What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, including lenalidomide, bortezomib, and dexamethasone, have various side effects. Lenalidomide can cause cytopenias, fatigue, gastrointestinal issues, and rash. Bortezomib is associated with peripheral neuropathy, gastrointestinal distress, and cytopenias. Dexamethasone can lead to hyperglycemia, insomnia, and increased infection risk. Siltuximab, an IL-6 inhibitor, aims to reduce inflammatory symptoms but may also cause infections, infusion reactions, and gastrointestinal disturbances. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Multiple Myeloma, including monoclonal antibodies and proteasome inhibitors. Daratumumab, an anti-CD38 monoclonal antibody, has shown efficacy in relapsed or refractory Multiple Myeloma. Lenalidomide, often used in combination with dexamethasone, is another cornerstone of treatment. While Siltuximab specifically targets IL-6, other approved treatments like bortezomib and carfilzomib target different pathways but are also integral in managing Multiple Myeloma. These treatments aim to improve progression-free survival and overall survival in patients.

What other types of research exist?

Promising novel alternatives to Siltuximab for Multiple Myeloma patients in 2024 include: 1) Daratumumab, a monoclonal antibody targeting CD38, often used in combination with other agents. 2) CAR-T cell therapies, such as idecabtagene vicleucel and ciltacabtagene autoleucel, which target BCMA (B-cell maturation antigen). 3) Bispecific T-cell engagers (BiTEs) like teclistamab, which also target BCMA. 4) Selinexor, a selective inhibitor of nuclear export, used in combination regimens. These therapies offer different mechanisms of action and have shown efficacy in clinical trials.

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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

Must not have

Clinically significant infection, including known HIV or hepatitis C infection, or known hepatitis B (Hep B) surface antigen positivity

Prior exposure to agents targeting IL-6 or the IL-6 receptor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days post asct

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing siltuximab, a medication that blocks a protein called IL-6, to help reduce severe symptoms like weakness and fatigue after a stem cell transplant. The target group is patients aged 60-75 with multiple myeloma or systemic amyloidosis. By reducing inflammation, the goal is to improve recovery and shorten hospital stays.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have HIV, hepatitis C, or active hepatitis B.

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I have been treated with drugs targeting IL-6 or its receptor before.

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I have not received any live vaccines in the last 4 weeks.

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I haven't been hospitalized for an infection or had major surgery in the last 2 weeks.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Neutrophil count decreased

Platelet count decreased

Nausea

Other

Bacteraemia

Sepsis

Cough

Rash maculo-papular

Multi-organ failure

Aspiration

Pneumothorax

Lower gastrointestinal haemorrhage

Hypotension

Alanine aminotransferase increased

Delirium

Diarrhoea

Gastroparesis

Hypokalaemia

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Multiple Myeloma treatments target both the malignant plasma cells and their supportive microenvironment. Proteasome inhibitors (e.g., bortezomib) disrupt protein degradation, leading to cancer cell death. Immunomodulatory drugs (e.g., lenalidomide) enhance immune response and inhibit tumor growth. Monoclonal antibodies (e.g., daratumumab) target specific antigens on myeloma cells, marking them for immune destruction. IL-6 inhibitors like siltuximab block the cytokine IL-6, which is involved in inflammation and supports myeloma cell survival. These mechanisms are vital as they address both the direct elimination of cancer cells and the disruption of their supportive environment, improving patient outcomes.

Novel treatment approaches for patients with relapsed and refractory multiple myeloma.