Siltuximab for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

Gunjan L. Shah, MD - MSK Bone Marrow ...

Overseen byGunjan Shah, MD, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

Your recent medical test results need to meet certain standards set by the study.

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

I can care for myself and perform daily activities.

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Exclusion Criteria

A woman who is pregnant or breast-feeding, or a woman who is planning to become pregnant or a man who plans to father a child while enrolled in this study or within 3 months after the last dose of study agent

Concurrent medical condition or disease likely to interfere with study procedures or results, or constitute a hazard for participating in the study

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

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Treatment Details

Interventions

Siltuximab (Monoclonal Antibodies)
The M.D. Anderson Symptom Inventory (MDASI) (Behavioral Intervention)

Trial OverviewThe 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.

Participant Groups

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).

Siltuximab is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Sylvant for: