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

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 regulations regarding the use of birth control methods for subjects participating in clinical studies: eg, established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); barrier methods: condom with spermicidal foam/gel/film/cream/suppository or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; male partner sterilization (the vasectomized partner should be the sole partner for that subject); true abstinence (when this is in line with the preferred and usual lifestyle of the subject)
• •* A woman of childbearing potential must have a negative serum (β-human chorionic gonadotropin \[β-hCG\]) pregnancy test at screening
• •* During the study and for 3 months after receiving the last dose of study agent, a woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction
• •* Note: If the childbearing potential changes after start of the study (eg, woman who is not heterosexually active becomes active) a woman must begin a highly effective method of birth control, as described above.
• •A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control eg, either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 3 months after receiving the last dose of study drug