NCT03315026

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

Phase II Study of Interleukin 6 Blockade With Siltuximab to Decrease Symptom Burden in Patients Age 60-75 Undergoing Autologous Stem Cell Transplantation for Multiple Myeloma and AL Amyloidosis

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 60 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Autologous stem cell transplant is beneficial to patients who are diagnosed with multiple myeloma or systemic amyloidosis. However, undesired symptoms such as weakness, fatigue, nausea, pain and sleep disturbance after transplant can contribute to complications and increase the how long the patient is in the hospital, especially in patients age 60-75. Research has shown that the development and the intensity of these symptoms are closely associated with an increase in a protein called a cytokine which is involved in the inflammatory response in the human body. One of the cytokines is called Interleukin-6 or IL-6.Therefore, this study will investigate if blocking IL-6 with an agent called siltuximab, administered before and after transplant, will decrease the symptom burden after transplant to improve quality of life and recovery in the immediate post-transplant period.

Conditions

• Multiple Myeloma
• AL Amyloidosis

Interventions

Type	Name	Description
DRUG	Siltuximab	Siltuximab at 11mg/kg will be administered as a 1-hour infusion on day -7 and day +21 (+/-2) after stem cell infusion.
BEHAVIORAL	The M.D. Anderson Symptom Inventory (MDASI)	assessments will be conducted at baseline (day -10 +/-3), day -2 (+/-1), , day +7 (+/-1 ), and day 30 (+/-3).

Timeline

• Start date: 2017-12-14
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2017-10-19
• Last updated: 2025-11-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study