Creatinine =< 2.0 mg/dL
Creatinine < 2.0 mg/dL
Creatinine =< 1.7 mg/dl
Creatinine =< 1.5 mg/dL
Creatinine < 2 mg/dL
Creatinine less than or equal to 2.0 mg/dL
Creatinine ?1.5mg/dL
Creatinine < 2 mg/dL
Creatinine < 1.5 mg/dl
Creatinine =< 2 mg/dL
Creatinine =< 2.0 mg/dL
Creatinine =< 1.4 mg/dl
Creatinine ? 1.5 mg/dl
Creatinine =< 2.0 mg/dL
Creatinine =< 2.0 mg/dL
Creatinine ? 2.5 mg/dl,
Creatinine < 2.0 mg/dl
Clinically significant renal disease (creatinine > 2.0 mg/dL, urea > 100 mg/dL)
Creatinine 0.6-1.3: MG/DL
Creatinine =< 1.5 mg/dL
A baseline creatinine reported as > 2.0 mg/dL
PART I: Creatinine =< 1.5 mg/dL
PART II: Creatinine =< 1.5 mg/dL
Creatinine =< 1.5 mg/dL is recommended; however, institutional norms are acceptable
Creatinine =< 1.5 mg/dL OR
ARM I&II: Creatinine =< 1.7 mg/dl
Creatinine less than or equal to 2.0 mg/dL (unless considered tumor related)
Creatinine > 1.5 mg/dL
Creatinine < 1.6 mg/dL
Creatinine =< 2.0 mg/dL
To be performed within 14 days prior to day 1 of protocol therapy: creatinine =< 2.5 mg/dL
Within 4 weeks of day 1: Creatinine =< 2.0 mg/dL
Creatinine =< 2.0 mg/dL
Creatinine ? 1.7 mg/dL
Creatinine < 2.0 mg/dL (a renal consult can override this criteria)
Creatinine > 2.0 mg/dL (a renal consult can override this criteria)
Creatinine =< 2.0 mg/dl
Creatinine =< 2.0 mg/dL
Creatinine =< 2.0 mg/dl
Creatinine =< 1.6 mg/dL obtained < 4 weeks prior to starting treatment
Creatinine <2 mg/dL
Creatinine =< 2.0 mg/dL
Creatinine =< 2.0 mg/dL
Creatinine =< 1.7 mg/dl
Creatinine =< 2.0 mg/dl
Creatinine less than or equal to 2.0 mg/dL (unless considered tumor related)
Creatinine (Cr) =< 1.5 mg/dL x ULN
Creatinine =< 1.5 mg/dL
Creatinine level of 3 mg/dL or lower
Creatinine =< 2.5 mg/dL
Creatinine =< 1.6 mg/dl
Creatinine =< 1.5 mg/dL
Creatinine: =< 2.0 mg/dl
Creatinine < 1.6 mg/dl
Creatinine < 1.6 mg/dl
Creatinine =< 1.6 mg/dl
Creatinine =< 2.0 mg/dL
Creatinine =< 2.0 mg/dL
Creatinine =< 1.5 mg/dL
Creatinine < 1.5 mg/dl (= 132 umol/L) or
Creatinine =< 1.5 mg/dl
Within 6 weeks of day 1: Creatinine =< 2.0 mg/dL
Creatinine =< 2.0 mg/dl
Creatinine < 1.5 mg/dl within 14 days of study entry
Creatinine =< 1.5 mg/dl
Creatinine < 2.5 mg/dl
Creatinine < 2 mg/dL
Creatinine > 1.5 mg/dL
Creatinine =< 2.0 mg
Creatinine < 2.5 mg/dL
Creatinine =< 1.5 mg/dL
Creatinine < 1.8 mg/dL
Creatinine < 1.5 mg/dl, obtained within 30 days of study registration or
Creatinine =< 1.5 mg/dl
Creatinine < 1.6 mg/dL
Creatinine less than or equal to 2.0 mg/dL (unless considered tumor related)
Within 2 weeks of enrollment: Creatinine =< 1.7 mg/dl
Creatinine =< 2.0 mg/dL
Creatinine =< 1.6 mg/dl
Creatinine < 1.6 mg/dL
Creatinine < 2.0 mg/dL
Renal impairment with a creatinine > 1.4 mg/dl
Creatinine < 2.0 mg/dL
Creatinine (Cr) =< 1.6 mg/dL
Creatinine =< 2.0 mg/dL
Creatinine =< 2.0 mg/dl
Creatinine =< 1.7 mg/dl
Creatinine =< 2.0 mg/dL
Creatinine =< 2.5 mg/dL
Creatinine < 2.5 mg/dl
Creatinine =< 1.5 mg/dL
Creatinine =< 2.0 mg/dl
Creatinine =< 2 mg/dL
Creatinine > 2.0 mg/dL
Creatinine =< 2.5 mg/dL
Creatinine =< 2.0 mg/dl
Creatinine < 1.5 mg/dl or 125 u/L
Creatinine: =< 2.0 mg/dL
Creatinine<2mg/dl
Creatinine < 1.6 mg/dL
Creatinine <1.5 mg/dL
Creatinine =< 1.5 mg/dL or 133 umol/L
Creatinine =< 1.5 mg/dL
Creatinine =< 1.9 mg/dL
Creatinine < 2 mg/dL
Creatinine =< 2.0 mg/dL
Creatinine < 2 mg/dl
Performed within 14 days prior to study: Creatinine =< 2.5 mg/dL
Creatinine =< 1.0 mg/dL
Creatinine < 2.0 mg/dL
Creatinine =< 2.0 mg/dl
Creatinine =< 2.0 mg/dL
Creatinine =< 2.0 mg/dl
Creatinine =< 2.2 mg/dL.
Creatinine < 1.5 mg/dl
Creatinine =< 1.3 mg/dl
Creatinine =< 2 mg/dL OR
Creatinine =< 2.0 mg/dL
Creatinine =< 1.6 mg/dL
Creatinine: =< 2.0 mg/dL
Creatinine =< 2.0 mg/dL
Creatinine =< 2.5 mg/dL
Creatinine =< 2.0 mg/dL
Creatinine =< 2.0 mg/dL
Creatinine =< 2.0 mg/dl
Creatinine =< 1.5 mg/dL
Creatinine < 2.0 mg/dL
Creatinine =< 1.5 mg/dL is recommended; however, institutional norms are acceptable
Creatinine =< 2.5 g/dl
Creatinine less than or equal to 2.0 mg/dL
Creatinine =< 1.5 mg/dL
Creatinine ?1.5mg/dL.
Creatinine less than 1.4 mg/dl
Creatinine =< 1.5 mg/dl
Creatinine =< 2.0 mg/dcL
Creatinine up to and including 2 mg/dL
Creatinine =< 1.6 mg/dl
Creatinine =< 1.5 mg/dL
Creatinine (Cr) =< 2 mg/dL
Creatinine < 2.0 mg/dL
Creatinine < 1.6 mg/dl
Creatinine =< 2.0 mg/dL
Creatinine =< 3.0 mg/dl, unless considered due to tumor
Creatinine =< 3 mg/dL
Creatinine less than or equal to 2.0 mg/dl
Creatinine < 1.5 mg/dL
Creatinine < 1.5 mg/dL is recommended; however, institutional norms are acceptable
Creatinine =< 1.5mg/dl
Creatinine =< 1.8 mg/dl
Creatinine =< 2 mg/dL
Creatinine =< 2.0 mg/dL
Creatinine =< 1.7 mg/dl within 21 days prior to study registration
Creatinine =< 1.5 mg/dl
Creatinine < 1.5 mg/dL
Creatinine =< 1.5 mg/dl
Creatinine =< 2.0 mg/dL
Creatinine < 2.0 mg/dL
Creatinine > 177 umol/L (2 mg/dL)
creatinine < 2 mg/dL
Creatinine =< 2.0 mg/dL
Creatinine ? 2.0 mg/dL
Creatinine =< 1.5 mg/dl
Creatinine =< 1.8 mg/dl
Creatinine =< 2.0 mg/dL
Creatinine > 1.5 mg/dl
Creatinine =< 1.7 mg/dl
Creatinine >= 2.0 mg/dL
Creatinine =< 2.0 mg/dL
Creatinine =< 2.0 mg
Creatinine < 1.6 mg/dl
Creatinine =< 3.0 mg/dL
Creatinine < 2.5 mg/dL
Creatinine =< 2.0 mg/dL
Creatinine =< 1.5 mg/dL
Creatinine > 177 umol/L (2 mg/dL)
Creatinine =< 1.8 mg/dL
Creatinine =< 1.5 mg/dL
creatinine ? 2.0 mg/dL OR
Creatinine =< 2.0 mg/dL
Creatinine =< 2.0 mg/dL
Creatinine (Cr) =< 2.0 mg/dl
Creatinine < 2.5 mg/dl
Renal insufficiency creatinine > 2.5 mg/dl
Creatinine < 1.5 mg/dL
Creatinine =< 2 mg/dL
Creatinine =< 2.0 mg/dL
Creatinine less than or equal to 3.0 mg/dL (unless considered tumor related)
Creatinine < 3 mg/dl
Creatinine < 2 mg/dL
(continued from no. 17) The lab will measure protein concentration (mg/dL) and creatinine concentration (mg/dL). The UPCR is derived as follows: protein concentration (mg/dL)/creatinine (mg/dL).
Creatinine =< 2.0 mg/dl
Creatinine =< 2.0 mg/dL
Creatinine =< 2.0 mg/dL
Creatinine =< 2 mg/dL
Creatinine =< 2.0 mg/dL
PRIOR TO POST-TRANSPLANT IMMUNOTHERAPY: Creatinine =< 2.0 mg/dL
Creatinine =< 2.0 mg/dL
Creatinine =< 2.0 mg/dL
Renal dysfunction defined as creatinine ? 2.0 mg/dL.
Creatinine =< 1.5 mg/dL
Creatinine =< 1.5 mg/dL
Creatinine should be < 3 mg/dL due to disease
Creatinine > 2.0 mg/dl
Creatinine =< 2.0 mg/dL
Creatinine =< 2.0 X mg/dL
Creatinine =< 2.0 mg/dL; patients on renal replacement therapy are not eligible
Creatinine =< 1.5 mg/dL
Creatinine ? 2.0 mg/dL
Renal insufficiency (creatinine >= 2.0 mg/dl)
Patients with plasma creatinine level greater than 1.3 mg/dL
Creatinine =< 2.0 mg/dL
Creatinine < 1.6 mg/dL
Creatinine =< 1.5 mg/dL
Creatinine < 2.5 mg/dl
Creatinine (Cr) > 2 mg/dL
Creatinine =< 3 mg/dL
Creatinine =< 1.8 mg/dl
Creatinine < 1.5 mg/dL
Creatinine < 1.7 mg/dL
Creatinine =< 2.0 mg/dL
Creatinine =< ULN for institution mg/dL
Creatinine =< 2.0 mg/dl
Creatinine > 1.5mg%
Creatinine < 1.5 mg/dL
Total creatinine =< 2.5 mg/dL
Creatinine < 1.7 mg/dL
Creatinine =< 3mg/dL
Creatinine > 2 mg/dL
Creatinine ? 1.5 mg/dl
Patients with plasma creatinine level greater than 1.3 mg/dL
Creatinine: =< 2.0 mg/dL
Patients with plasma creatinine level greater than 1.3 mg/dL
Creatinine < 2.0 mg/dl
Creatinine ? 1.2 mg/dL
Creatinine =< 1.5 mg/dl
Creatinine =< 1.4 mg/dL
Creatinine < 2.0 mg/dl
Creatinine < 1.5 mg/dL
Creatinine =< 2.0 mg/dl
Creatinine >= 1.4 mg/dL
Creatinine =< 3.0 mg/dL
Creatinine < 2 mg/dL
Patients with impaired kidney function (creatinine >= 1.3 mg/dL or < 0.6 mg/dL)
Creatinine > 1.3 mg/dl
Creatinine > 2.5 mg/dL
Creatinine =< 2.0 mg/dl
Creatinine < 2.0 mg/dL
Creatinine < 2.0 mg/ dL
Creatinine <3.0 mg/dl
Creatinine =< 1.5 mg/dL
Patients with plasma creatinine level greater than 1.3 mg/dL
Creatinine < 1.5 x ULN
Creatinine ? 2.0x ULN
creatinine <1.5 × institutional ULN OR
Creatinine =< 1.5 x ULN
Creatinine (Creat) =< 1.5 X ULN
Creatinine < 3×ULN
Creatinine ? 1.5 × ULN.
Creatinine ?1.5 ULN.
Creatinine ? 1.5 ULN
Creatinine =< 2.0 x ULN
Creatinine ?1.5 ULN OR
Creatinine ? 1.5 x ULN
Creatinine ?1.5 ULN.
Creatinine =< 1.5 x within normal institutional ULN OR
Creatinine =< 1.5 x ULN
Creatinine =< 2.5 x ULN
Creatinine =< 1.5 x ULN
Creatinine =< 1.5 x ULN
Creatinine up to 1.5 x ULN.
Creatinine =< 1.5 x institutional ULN
Creatinine =< 2 X institutional ULN
Creatinine > 1.5 x ULN
Creatinine =< 1.5 x ULN
Creatinine =< 1.5 x ULN
Creatinine < 1.5 X baseline, < 1.5 X ULN OR
Creatinine =< 2.5 x ULN
Creatinine =< 1.5 x ULN
Creatinine ? 1.5x ULN;
Creatinine ? 1.5x institutional ULN
Creatinine =< 1.2 x ULN prior to biopsy
Creatinine =< ULN
Creatinine =< 1.5 x ULN
Creatinine =< 1.5 x institutional ULN
Creatinine =< 1.5 x ULN OR
Creatinine =< 1.5 x institutional ULN OR
Creatinine =< 1.5 x ULN
Creatinine ? 1.5 × ULN
Creatinine < 2.0 x ULN
Creatinine < 1.5 x ULN
Creatinine > 1.5 x ULN
Creatinine up to 1.5 ULN, or
Creatinine > 1.5 ULN, or
Creatinine > 2.0 x ULN
Creatinine < 1.5 x ULN
Creatinine =< 2 x ULN
Creatinine =< 1.5 x ULN
Creatinine =<1.5 x ULN
Creatinine =< 1.5 x ULN
Creatinine < 2 x ULN
Creatinine < 2.5 x ULN
Creatinine =< 1.5 x ULN
creatinine ? 1.5 × ULN,,
plasma creatinine less than or equal to 1.5 x institutional ULN OR
Creatinine =< 1.5 x ULN
Creatinine < 2 X ULN
Creatinine > 1.5 x ULN.
Creatinine =< 1.5 x ULN
Creatinine =< 1.5 ULN
Creatinine < 1.5 x ULN
Creatinine =< institutional ULN
Creatinine =< 1.5 x ULN
Creatinine =< 1.5 x ULN OR
Creatinine =< 1.5 x ULN
Creatinine =< 1.5 x ULN
Creatinine =< 1.5 x the institutional ULN
Creatinine =< 1.5 x ULN
Creatinine =< 2.5 x ULN
Creatinine =< 1.5 x ULN
Creatinine =< 1.5 x ULN
Creatinine =< 2.0 x ULN
Creatinine =< 2.0 x ULN
Creatinine =< 1.5 x ULN
Creatinine =< 1.5 x ULN
Creatinine =< 2 x ULN
Creatinine =< 1.5 x ULN
Creatinine =< 1.5 x ULN OR
Creatinine < 2.0 × ULN
Creatinine <1.5 X institutional ULN OR
Creatinine < 1.5 x ULN
Creatinine =< 1.5 x the ULN
Creatinine ? 2.5 x ULN
Creatinine <= 1.5 x ULN.
Creatinine < or equal to 1.5 x ULN
Creatinine < 1.5 x ULN
Creatinine =< 1.5 x ULN
Creatinine =< 1.5 x ULN
Creatinine =< 1.5 x ULN for age
Creatinine =< 1.5 x ULN
Creatinine < 2 X ULN
Creatinine less than 1.5 x ULN
Creatinine > 1.5 x ULN
Creatinine =< 1.5 X ULN
Creatinine =< 1.5 x ULN
Creatinine =< 1.5 x ULN
Creatinine =< 1.5 x ULN
Creatinine =< 1.5 x ULN
Creatinine =< 1.5 x ULN
Creatinine =< 1.5 X ULN
COHORT B: Creatinine =< 2.0 x ULN
Creatinine ? 1.5 × ULN
Creatinine =< 1.5 x ULN
Creatinine =< ULN x 1.5
Creatinine < 1.5 x ULN
Creatinine =< 2 x ULN
Creatinine =< 1.5 x ULN
Creatinine =< 1.5 x institutional ULN
Creatinine =< 1.5 x ULN
Creatinine < 1.5 X institutional ULN
Creatinine =< 1.5 x ULN
Creatinine =< 2.5 x ULN
Creatinine < 2 x ULN
Creatinine < 2 x ULN
Creatinine =< 2.0 x ULN
Creatinine 1.5 x ULN
Creatinine < 1.5 x ULN
Creatinine =< 1.5 x ULN
Creatinine < 1.5 x ULN
Creatinine >2.0x ULN
Creatinine =< 1.5 x institutional ULN
Creatinine =< 2 X ULN
Creatinine =< 1.5 X ULN
Creatinine > 1.5 × ULN
Creatinine =< ULN
Creatinine < 3 x ULN
Creatinine =< 1.5 x ULN
Patients with creatinine more than 1.5 x the ULN
Creatinine less than 2.5 X ULN
Creatinine =< 1.5 X ULN
Creatinine =< 2 X ULN
Creatinine =< 1.5 x ULN
Creatinine > 1.5 x ULN
Creatinine =< 1.5 x ULN
Creatinine =< 2 x ULN
Creatinine =< 1.5 x ULN
Creatinine =< 1.5 x institutional ULN
Creatinine < 2 x ULN
Creatinine =< 1.5 x institutional ULN
Creatinine =< ULN
Creatinine =< 1.5 x institutional ULN
Creatinine < 2 x ULN
Creatinine within 2 x ULN
Creatinine > 2.0 x ULN
Creatinine <1.5 X ULN
Creatinine < 2 X institutional ULN
Greater than 1.5 x the ULN for creatinine
Creatinine >1.5 x ULN
Serum creatinine =< 1.5 x mg/dL
Obtained =< 48 hours prior to registration: Serum creatinine =< 2.0 mg/dl
Within 14 days of registration: Serum creatinine < 2.0 mg/dL (176.8 umol/liter)
Serum creatinine < 2.0 mg/dl
Serum creatinine =< 1.5 mg/dL within 14 days prior to study entry
Patients must have serum creatinine =< 1.5 mg/dl within 14 days prior to registration
Serum creatinine =< 1.5 mg/dl within 14 days prior to registration
Serum creatinine >2.0 mg/dL.
Serum creatinine =< 2.0 mg/dL
Serum creatinine =< 1.5 mg/dL (133 umol/L)
Serum creatinine < 2.0 mg/dl
Serum creatinine =< 2.5 mg/dL x ULN
Serum creatinine =< 2.0 mg/dL
Serum creatinine =< 2.0 mg/dL OR
Serum creatinine < 2.0 mg/dL
Serum creatinine >2.5 mg/dL
Serum creatinine ? 2.0 mg/dL
Have a serum creatinine level ?1.8 mg/dL
Serum creatinine > 2 mg/dL
Serum creatinine ? 2.0 mg/dL
Serum creatinine ? 3 mg/dL
Within 14 days prior to registration: Serum creatinine =< 1.5 mg/dL
Serum creatinine =< 2.0 x mg/dL
Serum creatinine less than or equal to 1.6 mg/dl
Serum creatinine < 2.5 mg/dL
Serum creatinine =< to 1.6 mg/dl
Serum creatinine levels =< 2 mg/dL
Serum creatinine =< 2.0 mg/dL
Serum creatinine < 1.5 mg/dl
Serum creatinine less than or equal to 1.6 mg/dl
Serum creatinine < 2.0 mg/dL
Serum creatinine less than or equal to 1.6 mg/dl
Serum creatinine =< 1.6 mg/dl.
Serum creatinine ? 2.0 mg/dl
The patient has a serum creatinine value greater than 1.5 mg/dL
Serum creatinine less than or equal to 1.6 mg/dl
Research participant serum creatinine < 1.8 mg/dL
Serum creatinine =< 1.5 mg/dL.
Serum creatinine =< 1.6 mg/dL
Serum creatinine =< 1.5 mg/dl (prior to biopsy)
CHEMOTHERAPY/CELL INFUSION ELIGIBILITY: Serum creatinine less than or equal to 1.7 mg/dL
Serum creatinine =< to 1.6 mg/dL
Renal dysfunction defined as a serum creatinine >1.6 mg/dL.
Serum creatinine < 140 umol/L (< 1.6 mg/dL) or 1.5 x the upper limit of normal, whichever is less
Renal insufficiency, defined as serum creatinine > 2.0 mg/dL
Patients with serum creatinine levels less than 1.5 mg/dL
Serum creatinine < 2 mg/dl, within 28 days prior to registration
Serum creatinine < 1.8 mg/dl
Serum creatinine less than or equal to 1.4 mg/dL
Serum creatinine < 3.0 mg/dL
DONOR: Serum creatinine < 1.8 mg/dl
Serum creatinine < 1.7 mg/dL
Serum creatinine =< 2.0 mg/dL
Serum creatinine < 1.5 mg/dl
Serum creatinine =< 2.0 mg/dL (assessed within 14 days prior to registration)
Serum creatinine < 1.5 mg/dL
Patients with serum creatinine levels less than 1.5 mg/dL
Patients with serum creatinine level greater than 1.5 mg/dL
Serum Creatinine =< 3.0 mg/dL
Serum creatinine that is at or below 2.0 mg/dL
Serum creatinine =< to 1.6 mg/dL
Serum creatinine =< 2.0 mg/dL, within 14 day prior to registration
Serum creatinine =< to 1.6 mg/dl
Serum creatinine > 1.4 mg/dl =< 30 days prior to study entry
Serum creatinine >= 2.5 mg/dL
Serum creatinine =< 2.0 mg/dL (assessed within 10 days prior to study day 0)
Serum creatinine > 2.5 mg/dL
EXCLUSION CRITERIA FOR TNBC: Serum creatinine > 2.5 mg/dL
Serum creatinine =< 2.0 mg/dl
Serum creatinine < 1.5 mg/dL
Serum creatinine above 2.0mg/dl
Serum creatinine less than or equal to 1.4 mg/dL
Serum creatinine =< 2.0 mg/dL
Serum creatinine =< 2.0 mg/dL
Serum creatinine =< to 1.6 mg/dl
Serum creatinine =< 1.5 mg/dl
Serum creatinine =< 2.0 mg/dL
Serum creatinine =< 1.5 mg/dL or 133 umol/L
ADDITIONAL CRITERIA FOR STUDY CONTINUATION: Serum creatinine =< 2 mg/dl
Serum creatinine =< 3 mg/dL
Serum creatinine ? 2.5 mg/dL;
Serum creatinine < 2.0 mg/dl
Serum creatinine =< 3.0 mg/dL
Serum creatinine < or =< 2.0 mg/dl
Serum creatinine =< 1.5 mg/dL or 13 umol/L
Serum creatinine less or equal to 2 mg/dl
Research participant serum creatinine =< 1.8 mg/dL
Serum creatinine =< 2 mg/dl
Serum creatinine > 2.0 mg/dL
Serum creatinine =< 1.5 mg/dL or 133 umol/L
Serum creatinine > 1.5 mg/dL
Serum creatinine =< to 1.6 mg/dl
Serum creatinine =< 3 mg/dL
Serum creatinine =< 1.5 mg/dL
Serum creatinine ? 2.0 mg/dL
Serum creatinine > 2.0 mg/dl
Serum creatinine =< to 1.6 mg/dl
Patients are required to have a serum creatinine =< 2.0 mg/dL; this value must be obtained within two weeks before protocol entry
Serum creatinine =< 2.0 mg/dl
Serum creatinine < 2 mg/dl
Serum creatinine =< 2 mg/dl
Renal disease: serum creatinine > 2.0 mg/dl
Serum creatinine =< 1.5 mg/dL
Serum creatinine =< 2.0 mg/dL
Serum creatinine =< to 1.6 mg/dl
Serum creatinine > 2.0 mg/dl
Serum creatinine > 2 mg/dL
Serum creatinine < 1.5 mg/dl
Serum creatinine =< 1.5 mg/dL or 133 umol/L obtained =< 2 weeks prior to enrollment
Serum creatinine < 3 mg/dl
Serum creatinine > 2.5 mg/dL
Serum creatinine > 2 mg/dL
Serum creatinine < 1.5 mg%
Serum creatinine =< 2.0 mg/dL or 177 umol/L
Serum creatinine =< 3 mg/dL
Serum creatinine =< 2.0 mg/dl
Serum creatinine =< 1.6 mg/dL
Serum creatinine < 2.0 mg/dl
Serum creatinine < 1.6 mg/dL
Serum creatinine (Cr) =< 1.5 mg/dl
Serum creatinine =< 1.5 mg/dl
Serum creatinine =< 1.5 mg/dL (133 umol/L)
Serum creatinine =< 1.6 mg/dl
Have a serum creatinine level ?1.8 mg/dL
Serum creatinine > 2.0 mg/dl
Serum creatinine =< 2 mg/dl
Serum creatinine greater than 1.6 mg/dL
Serum creatinine < 1.8 mg/dL
Serum creatinine > 2.0 mg/dl
Serum creatinine less than or equal to 2.0 mg/dL unless considered due to involvement by tumor when an upper limit of 2.5 mg/dL is acceptable
Serum creatinine =< 2.0 mg/dL
A serum creatinine ? 1.5 mg% obtained ? 2 weeks prior to entry
Serum creatinine ? 2.0 mg/dL (assessed within 14 days prior to study day 0)
Serum creatinine =< 2.0 mg/dL within 21 days of RT fraction 1.
Serum creatinine =< to 1.6 mg/dl
Within 14 days of study registration: Serum creatinine =< 2 mg/dL
Serum creatinine ? 2.0 mg/dL or 177 micromol/L ? 2 weeks
DONORS: Serum creatinine < 1.8 mg/dl
Serum creatinine =< 2.0 mg/dl
Serum creatinine < 1.8 mg/dl
Serum creatinine =< 2.0 mg/dL
Serum creatinine =< 2.0 mg/dL
Serum creatinine < 2.0 mg/dL
Step 2: Serum creatinine < 2.0 mg/dL
Serum creatinine ? 2.0 mg/dL.
Serum creatinine > 3.0 mg/dl
Serum creatinine =< 1.5 mg/dL
Serum creatinine > 1.5 mg/dl
DONOR: Serum creatinine < 1.8 mg/dl
Serum creatinine =< 2mg/d
Serum creatinine less than or equal to 1.3 mg/dL
Serum creatinine =< to 1.6 mg/dl
Serum creatinine =< 1.5 mg/dL or 133 umol/L
Serum creatinine =< 1.8 mg/dl
Serum creatinine less than or equal to 1.7 mg/dL
Serum creatinine =< 1.7 mg/dL
Serum creatinine > 2.0 mg/dL
Serum creatinine < 1.5 mg/dL
Serum creatinine less than or equal to 2.5 mg/dl
Serum creatinine =< 2 mg/dL
Serum creatinine =< 2 mg/dL
Serum creatinine ? 1.5 mg/dl
Serum creatinine ? 1.5 mg/dl
Serum creatinine ? 2.0 mg/dL
Serum creatinine > 2.0 mg/dl
Within 14 days prior to registration: Serum creatinine =< 2.0 mg/dL
Serum creatinine < 2.0 mg/dl within 14 days prior to registration
Serum creatinine < 2.0 mg/dl
Serum/plasma creatinine ?1.5 mg/dL.
Serum creatinine ? 2.5 mg/dL x ULN.
Serum creatinine ? 2.0 mg/dL.
Serum creatinine level =< 1.5 mg/dL
Serum creatinine =< 2 mg/dL
Serum creatinine ? 1.5 g/dL
Serum creatinine =< 1.7 mg/dl
Serum creatinine =< 2.0 mg/dL
Serum creatinine of =< 2 mg/dl
Serum creatinine =< 1.5 mg/dL
Serum creatinine =< 2.0 mg/dl
Serum creatinine =< 2.0 mg/dL (assessed within 14 days prior to study day 0)
Serum creatinine =< 2.0 mg/dL
If the patient is to be treated with cisplatin, the serum creatinine should be =< 1.5 mg%
Serum creatinine =< 2.0 mg/dL
Serum creatinine =< 1.5 mg/dL
Serum creatinine =< 2 mg/dl
Serum creatinine < 2.0 mg/dl
Serum creatinine =< 1.5 mg/dl
serum creatinine ? 3 mg/dL
Serum creatinine < 1.4 mg/dl
Serum creatinine =< 1.5 mg/dL
Serum creatinine that is at or below 2.0 mg/dL
Serum creatinine =< 1.5 mg/dL
Serum creatinine =< 2.5 mg/dL
Serum creatinine =< 2.0 mg/dL
Serum creatinine < 2.0 mg/dL
Serum creatinine >= 2.0 mg/dL
Serum creatinine less than or equal to 2.0 mg/dL
Serum creatinine ?2.0 mg/dL
Serum creatinine =< 2.5 mg/dL
Serum creatinine =< 1.5 mg/dL or 133 umol/L
Serum creatinine =< 2 mg/dL
Serum creatinine =< 2.0 mg/dL or 177 umol/L
Serum creatinine =< 2.0 mg/dL or 177 umol/L
Serum creatinine < 2 mg/dL
Serum creatinine =< 1.5 mg/dl
Serum creatinine =< 1.4 mg/dL
Serum creatinine < 1.4 mg/dL (per manufacturer, metformin is contraindicated in the presence of renal dysfunction defined as a serum creatinine > 1.4 mg/dL in females and in patients with abnormal clearance)
Serum creatinine =< 2.0 mg/dl
Serum creatinine >= 2.0 mg/dL
Serum creatinine =< 2.0 mg/dL
Serum creatinine =< 1.8 mg/dL
Serum creatinine =< 2.5 mg/dL
Serum creatinine < 2.0 mg/dL
DONOR: Serum creatinine < 1.8 mg/dl
Within one week of study entry: Serum creatinine =< 1.5 mg/dl
Serum creatinine =< 1.5 mg/dl
Serum creatinine =< 2.0 mg/dL
Serum creatinine < 2.0 mg/dL
Serum Creatinine < 1.5 mg/dL
Serum creatinine =< 1.6 mg/dL
Serum creatinine =< 2.0 mg/dl
Serum creatinine =< to 1.6 mg/dl
Serum creatinine > 1.5 mg/dL
Serum creatinine < 2.0 mg/dl
Serum creatinine > 1.4 mg/dl =< 28 days prior to study entry
Serum creatinine =< 2.0 mg/dl or
Serum creatinine > 1.6 mg/dl
Serum creatinine less than or equal to 2.0 mg/dL
Serum creatinine =< 2 mg/dL
Serum creatinine =< 2 mg/dL
Serum creatinine =< 1.5 mg/dL
Serum creatinine less than or equal to 1.6 mg/dl
Serum Creatinine ? 2.0 mg/dL
Serum creatinine > 2.0 mg/dL
Serum creatinine =< 2.0 mg/dL
Serum creatinine < 2 mg/dl
Renal insufficiency (serum creatinine > 2 mg/dL).
Serum creatinine =< 2.0 mg/dl
Patients must have a serum creatinine =< 2.0 mg/dL within 72 hours of initiating the induction cycle
Serum creatinine =< 1.8 mg/dl
Serum creatinine > 1.7 mg/dL
Serum creatinine levels =< 1.5 mg/dL
Serum creatinine =< 1.5 mg/dL or 133 umol/L
Serum creatinine =< to 1.6 mg/dl
Serum creatinine =< 1.5 mg/dl
Serum creatinine < 2.0 mg/dl
Serum creatinine > 2 mg/dl
Serum creatinine =< to 1.6 mg/dl
Serum creatinine=< 2.0 mg/dL
Serum creatinine =< 3 mg/dL
Serum creatinine less than or equal to 3 mg/dL within 24 hours of enrollment
Serum creatinine =< 2.0 mg/dL
Serum creatinine less than or equal to 1.6 mg/dl
DONOR: Serum creatinine < 1.8 mg/dL
Serum creatinine greater than 2.0 mg/dl
Renal dysfunction defined as serum creatinine ? 2.0 mg/dl.
Serum creatinine =< 3 mg/dL
Serum creatinine =< 2.9 mg/dL
Serum creatinine ? 1.5 g/dL
Serum creatinine =< to 1.6 mg/dL
Serum creatinine equal to or less than 2.0 mg/dL
Serum Creatinine ? 2.0mg/dL
Serum creatinine ? 1.5 g/dL
Serum creatinine =< 1.5 mg/dl
Serum creatinine =< 2.0 mg/dL
Serum creatinine ? 1.5 mg/dl
Serum creatinine =< 2.0 mg/dL
Serum creatinine =< 3 mg/dL
Serum creatinine =< 2.5 mg/dL
Serum creatinine ?1.5 mg/dL
Serum creatinine =< 2 mg/dL
Serum creatinine =< to 1.6 mg/dl
Serum creatinine < 1.4 mg/dL
Serum creatinine < 1.5 mg/dl
Serum creatinine =/< 2.0mg/dL
Serum M ?500 mg/dL
Serum M ?500 mg/dL
Serum M ?500 mg/dL
A history of renal dysfunction (serum creatinine > 1.8 mg/dL)
Serum creatinine > 1.5 mg/dl
Serum creatinine levels =< 1.5 mg/dL
Adequate renal sufficiency (serum creatinine <1.5 mg/dL).
Serum creatinine < 1.5 mg/dL
Serum creatinine levels =< 1.5 mg/dL
Serum creatinine < 2.0 mg/dL
Serum creatinine > 1.5 mg/dL
Serum creatinine ? 2.0mg/dL.
Serum creatinine =< 2.0 mg/dl
Serum Creatinine =< to 1.6 mg/dl
Serum creatinine =< to 1.6 mg/dl
Serum creatinine < 2.5 mg/dL
Serum creatinine > 2 mg/dL
Serum creatinine =< 1.5 mg/dL OR 1.5 x institutional normal
Serum creatinine < 1.5 mg/dl
Have serum creatinine < 2.0 mg/dl =< 120 days prior to registration
Serum creatinine > 2.5 mg/dL
Serum creatinine >= 2.0 mg/dL
Serum creatinine < 1.5 mg/dL
Serum creatinine < 1.5 mg/dL
Serum creatinine =< 2.0 mg/dl
Serum creatinine =< 1.5 mg/dL
Serum creatinine < 1.5 mg/dl
Serum creatinine =< 1.5 mg/dl
Serum creatinine =< 2 mg/dL
Severe renal failure (serum creatinine > 3.0 mg/dL) within 6 months of study registration
Serum creatinine >1.2 mg/dL
Serum creatinine < 2.0 mg/dl
Serum creatinine < 1.5 mg/dl
Serum creatinine > 2 mg/dL
Serum creatinine =< 2.0 mg/dL
Serum creatinine =< 2.0 mg/dl
Serum creatinine equal to or less than 2 mg/dl
Serum creatinine =< 2 mg/dL
Serum creatinine =< 1.4 mg/dl
Serum creatinine: =< 2.0 mg/dL
Within 28 days prior to signing consent: Serum creatinine > 2.0 mg/dL or 177 umol/L
Serum creatinine < 1.5 mg/dl
Serum creatinine =< 115 umol/L (1.3mg/dL)
Serum creatinine >= 1.4 mg/dl
Serum creatinine =< 1.5 mg/dl
Serum creatinine > 2.5 mg/dL
Serum creatinine > 3.0 mg/dL (270 uM/L)
Serum creatinine =< 2.0 mg/dL, within 2 weeks prior to study start
Serum creatinine > 2.5 mg/dL
Serum creatinine > 2.5 mg/dL
Serum creatinine =< 2.0 mg/dL, obtained within 2 weeks prior to registration
Serum creatinine < 1.6 mg/dL
Have a serum creatinine =< 1.0 mg/dL
Serum creatinine =< 1.5 mg/dL
Serum/plasma creatinine ?1.5mg/dL.
Albumin >= 2.8 g/dL
Albumin >= 2 g/dl
Albumin >= 2.0 g/dL
Albumin ? 2.0 g/dL
Albumin ?3 g/dL
Albumin >= 2.5 g/dL
Albumin > 3.0 g/dL.
Albumin > 3 g/dL
Albumin >= 2.8 g/dL
Albumin >= 2 g/dL
Albumin >= 2.4 g/dL
Albumin ? 3.0 g/dL.
Albumin >= 2 g/dl
Albumin >= 2.5 g/dl
Albumin > 2.8 g/dL.
Albumin ? 3.0 g/dl
Albumin at least 2.8 g/dL
Albumin > 2.7 g/dL
Albumin >= 2.8 g/dL
Albumin >= 3.0 g/dL
Albumin >= 2.5 g/dL
Albumin level ?3 g/dL
Albumin >= 2.0 g/dL
Albumin >= 2.5 g/dL
Albumin >= 3 g/dL.
Albumin >= 2.5 g/dL
Albumin >= 2.0 g/dL
Albumin ? 2 g/dL
Albumin > 2.8 g/dl
Albumin >= 2.5 g/dL
Albumin > 2.7 g/dL
Albumin ? 3g/dL
Albumin > 2.8 g/dL.
Albumin > 3.0 g/dl
Albumin > 2.5 g/dL
Albumin >= 2.5 g/dL
Albumin < 2.0 g/dL or < 20 g/L
Albumin >= 2.5 g/dL
Albumin < 2.0 g/dL or < 20 g/L
Albumin > 2.5 g/dL
Albumin >= 2.5 g/dL
Albumin >= 2.5 g/dL
Albumin > 2.4 g/dL
Albumin > 2.4 g/dL
Albumin > 2 g/dL
Albumin >= 2 g/dl
Albumin < 30 g/L (3.0 g/dL) at screening
Albumin >= 2.5 g/dL
Albumin >= 2 g/dL
Albumin >= 2g/dL
Low baseline albumin < 3.5 g/dl
Albumin ? 2.5 g/dL
albumin ? 2.8 g/dL.
Albumin >= 3 g/dl
Albumin >= 2.0 g/dL
Albumin >= 2.5 g/dL
Albumin >= 2.5 g/dL
Albumin > 2.7 g/dL
Albumin >= 2.5 g/dL
Albumin >= 3 g/dl
Albumin >= 2.5 g/dl
Albumin > 2 g/dL
Albumin >= 2.5 g/dL
Albumin > 2.5 g/dL
Albumin >= 3.0 g/dL
Albumin >= 2.5 g/dL
Albumin >= 2.5 g/dL
Albumin >= 2.5 g/dL
Albumin >= 2.5 g/dL
Albumin < 2.0 g/dL or < 20 g/L
Albumin >= 2.8 g/dL
Albumin >= 2.5 g/dL
Albumin greater than or equal to 3.0 g/dL
Albumin ? 3.0 g/dL
Albumin > 3.0 g/dL
Albumin >= 2.5 g/dL
Subject has albumin < 3.0 g/dL (30 g/L).
Albumin < 3.0 g/dL (30 g/L) at screening;
Albumin > 2.5 g/dL
Albumin ? 2.5 g/dL.
Albumin >2.7 g/dL.
Albumin ? 2 g/dl
Albumin >= 2.8 g/dL
Albumin greater than or equal to 2.8 g/dL
Albumin >= 2.5 g/dL
Albumin >= 2.8 g/dL
Albumin greater than or equal to 2.8 g/dL
Albumin < 3 g/dL
Albumin < 2.8 g/dL (< 28 g/L)
Albumin >= 2.5 g/dL
Albumin >= 3 g/dl
Albumin >= 3 g/dL
Albumin >= 2.5 g/dL
Albumin levels < 2.5 g/dl
Albumin >= 2 g/dl
Albumin >= 3.0 g/dL
Albumin >=2.5 g/dL
Albumin >= 2.5 g/dL
Severe hypoalbuminemia (albumin < 3.0 g/dL);
Albumin >= 2.5 g/dL
Albumin >= 3 g/dl
Albumin > 3.0 g/dL or > 30 g/L
Albumin > 2 g/dL
Albumin ? 2.8 g/dL
Albumin >= 2.5 g/dL
Albumin >= 2.5 g/dL
Albumin < 30 g/L (3.0 g/dL)
Albumin =< 2.5 g/dL
Albumin >= 2 g/dL
Albumin: > 2.5 g/dL
Albumin >= 2.5 g/dl
Albumin > 3.0 g/dl
Albumin > 3.0 g/dl
Albumin > 3.0 g/dl
Albumin ? 2.8 g/dL
Albumin >= 2.6 g/dL
Albumin < 30 g/L (3.0 g/dL) at screening.
Albumin ? 3g/dL
Albumin ? 3g/dL
Albumin < 2.0 g/dL or < 20 g/L
Albumin >= 2.5 g/dL
Albumin >= 2.5 g/dL
Albumin > 3.0 g/dl
Albumin >= 2 g/dL
Albumin ? 2.5 g/dL
Albumin >= 3.0 g/dL
Albumin >= 2 g/dL
Albumin >= 3 g/dL
Albumin > 2.8 g/dl
Albumin > 2.5 g/dl
Albumin >= 2.5 g/dL
Albumin of >= 2.5 g/dl
Plasma albumin >= 3 g/dL
Plasma albumin < 3 g/dL
Albumin >= 2.5 g/dl
Albumin < 3 g/dl
Albumin < 2 g/dl
Albumin < 2 g/dl
Albumin < 2 g/dl
Albumin < 2 g/dL
Albumin >= 2.5 g/dL
Albumin >= 2.5 g/dL
Hypoalbuminemia (albumin < 3.5 g/dL)
Albumin ? 2.5 g/dl.
Progressive disease defined by any of following: 25% increase in serum M-protein from lowest response value during (or after) last therapy and/or absolute increase in serum M-protein of > or equal to 0.5 g/dL; 25% increase in urine M-protein from lowest response value during (or after) last therapy and/or absolute increase in urine M-protein of > or equal to 200 mg/24h; 25% increase in bone marrow plasma cell percentage from lowest response value during (or after) last therapy - absolute bone marrow plasma cell percentage must be > or equal to 10% unless prior complete response when absolute bone marrow plasma cell percentage must be > or equal to 5%; 25% increase in serum FLC level from the lowest response value during (or after) last therapy - the absolute increase must be > 10 mg/dL; new onset hypercalcemia > 11.5 mg/dL
Key Inclusion Criteria:\n\n        Individuals eligible to participate in this study must meet the following key criteria and\n        additional criteria as specified in the protocol:\n\n          1. Male or female, aged ? 18 years\n\n          2. Confirmed diagnosis of MM per IMWG criteria\n\n          3. Measurable disease as defined by one or more of the following:\n\n               -  Serum M-protein ? 0.5 g/dL\n\n               -  Urine M-protein ? 200 mg/24 hours\n\n               -  Serum Free Light Chain (FLC) assay: involved FLC level ? 10 mg/dL provided serum\n                  FLC ratio is abnormal\n\n               -  In cases where SPEP is unreliable, serum quantitative immunoglobulin (qIgA) ? 750\n                  mg/dL (0.75 g/dL) is acceptable\n\n          4. Relapsed or refractory (Rajkumar, 2011) to 3 or more different prior lines of therapy\n             for MM, including immunomodulatory drugs (IMiDs), proteasome inhibitors (PIs),\n             chemotherapies, or monoclonal antibodies, and not a candidate for, or intolerant to\n             established therapy known to provide clinical benefit.\n\n          5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 1\n\n          6. Adequate organ and marrow function at Screening, as defined by the study protocol.\n\n        Key Exclusion Criteria:\n\n          1. Monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma,\n             Waldenstrom's macroglobulinemia, or IgM myeloma\n\n          2. Active plasma cell leukemia (? 2.0 × 109/L circulating plasma cells by standard\n             differential)\n\n          3. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and\n             skin changes)\n\n          4. Prior treatment directed to B-cell Activating Factor (BAFF; BLyS), B-cell Maturation\n             Antigen (BCMA;TNFSF17) or Transmembrane Activator and CAML interactor (TACI;\n             TNFSF13B), including antibodies or BCMA- or TACI-directed Chimeric Antigen Receptor\n             (CAR)-T cell therapy
High-risk MGUS: must have < 10% plasma cells and < 3.0g/dL M-spike and at least 3 of the following 5 criteria:\r\n* Abnormal free light-chain (FLC) ratio (< 0.26 or > 1.65)\r\n* M-protein concentration (>= 1.5 g/dL)\r\n* Reduction of =< 2 non-involved immunoglobulin isotype levels (immunoparesis)\r\n* Abnormal ratio of plasma cells in the bone marrow > 95%\r\n* Non-IgG M protein (including IgA)
Low-risk smoldering multiple myeloma: must only present with 1 of the following criterion:\r\n* Monoclonal Protein >= 3 g/dL\r\n* >= 10% bone marrow plasma cells\r\n* FLC ratio < 0.125 or > 8
No evidence of hypercalcemia, renal-failure, anemia and bone-lesions (CRAB) criteria or new criteria of active MM which including the following:\r\n* Increased calcium levels (corrected serum calcium > 0.25 mmol/dL above the upper limit of normal or > 0.275 mmol/dL)\r\n* Renal insufficiency (attributable to myeloma)\r\n* Anemia (hemoglobin [Hb] 2 g/dL below the lower limit of normal or < 10 g/dL)\r\n* Bone lesions (lytic lesions or generalized osteoporosis with compression fractures)\r\n* No evidence of the following new criteria for active MM including the following: bone marrow plasma cells > 60%, serum involved/uninvolved FLC ratio >= 100, and magnetic resonance imaging (MRI) with more than one focal lesion\r\n** Participants with CRAB criteria that are attributable to conditions other than the disease under study may be eligible
Subject must have documented monoclonal plasma cells in the bone marrow of ?10%, as defined by their institutional standard at some point in their disease history or the presence of a biopsy proven plasmacytoma.
Must meet criteria of high-risk smoldering multiple myeloma (MM) based on the criteria described below:\r\n* Definition of high-risk smoldering multiple myeloma (SMM):\r\n** Bone marrow clonal plasma cells >= 10% and =< 60% and any one or more of the following:\r\n*** Serum M protein >= 3.0 g/dL (immunoglobulin [Ig]A, IgG, IgM, or IgD)\r\n*** IgA SMM\r\n*** Immunoparesis with reduction of two uninvolved immunoglobulin isotypes\r\n*** Serum involved/uninvolved free light chain ratio >= 8 (but less than 100)\r\n**** Free light chain smoldering myeloma patients are not excluded\r\n*** Progressive increase in M protein level (evolving type of SMM)\r\n**** Increase in serum monoclonal protein by >= 10% on two successive evaluations within a 6 month period\r\n*** Bone marrow clonal plasma cells 50-60%\r\n*** Abnormal plasma cell immunophenotype (>= 95% of bone marrow plasma cells are clonal) and reduction of one or more uninvolved immunoglobulin isotypes\r\n*** t (4;14) or del 17p or 1q gain\r\n*** Increased circulating plasma cells\r\n*** Magnetic resonance imaging (MRI) with diffuse abnormalities or 1 focal lesion\r\n*** Positron emission tomography (PET)-computed tomography (CT) with one focal lesion with increased uptake without underlying osteolytic bone destruction\r\n*** Urine monoclonal light chain excretion >= 500 mg/24 hours
No evidence of hypercalcemia, renal failure, anemia, and bone lesions (CRAB) criteria or new criteria of active MM which including the following:\r\n* Increased calcium levels (corrected serum calcium > 0.25 mmol/dL above the upper limit of normal or > .275 mmol/dL) related to MM\r\n* Renal insufficiency (attributable to MM)\r\n* Anemia (hemoglobin [Hb] 2 g/dL below the lower limit of normal or < 10 g/dL) related to MM\r\n* Bone lesions (lytic lesions or generalized osteoporosis with compression fractures)\r\n* Bone marrow plasma cells > 60%\r\n* Serum involved/uninvolved free light chain (FLC) ratio >= 100, provided the absolute level of the involved free light chain is at least 100 mg/L and repeated twice\r\n* MRI with two or more focal lesion that is at least 5 mm or greater in size\r\n** Participants with CRAB criteria that are attributable to conditions other than the disease under study may be eligible
Previously treated myeloma, currently with extramedullary disease (defined as plasmacytoma outside bone marrow that is not contiguous with a bone lesion) with at least one lesion that has a single diameter of >= 2 cm or plasma cell leukemia (defined as circulating plasma cells exceeding 5% of peripheral blood leukocytes or 0.5 X 10^9/L or 200 cells/150000 events by flow cytometry)
Patient must have relapsed or refractory myeloma that fits or did fit International Myeloma Working Group (IMWG) diagnostic criteria for symptomatic myeloma (although new or worsening end organ damage is not required to be eligible) as defined below:\r\n* Presence of clonal bone marrow plasma cells\r\n* Presence of serum and/or urinary measurable monoclonal protein or light chains\r\n* Evidence of any end organ damage criteria listed below (at any time) attributed to the patient’s myeloma:\r\n** Hypercalcemia: serum calcium > 11.5 mg/dL or\r\n** Renal insufficiency: serum creatinine > 2 mg/dL\r\n** Anemia > 2 g/dL below the lower limit of normal or a hemoglobin value < 10 g/dL\r\n** Bone lesions: lytic lesions, severe osteopenia or pathologic fractures
Serum M-protein >= 3 g/dl and/or bone marrow plasma cells >= 10% and < 60%
In addition to having SMM, patients must also be classified as “high-risk SMM” per Mayo Clinic or Spanish Programa Espanol de Tratamientos en Hematologia (PETHEMA) criteria; NOTE:\r\n* Criteria set forward by Rajkumar, Landgren, Mateos may also be used to define high risk disease, namely clonal bone marrow plasma cells >= 10% and any one or more of the following:\r\n** Serum M protein >= 30 g/L\r\n** IgA SMM\r\n** Immunoparesis with reduction of 2 uninvolved immunoglobulin isotypes\r\n** Serum involved/uninvolved FLC ratio >= 8 (but < 100)\r\n** Progressive increase in M protein level (evolving type of SMM; increase in serum M protein by >= 25% on 2 successive evaluations within a 6-month period)\r\n** Clonal bone marrow plasma cells (BMPCs) 50%-60%\r\n** Abnormal PC immunophenotype (>= 95% of BMPCs are clonal) and reduction of >= 1 uninvolved immunoglobulin isotypes\r\n** t(4;14) or del(17p) or 1q gain\r\n** Increased circulating plasma cells (PCs)\r\n** MRI with diffuse abnormalities or 1 focal lesion\r\n** PET-CT with focal lesion with increased uptake without underlying osteolytic bone destruction
Patients with clinical relapse/progression as per the International Myeloma Working Group (IMWG) uniform criteria defined as one or more of the following criteria:\r\n* Development of new soft tissue plasmacytomas or bone lesions (osteoporotic fractures do not constitute progression)\r\n* Definite increase in the size of existing plasmacytomas or bone lesions. A definite increase is defined as a 50% (and >= 1 cm) increase as measured serially of the measurable lesion\r\n* Hypercalcemia (> 11 mg/dL)\r\n* Decrease in hemoglobin of >= 2 g/dL not related to therapy or other non-myeloma-related conditions\r\n* Rise in serum creatinine by 2 mg/dL or more from the start of the therapy and attributable to myeloma\r\n* Hyperviscosity related to serum paraprotein
Clinically overt myeloma a.) Lytic bone lesions or biopsy proven plasmacytoma b.) Hypercalcemia (corrected for albumin) > 11 mg/dL unexplained by other causes
Patients must have been previously diagnosed with histologically or cytologically confirmed symptomatic multiple myeloma, which require the presence of all three of the following International Myeloma Working Group criteria, except as noted:\r\n* Clonal bone marrow plasma cells >= 10%\r\n* A monoclonal protein in either serum or urine\r\n* Evidence of end-organ damage that can be attributed to the underlying plasma cell proliferative disorder (to include one of the following)\r\n** Hypercalcemia (corrected calcium > 2.75 mmol/L or 11.5 mg/dL); OR\r\n** Renal insufficiency attributable to myeloma (serum creatinine > 1.9 mg/dL); OR\r\n** Anemia; normochromic, normocytic with a hemoglobin value >= 2 g/dL below the lower limit of normal, or a hemoglobin or < 10 g/dL; OR\r\n** Bone lytic lesions (magnetic resonance imaging [MRI], computed tomography [CT] or positron emission tomography [PET]/CT with > 1 focal lesions >= 5 mm in size), severe osteopenia or pathologic fractures\r\n* Patients with a biopsy-proven plasmacytoma and either a serum or urine monoclonal protein will also be considered to have met the diagnostic criteria for multiple myeloma in the absence of clonal marrow plasmacytosis of >= 10%\r\n* Patient with bone marrow plasma cells of >= 60% or serum free light chain ratio of >= 100 will also be considered to have met the diagnostic criteria for multiple myeloma
Patients must have disease that has relapsed after carfilzomib therapy, with progressive disease (PD) being defined as an increase of 25% from the lowest response value in any one or more of the following:\r\n* Serum M-component (the absolute increase must be >= 0.5 g/dL) and/or\r\n* Urine M-component (the absolute increase must be >= 200 mg/24 hours) and/or\r\n* Only in patients without a measurable serum and urine M protein level: the difference between involved and uninvolved free light chain (FLC) levels (absolute increase) must be > 10 mg/dL\r\n* Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas\r\n* Development of hypercalcemia (corrected serum calcium > 11.5 mg/dL) that can be attributed solely to the plasma cell proliferative disorder\r\nPatients with relapsed disease will be considered to be those who have had progression, as defined above, off of any therapy, and who completed their therapy more than 60 days prior to the finding of progression; patients with relapsed and refractory disease will be considered to be those who have had progression, as defined above, while still on their last line of therapy, or who progressed within 60 days of finishing their most recent therapy
Previous or current diagnosis of symptomatic multiple myeloma, including the presence of lytic bone disease, plasmacytomas, >= 60 percent (%) plasma cells in the bone marrow, or hypercalcemia
Monoclonal plasma cells in the bone marrow (BM) 10% or presence of a biopsy-proven plasmacytoma
Patients must have histologically confirmed smoldering multiple myeloma (SMM) based on the following criteria; both criteria must be met: (a) serum monoclonal protein (IgG or IgA) >= 3 g/dL or urinary monoclonal protein >= 500 mg per 24 hours and/or clonal bone marrow plasma cells 10-60% (b) absence of myeloma defining events or amyloidosis
Additionally, patients must meet criteria for high risk of progression to multiple myeloma by PETHEMA CRITERIA (patients must have at least 2 risk factors present)\r\n* 1. >= 95% abnormal plasma cells/total plasma cells in bone marrow compartment (this is measured as a percentage of the total abnormal versus normal plasma cells in the bone marrow compartment using standard flow cytometry of the bone marrow aspirate; having >= 95% abnormal plasma cells/total plasma cells constitutes a risk factor for progression to multiple myeloma by PETHEMA criteria) \r\n* 2. Immunoparesis (this term refers to the patient having low uninvolved immunoglobulins in peripheral blood, for example if a patient has IgA smoldering multiple myeloma, then either having a low IgM and/or low IgG will qualify as a risk factor for progression to multiple myeloma)\r\n** 2 of 2 risk factors: high risk for progression at a rate of 72% at 5 years
Evidence of myeloma defining events or biomarkers of malignancy due to underlying plasma cell proliferative disorder meeting at least ONE of the following: \r\n* 1. Hypercalcemia: serum calcium > 0.25 mmol/L (> 1 mg/dL) higher than the upper limit of normal or > 2.75 mmol/L (> 11 mg/dL) \r\n* 2. Renal insufficiency: creatinine clearance < 50 ml/min or serum creatinine > 2 mg/dL \r\n* 3. Anemia: hemoglobin value < 10 g/dL or 2 g/dL < normal reference \r\n* 4. Bone lesions: one or more osteolytic lesions on skeletal radiography, computerized tomography (CT) or 2-deoxy-2[F-18] fluoro-D-glucose positron emission tomography CT (PET-CT) \r\n* 5. Clonal bone marrow plasma cell percentage >= 60% \r\n* 6. Involved: uninvolved serum free light chain ratio >= 100 measured by freelite assay\r\n* 7. > 1 focal lesions on magnetic resonance imaging (MRI) studies (each focal lesion must be 5 mm or more in size)
No end organ damage attributable to a plasma cell disorder, defined as having ANY of the following:\r\n* Hypercalcemia: serum calcium > 1 mg/dL above the upper limit of normal or > 11 mg/dL\r\n* Renal insufficiency: serum creatinine > 2 mg/dL or creatinine clearance < 30 mL per min\r\n* Anemia: hemoglobin value > 2 g/dL below the upper limit of normal or a hemoglobin value < 10 g/dL\r\n* Bone lesions: one or more lytic lesions on skeletal radiography, computed tomography (CT), MRI, PET-CT, or PET-MRI
Clonal bone marrow plasma cells >= 10% or biopsy-proven bony or extramedullary plasmacytoma and any one or more of the following myeloma defining events:\r\nEvidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically:\r\n* Serum calcium > 0.25 mmol/L (> 1 mg/dL) higher than the upper limit of normal or > 2.75 mmol/L (> 11 mg/dL)\r\n* Creatinine clearance < 40 mL per min (measured or estimated by validated equations) or serum creatinine > 177 umol/L (> 2 mg/dL)\r\n* Hemoglobin value of > 20 g/L below the lower limit of normal, or a hemoglobin value\r\n* One or more osteolytic lesions on skeletal radiography, computed tomography (CT), or positron emission tomography (PET)-CT; if bone marrow has less than 10% clonal plasma cells, more than one bone lesion is required to distinguish from solitary plasmacytoma with minimal marrow involvement\r\n* Any one or more of the following biomarkers of malignancy: \r\n** Clonal bone marrow plasma cell percentage ?60%; clonality should be established by showing kappa/lambda-light-chain restriction on flow cytometry, immunohistochemistry, or immunofluorescence; bone marrow plasma cell percentage should preferably be estimated from a core biopsy specimen; in case of a disparity between the aspirate and core biopsy, the highest value should be used\r\n** Involved:uninvolved serum free light chain ratio >= 100 mg/L; these values are based on the serum Freelite assay (The Binding Site Group, Birmingham, UK); the involved free light chain must be >= 100 mg/L\r\n** > 1 focal lesions on magnetic resonance imaging (MRI) studies; each focal lesion must be 5 mm or more in size
Subjects must have disease that has relapsed and/or refractory after their most recent therapy, with progressive disease (PD) being defined as an increase of 25% from the lowest response value in any one or more of the following: \r\n* Serum M-protein (the absolute increase must be >= 0.5 g/dL) and/or\r\n* Urine M-protein (the absolute increase must be >= 200 mg/24 hours) and/or\r\n* Only in subjects without a measurable serum and urine M protein level: the difference between involved and uninvolved free light chain (FLC) levels (absolute increase) must be > 10 mg/dL\r\n* Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas\r\n* Development of hypercalcemia (corrected serum calcium > 11.5 mg/dL) that can be attributed solely to the plasma cell proliferative disorder
Patients must have histologically or cytologically confirmed symptomatic multiple myeloma (MM), Salmon-Durie stage II or III, or International Staging System II or III or fulfill the calcium, renal failure, anemia, and bone lesions (CRAB) criteria; patients should not have previously been treated; finally, patients must meet at least one of the following parameters of measurable disease:\r\n* Bone marrow plasmacytosis with > 10% plasma cells, or sheets of plasma cells, or biopsy proven plasmacytoma which must be obtained within 6 weeks prior to registration\r\n* Measurable levels of M-protein: >= 1 g/dL on serum protein electrophoresis (SPEP) or >= 200 mg of monoclonal light chain on a 24 hour urine protein electrophoresis (UPEP) or involved free light chain (FLC) >= 10 mg/dL (>= 100 mg/L) which must be obtained within 4 weeks prior to registration\r\nSerum and urine M-protein levels should be determined by electrophoresis rather than by quantitative immunoglobulin (Ig) measurement; exceptions are made in cases in which the M-spike value may be deemed to be unreliable (e.g. co-migrating M-spike); in these cases, quantitative Ig should be used; to assess response and progression, however, SPEP values should only be compared to SPEP values and quantitative Ig values only to quantitative Ig values
Clonal bone marrow plasma cells > 10%
Subjects must have documented multiple myeloma as defined by the criteria below:\r\n* Clonal bone marrow plasma cells >= 10% or biopsy-proven bony or extramedullary plasmacytoma and any one or more of the following calcium, renal failure, anemia, bone lesions (CRAB) features and myeloma-defining events (MDEs)\r\n* Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically:\r\n** Hypercalcemia: serum calcium > 0.25 mmol/L (> 1 mg/dL) higher than the upper limit of normal or > 2.75 mmol/L (> 11 mg/dL)\r\n** Renal insufficiency: creatinine clearance < 40 mL per minute or serum creatinine > 177 umol/L (> 2 mg/dL)\r\n** Anemia: hemoglobin value of > 20 g/L below the lowest limit of normal, or a hemoglobin value < 100 g/L\r\n** Bone lesions: one or more osteolytic lesion on skeletal radiography, computed tomography (CT), or positron emission tomography (PET)/CT\r\n* Any one or more of the following biomarkers of malignancy (MDEs)\r\n** 60% or greater clonal plasma cells on bone marrow examination\r\n** Serum involved / uninvolved free light chain ratio of 100 or greater, provided the absolute level of the involved free light chain is at least 100 mg/L (a patient’s “involved” free light chain – either kappa or lambda – is the one that is above the normal reference range; the uninvolved light chain is the one that typically is in, or below, the normal range)\r\n** More than one focal lesion on magnetic resonance imaging (MRI) that is at least 5 mm or greater in size
Subjects must have disease that has relapsed and/or refractory after their most recent therapy, with progressive disease (PD) being defined as an increase of 25% from the lowest response value in any one or more of the following:\r\n* Serum M-component protein (the absolute increase must be >= 0.5 g/dL) and/or\r\n* Urine M-component protein (the absolute increase must be >= 200 mg/24 hours) and/or\r\n* Only in subjects without a measurable serum and urine M protein level: the difference between involved and uninvolved free light chain (FLC) levels (absolute increase) must be > 10 mg/dL\r\n* Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas\r\n* Development of hypercalcemia (corrected serum calcium > 11.5 mg/dL) that can be attributed solely to the plasma cell proliferative disorder
Patient has confirmed SMM according to a definition derived from the International Myeloma Working Group (IMWG) definition (International Working Group, 2003): serum M-protein >= 3 g/dL or bone marrow plasma cells (BMPC) > 10%, or both, along with normal organ and marrow function (CRAB) within 4 weeks before baseline\r\n* C: absence of hypercalcemia, evidenced by a calcium < 10.5 mg/dL\r\n* R: absence of renal failure, evidenced by a creatinine < 1.5 mg/dL (177 umol/L) or calculated creatinine clearance (using the Modification of Diet in Renal Disease [MDRD] formula) > 50 mL/min\r\n* A: absence of anemia, evidenced by a hemoglobin > 10 g/dL\r\n* B: absence of lytic bone lesions on standard skeletal survey
Participants must have a diagnosis of MM, according to International Myeloma Foundation 2003 Diagnostic Criteria; according to these criteria, the following must be met:\r\n* Monoclonal plasma cells in the bone marrow >= 10% (or proven plasmocytic infiltration in bone marrow biopsy) and/or presence of a biopsy-proven plasmacytoma within 35 days of initiation of protocol therapy\r\n* Monoclonal protein (M-protein) present in the serum and/or urine\r\n* Myeloma-related organ dysfunction (1 or more) of the following; a variety of other types of end-organ dysfunctions can occasionally occur and lead to a need for therapy; Note: laboratory assessments used to support the calcium, kidney (renal) failure, anemia, bone lesions (CRAB) criteria in the International Myeloma Foundation (IMF) 2003 Diagnostic Criteria of MM are performed at the time of diagnosis; these assessments are not required to be performed within the 21 days of initiation of protocol therapy\r\n** [C] Calcium elevation in the blood, defined as serum calcium > 10.5 mg/dl or upper limit of normal\r\n** [R] Renal insufficiency (defined as serum creatinine above normal)\r\n** [A] Anemia, defined as hemoglobin < 10 g/dl or 2 g < normal\r\n** [B] Lytic bone lesions or osteoporosis; if a solitary (biopsy-proven) plasmacytoma or osteoporosis alone (without fractures) are the sole defining criteria, then >= 30% plasma cells are required in the bone marrow or proven plasmocytic infiltration in bone/bone\r\n* Note: these criteria identify stage IB (if the creatinine is > 2 mg/dl at marrow biopsy presentation) and stages II and III A/B myeloma by Durie-Salmon stage; stage IA becomes smoldering or indolent myeloma
Patients must be diagnosed with asymptomatic high-risk smoldering multiple myeloma (SMM) within the past 60 months, as confirmed by both of the following:\r\n* Bone marrow plasmacytosis with >= 10% plasma cells or sheets of plasma cells at any time before initiating study treatment, including a marrow which must be obtained by bone marrow aspiration and/or biopsy within 4 weeks prior to randomization\r\n* Abnormal serum free light chain ratio (< 0.26 or > 1.65) by serum free light chain (FLC) assay; FLC assay must be performed within 28 days of randomization
Patients diagnosed with symptomatic multiple myeloma based on International Myeloma Working Group (IMWG) diagnostic criteria; according to these criteria, patient must have monoclonal plasma cells in the bone marrow >= 10% and/or presence of a biopsy-proven bony or extramedullary plasmacytoma and any one or more of the following myeloma defining events:\r\n* Clonal bone marrow plasma cell percentage >= 60% (Note: clonality should be established by showing kappa/lambda-light-chain restriction on flow cytometry, immunohistochemistry, or immunofluorescence; bone marrow plasma cell percentage should preferably be estimated from a core biopsy specimen; in case of a disparity between the aspirate, the highest value should be used) \r\n* Involved: uninvolved serum free light chain ratio >= 100 (values are based on the serum Freelite assay); the involved free light chain must be >= 10 mg/dL\r\n* > 1 focal lesions on magnetic resonance imaging (MRI) studies (each focal lesion must be 5 mm or more in size) \r\n* (C) Calcium elevation in the blood, defined as serum calcium > 11 mg/dL or > 1 mg/dL higher than the upper limit of normal\r\n* (R) Renal insufficiency, defined as serum creatinine > 2 mg/dl or creatinine clearance < 40 mL/min\r\n* (A) Anemia, defined as hemoglobin < 10 g/dl or > 2 g/dl below the lower limit of normal\r\n* (B) Lytic bone lesions, one or more osteolytic lesions on skeletal radiography, computed tomography (CT), or positron emission tomography (PET)-CT (if bone marrow has less than 10% clonal plasma cells, more than one bone lesion is required to distinguish from solitary plasmacytoma with minimal marrow involvement)
Participant has a diagnosis of Waldenström's disease, or other conditions in which IgM M protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions
Clonal bone marrow plasma cells ?10% or biopsy-proven bony or extramedullary plasmacytoma
Clonal bone marrow plasma cell percentage* ?60%
If no monoclonal protein is detected, then ? 30% monoclonal bone marrow plasma cells
Must meet criteria of high risk smoldering MM based on the criteria described below:\r\n* Definition of high-risk smoldering multiple myeloma (SMM):\r\n** Bone marrow clonal plasma cells >= 10% and =< 60% and any one or more of the following:\r\n*** Serum monoclonal (M) protein >= 3.0 g/dL (IgA, IgG, IgM, or IgD)\r\n*** IgA SMM\r\n*** Immunoparesis with reduction of two uninvolved immunoglobulin isotypes\r\n*** Serum involved/uninvolved free light chain ratio >= 8 (but less than 100)\r\n**** Free light chain smoldering myeloma patients are not excluded\r\n*** Progressive increase in M protein level (evolving type of SMM)\r\n**** Increase in serum monoclonal protein by >= 10% on two successive evaluations within a 6 month period\r\n*** Bone marrow clonal plasma cells 50-60%\r\n*** Abnormal plasma cell immunophenotype (>= 95% of bone marrow plasma cells are clonal) and reduction of one or more uninvolved immunoglobulin isotypes\r\n*** t (4;14) or del 17p or 1q gain\r\n*** Increased circulating plasma cells\r\n*** Magnetic resonance imaging (MRI) with diffuse abnormalities or 1 focal lesion\r\n*** Positron emission tomography (PET)-computed tomography (CT) with one focal lesion with increased uptake without underlying osteolytic bone destruction\r\n*** Urine monoclonal light chain excretion >= 500 mg/24 hours
No evidence of increased calcium levels, renal insufficiency, anemia or bone lesions (CRAB criteria) or new criteria of active MM which including the following:\r\n* Increased calcium levels (corrected serum calcium > 0.25 mmol/dL [> 1mg/dL] above the upper limit of normal or > 2.75 mmol/dL [11mg/dL]) related to MM\r\n* Renal insufficiency (attributable to MM)\r\n** Participants with creatinine levels =< 1.5 mg/dL not attributable to myeloma are eligible\r\n* Anemia (hemoglobin [Hb] 2 g/dL below the lower limit of normal or < 10 g/dL) related to MM\r\n* Bone lesions (lytic lesions or generalized osteoporosis with compression fractures)\r\n* Bone marrow plasma cells >= 60%\r\n* Serum involved/uninvolved free light chain (FLC) ratio >= 100, provided the absolute level of the involved free light chain is at least 100 mg/L and repeated twice (light chain smoldering myeloma is not an exclusion criteria)\r\n* MRI with two or more focal lesions that are at least 5 mm or greater in size\r\n* Participants with CRAB criteria that are attributable to conditions other than the disease under study may be eligible
Absence of clonal bone marrow plasma cell percentage >= 60%
Adult patients with intermediate or high-risk smoldering multiple myeloma (SMM) are eligible; patients need to have clonal bone marrow plasma cells >= 10% and/or monoclonal spike in blood of >= 3 g/dL and/or monoclonal urine component (Bence jones proteinuria) >= 500 mg/24 hours and need to meet subject inclusion criteria and exclusion criteria as per below
Evidence of myeloma defining events or biomarkers of malignancy due to underlying plasma cell proliferative disorder meeting at least one of the following\r\n* 1) Hypercalcemia: serum calcium > 0.25 mmol/L (> 1 mg/dL) higher than the upper limit of normal or > 2.75 mmol/L (> 11 mg/dL)\r\n* 2) Renal insufficiency: creatinine clearance < 40 ml/min or serum creatinine > 2 mg/dL\r\n* 3) Anemia: hemoglobin value < 10 g/dL or 2 g/dL < normal reference\r\n* 4) Bone lesions: one or more osteolytic lesions on skeletal radiography, computerized tomography (CT) or 2-deoxy-2[F-18] fluoro-D-glucose positron emission tomography CT (PET-CT)\r\n* 5) Clonal bone marrow plasma cell percentage >= 60%\r\n* 6) Involved: uninvolved serum free light chain ratio >= 100 measured by Freelite assay (The Binding Site Group, Birmingham, United Kingdom [UK])\r\n* 7) > 1 focal lesions on magnetic resonance imaging (MRI) studies (each focal lesion must be 5 mm or more in size), if clinically indicated
Clonal bone marrow plasma cells >= 10% or biopsy-proven bony or extramedullary plasmacytoma and any one or more of the following defining events: \r\n* End organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically:
One or more of the following biomarkers of malignancy:\r\n* Clonal bone marrow plasma cell percentage >= 60%\r\n* Involved: uninvolved serum free light chain ratio >= 100\r\n* > 1 focal lesions on magnetic resonance imaging (MRI) studies
Participants must have a diagnosis of multiple myeloma (MM) according Revised International Myeloma Working Group diagnostic criteria, which require the following findings,\r\n* Clonal bone marrow plasma cells >= 10% or biopsy-proven bony or extramedullary plasmacytoma and any one or more of the following myeloma defining events:\r\n** End organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically:\r\n*** Hypercalcemia: serum calcium > 0.25 mmol/L (> 1 mg/dL) higher than the upper limit of normal or > 2.75 mmol/L (> 11 mg/dL)\r\n*** Renal insufficiency: creatinine clearance < 40 mL per min or serum creatinine > 177 umol/L (> 2 mg/dL)\r\n*** Anemia: hemoglobin value of > 20 g/L below the lower limit of normal, or a hemoglobin value < 100 g/L\r\n*** Bone lesions: one or more osteolytic lesions on skeletal radiography, computed tomography (CT), or positron emission tomography (PET)-CT\r\n** One or more of the following biomarkers of malignancy:\r\n*** Clonal bone marrow plasma cell percentage >= 60%\r\n*** Involved: uninvolved serum free light chain ratio >= 100\r\n*** > 1 focal lesions on magnetic resonance imaging (MRI) studies
Must meet criteria of high risk smoldering MM as described with one of the below criteria:\r\n* Bone marrow clonal plasma cells >= 10% and any one or more of the following: \r\n** Serum M protein >= 3.0 g/dL \r\n** Immunoglobulin A (IgA) smoldering multiple myeloma (SMM)\r\n** Immunoparesis with reduction of two uninvolved immunoglobulin isotypes\r\n** Serum involved/uninvolved free light chain ratio >= 8 (but less than 100)\r\n*** Free light chain smoldering myeloma patients are not excluded\r\n** Progressive increase in M protein level (evolving type of SMM)\r\n** Bone marrow clonal plasma cells 50-60%\r\n** Abnormal plasma cell immunophenotype (>= 95% of bone marrow plasma cells are clonal) and reduction of one or more uninvolved immunoglobulin isotypes\r\n*** All patients should have four or six color flow cytometry performed on the baseline bone marrow sample, as feasible; patients evaluated for eligibility by Spanish Criteria must have their result confirmed by four color flow cytometry; if four or six color flow cytometry is not available at the site, the baseline bone marrow must be sent to Dana-Farber Cancer Institute to confirm eligibility prior to enrollment\r\n** t (4;14) or del 17p or 1q gain\r\n** Increased circulating plasma cells\r\n** Magnetic resonance imaging (MRI) with diffuse abnormalities or 1 focal lesion (>= 5 mm)\r\n** Positron emission tomography (PET)-computed tomography (CT) with one focal lesion (>= 5 mm) with increased uptake without underlying osteolytic bone destruction\r\n*** Increase in serum monoclonal protein by >= 10% on two successive evaluations within a 6 month period
No evidence of Calcium, Renal, Anemia, and Bone (CRAB) criteria or new criteria of active MM which including the following:\r\n* Increased calcium levels: corrected serum calcium > 0.25 mmol/L (> 1 mg/dL) above the upper limit of normal or > 2.75 mmol/L (> 11 mg/dL)\r\n* Renal insufficiency (attributable to myeloma)\r\n* Anemia (hemoglobin [Hgb] 2 g/dL below the lower limit of normal or < 10 g/dL)\r\n* Bone lesions (lytic lesions or generalized osteoporosis with compression fractures)\r\n* No evidence of the following new criteria for active MM including the following:\r\n** Bone marrow plasma cells > 60%, serum involved/uninvolved free light-chain (FLC) ratio >= 100, and MRI with more than one focal lesion\r\n* Participants with CRAB criteria that are attributable to conditions other than the disease under study may be eligible
Participant must have documented multiple myeloma satisfying the calcium elevation, renal insufficiency, anemia, and bone abnormalities (CRAB) diagnostic criteria, monoclonal plasma cells in the bone marrow greater than or equal to 10 percent (%) or presence of a biopsy proven plasmacytoma, and measurable secretory disease, as assessed by the central laboratory, and defined in protocol
Participant has a diagnosis of Waldenstrom's disease, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions
Multiple Myeloma according to the International Myeloma Working Group definition (2) i.e.: clonal bone marrow plasma cells >= 10% or biopsy-proven bony or extramedullary plasmacytoma and any one or more of the following myeloma defining events and/or one or more of the biomarkers for malignancy at the time of diagnosis:\r\n* Myeloma defining events:\r\n** Hypercalcemia: serum calcium > 0.25 mmol/L (> 1 mg/dL) higher than the upper limit of normal or > 2.75 mmol/L (> 11 mg/dL)\r\n** Renal insufficiency: creatinine clearance < 40 mL per minimum (min) or serum creatinine > 177 umol/L (> 2 mg/dL)\r\n** Anemia: hemoglobin value of > 20 g/L below the lower limit of normal, or a hemoglobin value < 100 g/L\r\n** Bone lesions: one or more osteolytic lesions on skeletal radiography, computed tomography (CT), or positron emission tomography (PET)-CT\r\n* Biomarkers of malignancy:\r\n** Clonal bone marrow plasma cell percentage >= 60%\r\n** Involved: uninvolved serum free light chain ratio >= 100\r\n** > 1 focal lesions on magnetic resonance imaging (MRI) studies
Evidence of underlying end organ damage and/or myeloma defining event attributed to underlying plasma cell proliferative disorder meeting at least one of the following:\r\n* Hypercalcemia: serum calcium > 0.25 mmol/L (> 1 mg/dL) above upper limit of normal or >= 2.75 mmol/L (11 mg/dL)\r\n* Anemia: hemoglobin value < 10 g/dL or > 2 g/dL below lower limit of normal\r\n* Bone disease: >= 1 lytic lesions on skeletal X-ray, computed tomography (CT), or positron emission tomography (PET)-CT; for patients with 1 lytic lesion, bone marrow should demonstrate >= 10% clonal plasma cells\r\n* Clonal bone marrow plasma cell percentage >= 60%\r\n* Involved/un-involved serum free light chain ratio >= 100 and involved free light chain > 100 mg/L\r\n* > 1 focal lesion on magnetic resonance imaging study (lesion must be > 5 mm) in size
Plasma phosphate >= 2.3 and < 4.8 mg/dL
Meets criteria for symptomatic multiple myeloma, defined as:\r\n* >= 10% monoclonal plasma cells in the marrow AND ANY OF THE FOLLOWING:\r\n** Biopsy-confirmed plasmacytoma\r\n** Lytic bone lesion(s)\r\n** Hypercalcemia without other explanation
Clonal bone marrow plasma cells >= 10% or biopsy-proven bony or extramedullary plasmacytoma and any one or more of the following myeloma defining events: \r\n* Myeloma defining events: \r\n** Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically:\r\n*** Hypercalcaemia: serum calcium > 0.25 mmol/L (> 1 mg/dL) higher than the upper limit of normal or > 2.75 mmol/L (> 11 mg/dL) \r\n*** Renal insufficiency: creatinine clearance < 40 mL per min or serum creatinine > 177 mol/L (> 2 mg/dL)\r\n*** Anemia: hemoglobin value of > 20 g/L below the lower limit of normal, or a hemoglobin value < 100 g/L\r\n*** Bone lesions: one or more osteolytic lesions on skeletal radiography, computed tomography (CT), or positron emission tomography (PET)-CT \r\n* Any one or more of the following biomarkers of malignancy: \r\n** Clonal bone marrow plasma cell percentage 60% \r\n** Involved:uninvolved serum free light chain ratio 100 > 1 focal lesions on magnetic resonance imaging (MRI) studies\r\n* If bone marrow has less than 10% clonal plasma cells, more than one bone lesion is required to distinguish from solitary plasmacytoma with minimal marrow involvement
For lymphoplasmacytic lymphoma patients without measurable lymphadenopathy, measurable disease can be defined by both of the following criteria: bone marrow lymphoplasmacytosis with > 10% lymphoplasmacytic cells or aggregates, sheets, lymphocytes, plasma cells, or lymphoplasmacytic cells on bone marrow biopsy; quantitative immunoglobulin (Ig)M monoclonal protein > 1,000 mg/dL
Evidence of underlying end organ damage and/or myeloma defining event attributed to underlying plasma cell proliferative disorder meeting at least one of the following:\r\n* Hypercalcemia: serum calcium > 0.25 mmol/L (> 1 mg/dL) above upper limit of normal or >= 2.75 mmol/L (11 mg/dL)\r\n* Anemia: hemoglobin value < 10 g/dL or > 2 g/dL below lower limit of normal\r\n* Bone disease: >= 1 lytic lesions on skeletal X-ray, computed tomography (CT) or positron emission tomography (PET)-CT; for patients with 1 lytic lesion, bone marrow should demonstrate >= 10% clonal plasma cells\r\n* Clonal bone marrow plasma cell percentage >= 60%\r\n* Involved/un-involved serum free light chain ratio >= 100 and involved free light chain > 100mg/L\r\n* > 1 focal lesion on magnetic resonance imaging study (lesion must be > 5 mm) in size
Myeloma relapsing from partial response or better\r\n* Patients relapsing > 18 months from transplant if not on maintenance, or\r\n* If off maintenance, discontinued at least 6 months ago, or\r\n* If relapsing on maintenance, at least 3 years from transplant, or\r\n* Off prior myeloma therapy at least 6 months ago\r\n* Sufficient tumor burden that is assessable for response\r\n** Serum M-spike >= 0.5 g/dL, or\r\n** If immunoglobulin A (IgA) myeloma, IgA > 1000 mg/dL, or\r\n** Difference between involved and uninvolved free light chain (dFLC) > 10 mg/dL, or\r\n** Urine M-spike >= 200 mg/24 hours, or\r\n** Bone marrow plasmacytosis >= 10%, or\r\n** Plasmacytoma >= 2 cm in diameter
Bone marrow plasma cells ? 30% or clinical manifestations of multiple myeloma, such as hypercalcemia or lytic bone lesions
Patients must have a history of symptomatic multiple myeloma according to the International Myeloma Working Group criteria (IMWG, 2003), as defined as the following three criteria:\r\n* Clonal plasma cells > 10% on bone marrow biopsy\r\n* A monoclonal protein (paraprotein) in either serum or urine (except in cases of non-secretory myeloma)\r\n* Evidence of end-organ damage felt related to the plasma cell disorder (related organ or tissue impairment, ROTI, commonly referred to by the acronym \calcium, renal failure, anemia, and bone lesions [CRAB]\):\r\n* Hypercalcemia serum calcium (Ca) >= 11.5 mg/dL or\r\n* Renal insufficiency attributable to myeloma; serum creatinine > 2mg/dL\r\n* Anemia: Normochromic, normocytic with a hemoglobin value > 2g/dL below the lower limit of normal or a hemoglobin < 10 g/dL\r\n* Bone lesions (lytic lesions, severe osteopenia or pathologic fractures)
Monoclonal plasma cells in the bone marrow ?10% and/or presence of a biopsy-proven plasmacytoma
Participants must have confirmed high-risk monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma (SMM) as defined below:\r\n* MGUS\r\n** Serum monoclonal protein level < 3 g/dL but > 1.5 g/dl\r\n** Non-immunoglobulin (Ig)G MGUS (i.e. IgA, IgM, IgD MGUS)\r\n** Abnormal serum free light chain ratio (i.e. ratio of kappa to lambda free light chains < 0.26 or > 1.65)\r\n* SMM (also referred to as asymptomatic multiple myeloma)\r\n** Serum monoclonal protein (IgG or IgA) level >= 3 g/dL,\r\n** And/or bone marrow plasma cells >= 10%\r\n** Absence of end-organ damage, such as lytic bone lesions, anemia, hypercalcemia, or renal failure, that can be attributed to a plasma cell proliferative disorder
Diagnosis of any stage of multiple myeloma based on standard criteria as follows:\r\n* Major criteria\r\n1. Plasmacytomas on tissue biopsy\r\n2. Bone marrow plasmacytosis (> 30% plasma cells)\r\n3. Monoclonal immunoglobulin spike on serum electrophoresis (immunoglobulin G [IgG] > 3.5 G/dL or immunoglobulin A [IgA] > 2.0 G/dL) or kappa or lambda light chain excretion > 1 G/day on 24 hour urine protein electrophoresis\r\n* Minor criteria\r\na. Bone marrow plasmacytosis (10 to 30% plasma cells)\r\nb. Monoclonal immunoglobulin present but of lesser magnitude than given under major criteria\r\nc. Lytic bone lesions\r\nd. Normal immunoglobulin M (IgM) < 50 mg/dL, IgA < 100 mg/dL, or IgG < 600 mg/dL\r\n* Any of the following sets of criteria will confirm the diagnosis of multiple myeloma:\r\n** Any two of the major criteria\r\n** Major criterion 1 plus minor criterion b, c, or d\r\n** Major criterion 3 plus minor criterion a or c\r\n** Minor criteria a, b and c or a, b and d
Monoclonal plasma cells in the bone marrow greater than or equal to 10% and/or presence of a biopsy-proven plasmacytoma, and
MM\r\n* Absence of monoclonal protein in serum and urine by immunofixation with no current evidence of soft tissue plasmacytoma\r\n* Bone marrow aspirate and biopsy must demonstrate less than 5 percent clonal plasma cells\r\n* In patients who lack measurable M proteins in the serum and urine being monitored using the free light chain (FLC) levels, the definition of complete response (CR) requires a normalization of the FLC ratio in addition to the above criteria