Combination Bortezomib and Rituximab in Patients With Waldenstrom's Macroglobulinemia (WM)
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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 : October 27, 2020
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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 |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: bortezomib and rituximab
bortezomib and rituximab
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Drug: Bortezomib
Once weekly for 3 weeks
Other Name: Velcade Drug: Rituximab 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 Waldenstrom's Macroglobulinemia (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 Waldenstrom's Macroglobulinemia (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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 18 years of age or older
- Patients with previously untreated WM and those who have received prior therapy are eligible
- Must have received prior therapy for their WM and have relapsed or refractory WM.
- CD20 positive disease based on any previous bone marrow immuno-histochemistry or flow cytometric analysis performed up to 3 months prior to enrollment.
- Measurable disease
- ECOG Performance Status 0,1, or 2
- Total bilirubin < 2.0 mg/dl
- AST < 3 x ULN
- Life expectancy of greater than 12 weeks
Exclusion Criteria:
- Uncontrolled infection
- Other active malignancies
- Cytotoxic chemotherapy less than 3 weeks, or biologic therapy less than 2 weeks, or corticosteroids less than 2 weeks, prior to registration.
- Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational
- Known to be HIV positive or HEP B positive
- Radiation therapy less than 2 weeks prior to registration
- Grade 2 or greater peripheral neuropathy
- Myocardial infarction within 6 months rior to enrollment or has NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- Hypersensitivity to bortezomib, boron, or mannitol
- Pregnant or breast feeding women
- Other investigational drugs within 14 days of enrollment
- Serious medical or psychiatric illness likely to interfere with participation

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 |
Responsible Party: | Irene Ghobrial, MD, Principal Investigator, Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00422799 |
Other Study ID Numbers: |
06-008 |
First Posted: | January 17, 2007 Key Record Dates |
Results First Posted: | January 26, 2018 |
Last Update Posted: | October 27, 2020 |
Last Verified: | October 2020 |
relapsed Waldenstrom's macroglobulinemia refractory Waldenstrom's macroglobulinemia Velcade WM |
Waldenstrom Macroglobulinemia Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Rituximab Bortezomib Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |