The subject has received systemic dexamethasone continuously at a dose > 8 mg/day for 8 weeks prior to the date of the screening assessment
Receive dexamethasone equivalent dose </=2 mg per day, stable or decreased for >/= three days prior to Day 0;
Dexamethasone equivalent dose >2 mg per day;
Diagnosis of immunodeficiency or treatment with systemic immunosuppressive therapy within 28 days prior to the first dose of trial treatment, other than dexamethasone for the underlying disease under investigation, as noted in the inclusion criteria;
Recent corticosteroid therapy at a cumulative dose equivalent to >= 140 mg of prednisone or a single dose equivalent to >= 40 mg of dexamethasone within 2 weeks prior the first dose of study drug.
Stable dose of dexamethasone 2 mg or less for at least 7 days prior to initiation of treatment
Requires treatment with high dose systemic corticosteroids defined as dexamethasone > 2 mg/day or bioequivalent within at least 7 days of initiating therapy
Dexamethasone: 7 days
< 4 mg dexamethasone daily (or equivalent if on another corticosteroid) at time of start of therapy; patients on a steroid taper post-surgery and are anticipated to be on < 4 mg at time of chemoradiation initiation will be eligible to consent but to initiate treatment on trial, the participant must be on < 4 mg or equivalent of steroids otherwise participate will be deemed a screen fail and be replaced
Stable dose of dexamethasone 2 mg or less for 7 days prior to initiation of treatment
Stable dose of dexamethasone 2 mg or less for 7 days prior to initiation of treatment
Requires treatment with high dose systemic corticosteroids defined as dexamethasone > 2 mg/day or bioequivalent within 7 days of initiating therapy
Stable dose of dexamethasone 2 mg or less for at least 7 days prior to initiation of treatment
Treatment with high dose systemic corticosteroids defined as dexamethasone > 2 mg/day or bioequivalent within 7 days of initiating therapy
Stable dose of dexamethasone 2 mg or less for at least 7 days prior to initiation of treatment
Treatment with high dose systemic corticosteroids defined as dexamethasone > 2mg/day or bioequivalent within 7 days of initiating therapy
For Daratumumab + bortezomib + lenalidomide + dexamethasone (D-VRd) and Daratumumab + bortezomib + melphalan + prednisone + dexamethasone (D-VMP) regimen: newly diagnosed myeloma
The patient must be either off systemic steroids or be on stable dose of dexamethasone (max 0.1 mg/kg/day; maximum 4mg/day) at time of enrollment
Ongoing treatment with immunosuppressive drugs or dexamethasone > 4 mg
EXCLUSION CRITERIA FOR STRATUM C: Patients may not be on immunosuppressive therapy, including corticosteroids (with the exception of physiologic replacement, defined as =< 0.75 mg/m^2/day dexamethasone equivalent) at time of enrollment; however, patients who require intermittent use of bronchodilators or local steroid injections will not be excluded from the study
Daily dexamethasone > 4 mg at the time of registration
Corticosteroids use exceeding a cumulative dose of 160 mg of dexamethasone during screening
Research participant must not require more than 2 mg three times daily TID of dexamethasone on the day of PBMC collection.
Research participants must not require more than 2 mg TID of dexamethasone during CAR T cell therapy
Phase I patients must not be receiving greater than 1 mg dexamethasone/day (or an equivalent amount of an alternative corticosteroid) for at least 1 week prior to treatment start
Has a diagnosis of immunodeficiency including human immunodeficiency virus (HIV) (HIV 1/2 antibodies) and is not on continuous daily immunosuppressive therapy within 7 days prior to the first dose of trial treatment; (an exception to this is the use of steroids for brain edema and resulting symptom); subjects may receive a stable or reducing dose of steroids (up to 8 mg dexamethasone or equivalent for at least 5 days prior to signing consent) to prevent or manage cerebral edema; subjects requiring over 8mg of dexamethasone per day on or five days prior to signing consent are excluded)
Dexamethasone dose =< 4 mg daily
If applicable, stable dose of dexamethasone 2 mg or less for 7 days prior to initiation of treatment
Patients who are on dexamethasone receiving > 4 mg/day in the two weeks prior to admission for intra-cerebral delivery of PVSRIPO
Prior therapy for AL amyloidosis or multiple myeloma including medications that target CD38, with the exception of 160 mg dexamethasone (or equivalent corticosteroid) maximum exposure prior to randomization
Requires treatment with high dose systemic corticosteroids defined as dexamethasone > 4 mg/day or bioequivalent for at least 3 consecutive days within 2 weeks of registration
Dexamethasone dose should be =< 4 mg/day or steroid equivalent prior to starting treatment; if higher doses are needed, consult with study chair
Patients on greater than 4 mg per day of dexamethasone within the 2 weeks prior to admission for PVSRIPO infusion
Ongoing or recent (within 21 days prior to study entry) use of high dose oral corticosteroids (>= 2 mg of dexamethasone daily or equivalent); intranasal and/or inhaled corticosteroid use is permitted
The ability to take folic acid, vitamin B12, and dexamethasone according to protocol
Use of systemic glucocorticoid (eg, prednisone, dexamethasone) within 14 days prior to the start of study medication.
High doses of systemic corticosteroids within 7 days prior to first dosing; high dose is considered as > 20 mg of dexamethasone a day (or equivalent) for > 7 consecutive days
Participant may be receiving steroid therapy at time of enrollment (stable dose of ? 4 mg/day of dexamethasone or steroid equivalent).
Time interval from last systemic chemotherapy (not including low dose dexamethasone) more than 2 weeks prior to initiation of ABC294640; patients receiving high dose dexamethasone defined as 40 mg dexamethasone a day for 4 days will need 2 weeks washout prior to initiation of ABC294640
Is taking > 4mg/day of dexamethasone or its equivalent at the start of immunotherapy or has required > 4mg/day of dexamethasone or its equivalent for 3 consecutive days within 1 week of starting treatment
The ability to take folic acid, vitamin B12, and dexamethasone according to protocol
PHASE II DOSE EXPANSION IN RECURRENT GBM UNDERGOING RESECTION: A baseline brain MRI must be obtained no more than 14 days (+ 3 working days) prior to study enrollment; the patient must either be on no steroids or a stable dose of dexamethasone no greater than 2 mg a day for at least 5 days prior to entrance onto the study
PHASE II DOSE EXPANSION IN NEWLY DIAGNOSED GBM: A baseline brain MRI obtained no more than 14 days (+ 3 working days) prior to study enrollment on a stable dose of steroids no greater than 2 mg a day of dexamethasone for at least 5 days, is required prior to entrance of a patient onto the study; patients must be registered on the study within 5 weeks of completion of concurrent chemoradiation
Subject requires escalating or chronic supraphysiologic doses of corticosteroids > 2 mg dexamethasone or equivalent
Ability to take folic acid, vitamin B12, and dexamethasone according to the protocol instructions
AT THE TIME OF INFUSION: Subjects should have been off other investigational antineoplastic therapy for two weeks prior to entry in this study; temozolomide will be allowed up to 48 hours pre-infusion; dexamethasone up to a total dose of 2 mg per day will be allowed if medically indicated
Use of immunosuppressives within four weeks prior to study entry or anticipated use of immunosuppressive agents; dexamethasone, or other corticosteroid medications, if used in the peri-operative period must be tapered to no more than 0.1 mg/kg/day, max 4 mg/day dexamethasone for at least one week before study registration; topical corticosteroids are acceptable
Systemic corticosteroid therapy > 2 mg of dexamethasone or equivalent per day at study entry
Patients on greater than 4 mg per day of dexamethasone within the 2 weeks prior to admission for D2C7-IT infusion
Research participant must not require more than 2 mg three times daily (TID) of dexamethasone on the day of PBMC collection.
Research participants must not require more than 2 mg TID of dexamethasone during T cell therapy
Steroid use is allowed as long as dose has not increased within 2 weeks of scheduled M032 administration; whenever possible, the patient should be on a steroid dose that is equivalent to a dexamethasone dose of =< 2 mg daily at the time of treatment
Required steroid increase within 2 weeks of scheduled M032 administration; when possible, the patient should be on a dexamethasone equivalent dose of =< 2 mg daily at the time of treatment
Patients are allowed up to two cycles of high dose steroids (maximum total dose of 320 mg dexamethasone or equivalent) if needed for symptomatic disease before study enrollment
Patients currently receiving high dose systemic steroids for treatment of MM in excess of 320mg total dose of dexamethasone or equivalent, patients who received an investigational agent within 5 half-lives of the agent
Systemic corticosteroid therapy must be at a dose of =< 4 mg of dexamethasone or equivalent per day during the week prior to day 1
Patients on total daily dose of dexamethasone greater than 16 mg
Patients needing more than 8 mg dexamethasone per day at the time of start of WBRT will not be eligible to participate in the study; however, patients will be allowed entry into the study if it is medically safe to reduce the daily dose of dexamethasone to 8 mg or less from the day of the start of WBRT; the dexamethasone dose for such patients may be increased beyond 8 mg per day during the course of treatment if medically necessary; this increased need for dose should be communicated to the study’s principal investigator, Dr Mohindra at the University of Maryland
Use of immunosuppressives within four weeks prior to study entry or anticipated use of immunosuppressive agents; dexamethasone, or other corticosteroid medications, if used in the peri-operative period and/or during radiotherapy, must be tapered (no more than 0.1 mg/kg/day, max 4 mg/day dexamethasone) for at least one week before study registration; topical corticosteroids are acceptable
Medical need for the continuous administration of any drugs which affect CYP3A4 though the use of low dose glucocorticoids (e.g. dexamethasone =< 4 mg daily or equivalent) for anorexia and /or nausea is permitted
Patients who are receiving high dose steroids (more than a dexamethasone-equivalent dose of 4 mg per day).
Patients with active autoimmune diseases or active immune suppressive therapy or inflammatory bowel disease; a low dose steroid daily administration (equivalent dexamethasone < 10mg/day) is acceptable
Systemic corticosteroid therapy is permitted provided dosing is no greater than 4 mg per day (dexamethasone or equivalent) on the day of vaccine administration.
Systemic corticosteroid therapy, > 8 mg of dexamethasone daily (or equivalent) at study enrollment
Concurrent Therapy \r\n* Patients who are receiving any other anticancer or investigational drug therapy\r\n* Patients requiring systemic treatment with either corticosteroids (greater than dexamethasone 0.75 mg/m^2/day or the equivalent dose of other steroids) or other immunosuppressive medications within 14 days of study drug administration will be excluded; however, patients who require intermittent use of bronchodilators or local steroid injections will not be excluded from the study
Intolerance of dexamethasone
The subject requires dexamethasone =< 4 mg daily on a stable dose
No dexamethasone (or other corticosteroid bioequivalent) within one week of vaccination initiation
Stable topical steroid therapy with dexamethasone, clobetasol, or budesonide oral solutions (5 min, four times a day) for seven days prior to study enrollment
Concurrent use of high dose steroids; chronic steroid use of < 2 mg dexamethasone or equivalent per day is permissible
Receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment; patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., limited low-dose dexamethasone for nausea, multiple doses for contrast allergy) may be enrolled in the study and would not require a 7 day washout
Patients who are receiving dexamethasone must be on a stable dose for at least 1 week prior to study entry
A patient's daily total dose of dexamethasone must be =< 16 mg by day 4
Patients receiving chronic, systemic treatment with corticosteroids (of more than 4 mg/day or equivalent of dexamethasone; doses of dexamethasone of up to 8 mg/day may be administered for less than 2 weeks) or another immunosuppressive agent; topical or inhaled corticosteroids are allowed
Has not had prior systemic therapy for multiple myeloma. An emergency course of steroids (defined as no greater than 40 milligram [mg] of dexamethasone, or equivalent per day for a maximum of 4 days (that is, a total of 160 mg) is permitted. In addition, radiation therapy is permitted prior to study entry, during screening, and during Cycles 1-2 of study treatment as needed for lytic bone disease
Non-escalating corticosteroid dose (not exceeding more than 16 mg daily of dexamethasone oral) for >= 5 days
Participant has prior or current systemic therapy or SCT for multiple myeloma, with the exception of an emergency use of a short course (equivalent of dexamethasone 40 mg/day for 4 days) of corticosteroids before treatment
Patients needing more than 8 mg dexamethasone per day at the time of start of WBRT will not be eligible to participate in the study; however, patients will be allowed entry into the study if it is medically safe to reduce the daily dose of dexamethasone to 8 mg or less from the day of the start of WBRT; the dexamethasone dose for such patients may be increased beyond 8 mg per day during the course of treatment if medically necessary; this increased need for dose should be communicated to the study’s principal investigator, Dr Mohindra at the University of Maryland
No more than 16 mg dexamethasone (or equivalent) per day
Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid (ie, less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 14 days of Cycle 1 Day 1), for Cohort C, the induction and consolidation treatment along with the first Autologous stem cell transplantation (ASCT) are allowed)
Participants no longer need to be able to receive intravenous (IV) dexamethasone or an equivalent IV corticosteroid
Be willing to use dexamethasone mouthwash as directed
Noncompliant with oral medication and/or dexamethasone mouth wash
Any anti-myeloma drug treatment within 14 days before randomization, including dexamethasone.
Systemic corticosteroid therapy is permitted provided dosing is no greater than 4 mg per day (dexamethasone or equivalent) on the day of vaccine administration
Intolerance to dexamethasone
Dexamethasone dose less than or equal to 4 mg daily at time of study enrollment
Immunosuppressants: patients must be receiving a stable or decreasing dose of dexamethasone for at least 1 week prior to start of therapy AND dexamethasone dose must be =< 0.1 mg/kg/day AND =< a total daily dose of 4 mg/day
Glucocorticoid therapy within the 14 days prior to randomization that exceeds a cumulative dose of 160 mg of dexamethasone or 1000 mg prednisone
Stable dose of steroids for 5 days, no more than 2 mg dexamethasone (or equivalent) total per day
Requires treatment with high dose systemic corticosteroids defined as dexamethasone > 4 mg/day or bioequivalent for at least 3 consecutive days within 2 weeks of start of study drug
Patient requires more than 8 mg of dexamethasone daily or the equivalent
Participant has prior or current systemic therapy or SCT for multiple myeloma, with the exception of an emergency use of a short course (equivalent of dexamethasone 40 mg/day for 4 days) of corticosteroids before treatment
Foreseeable condition which would preclude the reduction of steroids (dexamethasone) to a maximum of 2 mg BID within a week prior to apheresis -
Dexamethasone at cumulative doses greater than 160 mg or equivalent within 14 days prior to the first dose of study treatment is not allowed. Use of topical or inhaled steroids is acceptable.
Patients on total daily dose of dexamethasone greater than 16 mg/day
Intolerance of vitamin B12, folic acid or dexamethasone
Up to one cycle of prior therapy is allowed (maximum of 160 mg total dexamethasone [dex] [or equivalent amount of prednisone]), 4 days of melphalan, 4 doses of cyclophosphamide and/or 4 doses of Velcade; at least 4 weeks (wks) has to have had passed since last dose of melphalan, 2 weeks since last Velcade or glucocorticoid dose
Patients taking greater than 12 mg daily of dexamethasone
The ability to take folic acid, vitamin B12, and dexamethasone according to protocol for all pemetrexed arms
Stable dose of glucocorticoids pre-therapy; if patients are receiving dexamethasone, the dose of dexamethasone should not increase during the 96 hours prior to initiation of therapy
Patients on greater than 4 mg per day of dexamethasone within the 2 weeks prior to admission for PVSRIPO infusion
If patient is on dexamethasone, must be on stable or decreasing dose of dexamethasone for >= 7 days; if patient is on different glucocorticoid e.g., prednisone, must be converted to dexamethasone prior to enrollment
Prior treatment for myeloma except for one cycle of dexamethasone
Patients receiving corticosteroids at the time of the first vaccine, with the exception of nasal or inhaled steroid, at a dose above physiologic levels will be removed and replaced; for the purposes of this study, physiologic dose will be defined as < 2 mg of dexamethasone/day; once vaccinations have been initiated, if patients subsequently require increased steroids, they will still be permitted to remain on the study, but every effort will be made to minimize steroid requirements
Use of systemic glucocorticoid (eg, prednisone, dexamethasone) within 14 days prior to the start of study medication
Participants in the combination therapy arms must be eligible to receive pomalidomide/dexamethasone, bortezomib/dexamethasone or lenalidomide/dexamethasone or other approved agents per current prescribing information for MM.
Intolerance to dexamethasone, as determined by Investigator.
High doses of systemic corticosteroids within 7 days prior to first dosing. High dose is considered as > 20 mg of dexamethasone a day (or equivalent) for > 7 consecutive days Exclusion Criteria (Part B):
Patients with central nervous system (CNS) tumors who are receiving dexamethasone must have been on a stable or decreasing dose of dexamethasone for the 7 days prior to enrollment
Patients for whom dexamethasone is contraindicated.
Active infection or other medical condition that would make corticosteroids (i.e. dexamethasone) use contraindicated
a short duration (< 5 days) of systemic corticosteroids e.g., of chronic obstructive pulmonary disease, or as an antiemetic corresponding at maximum to the anti-inflammatory potency of 4 mg dexamethasone for treatment;
Requirement of systemic corticosteroid therapy > 4 mg/day of dexamethasone or equivalent or requirement of increasing dose of systemic corticosteroids during the 7 days prior to the start of SL-701 treatment.
Dexamethasone (or equivalent systemic steroid) higher than the physiologic dosing with 7 days before study drug administration
Glucocorticoid therapy within 14 days prior to randomization that equals or exceeds a cumulative dose of 160 mg of dexamethasone
Patients must be on a steroid dose less than or equal to 2 mg of dexamethasone daily (or equivalent), and this dose must not have increased for at least 14 days prior to obtaining the enrollment.
Systemic corticosteroid therapy > 2 mg of dexamethasone daily (or equivalent) at study enrollment.
If a patient is on corticosteroids, he/she must be on a non-escalating corticosteroid dose (not exceeding more than 16 mg daily of dexamethasone oral) for >= 5 days
Patients receiving corticosteroids aside from dexamethasone treatment directed at leukemia
Resistance to high-dose dexamethasone used in the last line of therapy
taking more than 8 mg of dexamethasone per day
Corticosteroid therapy at a dose equivalent to dexamethasone > 4 mg/day within 21 days prior to randomization
Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid [i.e., less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 14 days of randomization]).
Systemic corticosteroid therapy > 2 mg of dexamethasone or equivalent (as defined by the investigator) per day at study enrollment.
For patients on oral corticosteroids, they must be stable clinically on corticosteroids or tapered off prior to starting the study drug; for patients taking dexamethasone, the dose should not exceed 8 mg QD (or 4 mg twice daily [BID]), if clinically stable, and the dose should not be escalated over entry dose level, if clinically possible; the patient’s dose of dexamethasone will be evaluated by the principal investigator (PI), the patient’s study physician, and/or the study pharmacist on a case by case basis for safety; all doses of oral corticosteroids will be reduced by 50%, unless oral corticosteroids are at physiologic dose (e.g. dexamethasone 1 mg, prednisone 10 mg, or cortisone 30 mg); it is recommended that oral corticosteroid doses be escalated back to full dose on day 7 (2 days after aprepitant is discontinued)
Dexamethasone dose must be provided for treatment group assignment:\r\n* Group A: patients not on dexamethasone or on a dose =< 0.75 mg daily (or equivalent of an alternative corticosteroid)\r\n* Group B: patients who require dexamethasone >= 4 mg daily (or equivalent of an alternative corticosteroid)\r\n** Patients must have been on the group assignment dose of corticosteroids for at least 5 days prior to the dose of NT-I7; corticosteroid dose changes prior to the start of treatment are allowed as long as they do not alter patient’s group assignment
Use of dexamethasone for cancer related fatigue
Patient requires more than 8 mg of dexamethasone daily or the equivalent
Patients on stable doses (defined as same dose for 2 weeks) of dexamethasone, mirtazapine, zolpidem, benzodiazepines, phenothiazines are allowed to participate in the study
More than 30 days of previous treatment (before screening) with anti-myeloma therapy (does not include radiotherapy or a single short course of steroid [ie, less than or equal to the equivalent of dexamethasone 60 mg/day for 4 days]).
Hypersensitivity to dexamethasone or corticosteroids or Equal sugar substitute
Chemotherapy regimen: Doxorubicin/cyclophosphamide. Antiemetic regimen: Aprepitant + palonosetron + dexamethasone on Day 1 and aprepitant + dexamethasone on Days 2 & 3.
Chemotherapy regimen: Doxorubicin/cyclophosphamide/docetaxel. Antiemetic regimen: Aprepitant + palonosetron + dexamethasone on Day 1 and aprepitant + dexamethasone on Days 2 & 3.
Off dexamethasone treatment for ?4 weeks before the first dose of study drug.
No ongoing requirement for dexamethasone or anti-epileptic drugs.