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Hemoglobin >= 8 g/dL
Hemoglobin >= 9 g/dl
Hemoglobin >= 9 g/dL
Hemoglobin >= 8.0 g/dL
Hemoglobin > 8.0 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9.0 g/dl
Hemoglobin ? 10g/dL
Hemoglobin >= 8 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 8.0 g/dL
Hemoglobin 8-13 g/dL (patients with hemoglobin > 13 g/dL are excluded)
Hemoglobin >= 9.0 g/dL
Hemoglobin < 10 g/dL
Hemoglobin > 9 g/dL
Hemoglobin ? 9 g/dL
Hemoglobin < 9.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin ? 8.0 g/dl
Hemoglobin >= 9.0 g/dL
Hemoglobin 9 g/dL
Hemoglobin > 9 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin ? 9.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin > 9 g/dL
Hemoglobin > 9 g/dL
Hemoglobin >= 8.0 g/dL
Hemoglobin ? 9.6 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin >= 10.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin > 9.0 g/dL
Hemoglobin >= 9.0 g/dl
Hemoglobin >= 8 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin ?90 g/L
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dl
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin > 9.0 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin > 9 g/dL
Hemoglobin >= 10
Hemoglobin >= 9 g/dl
Hemoglobin >= 8 g/dL
Hemoglobin ? 8 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin ? 9.0 g/dL
Hemoglobin ? 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin ? 9 g/dL
Hemoglobin > 9.0 g/dL
Hemoglobin > 9 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin > 9.0 g/dL
Hemoglobin >= 9 g/dL
hemoglobin must be ?10 g/dL.
Hemoglobin ? 9 g/dL
Hemoglobin 9 g/dl or more
Hemoglobin ? 8.0 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin > 10.0 g/dL
Hemoglobin >= 9 g/dL
hemoglobin: ? 9 g/dL
Hemoglobin > 9.0 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dl
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 8 g/dl
Hemoglobin >= 9 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin < 90 g/L (< 9 g/dL).
Hemoglobin >= 9 g/dL
Hemoglobin >= 10 g/dl
Hemoglobin ?9 g/dL
Hemoglobin > 10 g/dL
Hemoglobin > 9.0 g/dL
Hemoglobin > 8.0 g/dL
Hemoglobin >= 9g/dL (women) or >= 11g/dL (men)
Hemoglobin > 9.0 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin <90 g/L
Hemoglobin > 9.0 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 10 g/dL
Hemoglobin > 9 g/dL
Hemoglobin > 9.0 g/dL
ARM 2 - A: Hemoglobin > 9.0 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 8.0 g/dL
Hemoglobin >= 8.5 g/dl
Hemoglobin ?9 g/dL
Hemoglobin >= 10.0 g/dL
Hemoglobin ?9.0 g/dL;
Hemoglobin >= 10.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin > 8.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 8 g/dl
Hemoglobin ? 9 g/L.
Hemoglobin >= 9 g/dL
Hemoglobin >= 10 mg/dL
Hemoglobin ? 9.0 g/dL.
Hemoglobin >= 8.5 g/dL
Hemoglobin >= 7.0 g/dl
Hemoglobin >9.0 g/dl
Hemoglobin > 8.0 g/dl
Hemoglobin ?9 g/dL
Hemoglobin >= 12 g/dL
Hemoglobin > 9.0 g/dL
Hemoglobin >= 9 mg/dL
Hemoglobin >= 8 g/dL
Hemoglobin > 9 g/dL
Hemoglobin >= 10 g/dL
Hemoglobin >= 8.0 g/dl
Hemoglobin > 10 g/dl
Hemoglobin >= 9.0g/dL
Hemoglobin > 9.0 g/dL
Hemoglobin ? 9.0g/dL
Hemoglobin >= 9
Hemoglobin >= 9.0 g/dL.
Hemoglobin >= 8g/dl.
Hemoglobin >= 9.0 g/dL
Hemoglobin ? 9.0 g/dL
Hemoglobin >= 9 g/dL.
Hemoglobin above 9 g/dl
Hemoglobin ? 9.0 g/dL
Hemoglobin >= 9 g/dL.
Hemoglobin ? 9 g/dL
Hemoglobin ? 9.0 g/dl
Hemoglobin >= 9 g/dL
Hemoglobin less than 9 g/dL
Hemoglobin >= 9.0 g/dL.
Hemoglobin >= 8 g/dL
Hemoglobin at least 9 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9.0g/dL.
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin ? 8.0 g/dL
Hemoglobin >= 10.0 g/dL
Hemoglobin < 9.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 10 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin* ? 9.0 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 7 g/L
Hemoglobin ? 9 g/dL
Hemoglobin >= 10 g/dL
Hemoglobin >= 9 g/dl
Hemoglobin >= 8.0 g/dL
Hemoglobin ? 8 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin ? 9 g/dL.
Hemoglobin > 9 g/dL
Hemoglobin > 9 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin > 9.0 g/dl
Hemoglobin > 8.0 g/dl
Hemoglobin >= 9 g/dl
Hemoglobin > 9 g/dL.
Hemoglobin >= 9 g/dL
Hemoglobin >= 9
Hemoglobin ? 9 g/dL
Hemoglobin >= 9 g/dL.
Hemoglobin >= 9.0 g/dl (prior to biopsy)
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin ? 9.0 g/dL
Hemoglobin >= 7 g/dL
Hemoglobin >= 9g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL.
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 8.5 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin >= 9.0 g/dL, at the time of enrollment
Hemoglobin >= 10.0 g/dl
Hemoglobin >= 11.0 g/dL.
Hemoglobin >= 9.0 g/dL
Hemoglobin > 9.0 g/dL
Hemoglobin >= 10.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin > 8.0 g/dL
Hemoglobin >= 9 g/dL
STUDY TREATMENT: Hemoglobin >= 9.0 g/dl
Hemoglobin >= 9.0 g/dl
Hemoglobin > 9 g/dL
Hemoglobin >= 8.0 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin > 9.0 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin >= 10 g/dL
Hemoglobin >= 8.0 g/dL
Hemoglobin > 9.0 g/dL
Hemoglobin >= 10.0 g/dl
Hemoglobin >= 9.0 g/dL
hemoglobin ? 9 g/dL;
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin ? 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin =< 9 g/dL
Hemoglobin >= 9g/dL
Hemoglobin > 8.0 g/dL
Hemoglobin >= 10 g/dL
Hemoglobin >= 8.0 g/dl
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 8.0 g/dL
Hemoglobin >10 mg/dL
Hemoglobin >= 8 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9 g/dL.
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin < 9 g/dL
Hemoglobin > 9.0 g/dL
Hemoglobin > 8 g/dL
Hemoglobin >= 10.0 g/dl
Hemoglobin >= 9 g/dL
Hemoglobin >= 9.5 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 10g/dL
Hemoglobin < 9.0 g/dL
Hemoglobin ?8 g/dL
Hemoglobin >= 10.0 g/dl
Hemoglobin > 9 g/dL
Hemoglobin >= 8.5 g/dl
Hemoglobin >= 8 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin ? 9.0 g/dl;
Hemoglobin >= 9 mg/dL
Hemoglobin >= 10.0 g/dl
Hemoglobin >= 9 g/dL
Hemoglobin > 9.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dl
Patients must have a hemoglobin >= 9 g/dL
Hemoglobin >= 10.0 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin ? 9.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9.0 g/dl
Hemoglobin >= 8 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin > 9.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin ? 8g/dL
Hemoglobin > 9.0 g/dL
Hemoglobin < 9.0 g/dL
Hemoglobin   < 9.0 g/dl
Hemoglobin >= 9.0 g/dL
Hemoglobin > 8.0 g/dL
Hemoglobin >= 10 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 10 g/dL
Hemoglobin >= 9.0 g/dl
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9.0 g/dl
Hemoglobin > 8.0 g/dL
Hemoglobin >= 8.0 g/dL
Hemoglobin < 9 g/dL
Hemoglobin >= 8.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 90 g/L
Hemoglobin =< 9.0 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin > 8.0 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin > 9 g/dL
Hemoglobin > 9 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 8.5 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 7.0 g/dl
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin > 8.0 g/dl
Hemoglobin > 9 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin < 90 g/L
Hemoglobin >= 9 g/dL
Hemoglobin >= 8 g/dl
Hemoglobin >= 9 g/dL
Hemoglobin < 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin < 10.0 g/dL
Hemoglobin > 9 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 8.0 g/dL
Hemoglobin ? 9 g/dL (90 g/L)
Hemoglobin >= to 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 8 g/dl
Hemoglobin >= 9g/dl
Hemoglobin >= 8 g/dL
Hemoglobin < 10.0 g/dL
Hemoglobin >= 8.5 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin > 8.0 g/dl
Hemoglobin >= 9 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin ? 9.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9.0 g/dL
PHASE I: Hemoglobin > 10 g/dL
Hemoglobin ? 9.0 g/dl
Hemoglobin >= 9 g/dL
Hemoglobin >= 7.0 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9.0 mg/dl
Hemoglobin ?9 mg/dL
Hemoglobin >= 90 d/L (or >= 9g/dL)
Hemoglobin >= 9 g/dL
Hemoglobin >= 8.5 g/dL
Hemoglobin >= 9 g/dl
Hemoglobin >= 10 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 7 mg/dL
Hemoglobin < 9.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 10 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin above 9 g/dl
Hemoglobin >= 9 g/dL
Hemoglobin > 9.0 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin > 8 g/dL
Hemoglobin > 8.0
Hemoglobin >= 8 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin > 9.0 g/dL
Hemoglobin > 9.0 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9 mg/dL
Hemoglobin of >= 9.0 g/dl
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL or >= 90 g/L
Hemoglobin >= 9.5 g/dL
Hemoglobin > 10 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin < 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin > 8.0 g/dl
Hemoglobin >= 9.0 g/dl
Hemoglobin >= 9 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin of >= 10.0 g/dL
Hemoglobin > 8.0 g/dl
Hemoglobin >= 9 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 8 g/dl
Hemoglobin >= 10 g/dL
Hemoglobin >= 10 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin > 8.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin > 8.0 g/dl
Hemoglobin >= 9.0 g/dl
Hemoglobin >= 9.0 g/dL
Hemoglobin (Hbg) > 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL or >= 90 g/L
Hemoglobin >= 10 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 10 g/dL
Hemoglobin >= 9.5 g/dL
Hemoglobin >= 9 g/dl
Hemoglobin < 90 g/L
Hemoglobin >= 9 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 8.0 g/dL
Hemoglobin >= 8.5 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin < 8.0 g/dL
Hemoglobin >= 8 g/dl
Hemoglobin >/= 10.0g/dL
Hemoglobin ? 10 g/dL
hemoglobin ? 9 g/dL
Hemoglobin ? 10g/dl
Hemoglobin > 8 g/dL
hemoglobin > 8 g/dl
Hemoglobin <9g/dL
Hemoglobin >9 g/dL.
Hemoglobin < 9 g/dL
Hemoglobin ? 9 g/dL
Hemoglobin ? 7 g/dL
Hemoglobin > 9 g/dL.
Hemoglobin >= 9 g/dL
Hemoglobin ? 9.0 g/dL
Hemoglobin < 8.0 g/dL
Hemoglobin ? 9 g/dL
Hemoglobin >= 10 g/dl
Hemoglobin ?9.0 g/dL
Hemoglobin ? 8 g/dL
Hemoglobin > 9.0 g/dL
Hemoglobin ?9.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin ? 8 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin ?9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 8.5 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin > 9 g/dL
Hemoglobin > 8.0 g/dl
Hemoglobin >= 9.0 g/dL
Hemoglobin ? 9 g/dL ? 2 weeks
Hemoglobin >= 9.5 g/dL
Hemoglobin >= 9.0 g/dL.
Hemoglobin >= 9 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 7 g/dL
Hemoglobin^3 10g/dL
Hemoglobin >= 8.0 g / dL
Hemoglobin >= 8.0 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9 g/dL or equivalent
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin > 9 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 90 g/L
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 10 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9.5 g/dL
Hemoglobin > 9 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 8.0 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 90 g/L
Hemoglobin > 9.0 g/dL
Hemoglobin 9 g/dl or more
Hemoglobin >= 8.5 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin > 8 g/dl
Hemoglobin >= 9 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin > 9 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 10 g/dL
Hemoglobin >= 10 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 10.0 g/dL
Minimum hemoglobin of 9 g/dL
Hemoglobin > 10 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin > 9 mg/dl
Hemoglobin > 8.0 g/dL
Hemoglobin > 9 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 10 g/dL
Hemoglobin >= 10 g/dL
Hemoglobin >= 8.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9 g/dl
Hemoglobin >= 9 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin > 10 g/dL
Hemoglobin >= 8.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dl
Hemoglobin >= 9.0 g/dL
Hemoglobin > 10 g/dL
Hemoglobin > 11g/dL
Hemoglobin >= 9 g/dL
Hemoglobin must be >= 10 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin > 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dl
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin > 8.0 g/dl
Hemoglobin >= 10 g/dL
Hemoglobin >= 8.5 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin =< 9
Hemoglobin >= 9 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin > 9.0 g/dL
Hemoglobin >= 8.5 g/dL
Hemoglobin ? 8 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 10 g/dL
Hemoglobin ?8.0 g/dL;
Hemoglobin > 8 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin > 8.0 g/dl
Hemoglobin > 9 g/dL
Hemoglobin >= 10 g/dL
Hemoglobin >= 9 g/dl
Hemoglobin >= 9.0 g/dL
Hemoglobin > 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9.0 g/dl
Hemoglobin ? 9 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9.0 g/dl
Hemoglobin >= 9 g/dL
Hemoglobin ?9 g/dL
hemoglobin >8.0 g/dL
Hemoglobin > 8 g/dL (> 80 g/L)
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9.0 g/dl
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 8.0 g/dL
Hemoglobin ?9 mg/dL
Hemoglobin > 9 mg/dL
Hemoglobin ? 9g/dL
Hemoglobin at least 9 g/dL
Hemoglobin ? 8 g/dL
Hemoglobin > 8.0 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin ? 8.0 g/dL
Hemoglobin ? 8.0 g/dl
Hemoglobin ? 8.5 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 11.0 g/dL
Hemoglobin >= 8.0 g/dL
Hemoglobin >= 10.0 g/L
Hemoglobin >9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin ?9 g/dL
Hemoglobin < 9 g/dL
B-Hemoglobin ?90 g/L
Hemoglobin > 9 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin >= 10 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin: >= 9 mg/dL
Hemoglobin >= 9 g/dL
Hemoglobin ? 9.0 g/dL
Hemoglobin >= 10 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin > 8.0 g/dl
Hemoglobin less than 10.0 g/dl
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin > 8.0 g/dl
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 10 g/dL
Hemoglobin >= 8.5 g/dL
Hemoglobin ? 10.0 g/dL
Hemoglobin* > 9.0 g/dL
Hemoglobin > 9 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin > 9.0 g/dl
Hemoglobin < 8 g/dL
Hemoglobin >= 8 g/dl
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 8.0 g/dl
Hemoglobin >= 9.0 g/dL.
Hemoglobin >= 9 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin > 9.0 g/dL
Hemoglobin < 9.0 g/dl
Hemoglobin > 9.0 g/dl
Hemoglobin >= 9 g/dL
Hemoglobin >= 10 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 10 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin ? 9 g/dL
Hemoglobin > 8.0
Hemoglobin >= 9.5 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin > 9 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dl
Subjects with a hemoglobin < 8.0 g/dL
Hemoglobin: ? 9 g/dL
Hemoglobin < 8 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin > 10 g/dl
Hemoglobin >8.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin > 9.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin > 10 g/dL
Hemoglobin >= 9.0 g/dl
Hemoglobin > 9.0 g/dL
hemoglobin ? 9 g/dL
Hemoglobin >= 10.0 g/dl
Hemoglobin >= 10 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 8.0 g/dL
Hemoglobin ?9.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 10 g/dL
Hemoglobin > 9.0 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9 g/dl
Hemoglobin >= 10 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 10.0 g/dl
Patients with a hemoglobin of less than 12%
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin =< 8.0 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 10 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 8.5 g/dL
Hemoglobin >= 10 g/dL
Hemoglobin ?10 g/dL
Hemoglobin >= 8 g/dl
Hemoglobin ?9 mg/dL.
Hemoglobin < 8 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin ?10 g/dl.
Hemoglobin > 9.0 g/dL
Hemoglobin >= 10g/dL
Hemoglobin ? 9 g/dL
Hemoglobin ? 9 g/dL
Hemoglobin < 9.0 g/dL
Hemoglobin >= 9.0/dL
Hemoglobin >= 9 g/dL within 4 weeks of enrollment
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 10 g/dL
Hemoglobin >= 8.0 g/dl
Hemoglobin >= 9 g/dL
Hemoglobin > 8.0 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
PART B: Hemoglobin >= 9 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin > 9 g/dl
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 8.5 g/dL
Hemoglobin > 9 g/dL
Hemoglobin > 8 mg/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 10 g/dL
Hemoglobin >= 10 g/dl
Hemoglobin >= 9 g/dL
Hemoglobin >= 8 g/dl
Hemoglobin >= 8.0 g/dL
Hemoglobin >= 9 g/dL or >= 90 g/L
Hemoglobin >= 9 g/dL or >= 90 g/L
Hemoglobin >= 9 g/dL
Hemoglobin > 9.0 g/dL
Hemoglobin >= 10 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin > 8 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 10 g/dl
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 10 g/dl
Hemoglobin ? 9.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin > 9.0 g/dL
Hemoglobin < 9.0 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 8.5 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 10 g/dL
Hemoglobin >= 9.0 g/dl
Hemoglobin >= 9 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin >= 10 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9 mg/dl
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin at least 10.0 g/dL
Hemoglobin > 8.0 g/dl
Hemoglobin: >= 9 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin >= 8.0 g/dl
Hemoglobin >= 9 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin >= 10 g/dl
Hemoglobin > 10 g/dL
Hemoglobin >= 8.0 g/dl
Hemoglobin > 9 g/dL
Hemoglobin >= 8.5 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 7.0 g/dl
Hemoglobin >= 9.0 g/dl
Hemoglobin ?8.0 g/dL
Hemoglobin > 9.0 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin > 9.0 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin < 8.0 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin ?9 g/dL,
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 8.0 g/dL
Hemoglobin > 9 g/dL\r\n* For patients enrolled to the Phase 1-T portion of the protocol, the hemoglobin should be >= 10 g/dL
Hemoglobin >= 9.0 g/dl
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 12 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin ? 8 g/dL
Hemoglobin > 9 g/dl
Hemoglobin =< 9.0 g/dl
Hemoglobin < 8.0 g/dL
Hemoglobin >= 9.0 g/dl
Hemoglobin >= 8.5 g/dl
Hemoglobin >= 9 g/dL
Hemoglobin > 8.0 g/dL
Hemoglobin ?9 g/dL
Hemoglobin ? 9 g/dL
Hemoglobin of at least 9 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin of 7
Hemoglobin >= 9.0 g/dL
Hemoglobin > 8.0 g/dL
Hemoglobin > 9.0 g/dL
Hemoglobin ?9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 10.0 g/dl
Hemoglobin < 9.0 g/dl
Hemoglobin > 8.0 g/dL
Hemoglobin > 10 g/dL
Hemoglobin > 9.0 g/dL
Hemoglobin ? 8.0 g/dL
Hemoglobin ? 9 g/dL
Hemoglobin ? 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin > 10 g/dL
Hemoglobin >= 100 g/L (>= 10 g/dL)
Hemoglobin > 9.0 g/dl
Hemoglobin >= 8 g/dL
Hemoglobin: >= 9 g/dL
Hemoglobin > 8.0 g/dl
Hemoglobin > 9.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin ? 10
Hemoglobin > 8.0 g/dl
Minimum hemoglobin of 9 g/dL
Hemoglobin: >= 10 g/dl
Hemoglobin >= 8 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin < 9 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin > 10 g/dL
Hemoglobin ? 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin ? 10.0 g/dL
Hemoglobin >= 8.0 g/dL
Hemoglobin >= 9.0 g/dl
Hemoglobin <8.0 g/dL
Hemoglobin >= 8 g/dl
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin > 9 g/dL
Hemoglobin <8 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin must be >= 9.0 mg/dL
Hemoglobin: >= 8 g/dl
Hemoglobin > 9.0 g/dl
Hemoglobin >= 11.0 g/dL
Hemoglobin less than 9.0 g/dL
Hemoglobin >= 10 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin <10 g/dL,
Hemoglobin >= 9.0 g/dL
A hemoglobin < 10 g/dL and ? 8 g/dL
Hemoglobin ? 9.0 g/dL
Hemoglobin ? 9.0 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin ? 9.0 g/dL
Hemoglobin >= 8.0 g/dL
Hemoglobin >= 10
Hemoglobin ? 9.0 g/dL;
Hemoglobin >= 8
Hemoglobin ? 10 g/dL
Hemoglobin ? 9 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin <10.0 g/dL.
Hemoglobin >= 9.0 g/dl
Hemoglobin > 8.0 g/dL
Hemoglobin < 9.0 g/dL
Hemoglobin ? 9 g/dL
Hemoglobin must be ? 8 g/dL.
Hemoglobin > 9.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin ? 9 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin >=9 g/dL
Hemoglobin >= 9 g/dl
Hemoglobin >= 9 g/dl
Hemoglobin > 9 g/dl
Hemoglobin ? 9.0 g/dL
Hemoglobin <4.0 g/dL
Hemoglobin ?9 mg/dL.
Hemoglobin >= 9.0 g/dL
Hemoglobin > 8.5 g/dl
hemoglobin ?9 g/dL
Hemoglobin >= 8.0 g/dL
Hemoglobin < 9.0 g/dL
Hemoglobin > 9.0 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin ? 9 g/dL
Hemoglobin >= 6 g/dL
Hemoglobin >= 8.0 g/dl
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 10 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dl
Hemoglobin ? 9 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin > 8.0 g/dl
Hemoglobin ? 10g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin > 9 g/dL
Hemoglobin >= 8.0 g/dl
Hemoglobin >=10.0 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin ? 8 g/dL
Hemoglobin > 9 g/dL
Hemoglobin =< 9.0 g/dl
Hemoglobin >= 8 g/dl
Hemoglobin >= 9 g/dL
Hemoglobin >= 9.0 g/dL
hemoglobin > 10 g/dL
Hemoglobin > 10 g/dL
Hemoglobin >= 10.0 g/dl
hemoglobin of >= 10.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 10 g/dl
Hemoglobin >= 9.0 g/dL
Hemoglobin > 9.0 g/dL
Hemoglobin >= 8.0 g/dL
Hemoglobin > 9 g/dL
Hemoglobin >= 10 g/dl
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin ? 9.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin > 9 g/dL
Hemoglobin >= 90 g/L
Hemoglobin > 8.0 g/dl
Hemoglobin > 8.0 g/dl
Hemoglobin >= 10 g/dl
Hemoglobin > 9.0 g/dL
Hemoglobin >= 10 g/dL
Hemoglobin < 9.0 g/dl
Hemoglobin >= 9.0 g/dl
Hemoglobin >= 9.0 g/dL
Hemoglobin < 9 g/dL
Hemoglobin >= 8g/dL
Hemoglobin >= 8 g/dl
Hemoglobin >= 9 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9.0g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin > 11 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin > 9.0 g/dL
Hemoglobin ? 9.0 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin >= 8 g/dL (>= 80 g/L)
Hemoglobin >= 9 g/dL
Hemoglobin <9 g/dL
Hemoglobin >= 90 g/L (or >= 9 g/dL)
Hemoglobin >= 9 mg/dL
Hemoglobin levels < 6 g/dL
Hemoglobin >= 7.5 g/dL and =< 13 g/dL
Hemoglobin ? 10.0 g/dL
Hemoglobin >= 10.0 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 11.5 g/dL
Hemoglobin > 10 g/dL
Hemoglobin >= 10 g/dL
Hemoglobin >= 10 g/dL
Hemoglobin >= 10 g/dL
Blood hemoglobin >= 12.0 g/dL
Hemoglobin > 7 g/dL
Hemoglobin < 9 g/dl
Hemoglobin >= 9 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin >= 10 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin ? 9 g/L
Hemoglobin >= 9 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin ? 8 g/L
Hemoglobin of =< 8 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 10 g/dL
Hemoglobin >= 110 g/L
Hemoglobin >= 10 g/dl
Hemoglobin > 10 g/dL
Hemoglobin >= 9.0 g/dL
Hemoglobin >= 10 g/dL
Hemoglobin < 10 g/dL
Hemoglobin >= 9 g/dl
Hemoglobin >= 9.0 mg/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 10 g/dL
Hemoglobin > 10 g/dL
Hemoglobin > 8 g/dL
Hemoglobin > 9 g/dl
Hemoglobin > 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 10.0g/dL
Hemoglobin < 8 g/dL
Hemoglobin ? 9 g/dL
Hemoglobin > 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Hemoglobin >= 8 g/dL
Hemoglobin >= 9 g/L
Hemoglobin >= 9 g/dL
Hemoglobin >= 9 g/dL
Anemia (hemoglobin < 12.0 g/dL)
Hemoglobin >= 9 g/dL
Hemoglobin ? 9.0 g/dL
Hemoglobin > 100 g/L
Hemoglobin ? 9.0 g/dL;
Hemoglobin >= 10 g/dL
Hemoglobin ?9.0 g/dL
Hemoglobin >= 9 g/dl
hemoglobin ? 9.0 g/dL,
Zubrod performance status 0-2 within 28 days prior to study entry
Patients must have Zubrod performance status 0-1 documented within 28 days prior to screening/pre-screening registration
Patients must have Zubrod performance status 0-1 documented within 28 days prior to sub-study registration
STEP 3 CROSSOVER REGISTRATION (OPTIONAL): Patients must have a Zubrod performance status of 0 or 1
Zubrod performance status 0, 1, or 2 within 30 days prior to registration.
Zubrod performance status 0-1 within 21 days prior to registration
Zubrod performance status =< 2 within 60 days prior to registration
Patient must have Zubrod performance status 0 or 1 documented within 28 days prior to step 1 registration
Patients must have a Zubrod performance status of 0-1 documented within 28 days prior to step 2 registration
Patients must have a Zubrod performance status of 0-1 documented within 28 days prior to step 3 registration
Post-operative Zubrod performance status 0-1 within 60 days prior to step 2 registration
Zubrod performance status 0-1 within 30 days prior to registration
Zubrod performance status 0-2 within 30 days prior to Step 1 registration
Zubrod performance status of 0-1 within 8 weeks prior to registration
Zubrod performance status 0-1 within 90 days prior to registration
Zubrod performance status 0-1 within 30 days prior to registration
Zubrod performance status of 0-1 within 28 days prior to registration
Zubrod performance status of 0-1 within 14 days prior to registration
Patients must have Zubrod performance status of 0-1 documented within 28 days prior to Step 2 re-registration
Patients must have Zubrod performance status of 0-1 documented within 28 days prior to Step 2 re-registration
Patients must have Zubrod performance status of 0-1 documented within 28 days prior to step 2 re-registration
Zubrod performance status of 0-1 within 56 days prior to registration
Zubrod performance status 0-1 within 30 days prior to registration
Zubrod performance status 0-2 within 14 days prior to step 2 registration
Zubrod performance status 0-1 within 8 weeks of registration
REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Patients must have Zubrod performance status 0-1
Patients must have Zubrod performance status of 0-1 documented within 28 days prior to RE-TREATMENT registration
Zubrod performance status 0-1 within 60 days prior to step 1 registration
Performance status of 0, 1 or 2 within 28 days prior to registration
Zubrod performance status =< 2 within 45 days prior to study registration
Zubrod performance status 0-2 within 30 days prior to registration
Zubrod performance status 0-2 =< 45 days prior to registration
Zubrod performance status 0-1 within 30 days prior to registration
Zubrod performance status 0-1 within 14 days prior to registration
Patients must have Zubrod performance status 0-2 within 28 days prior to registration
Patients must meet one of the following criteria:\r\n* Patients must have tumor amenable to image guided or direct vision biopsy and be willing and able to undergo a tumor biopsy for molecular profiling; patients with multiple myeloma other than plasmacytomas are to have a bone marrow aspirate to obtain tumor cells; biopsy must not be considered to be more than minimal risk to the patient\r\n** NOTE: Registration to screening steps (Step 0, 2, 4, 6) must occur after stopping prior therapy; there is no specific duration for which patients must be off treatment prior to registration to the relevant screening step (and subsequently, the biopsy), as long as all other eligibility criteria are met OR\r\n* Patient will be undergoing a procedure due to medical necessity during which the tissue may be collected\r\n** NOTE: Registration to screening steps (Step 0, 2, 4, 6) must occur after stopping prior therapy; there is no specific duration for which patients must be off treatment prior to registration to the relevant screening step (and subsequently, the biopsy), as long as all other eligibility criteria are met OR\r\n* Formalin-fixed paraffin-embedded tumor tissue block(s) are available for submission following pre-registration (not applicable for bone marrow aspirate specimens); criteria for the submission of formalin-fixed paraffin-embedded (FFPE) tissue are:\r\n** Tissue must have been collected within 6 months prior to pre-registration to Step 0\r\n*** Patient may receive treatment after tissue collection; however, lack of response must be documented prior to Step 1; the following restrictions apply:\r\n**** Enrollment onto another investigational study is not permitted\r\n**** Intervening therapy that constitutes a new, molecularly targeted therapy is not permitted; please note, immunotherapy is not considered molecularly targeted\r\n***** Continuation of an agent/regimen for which disease progression has been observed prior to biopsy is permitted, including targeted therapy\r\n**** A new immunotherapy regimen is permitted; but, lack of response must also be documented prior to registration to Step 0\r\n** Formalin-fixed paraffin-embedded tumor tissue block(s) must meet the minimum requirements OR\r\n* Results from one of the designated outside laboratories indicate a “rare variant” that is an actionable mutation of interest (aMOI) for specific designated rare variant subprotocols; the following requirements apply:\r\n** The outside laboratory notified the site that patient may be a potential candidate for MATCH due to a detected “rare variant”\r\n** Patients with an applicable “rare variant” must be able to meet the eligibility criteria for the appropriate subprotocols within 4 weeks following entry on the EAY131 Step 0 screening step\r\n** Registration to Step 0 must occur after stopping prior systemic anti-cancer therapy; there is no specific duration for which patients must be off treatment prior to registration to Step 0, as long as all eligibility criteria are met\r\n*** NOTE: Other potential aMOIs that would be eligibility criteria for NON RARE arms, as determined by the above laboratories, are not applicable for direct treatment assignment on MATCH\r\n*** NOTE: Tumor tissue for the confirmation of “rare variant” by the MATCH assay is to be submitted, preferably from the same time of collection as that evaluated by the designated outside laboratory
Within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration: Leukocytes >= 3,000/mcL
Within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration: Absolute neutrophil count >= 1,500/mcL
Within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration: Platelets >= 100,000/mcL
Within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration: Creatinine clearance >= 45 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
STEP II: Step 2 registration must be within 6 weeks of completing step 1 therapy
STEP II: Any adverse event related to step 1 therapy must have resolved to grade 2 or less
STEP 1 INITIAL REGISTRATION: HER-2 TESTING
STEP 3 CROSSOVER REGISTRATION (OPTIONAL): Patients must have documented disease progression while on CETIRI (Arm 2) on this protocol; the Follow-up Tumor Assessment Form documenting disease progression must be submitted to Southwest Oncology Group (SWOG) prior to step 3 crossover registration; registration to step 3 crossover must be within 28 days of discontinuation of CETIRI protocol treatment; patients going off treatment for any other reason are not eligible
STEP 3 CROSSOVER REGISTRATION (OPTIONAL): ANC >= 1,500/mcL within 14 days prior to step 3 crossover registration
STEP 3 CROSSOVER REGISTRATION (OPTIONAL): Platelets >= 75,000/mcL within 14 days prior to step 3 crossover registration
STEP 3 CROSSOVER REGISTRATION (OPTIONAL): Hemoglobin >= 9 g/dL within 14 days prior to step 3 crossover registration
STEP 3 CROSSOVER REGISTRATION (OPTIONAL): AST and ALT both =< 5 x institutional upper limit of normal (IULN) within 14 days prior to step 3 crossover registration
STEP 3 CROSSOVER REGISTRATION (OPTIONAL): Bilirubin =< 1.5 mg/dL within 14 days prior to step 3 crossover registration
STEP 3 CROSSOVER REGISTRATION (OPTIONAL): Calculated creatinine clearance > 30 ml/min within 14 days prior to step 3 crossover registration
STEP 3 CROSSOVER REGISTRATION (OPTIONAL): Patients must have left ventricular ejection fraction (LVEF) >= 50% or >= lower limit of normal for the institution by echocardiogram within 14 days prior to step 3 crossover registration
STEP 3 CROSSOVER REGISTRATION (OPTIONAL): Patients must have a magnesium, potassium, calcium, sodium, bicarbonate, and chloride performed within 14 days prior to step 3 crossover registration
STEP 1
The patient must have met all eligibility criteria (except as detailed below) at the time of crossover\r\n* RECIST defined measurable disease is not required\r\n* Only prior systemic therapy as part of step 1 is allowed; patients who received allowed systemic therapy in the adjuvant setting prior to Step 1 and were eligible for Step 1 are not excluded from proceeding to Step 2 if they meet other eligibility criteria\r\n* Malabsorption, swallowing difficulty, or other conditions that would interfere with the ingestion or absorption of dabrafenib or trametinib, or history of retinal vein occlusion are acceptable for patients crossing over to ipilimumab + nivolumab treatment\r\n* History of autoimmune disease, excluding interstitial lung disease or pneumonitis, is allowed in patients crossing over to dabrafenib/trametinib therapy\r\n* Patients crossing over from nivolumab/ipilimumab to dabrafenib/trametinib who underwent surgery or SRS to CNS metastases need not be off of steroids to start treatment \r\n* There is no restriction on serum LDH at crossover\r\n* Patients with a history of cardiovascular risks that developed during step 1 of therapy should be discussed with study principal investigator (PI) at time of crossover
Patients must have discontinued radiation therapy prior to registering to Step 2 of the study and recovered from any adverse events associated with treatment; prior surgery must be >= 2 weeks from registration to Step 2 and patients must be fully recovered from post-surgical complications
REGISTRATION STEP 2-RANDOMIZATION: Patients must be registered to Step 2 no more than 42 days after registration to Step 1 and no more than 42 days after collection of specimens for FLT3 testing
PRE-REGISTRATION (STEP 0)
STEP 1 REGISTRATION
STEP 2 REGISTRATION
Alkaline phosphatase =< 2.5 x IULN, obtained within 28 days prior to step 2 registration
Baseline testosterone level obtained post prostatectomy prior to step 1 registration
Prostatectomy performed greater than 365 days (1 year) prior to step 1 registration
PRIOR TO STEP 1 REGISTRATION
PRIOR TO STEP 2 REGISTRATION
Documentation of steroid doses within 28 days prior to step 2 registration
Karnofsky performance status >= 70 within 28 days prior to step 2 registration
Patents treated on any other therapeutic clinical protocols within 30 days prior to step 2 registration
Sites are required to complete Step 1 registration before submitting specimens for EBV DNA analysis\r\n* Patients must have detectable pretreatment plasma EBV DNA, determined by the central lab prior to Step 2 registration\r\n* For patients who have detectable plasma EBV DNA tested at one of the credentialed central labs within 28 days prior to Step 1 registration: that test result can be used for eligibility without the need for re-testing; to use this test result for eligibility, the central lab must enter the test result through the pathology portal
Karnofsky performance status of 70-100 within 90 days prior to Step 1 registration
History of any of the following:\r\n* Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year prior to Step 1 registration)\r\n* History of documented inflammatory bowel disease\r\n* Transmural myocardial infarction within the last 4 months prior to Step 1 registration\r\n* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to Step 1 registration\r\n* History of any condition that in the opinion of the investigator, would preclude participation in this study
For patients who have not undergone prior Decipher analysis, submission of the specimen to GenomeDx should be as soon as possible after study registration (Step 1) as these results can take up 21 days after the specimen is received at GenomeDx; Step 2 registration must occur within 6 weeks (42 days) of Step 1 registration; if Decipher results have already been obtained, in lieu of tissue, results must be submitted to GenomeDx for validation
Hemoglobin >= 9 g/dl documented within 28 days prior to step 1 registration
Platelets >= 100,000 documented within 28 days prior to step 1 registration
STEP 2: SURGERY
Patients must have postoperative oxygen consumption (VO2) max > 15 ml/kg/min prior to surgery obtained within 28 days prior to step 2 registration
STEP 3: MAINTENANCE
ANC > 1,500/mcl within 28 days documented prior to step 3 registration
Hemoglobin > 9 g/dl documented within 28 days prior to step 3 registration
Creatinine < 1.5 x ULN documented within 28 days prior to step 3 registration
Registration Step 2 – Post-Remission Therapy:
Registration Step 3 – Maintenance: Patients must have serum creatinine =< 1.5 mg/dl within 14 days prior to registration
Registration Step 3 – Maintenance: Patients must have AST and ALT =< 3.0 x institutional upper limit of normal (IULN) within 14 days prior to registration
Registration Step 3 – Maintenance: Patients must have adequate marrow function as evidenced by ANC >= 750/mcl within 28 days prior to registration
PRIOR TO STEP 1 REGISTRATION:
Step 1 registration must occur within 180 days of the initial surgery; within this 180 day interval, a second surgery is permitted in order to achieve GTR, but even with a second surgery, step 1 registration must occur within 180 days of the initial resection
For step 1 registration the operating neurosurgeon must provide the modified Simpson grade
PRIOR TO STEP 2 REGISTRATION:
PRIOR TO STEP 1 REGISTRATION
After chemotherapy, patients must be restaged prior Step 1 registration using the same diagnostic work-up as required pre-chemotherapy; repeat PET/CT or bone scan is not required; patients must have:\r\n* History/physical examination within 30 days of Step 1 registration\r\n* No central nervous system (CNS) metastases (repeat MRI required) within 56 days prior to Step 1 registration\r\n* No progression in any site\r\n* Radiographic partial or complete response to chemotherapy in at least one disease site within 56 days prior to Step 1 registration\r\n** If PET/CT was obtained prior to chemotherapy, either a repeat PET/CT or CT of the chest and abdomen with contrast can be obtained for response assessment\r\n** Patients who underwent resection for limited-stage SCLC prior to chemotherapy and have no radiographically evident disease for response assessment remain eligible if post-chemotherapy imaging demonstrates no progression
PRIOR TO STEP 2 REGISTRATION
Karnofsky performance status >= 70 within 14 days prior to Step 2 registration
Serum creatinine =< 1.7 mg/dl within 14 days prior to Step 2 registration
STEP I (IMAGING AND DOSIMETRY)
STEP I
STEP 1 SUBJECTS ONLY:
STEP 2 SUBJECTS ONLY:
STEP 1 AND 2 SUBJECTS:
PREREGISTRATION (STEP 0): Patient must be scheduled to undergo a standard of care bone marrow biopsy within 7 days of step 0 registration
REGISTRATION TO TREATMENT (STEP 1): Institution has received central BCR-ABL test results confirming MRD positive status
REGISTRATION TO TREATMENT (STEP 1): Patients must have been on a stable dose of the TKI for the last 3 months before prior to pre-registration
REGISTRATION TO TREATMENT (STEP 1): Platelet count >= 100,000 /mcL, within 14 days prior to first dose of pembrolizumab
REGISTRATION TO TREATMENT (STEP 1): Patients who received prior allogeneic transplant are not eligible
REGISTRATION TO TREATMENT (STEP 2): Institution has received central BCR-ABL test results confirming MRD positive status following Step 1 treatment
REGISTRATION TO TREATMENT (STEP 2): Patients have an ECOG performance status of 0-1
REGISTRATION TO TREATMENT (STEP 2): Platelet count >= 100,000 /mcL, within 14 days prior to first dose of pembrolizumab
REGISTRATION TO TREATMENT (STEP 2): Patients who received prior allogeneic transplant are not eligible
PRIOR TO STEP 1 REGISTRATION INCLUSION CRITERIA
Within 14 days prior to step 1 registration: Serum bilirubin =< 1.5 x institutional upper limit of normal
PRIOR TO STEP 2 REGISTRATION INCLUSION CRITERIA
For patients with oropharyngeal or unknown primaries: p16 determination by immunohistochemistry (defined as greater than 70% strong nuclear or nuclear and cytoplasmic staining of tumor cells), confirmed by central pathology review\r\n* Note: for patients with oral cavity, laryngeal, and hypopharyngeal primaries, analysis of p16 status prior to step 2 registration/randomization is not required (p16 status will be analyzed centrally post-hoc); step 2 registration for these patients can be completed after step 1 registration
PRIOR TO STEP 1 REGISTRATION EXCLUSION CRITERIA
Within 14 days of step 1 registration, unless corrected prior to step 1 registration: Sodium < 130 mmol/L or > 155 mmol/L
Within 14 days of step 1 registration, unless corrected prior to step 1 registration: Potassium < 3.5 mmol/L or > 6 mmol/L
Within 14 days of step 1 registration, unless corrected prior to step 1 registration: Fasting glucose < 40 mg/dl or > 400 mg/dl
Within 14 days of step 1 registration, unless corrected prior to step 1 registration: Magnesium < 0.9 mg/dl or > 3 mg/dl
STEP 1 (REGISTRATION)
STEP 2 (REGISTRATION)
STEP 1
STEP 2
STEP 2 TO GDC-0032 RE-REGISTRATION:
HbA1c < 7% obtained within 28 days prior to Step 2 re-registration
STEP 2 TO AZD4547 RE-REGISTRATION:
STEP 2 PALBOCICLIB RE-REGISTRATION:
STEP 1: REGISTRATION
STEP 1 (REGISTRATION)
REGISTRATION STEP 2: CROSSOVER
PRIOR TO STEP 1 REGISTRATION BUT WITHIN 56 DAYS PRIOR TO STEP 2 REGISTRATION
Radiation oncology consultation to confirm that disease can be encompassed in a radiotherapy field within 56 days prior to step 2 registration
Consultation with a medical oncologist within 56 days prior to step 2 registration
Stage T1N1-2, T2-3N0-2, according to the AJCC 7th edition staging, based upon the following minimum diagnostic work-up:\r\n* History/physical examination, with documentation of the patient’s weight, within 14 days prior to step 2 registration\r\n* Whole-body PET/CT scan within 56 days prior to step 2 registration (if only CT performed prior to step 1 registration)\r\n* Endoscopic ultrasound within 56 days prior to step 2 registration, unless the patient is found to have adenopathy per CT or whole-body PET/CT scan\r\n* Electrocardiogram (EKG) within 56 days prior to step 2 registration\r\n* Serum creatinine =< 2 x the upper limit or normal within 14 days prior to step 2 registration
Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines; for Step 1 registration of patients who have not yet submitted specimens for the Oncotype DX Breast Cancer Assay, the appropriate consent form is the Step 1 Consent Form; for both Step 1 and Step 2 registration of patients whose Recurrence Score is already known and is 25 or less, the appropriate consent form is the Step 2 Consent Form
STEP 2 REGISTRATION
SECOND REGISTRATION (STEP 2)
STEP 1 REGISTRATION:
No tests or exams are required to be repeated for step 2 registration (randomization); however, patients who are known to have a change in eligibility status after step 1 registration are not eligible for step 2 registration; for example, ANC is not required to be repeated between step 1 and step 2 registration, but the most recent ANC performed before step 2 registration is required to be >= 1,500 mcL
STEP 2 TO MEDI4736 RE-TREATMENT REGISTRATION:
PRE-REGISTRATION (STEP 0)
PRIOR TO STEP 1 REGISTRATION
PRIOR TO STEP 2 REGISTRATION
The EPIC-26 must be completed in full and entered within 10 business days after step 1 registration; NRG Oncology Statistical and Data Management Center has 3 business days to score the results and send a notification to the site to proceed to step 2 randomization
STEP I INITIAL REGISTRATION: BRAFV600E TESTING:
Brain metastases are allowed if they have been adequately treated with radiotherapy or surgery and stable for at least 90 days prior to Step 1 Initial Registration; eligible patients should be neurologically asymptomatic and without corticosteroid treatment for at least 7 days prior to Step 1 Initial Registration
Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines; for Step 1 Initial Registration of patients who have not yet submitted specimens for the central BRAFV600E testing, the appropriate consent form is the Step 1 Consent Form; for both Step 1 Initial Registration and Step 2 Randomization of patients whose BRAF mutation status is already known, the appropriate consent form is the Step 2 Consent Form
STEP 3 CROSSOVER REGISTRATION:
Registration to Step 3 Crossover must be within 28 days of discontinuation of Arm 1 protocol treatment; patients going off treatment for any other reason are not eligible
ANC >= 1,500/mcL within 14 days prior to Step 3 registration
Hemoglobin >= 9 g/dL within 14 days prior to Step 3 registration
STEP 1 REGISTRATION:
STEP 2 REGISTRATION:
Patients must register to Step 1 prior to surgery
STEP 1 (REGISTRATION)
PRIOR TO STEP 1 REGISTRATION INCLUSION CRITERIA
PRIOR TO STEP 2 REGISTRATION INCLUSION CRITERIA
PRIOR TO STEP 1 REGISTRATION EXCLUSION CRITERIA
CROSSOVER (STEP 2) REGISTRATION: Patients must have progressed systemically on Arm 2 of this study (pemetrexed monotherapy)
CROSSOVER (STEP 2) REGISTRATION: Patients must be registered to crossover (Step 2) within 30 days of discontinuing treatment on Arm 2 of this study
CROSSOVER (STEP 2) REGISTRATION: ANC >= 1,500/ul
CROSSOVER (STEP 2) REGISTRATION: Platelet count >= 100,000/ul
CROSSOVER (STEP 2) REGISTRATION: Hemoglobin >= 9 g/dL
CROSSOVER (STEP 2) REGISTRATION: Serum bilirubin =< 2 X IULN
CROSSOVER (STEP 2) REGISTRATION: Male patients must have free and total testosterone level obtained within 28 days prior to crossover (Step 2) registration
CROSSOVER (STEP 2) REGISTRATION: Patients must have Zubrod performance status 0-2 within 28 days prior to crossover (Step 2) registration
STEP 2 - CONSOLIDATION
Patients cannot be receiving CYP3A4 inhibitors beginning at least 7 days prior to registration step 2
PRIOR TO STEP 1 REGISTRATION
Patients must have a FSFI desire subscale baseline score less than 3.3\r\n* NOTE-Both the PHQ4 and FSFI must be completed by the patient and data entered in Oncology Patient Enrollment Network (OPEN) at Step 1 registration to determine eligibility within 10 days prior to registration; both of these scores will be calculated in the OPEN system once submitted as part of Step 1 registration; an error message will appear once the patient begins Step 2 registration if one or both of the scores make the patient ineligible; in this situation, continue to complete Step 2 with the reason the patient will not continue on the study as “Other” and specify ineligible
Completion of the FSFI and PHQ4; both questionnaires will be required and data entered at the time of step 1 registration
Completion of the following baseline quality of life forms: PHQ4, FSFI, PROMIS sexual function and satisfaction, PROMIS fatigue short form 8a, impact of treatment scale, patient reported outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) items, and revised dyadic adjustment scale; these quality of life forms will be required and data must be entered in RAVE at step 2 registration; if available at the time of step 1 registration, step 2 registration can take place immediately after step 1, but cannot occur more than 30 days after step 1; women who do not currently have a partner do not have to complete the revised dyadic adjustment scale; enter “no partner” for this form
STEP 1 REGISTRATION
Patients must not have taken within 21 days prior to step 1 registration, be currently taking at the time of step 1 registration, or planning to take once registered to step 1 a beta blocker, ARB, or ACE inhibitor in order to be randomized (Arms 1 and 2)\r\n* Patients currently taking a beta blocker, ARB, or ACE inhibitor at the time of step 1 registration are eligible to register for the non-randomized observational cohort (Arm 3)
STEP 1 REGISTRATION
PRIOR TO STEP 2 REGISTRATION
Financial clearance for proton therapy treatment prior step 2 registration
PRIOR TO STEP 1 REGISTRATION:
PRIOR TO STEP 2 REGISTRATION:
The following baseline neurocognitive assessments must be completed prior to Step 2 registration: HVLT-R, TMT, and COWA; the neurocognitive assessment will be uploaded into the NRG RAVE System for evaluation by Dr. Wefel; once the upload is complete, within one business day a notification will be sent to proceed to Step 2; NOTE: completed baseline neurocognitive assessments can be uploaded at the time of Step 1 registration
Karnofsky performance status of >= 70 within 28 days prior to Step 2 registration
STEP 0: REGISTRATION (Optional)
Patients with a primary colon or rectal cancer resection who are potentially eligible for S0820 may be pre-registered at Step 0; patients registered to Step 0 will appear on an institutional patient tracking report; patients registered to Step 0 are not registered to the S0820 protocol; to participate in S0820, patients must be registered to Step 1 after patient is consented and evaluation of eligibility; patients registered to S0820 at Step 0 continuing to Step 1 registration must use the same Southwest Oncology Group (SWOG) patient identification (ID) for registration to S0820 Step 1
STEP 1: REGISTRATION
REGISTRATION TO STEP 0
REGISTRATION TO STEP 1
Registration to Step 1:
Registration to Step 2:
Registration to Step 3:
Patients must be registered to the first screening step (Step 0) for the National Cancer Institute (NCI)-MATCH trial (EAY131)
REGISTRATION EXCLUSION CRITERIA
EXCLUSION CRITERIA FOR REGISTRATION: Pregnant and/or breastfeeding
EXCLUSION CRITERIA FOR REGISTRATION: Experiencing grade 2 or greater diarrhea
EXCLUSION CRITERIA FOR REGISTRATION: Prior treatment with neratinib
REGISTRATION/RANDOMIZATION EXCLUSION CRITERIA:
REGISTRATION- EXCLUSION
REGISTRATION EXCLUSION CRITERIA
FIRST REGISTRATION-EXCLUSION:
SECONDARY REGISTRATION-EXCLUSION:
EXCLUSION CRITERIA FOR REGISTRATION: mucinous adenocarcinoma, borderline tumors
EXCLUSION CRITERIA FOR REGISTRATION: subjects who will undergo intraperitoneal chemotherapy
EXCLUSION CRITERIA FOR REGISTRATION: patients who are receiving any other investigational agents
REGISTRATION – EXCLUSION CRITERIA
REGISTRATION #1 EXCLUSION CRITERIA
RE-REGISTRATION EXCLUSION CRITERIA
REGISTRATION EXCLUSION CRITERIA
PHASE II REGISTRATION: EXCLUSION CRITERIA:
REGISTRATION EXCLUSION CRITERIA
REGISTRATION EXCLUSION
REGISTRATION EXCLUSION:
REGISTRATION EXCLUSION CRITERIA
REGISTRATION EXCLUSION CRITERIA
REGISTRATION/RANDOMIZATION EXCLUSION CRITERIA
REGISTRATION EXCLUSION CRITERIA
ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): ECOG performance status 0 or 1 within 2 weeks prior to randomization
ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Patients must have completed treatment with any investigational agent >= 30 days prior to randomization for protocol therapy, if applicable
STEP I: Hemoglobin >= 8 g/dL (obtained within 28 days prior to randomization)
STEP I: Bilirubin =< 1.5 mg/dL (obtained within 28 days prior to randomization)
STEP II: Hemoglobin >= 8 g/dL (within 28 days prior to randomization to Step II)
STEP II: Platelet count >= 75,000 cells/mm^3 (within 28 days prior to randomization to Step II)
STEP II: Absolute neutrophil count >= 1000 cells/mm^3 (within 28 days prior to randomization to Step II)
STEP II: Calculated creatinine clearance >= 30 mL/min (within 28 days prior to randomization to Step II)
STEP II: Bilirubin =< 1.5 mg/dL (within 28 days prior to randomization to Step II)
STEP II: SGPT (ALT) and SGOT (AST) < 2.5 times the upper limit of normal (within 28 days prior to randomization to Step II)
STEP 2 RANDOMIZATION
Brain metastases are allowed if they have been adequately treated with radiotherapy or surgery and stable for at least 30 days prior to step 2 randomization; eligible patients must be neurologically asymptomatic and without corticosteroid treatment for at least 7 days prior to step 2 randomization
Platelets >= 75,000/mcL within 14 days prior to step 2 randomization
Hemoglobin >= 9 g/dL within 14 days prior to step 2 randomization
Bilirubin =< 1.5 mg/dL within 14 days prior to step 2 randomization
STEP 2: RANDOMIZATION
After completing one cycle of therapy, patients will be registered for randomization between intermittent and continuous dosing, provided that they were eligible for the initial step 1 registration and satisfy the following criteria
REGISTRATION STEP 2-RANDOMIZATION: Patients must not be known to have AML in the CNS
REGISTRATION STEP 2-RANDOMIZATION: Pretreatment cytogenetics must be performed on all patients; collection of pretreatment specimens must be completed within 42 days prior to randomization (registration Step 2); reports of the results must be submitted
REGISTRATION STEP 2-RANDOMIZATION: FLT3 results will be used for stratification purposes at the time of randomization; E-mail notification that FLT3 specimens have been processed must be received prior to randomization (registration Step 2)
REGISTRATION STEP 2-RANDOMIZATION: Prior treatment with hydroxyurea is permitted; prior all-trans retinoic acid (ATRA) for suspected APL and prior intrathecal therapy are permitted, but must plan to be discontinued prior to initiating protocol therapy; patients with signs/symptoms of hyperleukocytosis or white blood cells (WBC) >= 50,000/mcL can be treated with leukapheresis prior to randomization (registration to Step 2)
REGISTRATION STEP 2-RANDOMIZATION: Patients may have received non-intensive therapy for antecedent hematologic disorders, including lenalidomide; patients may have received prior chemotherapy for prior cancers; these therapies must be discontinued at least 5 days prior to randomization (registration to Step 2)
REGISTRATION STEP 2-RANDOMIZATION: Patients must have complete history and physical examination within 28 days prior to randomization (registration to Step 2); history must include autoimmune disease status (to determine whether patient is eligible for Arm B)
All tests for establishing baseline values must be completed within 14 days prior to registration to Step 2 (randomization)
RANDOMIZATION (STEP 1)
RANDOMIZATION TO BLINATUMOMAB OR NO BLINATUMOMAB-STEP 3
STEP II (THERAPY)
PRIOR TO STEP ONE RANDOMIZATION:
PRIOR TO STEP TWO RANDOMIZATION:
STEP 2: RANDOMIZATION
REGISTRATION STEP 1: INITIAL RANDOMIZATION
STEP 2 REGISTRATION (RANDOMIZATION CRITERIA):
RANDOMIZATION (STEP 1)
Patients must have BRAFV600E mutant status documented by a Clinical Laboratory Improvements Amendments (CLIA) certified laboratory on a pathology report prior to Step 2 registration; use of an Food and Drug Administration (FDA)-approved test is preferred although other BRAF tests at a CLIA-certified laboratory will also be accepted \r\n* If a BRAFV600E mutation is known, then the patient must be registered to Step 2 Randomization immediately following Step 1 Initial Registration\r\n* If testing has not been performed locally, BRAFV600E testing must be completed by the central laboratory (lab) prior to Step 2 Randomization; if the specimen does not have a BRAFV600E mutation, the patient is ineligible for Step 2 Randomization
STEP 2 RANDOMIZATION:
Patients with known BRAF mutation must be registered to Step 2 Randomization immediately following Step 1 Initial Registration
Patients must have an electrocardiogram (ECG) within 14 days prior to Step 2 Randomization
STEP 2 RANDOMIZATION REGULATORY CRITERIA:
REGISTRATION/RANDOMIZATION TO STEP 2 - ARMS A, B, C AND D
STEP 2 ENROLLMENT AND RANDOMIZATION: less than or equal to three metastatic lesions and no evidence of disease progression based on RECIST criteria; note that patients that had > 3 metastatic lesions in Step 1 may be eligible for enrollment in Step 2 if the number of metastatic sites is reduced to three or less
STEP 2 ENROLLMENT AND RANDOMIZATION: platelet count >= 100,000/mm^3 within 3 weeks of study entry
STEP 2 ENROLLMENT AND RANDOMIZATION: hemoglobin >= 9 g/dL within 3 weeks of study entry
STEP 2 ENROLLMENT AND RANDOMIZATION: bevacizumab will not be permitted within 2 weeks of the initiation of the radiation therapy course
STEP 2 ENROLLMENT AND RANDOMIZATION: the patient has signed informed consent
STEP 2 (RANDOMIZATION)
PRIOR TO STEP 2 RANDOMIZATION
STEP 2 REGISTRATION (Randomization)
STEP 2: INCLUSION CRITERIA PRIOR TO RANDOMIZATION
STEP 2: EXCLUSION CRITERIA PRIOR TO RANDOMIZATION