| Eligibility |
Inclusion Criteria:
- Histologic confirmation of multiple myeloma by the enrolling institution in patient
undergoing autologous HCT with melphalan 140 or 200 mg/m^2
- Age 18-75
- Have at least 3 x 10^6 CD34+ autologous stem cells/kg to be infused
- Karnofsky performance greater than or equal to 60 within 2 weeks prior to enrollment.
- Organ function testing within 28 days before enrollment:
1. LVEF =45% by MUGA or rest ECHO
2. Diffusion capacity >45% (adjusted for hemoglobin) as predicted by pulmonary
function testing
- Clinical laboratory values meeting the following criteria within 14 days before
enrollment:
1. Platelet count = 20 x 109/L
2. ALT and AST = 2.5 x ULN
3. Total bilirubin = 2.5 x ULN; except if the elevation is due to Gilbert's syndrome
4. Calculated creatinine clearance > 40 mL/min
- All women of childbearing potential must:
1. Have a negative serum pregnancy test (ß-human chorionic gonadotropin [ß-hCG])
within 14 days prior to enrollment (and pre-AHCT per institutional guidelines)
2. 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)
3. For 180 days after receiving plinabulin, a woman must agree not to donate eggs
(ova, oocytes) for the purposes of assisted reproduction
4. 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
5. 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.
- 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 e.g., 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 for 180 days after receiving plinabulin
Exclusion Criteria:
- 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
- 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.
- Patients with uncontrolled systemic fungal, bacterial, viral, or other infection
despite appropriate treatment at the time of enrollment.
- Received an investigational drug (including investigational vaccines) or used an
invasive investigational medical device within 14 days or 5 half-lives before
enrollment
- 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
- 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
- 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.
- Significant cardiovascular history:
- 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
- Uncontrolled arrhythmia
- History of congenital QT prolongation
- Electrocardiogram (ECG) findings consistent with active ischemic heart disease
- New York Heart Association Class III or IV cardiac disease;
- Uncontrolled hypertension: blood pressure consistently >150 mm Hg systolic and >
100 mm Hg diastolic in spite of antihypertensive medication
- Prior transient ischemic attack or cerebrovascular accident with in the past year
(within an 18-day window). Any neurologic toxicities = Grade 2 within 3 weeks of
randomization.
- 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.
- Known prior hypersensitivity reaction to any product containing polysorbate 80,
polyoxyethylene 15-hydroxystearate/Macrogol 15 hydroxystearate (Solutol HS
15/Kolliphor HS 15).
- 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.
- Unwilling or unable to comply with procedures required in this protocol.
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