Siltuximab for Multiple Myeloma
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.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug Siltuximab for treating multiple myeloma?
Research shows that Siltuximab, when combined with other drugs like lenalidomide, bortezomib, and dexamethasone, resulted in a high response rate in newly diagnosed multiple myeloma patients, with 90.9% showing some level of positive response. Additionally, Siltuximab has been shown to enhance the effectiveness of melphalan, another drug used in treating multiple myeloma, by increasing cancer cell death in laboratory studies.12345
Is siltuximab generally safe for humans?
Siltuximab has been tested in various studies and is generally well tolerated in humans. Common side effects include skin itching, weight gain, rash, and upper respiratory infections, while serious side effects like pneumonia and low platelet counts have been observed in some cases. No deaths were reported in the studies reviewed.14678
How is the drug siltuximab unique in treating multiple myeloma?
Siltuximab is unique because it targets interleukin-6 (IL-6), a protein that plays a key role in the development of multiple myeloma, by using a monoclonal antibody to inhibit its activity. This approach is different from other treatments that may not specifically target IL-6, and it is administered intravenously every two weeks.12346
Research Team
Gunjan Shah, MD, MS
Principal Investigator
Memorial Sloan Kettering Cancer Center
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pre-Transplant Treatment
Siltuximab 11mg/kg is administered seven days before autologous stem cell infusion
Post-Transplant Treatment
Siltuximab 11mg/kg is administered 21 days after autologous stem cell infusion
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Siltuximab
- The M.D. Anderson Symptom Inventory (MDASI)
Siltuximab is already approved in European Union, United States, Canada, Japan for the following indications:
- Multicentric Castleman's disease
- Multicentric Castleman's disease
- Multicentric Castleman's disease
- Multicentric Castleman's disease
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Janssen Scientific Affairs, LLC
Industry Sponsor
Ricardo Attar
Janssen Scientific Affairs, LLC
Chief Executive Officer since 2008
PhD in Molecular Biology, University of Buenos Aires
Dr. Anastasia G. Daifotis
Janssen Scientific Affairs, LLC
Chief Medical Officer since 2023
MD