Females of child-bearing potential cannot be pregnant or breast-feeding; female participants > 10 years of age or post-menarche must have a negative serum or urine pregnancy test prior to enrollment
A negative serum pregnancy test is required for female participants of child bearing potential (?13 years of age or after onset of menses)
A negative serum pregnancy test is required for female participants of child bearing potential (?13 years of age or after onset of menses)
Pregnant or breast feeding; females of child-bearing potential must test negative for pregnancy at the time of enrollment based on a urine or serum pregnancy test; both male and female patients of reproductive potential must agree to use a reliable method of birth control, during the study and for 3 months following the last dose of study drug
Female subjects with child bearing potential must have a negative pregnancy test at screening; child bearing potential is defined as sexually active patients with menses less than 1 year prior to enrollment, < 65 years of age, have no history of oophorectomy or hysterectomy
Male and female patient of child bearing potential, (for female entering the study after a menstrual period and who have a negative pregnancy test at baseline) must agree to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake.
Female patients of child bearing potential must have negative serum pregnancy test at screening
Female subjects of child-bearing potential must have a negative serum pregnancy test within 14 days of the first day of drug dosing.
Female patients of child bearing potential must not be breastfeeding or pregnant as evidenced by a negative pregnancy test
Female patients of child bearing potential must have a negative pregnancy test within 7 days from the time of registration
A negative urine or serum pregnancy test is required for female subjects of child bearing potential (onset of menses or ?13 years of age).
Female patients of childbearing potential must have a negative serum pregnancy test and agree to use at least one form of pregnancy prevention during the study and for at least one month after treatment discontinuation; for the purposes of this study, child- bearing potential is defined as: all female patients that were not in post-menopause for at least one year or are surgically sterile (site-specific criteria applying to Avera only)
Pregnancy (patients of child-bearing age must be appropriately tested before chemotherapy)
Female patients who are not of child-bearing potential and female patients of child-bearing potential who agree to use adequate contraceptive measures or abstain from heterosexual intercourse during the entire study treatment period and for 4 months after the last dose of study drug, who are not breastfeeding, and who have had a negative serum/urine pregnancy test ?7 days prior to dosing
Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception; female patients of child-bearing potential must have negative pregnancy test
AUTOLOGOUS APHERESIS: For females of child bearing age:\r\n* Not lactating with intent to breastfeed\r\n* Not pregnant with negative serum pregnancy test within 7 days prior to enrollment
Female patients who are not of child-bearing potential and female patients of child-bearing potential who have a negative serum pregnancy test within 3 days prior to cycle 1, day 1
Female patients who are not of child-bearing potential, and female patients of child-bearing potential who agree to use adequate contraceptive measures.
Fertility requirements\r\n* Female patients with child bearing potential must have a negative pregnancy test at least 7 days before starting treatment drugs\r\n* Male patients must agree to use an adequate method of contraception for the duration of the study and for 7 months afterwards\r\n* Female patients must be either posy-menopausal, free from menses >= 2 years (yrs), surgically sterilized, willing to use two adequate barrier methods of contraception to prevent pregnancy, or agree to abstain from sexual activity starting from screening and for 5 months afterwards\r\n* Female patients of child bearing potential must agree to comply with the fertility and pregnancy test requirements dictated by the Rev-Assist program
Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days from the time of registration
If female and of child-bearing potential, must:
Women who are pregnant or lactating; patients must be either surgically sterile (via hysterectomy or bilateral tubal ligation), post-menopausal or using acceptable methods of contraception if they are of child bearing potential; female patients of child bearing potential must have a negative serum or urine pregnancy test within 7 days prior to starting drug; breastfeeding should be discontinued if the mother is treated with radiation
If a female of child-bearing age, have a negative pregnancy test prior to each ultrasound exam
Female patients of child-bearing potential must have a negative pregnancy test and use at least one form of contraception as approved by the investigator for 4 weeks prior to initiating study treatment and 4 months after the last dose of study drug. For the purposes of this study, child-bearing potential is defined as \all female patients unless they are post-menopausal for at least 3 years or surgically sterile\;
Not pregnant; if female with child bearing potential, must be confirmed by negative serum or urine pregnancy test within 14 days prior to enrollment
Women of child-bearing potential must have a negative serum or urine pregnancy test. Male and female patients must agree to use acceptable contraceptive methods for the duration of the study and for at least one month after the last drug administration.
If the patient is a sexually active female of child bearing potential whose partner is male, or if the patient is a sexually active male whose partner is a female of child bearing potential, the patient must agree to use appropriate contraceptive measures for the duration of the treatment of the tumor and for 6 months afterwards; female patients of child bearing potential must have a negative serum pregnancy test within 48 hours of starting study treatment
Female patients of child bearing age must have a negative pregnancy test, be surgically sterile or post-menopausal >= 1 year (yr)
Female subjects: if of child bearing potential, must have negative serum or urine pregnancy test within 7 days of enrollment
Pregnant or lactating; adequate birth control must be used if of child bearing potential per institutional policy; negative pregnancy test in female patients of child-bearing potential per institutional policy; post-menopausal women must have had amenorrhea for at least 18 months to be considered non-child bearing
If the patient is a sexually active female of child bearing potential, whose partner is male, or if the patient is a sexually active male, whose partner is a female of child bearing potential, the patient must agree to use appropriate contraceptive measures for the duration of the treatment of the tumor and for 6 months afterwards as stated in the informed consent; female patients of child bearing potential must have a negative serum pregnancy test at the time of screening and within 48 hours of starting the D2C7-IT infusion
Women of child-bearing potential must have a negative serum or urine pregnancy test. Male and female patients must agree to use acceptable contraceptive methods for the duration of the study and for at least one month after the last drug administration.
A negative urine pregnancy test is required for female subjects of child bearing potential (onset of menses or ?13 years of age).
DONOR: Female donors of child-bearing potential (> 7 yo) must have a negative serum or urine beta-HCG test within three weeks of marrow donation and agree to utilize contraception if sexually active
Female patients of child-bearing potential must have a negative pregnancy test within 14 days prior to study registration
Not pregnant; if female with child bearing potential, must be confirmed by negative serum or urine pregnancy test within 14 days prior to enrollment
Patients must not be pregnant or breast-feeding. Female patients of child-bearing potential must have a negative pregnancy test performed within 72 hours prior to randomization. Women of child-bearing potential must agree not to become pregnant while participating in the study.
Pregnancy test (serum or urine): negative for females of childbearing potential: a female is considered to be of child bearing potential unless she has had a tubal ligation or is postmenopausal (without a menstrual period for at least one year)
Lactating, breastfeeding, or positive pregnancy test for female patients of child-bearing potential.
Female patients of child-bearing potential must agree to practice abstinence or use dual methods of contraception during treatment and for 30-days after the last dose of carfilzomib and have a negative serum pregnancy test at screening
Female subjects of child bearing age must have negative serum pregnancy test at study entry
Female patients of child-bearing potential must have a negative pregnancy test.
Female subjects: if of child bearing potential, must have negative serum or urine pregnancy test within 7 days of enrollment
Female subjects who are pregnant intend to become pregnant or are nursing; female subjects with child-bearing potential must have a negative pregnancy test within one week of enrollment
The participant, if female and of child-bearing potential, must have a negative pregnancy test.
MF PATIENTS: Female patients of child-bearing potential (FOCBP) must have a negative serum beta-HCG pregnancy test within 7 days prior to registration
If female of child-bearing potential, have a negative pregnancy test =< 14 days prior to registration
Female patients who are not of child-bearing potential, and fertile female patients of child-bearing potential who agree to use adequate contraceptive measures, who are not breastfeeding, and who have a negative serum or urine pregnancy test within 72 hours prior to start of randomization
The participant, if female and of child-bearing potential, must have a negative serum or urine pregnancy test within 7 days prior to randomization.
Female patients who are not of child-bearing potential, and female patients of child-bearing potential who have a negative serum pregnancy test at study screening; a tubal ligation is sufficient documentation that a patient is not of child bearing potential; female patients of child-bearing potential, and all male partners must consent to use a medically acceptable method of contraception throughout the study period and for 30 days after the last dose of either study drug
Fertility requirements:\r\n* Female patients with child bearing potential must have a negative pregnancy test within 7 days before starting treatment drugs\r\n* Male patients must agree to use an adequate method of contraception for the duration of the study and for 90 days after therapy discontinuation\r\n* Female patients must be either posy-menopausal, free from menses >= 2 years (yrs), surgically sterilized, willing to use two adequate barrier methods of contraception to prevent pregnancy, or agree to abstain from sexual activity starting from screening and continuing through 90 days after study therapy discontinuation\r\n* Female patients of child bearing potential must agree to comply with the fertility and pregnancy test requirements dictated by the Rev-Assist program
Female patients of child bearing potential must have negative serum pregnancy test
If female and of child-bearing potential, has negative pregnancy test within 14 days prior to treatment.
Female patients of child-bearing potential must have a negative pregnancy test within 14 days prior to registration
Women of child-bearing potential must have a negative serum or urine pregnancy test. Male and female patients must agree to use acceptable contraceptive methods for the duration of the study and for at least one month after the last drug administration.
Negative pregnancy test if female of child-bearing potential. Fertile patients must use effective contraception*.
Female patients who are pregnant or lactating – or planning to become pregnant within 6 months after the end of the treatment (female patients of child-bearing potential must have negative pregnancy test =< 72 hours before enrollment and randomization and must have a negative pregnancy test =< 72 hours prior to treatment start)
Female patients with child-bearing potential must have a negative serum or urine pregnancy test within 7 days of study enrollment; nursing mothers should discontinue nursing
Female candidates of child bearing potential that are pregnant (confirmed by positive pregnancy test)
A female of child-bearing potential, must have two negative urine pregnancy test results within 10 to 14 days prior to starting the first dose of vaccine and Revlimid pre-transplant
If female of child bearing potential, have a negative pregnancy test at screening
Not pregnant; if female with child bearing potential, must be confirmed by negative serum or urine pregnancy test within 14 days prior to enrollment
If female of child bearing potential, have a negative pregnancy test at screening
Female patients who are not of child-bearing potential, and female patients of child-bearing potential who agree to use adequate contraceptive measures and who have a negative serum pregnancy test within 1 week prior to initial study treatment. (See Appendix B)
Female patients who are pregnant or lactating or planning to become pregnant within 6 months after the end of the treatment (female patients of child-bearing potential must have negative pregnancy test =< 72 hours before registration)
Not pregnant; if female with child bearing potential, must be confirmed by negative serum or urine pregnancy test within 14 days prior to enrollment
Non-pregnant female at least 18 years of age. If the subject is of child-bearing age, must have a negative serum pregnancy test at baseline and must agree to practice an acceptable form of birth control while on the study.
Female patients of child-bearing potential must have a negative serum pregnancy test within 14 days prior to registration.
Female patients of child bearing age who have a positive pregnancy test
Female patients who are pregnant (female patients of child-bearing potential must have a negative serum pregnancy test =< 14 days prior to surgery or 15 to 30 days prior to surgery with a negative urine pregnancy test the morning of surgery)
Female participants of child-bearing potential must have a negative urine or serum pregnancy test at the time of the screening visit
Pregnant or nursing female subjects, or female subjects of child bearing potential who refuse to take a pregnancy test prior to their enrollment in this study
Female subjects of child bearing potential must have a negative pregnancy test prior to first dose of tocilizumab and must agree to practice effective contraception during the study
A negative urine pregnancy test is required for female subjects of child bearing potential (onset of menses or ?13 years of age).
Female patients of child-bearing potential must have a negative pregnancy test prior to enrollment
A negative serum or urine pregnancy test is required for female subjects of child bearing potential (onset of menses or ?13 years of age).
A negative urine pregnancy test is required for female participants of child bearing potential (?13 years of age).
Non-pregnant and non-lactating; patients of child-bearing potential must have a negative pregnancy test within 7 days prior to registration; perimenopausal patients must be amenorrheic > 12 months to be considered not of child-bearing potential
If a female of child-bearing potential, must have a negative pregnancy test
Females who are pregnant or breast-feeding at the time of screening will not be eligible for this study; female participants of child-bearing potential will have a urine or serum pregnancy test at the time of the screening visit
Females who are pregnant or breast-feeding at the time of screening will not be eligible for this study; female participants of child-bearing potential will have a urine or serum pregnancy test at the time of the screening visit
Negative pregnancy test if female of child-bearing age
Subject is male; or is a female who is either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (> 1 years without menses), >= 60 years old, or of childbearing potential for whom a pregnancy test (with the results known prior to investigational product administration) is negative; a negative pregnancy test will be required for all female subjects with child bearing potential; if a false pregnancy test is suspected, e.g., perimenopausal condition, an obstetrician will be consulted to determine if she is/is not capable of becoming pregnant; female must also be non-lactating
If a female of child-bearing potential, must have a negative pregnancy test
Subject is male; or is a female who is either pre-menarchal, surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (> 1 years without menses), non-lactating, or of childbearing potential for whom a serum pregnancy test (with the results known prior to investigational product administration) is negative; a negative serum pregnancy test will be required for all female subjects with child bearing potential; if a false pregnancy test is suspected, e.g., perimenopausal condition, an obstetrician will be consulted to determine if she is/is capable of becoming pregnant
Pregnancy or breast feeding; a negative serum pregnancy test is required for all female subjects with child-bearing potential
Not pregnant; a negative serum pregnancy test is required for all female subjects with child-bearing potential
Subject is male; or is a female who is either pre-menarchal, surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (> 1 years without menses), non-lactating, or of childbearing potential for whom a serum pregnancy test (with the results known prior to investigational product administration) is negative; a negative serum pregnancy test will be required for all female subjects with child bearing potential; if a false pregnancy test is suspected, e.g., perimenopausal condition, an obstetrician will be consulted to determine if she is/is capable of becoming pregnant
If a female of child-bearing potential, must have a negative pregnancy test
All female participants with child bearing potential cannot be pregnant or nursing, as confirmed by serum pregnancy test; further, if the female patient is of child-bearing potential, she must agree with use birth control, including oral, injectable or mechanical contraception, abstinence, or vasectomy for 30 days following pimonidazole administration; female patients who become pregnant within six months after receiving the study treatment will be followed through birth or termination of the pregnancy; the Investigator or designee must report all pregnancies to the Sponsor or Sponsor’s authorized representative immediately after becoming aware of the event
If a female of child-bearing age, must have a negative pregnancy test