Brief Title
Combination Bortezomib and Rituximab in Patients With Waldenstrom's Macroglobulinemia (WM)
Official Title
Phase II Study of Combination Bortezomib (Velcade PS-341) and Rituximab in Patients With Previously Untreated and Relapsed/Refractory Waldenstrom's Macroglobulinemia
Brief Summary
In this study, we are trying to find out if the combination of these two drugs is effective
in treating Waldenstrom's macroglobulinemia (WM). The combination of these two drugs has not
been studied for patients with relapsed or refractory macroglobulinemia. The U.S. Food and
Drug Administration (FDA) has approved bortezomib for the treatment of multiple myeloma, a
cancer that is closely related to Waldenstrom's macroglobulinemia.
Detailed Description
- 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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
Overall Response Rate of Bortezomib and Rituximab (VR) in Patients With Relapsed or Refractory Waldenstrom's Macroglobulinemia (WM)
Secondary Outcome
Time to Progression in Patients With WM
Condition
Waldenstrom's Macroglobulinemia
Intervention
Bortezomib
Study Arms / Comparison Groups
bortezomib and rituximab
Description: bortezomib and rituximab
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
63
Start Date
August 30, 2006
Completion Date
October 9, 2015
Primary Completion Date
October 9, 2015
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Irene Ghobrial, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00422799
Organization ID
06-008
Responsible Party
Principal Investigator
Study Sponsor
Dana-Farber Cancer Institute
Collaborators
Millennium Pharmaceuticals, Inc.
Study Sponsor
Irene Ghobrial, MD, Principal Investigator, Dana-Farber Cancer Institute
Verification Date
October 2020