{"analyses":[{"ciNumSides":"TWO_SIDED","estimateComment":"Because no dose limiting toxicities were noted, the recommended phase 2 dose for patients with creatinine clearance of 30 to 60 mL/min is 25 mg/day","groupDescription":"Recommended Phase 2 dose for Group A","groupIds":["OG000","OG001","OG002"],"nonInferiorityComment":"Recommended Phase 2 dose for Group A","nonInferiorityType":"OTHER","paramType":"Dose in milligrams per day","paramValue":"25"},{"ciNumSides":"TWO_SIDED","estimateComment":"Because no dose limiting toxicities were noted, the recommended phase 2 dose of lenalidomide is 25 mg/day for patients with creatinine clearance \\< 30 mL/minute who are not on dialysis","groupDescription":"Recommended phase 2 dose for patients in Group B","groupIds":["OG003","OG004","OG005","OG006"],"nonInferiorityComment":"Recommended phase 2 dose for patients in Group B","nonInferiorityType":"OTHER","paramType":"Dose in milligrams/day","paramValue":"25"},{"ciNumSides":"TWO_SIDED","estimateComment":"Because no dose limiting toxicities were observed, the recommended phase 2 dose of lenalidomide is 25 mg/day for patients with creatinine clearance \\< 30 mL/min who are receiving dialysis","groupDescription":"Recommended phase 2 dose for Group C","groupIds":["OG007","OG008","OG009","OG010"],"nonInferiorityComment":"Recommended phase 2 dose for Group C","nonInferiorityType":"OTHER","paramType":"Lenalidomide dose in mg/day","paramValue":"25"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"8"},{"groupId":"OG007","value":"3"},{"groupId":"OG008","value":"3"},{"groupId":"OG009","value":"3"},{"groupId":"OG010","value":"5"}],"units":"Participants"}],"description":"Dose Limiting Toxicity (DLT) was defined as any of the following events determined by the investigator to be possibly, probably, or definitely related to lenalidomide within the first cycle of therapy irrespective of whether the adverse events resolved:\n\n* Grade 3 or higher neutropenia with fever ≥38.5 degrees C\n* Grade 4 neutropenia ≥7 days\n* Grade 4 or higher thrombocytopenia\n* Other non-hematologic Grade 4 or higher adverse event not present prior to starting therapy or not due to underlying cause","groups":[{"description":"CrCl 30-60 mL/min, Lenalidomide at 10 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days along with anticoagulants.","id":"OG000","title":"Group A Lenalidomide 10 mg/Day"},{"description":"CrCl 30-60 mL/min, Lenalidomide at 15 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.","id":"OG001","title":"Group A Lenalidomide 15 mg/Day"},{"description":"CrCL 30-60 mL/min, Lenalidomide at 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.","id":"OG002","title":"Group A Lenalidomide 25 mg/Day"},{"description":"CrCl\\<30 mL/min, not on dialysis, Lenalidomide at 15 mg/every 2 days for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.","id":"OG003","title":"Group B Lenalidomide 15 mg/2 Days"},{"description":"CrCl \\< 30 mL/min, not on dialysis, Lenalidomide at 25 mg every 2 days for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.","id":"OG004","title":"Group B Lenalidomide 25 mg/2 Days"},{"description":"CrCl \\< 30 mL/min, not on dialysis, Lenalidomide at 15 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.","id":"OG005","title":"Group B Lenalidomide 15 mg/Day"},{"description":"CrCl \\< 30 mL/min, not on dialysis, Lenalidomide at 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.","id":"OG006","title":"Group B Lenalidomide 25 mg/Day"},{"description":"CrCl \\< 30 mL/min, on dialysis, Lenalidomide at 15 mg 3 times per week for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.","id":"OG007","title":"Group C Lenalidomide 15 mg 3x/Week"},{"description":"CrCl \\< 30 mL/min, on dialysis, Lenalidomide at 10 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.","id":"OG008","title":"Group C Lenalidomide 10 mg/Day"},{"description":"CrCl \\< 30 mL/min, on dialysis, Lenalidomide at 15 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.","id":"OG009","title":"Group C Lenalidomide 15 mg/Day"},{"description":"CrCl \\< 30 ml/min, on dialysis, Lenalidomide at 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.","id":"OG010","title":"Group C Lenalidomide 25 mg/Day"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Patients treated during the dose finding phase of the study","reportingStatus":"POSTED","timeFrame":"First cycle of therapy (28 days)","title":"Number of Participants in Phase I Component With Dose Limiting Toxicities During the First Cycle of Therapy","type":"PRIMARY","unitOfMeasure":"Participants"}