Combination Bortezomib and Rituximab in Patients With Waldenstrom's Macroglobulinemia
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|ClinicalTrials.gov Identifier: NCT00422799|
Recruitment Status : Completed
First Posted : January 17, 2007
Results First Posted : January 26, 2018
Last Update Posted : January 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Waldenstrom's Macroglobulinemia||Drug: Bortezomib Drug: Rituximab||Phase 2|
- Participants will receive 6 cycles of the study treatment with bortezomib and rituximab. Each cycle is 28 days long (4 weeks).
- Participants will receive Rituximab intravenously once a week for the first and fourth cycles only. Participants will receive bortezomib once a week for three weeks on and one week off every cycle, for a total of 6 cycles.
- During the rituximab infusion, the participants blood pressure and pulse will be monitored frequently. The rate of infusion may be decreased depending upon the side effects that are experienced.
- Blood samples will be collected before the first dose and on follow up with every cycle. Blood counts will also be performed every week.
- Routine physical exams will be performed at each evaluation. A PET/CAT scan of the chest, abdomen and pelvis at the end of treatment. This scan is required to assess the response of the participants disease.
- In order to learn more on how bortezomib and rituximab affect WM, a bone marrow biopsy will be performed.
- We anticipate that participants will complete the active therapy over a period of 6 cycles provided that they are benefiting from therapy and have not had any serious side effects. The participant will be followed every three months for 2 years for office visits and laboratory tests.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Combination Bortezomib (Velcade PS-341) and Rituximab in Patients With Previously Untreated and Relapsed/Refractory Waldenstrom's Macroglobulinemia|
|Actual Study Start Date :||August 30, 2006|
|Actual Primary Completion Date :||October 9, 2015|
|Actual Study Completion Date :||October 9, 2015|
Experimental: bortezomib and rituximab
bortezomib and rituximab
Once weekly for 3 weeks
Other Name: Velcade
Intravenously once a week for the first and fourth weeks of a cycle
Other Name: Rituxan
- Overall Response Rate of Bortezomib and Rituximab (VR) in Patients With Relapsed or Refractory WM. [ Time Frame: 2 Years ]Overall Response Rate= Minor response (>25%-50% reduction in monoclonal IgM from baseline + Partial Response (>50-90% reduction in monoclonal IgM from baseline)+ Complete Response (Disappearance of monoclonal protein by immunofixation; no histologic evidence of bone marrow involvement, resolution of any adenopathy/organomegaly (confirmed by CT scan), or signs or symptoms attributable to WM. Reconfirmation of the CR status is required at least 6 weeks apart with a second immunofixation.)
- Overall Response Rate of Bortezomib and Rituximab (VR) in Patients With Previously Untreated WM [ Time Frame: 2 years ]Overall Response Rate= Minor response (>25%-50% reduction in monoclonal IgM from baseline + Partial Response (>50-90% reduction in monoclonal IgM from baseline)+ Complete Response (Disappearance of monoclonal protein by immunofixation; no histologic evidence of bone marrow involvement, resolution of any adenopathy/organomegaly (confirmed by CT scan), or signs or symptoms attributable to WM. Reconfirmation of the CR status is required at least 6 weeks apart with a second immunofixation.)
- Time to Progression in Patients With WM [ Time Frame: 5 Years ]Time to progresion is the defined as the time from study entry to disease progression (PD) or death. Patients without PD are censored at the date of last disease evaluation. PD is defined as a greater than 25% increase in serum monoclonal IgM electrophoresis confirmed by a second measurement at least 2 weeks apart, or progression of clinically significant findings due to disease or symptoms attributable to WM.
- Duration of Response in Patients With WM [ Time Frame: 5 Years ]Time from documentation of first response to progressive disease.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00422799
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Irene Ghobrial, MD||Dana-Farber Cancer Institute|