Response Evaluation
If yes, record details on the New Lymph Node form.
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Complete Response(CR) Complete response requires all of the following criteria: - Complete disappearance of serum monoclonal IgM by immunofixation - Resolution of adenopathy and / or organomegaly - No signs or symptoms that are directly attributable to WM (unexplained recurrent fever >38.4°C, drenching night sweats, >10% body weight loss, hyperviscosity, or symptomatic cryoglobulinemia) - Absence of malignant cell by bone marrow histologic examination Reconfirmation of the CR status is required > 6 weeks later with a second immunofixation Partial Response(PR) Partial response (PR) requires all of the following criteria: - A >50% reduction in the serum monoclonal IgM concentration on protein electrophoresis - A >50% improvement in bulky lymphadenopathy and / or organomegaly on CT scan - No new signs, symptoms, or evidence of disease Minor Response(MR) Minor Response requires all of the following criteria: - At least 25% but less than 50% reduction of serum monoclonal IgM by protein electrophoresis. - No new symptoms or signs of active disease. Stable Disease(SD) - A <25% decrease or a <25% increase in the serum monoclonal IgM - No progression of adenopathy and / or organomegaly, cytopenias or clinically significant symptoms caused by WM Progressive Disease(PD) - A >25% increase in serum monoclonal IgM levels from the lowest attained response value OR - Progression of clinically significant disease related symptoms Not Evaluable - Insufficient data and / or time from treatment for a determination of response to be made. Patients must have been followed for at least 3 months after treatment initiation to be considered unresponsive to therapy. Relapse for a Complete Responder Relapse for a Complete Responder is characterized at least one of the following: - Reappearance of the serum monoclonal IgM protein as determined by immunofixation OR - Progression of clinically significant signs or symptoms attributable to WM OR - Development of any clinically significant disease related symptoms OR - Recurrence of bone marrow involvement by lymphoplasmacytic cells Progression for both a Partial Responder and a Minor Responder Progression for a Partial Responder and a Minor Responder is characterized at least one of the following: - >=25% increase in serum monoclonal IgM from the lowest attained response value determined by immunofixation. An absolute increase of 50 mg/dL (confirmed on a second determination) is required in order to define disease progression when the only criterion for progressive disease is the increase of M-protein size. OR - Progression of clinically significant signs or symptoms attributable to WM OR - Development of any new clinically significant disease related symptoms
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Complete Response Confirmation
Systemic manifestations of WM, including hyperviscosity, neuropathy, amyloidosis, cryoglobulinemia, B symptoms
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