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Monoclonal Antibodies

Siltuximab for Multiple Myeloma

Phase 2

Waitlist Available

Led By Gunjan Shah

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control

KPS performance status ≥ 60% or ECOG Performance Status score of 0-2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days post asct

Awards & highlights

Study Summary

This trial will investigate if blocking the protein IL-6 with the agent siltuximab will decrease symptoms after an autologous stem cell transplant, to improve quality of life and recovery.

Who is the study for?

This trial is for individuals aged 60-75 with multiple myeloma or AL amyloidosis, undergoing stem cell transplant. They must have good lung function and enough CD34+ cells for infusion, stable clinical lab values, and agree to use contraception if necessary. Exclusions include recent major surgery or infection, prior IL-6 targeting treatment, other active malignancies within 2 years (with exceptions), significant concurrent illnesses, live vaccinations within 4 weeks before the study starts, certain infections like HIV/Hepatitis B/C, recent investigational drug/device use.Check my eligibility

What is being tested?

The trial tests whether Siltuximab can reduce symptoms such as weakness and nausea after autologous stem cell transplantation by blocking a protein called Interleukin-6 (IL-6). Participants will receive Siltuximab before and after their transplant to see if it improves recovery and quality of life during the post-transplant period.See study design

What are the potential side effects?

Potential side effects of Siltuximab may include allergic reactions at the injection site, headache, upper respiratory tract infections, weight gain due to fluid retention in the body (edema), itching or rash. It might also affect liver enzymes which would be monitored through blood tests.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a man who will use protection during sex with a woman who can have children.

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I can care for myself and perform daily activities.

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I have multiple myeloma or AL amyloidosis and am getting a stem cell transplant with melphalan.

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I am between 60 and 75 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days post asct

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days post asct

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days post asct for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

number of patients with improved symptoms

Side effects data

From 2021 Phase 3 trial • 342 Patients • NCT04330638

22%

Constipation

16%

Lung infection

Hyperglycaemia

Hypertriglyceridaemia

Hypertension

Atrial fibrillation

Other

Bacteraemia

Platelet count decreased

Neutrophil count decreased

Nausea

Sepsis

Cough

Rash maculo-papular

Aspiration

Pneumothorax

Lower gastrointestinal haemorrhage

Gastroparesis

Alanine aminotransferase increased

Multi-organ failure

Diarrhoea

Hypokalaemia

Hypotension

Delirium

Laryngeal stenosis

Respiratory failure

Stroke

Urinary tract infection

100%

80%

60%

40%

20%

Study treatment Arm

Anakinra + Tocilizumab

Anakinra

Siltuximab

Anakinra + Siltuximab

Tocilizumab

Usual Care

Trial Design

1Treatment groups

Experimental Treatment

Group I: SiltuximabExperimental Treatment2 Interventions

Siltuximab 11mg/kg will be administered seven days before and 21 days after autologous stem cell infusion (+/-2 day).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Siltuximab

2011

Completed Phase 3

~1190

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Scientific Affairs, LLCIndustry Sponsor

159 Previous Clinical Trials

580,488 Total Patients Enrolled

23 Trials studying Multiple Myeloma

2,066 Patients Enrolled for Multiple Myeloma

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,590 Total Patients Enrolled

80 Trials studying Multiple Myeloma

86,137 Patients Enrolled for Multiple Myeloma

Gunjan ShahPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Siltuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03315026 — Phase 2

Multiple Myeloma Research Study Groups: Siltuximab

Multiple Myeloma Clinical Trial 2023: Siltuximab Highlights & Side Effects. Trial Name: NCT03315026 — Phase 2

Siltuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03315026 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still possible for this medical experiment?

"This trial is not admitting patients at present. The listing on clinicaltrials.gov was initially posted in December of 2017, and recently updated in January 2022. For those searching for alternative studies, there are 895 trials recruiting multiple myeloma candidates and 4 studies utilizing Siltuximab that are actively accepting participants."

Answered by AI

Is this investigation open to participants aged under 70 years old?

"As per the requirements of this trial, participants must be at least 60 years old and no older than 75."

Answered by AI

To what degree do the risks of Siltuximab outweigh its potential benefits?

"As this is a Phase 2 trial, with existing data on safety but no evidence of efficacy, the team at Power assigned Siltuximab with a score of 2."

Answered by AI

Am I a suitable candidate for participating in this medical experiment?

"This clinical trial seeks 30 elderly individuals (aged between 60-75) with multiple myeloma to participate. Specific eligibility criteria includes: CD34+ cell count of at least 3 million x 10e6/kg, diffusion capacity over 45%, KPS performance score or ECOG Performance Status score of 0-2, LVEF>45% by MUGA or rest ECHO, platelet count greater than 20x10^9/L, ALT and AST ≤ 2.5 ULN and total bilirubin ≤ 2.5 ULN; unless the rise is due to Gilbert's syndrome."

Answered by AI

Could you please share any past research regarding Siltuximab?

"Currently, there are 4 separate studies related to the therapeutic agent siltuximab. None of these research projects have progressed into Phase 3 yet and most locations hosting trials for this medication can be found in Atlanta, Georgia. However, 6 medical sites across the country are conducting investigations with siltuximab."

Answered by AI

To what extent is this experiment being populated by participants?

"Participation in this trial has ended, with the original posting on December 14th 2017 and final update occurring January 21st 2022. However, there are still 895 studies concerning multiple myeloma recruiting patients as well as 4 trials for Siltuximab actively enrolling participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Siltuximab to Decrease Symptom Burden After Autologous Stem Cell Transplantation for Patients With Multiple Myeloma and AL Amyloidosis

2017. "Siltuximab to Decrease Symptom Burden After Autologous Stem Cell Transplantation for Patients With Multiple Myeloma and AL Amyloidosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03315026.

All > Al Amyloidosis > Amyloidosis