{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"24"}],"units":"Participants"}],"description":"The proportion of response-evaluable patients experiencing ORR will be estimated, with a 95% exact binomial confidence interval. Amyloid-related organ response will be evaluated on the basis of the accepted criteria described: Kidneys: 30% reduction or drop below 0.5 g in 24-hour urine protein excretion in the absence of progressive renal insufficiency. Heart: N-terminal pro b-type natriuretic peptide (NT-proBNP) or B-type natriuretic peptide response (\\>30% and \\>300 ng/L decrease in patients with baseline NT-proBNP ≥ 650 ng/L or New York Heart Association (NYHA) class response (≥ 2 class decrease in subjects with baseline NYHA class 3 or 4). Liver: 50% decrease of an initially elevated alkaline phosphatase level or reduction in the size of the liver by at least 2 cm. Neuropathy: improvement supported by clinical history, neurologic exam, orthostatic vital signs, resolution of severe constipation or reduction of diarrhea to less than 50% of previous movements/day.","groups":[{"description":"Subjects with AL will receive Bendamustine and Dexamethasone\n\nBendamustine: Patients will start bendamustine at dose level 0 and according to CrCl on day 1 and 2 of each cycle:\n\n* CrCl ≥ 60 mL/min: 100 mg/m2 IV on day 1 and 2 of each cycle\n* CrCl 59 - 30 mL/min: 90 mg/m2 IV on day 1 and 2 of each cycle\n\nAvailable to qualifying subjects is the option to dose escalate to dose level (+)1:\n\n* 120 mg/m2 (if CrCl ≥ 60 mL/min at the time of inclusion into the study)\n* 100 mg/m2 (if CrCl 59-30 mL/min at the time of inclusion into the study)\n\nDexamethasone: 40 mg orally on days 1, 8, 15, 22 of each cycle","id":"OG000","title":"Treatment Arm"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"Up to 2 years","title":"Organ Response Rate (ORR)","type":"SECONDARY","unitOfMeasure":"Participants"}