{"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"description":"Time to progression is defined as the time from randomization to disease progression.\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: Time to Progression","type":"SECONDARY"}