{"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"description":"Progression-free survival is defined as the time from randomization to progression or death, whichever occurred first.\n\nProgression is evaluated based on Recommended Response Criteria for Waldenstrom's Macroglobulinemia. Progression is defined as at least 25% increase in serum monoclonal IgM protein by electrophoresis confirmed by a second measurement at any time, as well as an absolute increase of the M-spike by 0.5g/dL, or progression of clinically significant findings due to disease, (i.e. anemia, thrombocytopenia, leukopenia, bulky adenopathy/organomegaly or symptoms of disease) or hyperviscosity, neuropathy, symptomatic cryoglobulinemia, or amyloidosis attributable to WM.","groups":[{"description":"Patients receive rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only) and bortezomib IV or SC and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"Arm E (Phase II: Rituximab, Bortezomib, Dexamethasone)"},{"description":"Patients receive temsirolimus IV over 30-60 minutes on days 1, 8, 15, and 22 and rituximab, bortezomib, and dexamethasone as in arm E. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.","id":"OG001","title":"Arm F (Phase II: Temsirolimus, Rituximab, Bortezomib, Dexamethasone)"}],"populationDescription":"No patients were enrolled in the phase II part of this study.","reportingStatus":"POSTED","timeFrame":"Assessed every 3 months if <2 years from study entry, every 6 months if 2-5 years from study entry, and annually if 6-10 years","title":"Phase II: Progression-free Survival","type":"PRIMARY"}