Siltuximab to Decrease Symptom Burden After Autologous Stem Cell Transplantation for Patients With Multiple Myeloma and AL Amyloidosis
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|ClinicalTrials.gov Identifier: NCT03315026|
Recruitment Status : Active, not recruiting
First Posted : October 19, 2017
Last Update Posted : January 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma AL Amyloidosis||Drug: Siltuximab Behavioral: The M.D. Anderson Symptom Inventory (MDASI)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a phase II study investigating the symptomatic and cytokine response to an anti-IL-6 chimeric monoclonal antibody (siltuximab) during the acute phase of autologous stem cell transplantation (ASCT) in older individuals with multiple myeloma (MM) and systemic AL amyloidosis (AL).|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||December 14, 2017|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||October 2020|
Siltuximab 11mg/kg will be administered seven days before and 21 days after autologous stem cell infusion (+/-2 day).
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).
- number of patients with improved symptoms [ Time Frame: 30 days post ASCT ]as assessed by the MD Anderson symptom inventory Multiple Myeloma Module (MDASI-MM)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03315026
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Gunjan Shah||Memorial Sloan Kettering Cancer Center|