptomatic multiple myeloma, unacceptable toxicity, withdrawal of consent, or the end of the study. |
| Placebo | DRUG | Form=intravenous infusion, route=intravenous use route=intravenous, use every 4 weeks until progression to symptomatic multiple myeloma, unacceptable toxicity, withdrawal of consent, or the end of the study. |
| Best Supportive Care (BSC) | DRUG | BSC included treatment for effusions, antipyretics, antipuretics, antihistamines, pain medication, treatment for infections, transfusions, management of infusion-related reactions, and corticosteroids. |
Inclusion Criteria: * Diagnosis of smoldering multiple myeloma (SMM) for \<4 years * Diagnosis of high-risk SMM (defined as bone marrow plasma cells \>=10% and either serum monoclonal protein \>=3 g/dL, or abnormal free light chain ratio \<0.126 or \>8 and serum M-protein \<3 g/dL but \>=1 g/dL) * ...
Siltuximab is an investigational drug being studied for use in multiple myeloma, monoclonal gammopathy of undetermined significance, multicentric Castleman's disease, and high-risk smoldering multiple myeloma. It is in Phase 2 clinical development for these oncology indications.
Siltuximab is an anti-IL-6 monoclonal antibody that targets interleukin-6, a cytokine involved in inflammation and cancer cell growth. By binding to IL-6, it is designed to block its activity, which may help slow disease progression in certain blood cancers.
Siltuximab is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is currently in Phase 2 clinical trials for multiple oncology indications.
Siltuximab is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. Clinical trials have been completed for multiple myeloma and high-risk smoldering multiple myeloma, with no active trials currently ongoing.
Siltuximab has been studied in several completed clinical trials, including NCT00401843 and NCT00911859 for multiple myeloma, NCT01219010 for monoclonal gammopathy of undetermined significance and related conditions, and NCT01484275 for high-risk smoldering multiple myeloma. These trials enrolled a total of 425 patients.
Yes, Siltuximab is also known as CNTO 328. Clinical trial records reference CNTO 328 as the study drug, and it is an anti-IL-6 monoclonal antibody being developed by Johnson & Johnson.