Siltuximab to Decrease Symptom Burden After Autologous Stem Cell Transplantation for Patients Wit… (NCT03315026) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Siltuximab to Decrease Symptom Burden After Autologous Stem Cell Transplantation for Patients With Multiple Myeloma and AL Amyloidosis
United States30 participantsStarted 2017-12-14
Plain-language 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.
Who can participate
Age range60 Years – 75 Years
SexALL
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Inclusion Criteria:
* Patients with histologically-confirmed symptomatic multiple myeloma or AL amyloidosis undergoing autologous HCT with melphalan 140 or 200 mg/m2
* Age 60 through 75 years
* Have at least 3 million x 10e6 CD34+ cells/kg to be infused
* Diffusion capacity \>45% (adjusted for hemoglobin) as predicted by pulmonary function testing.
* KPS performance status ≥ 60% or ECOG Performance Status score of 0-2
* Clinical laboratory values meeting the following criteria within 4 weeks before enrollment:
* LVEF \>45% by MUGA or rest ECHO
* Diffusion capacity \>45% (adjusted for hemoglobin) as predicted pulmonary function testing
* Platelet count ≥ 20 x 10\^9/L
* ALT and AST ≤ 2.5 x ULN
* Total bilirubin ≤ 2.5 x ULN; except if the elevation is due to Gilbert's syndrome
* Calculated creatinine clearance \> 40 mL/min
* Before enrollment, all women are expected to be not of childbearing potential as they will be age 60-75\>:
* Not of childbearing potential: postmenopausal (\>45 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level \>40 IU/mL); permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy); or otherwise be incapable of pregnancy
* Of childbearing potential and practicing (during the study and for 3 months after receiving the last dose of study agent) a highly effective method of birth control consistent with local regula…