{"denoms":[{"counts":[{"groupId":"BG000","value":"40"}],"units":"Participants"}],"groups":[{"description":"Dose schematic of Dexamethasone + Bortezomib + Pegylated Liposomal Doxorubicin + Lenalidomide (DVD-R) Therapy:\n\nPer 28 Day Cycle, patients will received drug in the following order, dosing and schedule:\n\n1\\) Dexamethasone- 40 mg intravenous infusion (IV) on Days 1, 4, 8 and 11; 2) Bortezomib- 1.0 mg/m2 infused over 3 to 5 seconds followed by a standard saline flush on Days 1, 4, 8 and 11; 3) Pegylated Liposomal Doxorubicin- 4.0 mg/m2 IV as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle; and 4) Lenalidomide- 10 mg PO on days 1-14","id":"BG000","title":"DVD-R Single Arm"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"}],"title":"<=18 years"},{"measurements":[{"groupId":"BG000","value":"13"}],"title":"Between 18 and 65 years"},{"measurements":[{"groupId":"BG000","value":"27"}],"title":">=65 years"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Age, Categorical","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"34","upperLimit":"86","value":"71"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"15"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"25"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"16"}]}],"title":"I (beta 2 microglobulin(B2M )<3.5 +Albumin ≥3.5)"},{"categories":[{"measurements":[{"groupId":"BG000","value":"14"}]}],"title":"II (B2M 3.5 +albumin < 3.5; or B2M 3.5-5.5)"},{"categories":[{"measurements":[{"groupId":"BG000","value":"10"}]}],"title":"III (B2M >5.5)"}],"paramType":"NUMBER","title":"International Staging System (ISS); stage (N)","unitOfMeasure":"participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"0.0","upperLimit":"7.0","value":"2.05"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Serum M-protein","unitOfMeasure":"g/dL"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"0.0","upperLimit":"7162.0","value":"261.1"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Urine-M protein","unitOfMeasure":"mg/dL"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"0.6","upperLimit":"3.4","value":"1.0"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Serum creatinine","unitOfMeasure":"mg/dL"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"1","upperLimit":"17","value":"3"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEAN","title":"Prior treatments","unitOfMeasure":"number of treatments"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"33"}]}],"title":"Bortezomib (BTZ)"},{"categories":[{"measurements":[{"groupId":"BG000","value":"20"}]}],"title":"Alkylating agents"},{"categories":[{"measurements":[{"groupId":"BG000","value":"15"}]}],"title":"PLD or Doxorubucin"},{"categories":[{"measurements":[{"groupId":"BG000","value":"15"}]}],"title":"Thalidomide"},{"categories":[{"measurements":[{"groupId":"BG000","value":"19"}]}],"title":"Lenalidomide (LEN)"},{"categories":[{"measurements":[{"groupId":"BG000","value":"35"}]}],"title":"Glucocorticoids"},{"categories":[{"measurements":[{"groupId":"BG000","value":"7"}]}],"title":"HDAC inhibitors (panobinostat/romidepsin)"},{"categories":[{"measurements":[{"groupId":"BG000","value":"5"}]}],"title":"Transplant (autologous)"},{"categories":[{"measurements":[{"groupId":"BG000","value":"11"}]}],"title":"Other"},{"categories":[{"measurements":[{"groupId":"BG000","value":"17"}]}],"title":"PLD+btz+dexamethasone (dex)"},{"categories":[{"measurements":[{"groupId":"BG000","value":"10"}]}],"title":"PLD+btz+dex and len+ glucocorticoids"}],"paramType":"NUMBER","title":"Total Number of prior lines of treatment","unitOfMeasure":"number of treatments"}],"populationDescription":"The estimated number of participants will allow to determine whether the true rate of response to DVD-R is at least 50%, at the one-sided alpha-level of 0.05 and having at least 85% power"}