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ACTIVE NOT RECRUITING
NCT03315026
PHASE2

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

Sponsor: Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

60 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2017-12-14

Completion Date

2026-10

Last Updated

2025-11-04

Healthy Volunteers

No

Interventions

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).

Locations (1)

Memorial Sloan Kettering Cancer Center

New York, New York, United States