Platelets >= ,/mm^, equivalent to CTCAE v . grade -
Bilirubin =< . x ULN (CTCAE v . grade )
Recovered to ? grade NCI CTCAE version . from toxicity of prior chemotherapy or biologic therapy administered more than weeks earlier.
Ongoing adverse effects from prior systemic treatment > NCI CTCAE Grade (with the exception of Grade alopecia)
Presence of ? CTCAE grade toxicity (except alopecia and ototoxicity, which are excluded if ? CTCAE grade ) due to prior cancer therapy.
Ongoing infection > grade NCI-CTCAE v.
Persistent proteinuria >= grade NCI-CTCAE v.
Any Grade > (according to the NCI CTCAE .) adverse reaction unresolved from previous treatments and not readily managed and controlled with supportive care.
Acute toxicities from any prior therapy, surgery, or radiotherapy must have resolved to Grade or as per the NCI-CTCAE v ..
Non-manageable electrolyte imbalances including hypokalemia, hypocalcemia, or hypomagnesemia (Grade or greater based on NCI-CTCAE v .).
Ongoing, clinically significant bleeding (CTCAE grade or )
Significant recent bleeding history defined as NCI CTCAE grade ? within the last months, unless precipitated by an inciting event (e.g., surgery, trauma, injury)
Ongoing infection > grade NCI-CTCAE v.
Ongoing infection > grade NCI-CTCAE version (v) .
Patients cannot have experienced a significant (CTCAE Grade or with or without neutropenia) infection within weeks of their first dose of MT-.
Serum bilirubin less than or equal to . x ULN (CTCAE v. grade )
Subject has symptomatic cardiac disorders (CTCAE v. . Grade and )
Afebrile (<C per CTCAE v.);
Patient has not recovered from toxicity from prior immune checkpoint inhibitor therapy. Recovery is defined as ? NCI-CTCAE Grade , except for liver function test levels which must be <Grade .
Afebrile (<C per CTCAE v.);
(Bevacizumab-related exclusion) Any previous venous thromboembolism > NCI CTCAE grade
serum potassium NCI-CTCAE version . Grade <;
serum calcium NCI-CTCAE version . Grade <;
serum magnesium NCI-CTCAE version . Grade <;
Ongoing infection > grade NCI-CTCAE v.
Subjects with baseline symptoms of fever and/or cough and/or shortness of breath and/or wheezing and/or fatigue grade >= (CTCAE version [v].)
Patients with hypertriglyceridemia defined as > mg/dL (CTCAE Grade ).
Serum creatinine =< . X ULN (CTCAE grade baseline)
Patients who have active clinically serious infection > CTCAE grade are not eligible
Serum creatinine =< . x ULN (CTCAE grade baseline)
Patients exhibiting baseline grade or by CTCAE criteria are excluded
Ongoing infection > Grade NCI-CTCAE v .
Creatinine less than . x ULN (CTCAE Grade )
Bilirubin less than . x ULN (CTCAE Grade )
Bilirubin less than or equal to . x ULN (CTCAE v grade )
Serious uncontrolled infection > grade (CTCAE v.)
Serious uncontrolled infection > grade (CTCAE v.)
At least one clinical symptom probably or definitely attributed to KSHV-MCD\r\n* Intermittent or persistent fever for at least week (> Celsius degree [C])\r\n* Fatigue (Common Terminology Criteria for Adverse Events [CTCAE] grade or greater)\r\n* Gastrointestinal symptoms (includes nausea and anorexia) (CTCAE grade or greater)\r\n* Respiratory symptoms (includes cough and airway hyperreactivity) (CTCAE grade or greater)
Clinical relevant AEs or laboratory results related to previous anti-neoplastic therapy have not resolved to a NCI-CTCAE grade ?.
Ongoing infection > grade NCI-CTCAE v.
Recovery to baseline or ? Grade CTCAE ver..
AST =< grade
Patients with ataxia >= CTCAE grade are ineligible
Grade - electrolyte abnormalities (CTCAE, v. ):
Triglycerides < CTCAE grade
Magnesium >= within institutional normal limits, or =< grade according to NCI-CTCAE version . if judged clinically not significant by the investigator
Subjects who have an active clinically serious infection of CTCAE grade >=
Bilirubin less than or equal to . x ULN (CTEP CTCAE version ., grade )
Subject has any other organ dysfunction (CTCAE version . Grade ) that will interfere with the administration of the therapy according to this protocol.
Ongoing acute adverse effects from prior anticancer or investigational therapy > NCI CTCAE Grade
Serum creatinine ? . X ULN (CTCAE Grade baseline)
Ongoing clinical adverse events NCI CTCAE Grade > resulting from prior cancer therapies
Evidence of significant CNS haemorrhage i.e. CTCAE grade or above;
All AEs resulting from prior chemotherapy, surgery, or radiotherapy, must have resolved to at least NCI-CTCAE (v. .) Grade (except for laboratory parameters outlined below).
Ongoing infection > grade NCI-CTCAE v .
Ongoing infection > Grade NCI-CTCAE v..
Subjects with known Gilbert's syndrome who have serum bilirubin ? x ULN (NCI CTCAE v. Grade ) may be enrolled.
Ongoing infection > grade NCI-CTCAE v.
? CTCAE Grade anemia, OR
? CTCAE Grade hematoma (bleed)
Active infection > CTCAE Grade , that is considered clinically serious by the treating physician
Any Grade or toxicities (according to NCI CTCAE) resolved for at least weeks prior to first treatment
CTCAE v. grade or anorexia or nausea related to metastatic disease.
Clinically significant bleeding NCI-CTCAE version . Grade or higher within days before randomization.
Bilirubin =< . x ULN, CTCAE grade
EXPANSION COHORT ONLY: Resolution of any pre-existing toxicity from prior therapy to NCI CTCAE version . =< grade except neuropathy (=< grade ) and tinnitus (=< grade ), and hearing loss (=< grade )
Any toxicity from prior chemotherapy has resolved or Grade (NCI-CTCAE, Version .)
Ongoing infection > Grade NCI-CTCAE v..
Subject has an ongoing toxicity ? Grade (NCI CTCAE Version .) attributable to prior medication to treat solid tumor (except alopecia) at screening.
Active, clinically serious infections of NCI CTCAE v. Grade or higher within weeks prior to Cycle , Day
Subject has an ongoing toxicity greater than or equal to grade (NCI CTCAE version .) attributable to prior NSCLC treatment at the time of screening.
Bilirubin less than or equal to . x ULN (CTCAE v. grade )
Ongoing infection > grade NCI-CTCAE v.
Anxiety ? CTCAE grade
Patients with active clinically serious infections defined as >= grade according to NCI CTCAE, version .
Subjects with valvular heart disease CTCAE (version .) grade
? CTCAE Grade anxiety.
Diarrhoea CTCAE v. Grade ?
Evidence of uncontrolled bradycardia or other cardiac arrhythmia defined as ?Grade according to NCI CTCAE, version ., or uncontrolled hypertension
History of bronchopulmonary hemorrhage NCI CTCAE >/= Grade within months prior to randomization
NCI CTCAE (version .) Grade or higher toxicities due to prior therapy that have not shown improvement and are considered to interfere with current study medication
Active clinically serious infections defined as >= Grade according to NCI CTCAE
CTCAE Grade or fatigue.
Any >=Grade hypophosphatemia (per CTCAE v.) at the time of enrolment
Active clinically serious infection > NCI-CTCAE grade
? CTCAE grade anxiety
Active clinically serious infection > CTCAE v . grade
Active clinically serious infections > Grade (NCI-CTCAE Version .)
Ongoing infection > CTCAE grade
Baseline alopecia (defined CTCAE v. grade > )
Ongoing infection > grade NCI-CTCAE v.
History of persistent proteinuria >= grade NCI-CTCAE v.
AST > . x ULN (CTCAE grade )
Bilirubin > . x ULN (CTCAE grade )
Current alopecia grade or greater as per NCI-CTCAE v.., or significant hair loss or hair breakage
Hepatic toxicity >= grade (using CTCAE version standard definitions)
Not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE Grade <= or baseline.
For Adjuvant Treatment: All AEs resulting from surgery must have resolved to NCI-CTCAE (v. .) Grade ?