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Histologic confirmation of multiple myeloma by the enrolling institution in patient undergoing autologous HCT with melphalan 140 or 200 mg/m^2 |
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Age 18-75 |
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Have at least 3 x 10^6 CD34+ autologous stem cells/kg to be infused |
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Karnofsky performance greater than or equal to 60 within 2 weeks prior to enrollment |
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Organ function testing within 28 days before enrollment |
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LVEF ≥45% by MUGA or rest ECHO |
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Diffusion capacity >45% (adjusted for hemoglobin) as predicted by pulmonary function testing |
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Clinical laboratory values meeting the following criteria within 14 days before |
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enrollment |
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Platelet count ≥ 20 x 109/L |
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ALT and AST ≤ 2.5 x ULN |
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Total bilirubin ≤ 2.5 x ULN; except if the elevation is due to Gilbert's syndrome |
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Calculated creatinine clearance > 40 mL/min |
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All women of childbearing potential must |
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Have a negative serum pregnancy test (β-human chorionic gonadotropin [β-hCG]) within 14 days prior to enrollment (and pre-AHCT per institutional guidelines) |
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For 180 days after receiving plinabulin practice a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies: e.g., 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) |
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For 180 days after receiving plinabulin, a woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction |
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Not of childbearing potential is defined as 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 (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy); or otherwise be incapable of pregnancy |
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Note: If the childbearing potential changes after start of the study (e.g., woman who is not heterosexually active becomes active) a woman must begin a highly effective method of birth control, as described above |
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A man who is sexually active with a woman of childbearing potential and has not had a |
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vasectomy must agree to use a barrier method of birth control e.g., either |
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condom with spermicidal foam/gel/film/cream/suppository or partner with |
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occlusive cap (diaphragm or cervical/vault caps) with spermicidal |
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foam/gel/film/cream/suppository, and all men must also not donate sperm for |
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days after receiving plinabulin |
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Other malignancy within the past 2 years, except for the following if treated and not active: basal cell or nonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in situ or International Federation of Gynecology and Obstetrics (FIGO) Stage 1 carcinoma of the cervix
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Clinically significant infection, including known HIV or hepatitis C infection, or known hepatitis B (Hep B) surface antigen positivity. Patients with Hep B Core Antibody positivity can be enrolled if the Hep B PCR is negative, and they are on antiviral suppression
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Patients with uncontrolled systemic fungal, bacterial, viral, or other infection despite appropriate treatment at the time of enrollment
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Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 14 days or 5 half-lives before enrollment
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Had hospitalization for infection or major surgery (e.g., requiring general anesthesia) within 14 days before enrollment or have not fully recovered from surgery. Note: subjects with surgical procedures conducted under local anesthesia may participate
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A woman who is pregnant or breast-feeding, or a woman who is planning to become pregnant or a man who plans to father a child while enrolled in this study or within 180 days after plinabulin
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Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, as judged by the PI; or unwillingness or inability to follow the procedures required in the protocol
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Significant cardiovascular history
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History of myocardial infarction or ischemic heart disease within 1 year (within a window of up to 18 days less than 1 year) before study drug administration
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Uncontrolled arrhythmia
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History of congenital QT prolongation
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Electrocardiogram (ECG) findings consistent with active ischemic heart disease
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New York Heart Association Class III or IV cardiac disease
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Uncontrolled hypertension: blood pressure consistently >150 mm Hg systolic and > 100 mm Hg diastolic in spite of antihypertensive medication
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Prior transient ischemic attack or cerebrovascular accident with in the past year
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(within an 18-day window). Any neurologic toxicities ≥ Grade 2 within 3 weeks
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of randomization
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History of hemorrhagic diarrhea, inflammatory bowel disease or active uncontrolled peptic ulcer disease. (Concomitant therapy with ranitidine or its equivalent and/or omeprazole or its equivalent is acceptable). History of ileus or other significant gastrointestinal disorder known to predispose to ileus or chronic bowel hypomotility
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Known prior hypersensitivity reaction to any product containing polysorbate 80, polyoxyethylene 15-hydroxystearate/Macrogol 15 hydroxystearate (Solutol HS 15/Kolliphor HS 15)
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Any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient. Examples of such conditions include uncontrolled diabetes, infection requiring parenteral anti-infective treatment, liver failure, any altered mental status or any psychiatric condition that would interfere with the understanding of the informed consent form
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Unwilling or unable to comply with procedures required in this protocol
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