This research study is evaluating a drug called ixazomib (also known as MLN9708) in combination with dexamethasone and rituximab (the regimen is called IDR) as a possible treatment for Waldenstrom's Macroglobulinemia (WM).
Name: Ixazomib
Name: Dexamethasone
Name: Rituximab
Description: Rate of very good partial response or better in patients treated with IDR. VGPR is defined as a >90% reduction in serum IgM levels from baseline.
Measure: Very Good Partial Response Rate (VGPR) for IDR Time: 76 weeksDescription: Overall response includes the rate of complete response (CR), partial response (PR), minimal response (MR), stabl disease (SD) and progressive disease (PD). Minor response is >25%-50% reduction in serum IgM from baseline. Partial Response is (>50-90% reduction in serum IgM from baseline. Very Good Partial Response is >90% reduction in serum IgM from baseline. Complete Response is resolution of all symptoms, normalization of serum IgM with disappearance of IgM paraprotein, resolution of any adenopathy or splenomegaly.
Measure: Overall Response Rate Time: 2 YearsDescription: Duration of time from start of treatment to disease progression. Progressive disease is defined as occurring when a >25% increase in serum IgM and an absolute 500mg/dL increase in IgM level occurs from the lowest attained response value, or progression of clinically significant disease related symptoms.
Measure: Progression-free Survival (PFS) Time: From start of treatment to time of disease progression, assessed up to 4 years after treatment startDescription: To evaluate the overall response rate of participants by MYD88 L265P and CXCR4-WHIM mutations in WM. Overall response is defined as achieving at least a minor response, or >25% reduction in serum IgM from baseline.
Measure: Overall Response Rate by MYD88 L265P and CXCR4-WHIM Status Time: 2 YearsDescription: Duration of time from start of treatment to time of disease progression.
Measure: Time to Progression (TTP) Time: From start of treatment to time of disease progression, assessed up to 4 years after treatment startDescription: The duration of response is measured from the time a participant achieved a response until the date of progression.
Measure: Duration of Response (DOR) Time: From the time each participant achieved a response to time of disease progression, assessed up to 4 years after treatment startDescription: Duration from start of protocol treatment to time of initiation of new therapy.
Measure: Time to Next Therapy (TTNT) Time: From start of treatment until the participant begins a new therapy, assessed up to 4 years after treatment startAllocation: N/A
Single Group Assignment
There is one SNP
Progressive disease is defined as occurring when a >25% increase in serum IgM and an absolute 500mg/dL increase in IgM level occurs from the lowest attained response value, or progression of clinically significant disease related symptoms.. Overall Response Rate by MYD88 L265P and CXCR4-WHIM Status. --- L265P ---
To evaluate the overall response rate of participants by MYD88 L265P and CXCR4-WHIM mutations in WM. --- L265P ---