{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"}],"units":"Participants"}],"description":"The event will be onset of grade II-IV aGvHD and time to aGvHD will be defined as the period of time from transplantation to the event of aGvHD. Death and early relapse without aGvHD will be competing risks. Cumulative incidence rate of aGVHD with 95% confidence intervals will be estimated from the cumulative incidence curves. To evaluate the association between patient characteristics and aGVHD, the Gray's test accounting for competing risks will be used to compare the cumulative incidence curves and a proportional hazards model for the sub distribution of competing risks will be used to estimate the hazard ratio. The cumulative incidence of chronic GVHD (cGVHD) will be similarly analyzed.","groups":[{"description":"Patients receive fludarabine IV on days -5 to -2 and melphalan IV on days -3 to -2, then undergo stem cell transplantation on day 0. Patients receive cyclophosphamide on days 3 and 4, tacrolimus PO BID or IV starting on day 5, and mycophenolate mofetil IV or PO TID on days 5 to 35. Patients also receive daratumumab IV starting between days 90-150 for up to 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\nAllogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic stem cell transplantation\n\nCyclophosphamide: Given IV\n\nDaratumumab: Given IV\n\nFludarabine: Given IV\n\nMelphalan: Given IV\n\nMycophenolate Mofetil: Given IV or PO\n\nTacrolimus: Given PO or IV","id":"OG000","title":"Treatment (Conditioning Regimen, Stem Cell Transplant)"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"Up to 6 weeks","title":"Number of Patients With Grade II-IV Acute Graft-versus Host Disease (GvHD (aGVHD)","type":"SECONDARY","unitOfMeasure":"participants"}