Combination Bortezomib and Rituximab in Patients With Waldenstrom's Macroglobulinemia
This study is ongoing, but not recruiting participants.
Sponsor:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00422799
First Posted: January 17, 2007
Last Update Posted: August 2, 2017
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Irene Ghobrial, MD, Dana-Farber Cancer Institute
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Waldenstrom's Macroglobulinemia | Drug: Bortezomib Drug: Rituximab | Phase 2 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Irene Ghobrial, MD, Dana-Farber Cancer Institute:
Primary Outcome Measures:
- Assess the response rate of bortezomib and rituximab (VR) in patients with relapsed or refractory WM. [ Time Frame: 2 Years ]
Secondary Outcome Measures:
- Evaluate the toxicity of VR in patients with WM [ Time Frame: 2 Years ]
- evaluate the time to progression in patients with WM [ Time Frame: Years ]
- Study the effect of bortezomib and rituximab on tumor cells in this patient population. [ Time Frame: 2 Years ]
| Estimated Enrollment: | 45 |
| Study Start Date: | September 2006 |
| Estimated Study Completion Date: | December 2017 |
| Primary Completion Date: | September 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: bortezomib and rituximab
bortezomib and rituximab
|
Drug: Bortezomib
Once weekly for 3 weeks
Drug: Rituximab
Intravenously once a week for the first and fourth weeks of a cycle
|
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.
Eligibility
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Information from the National Library of Medicine
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
Locations
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
Sponsors and Collaborators
Dana-Farber Cancer Institute
Millennium Pharmaceuticals, Inc.
Investigators
| Principal Investigator: | Irene Ghobrial, MD | Dana-Farber Cancer Institute |
More Information
Publications:
| Responsible Party: | Irene Ghobrial, MD, Principal Investigator, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00422799 History of Changes |
| Other Study ID Numbers: |
06-008 |
| First Submitted: | January 12, 2007 |
| First Posted: | January 17, 2007 |
| Last Update Posted: | August 2, 2017 |
| Last Verified: | July 2017 |
Keywords provided by Irene Ghobrial, MD, Dana-Farber Cancer Institute:
|
relapsed Waldenstrom's macroglobulinemia refractory Waldenstrom's macroglobulinemia Velcade WM |
Additional relevant MeSH terms:
|
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 Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |