Combination Bortezomib and Rituximab in Patients With Waldenstrom's Macroglobulinemia
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00422799 |
Recruitment Status
:
Completed
First Posted
: January 17, 2007
Results First Posted
: January 26, 2018
Last Update Posted
: January 26, 2018
|
Sponsor:
Dana-Farber Cancer Institute
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Irene Ghobrial, MD, Dana-Farber Cancer Institute
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | January 12, 2007 | |||
First Posted Date ICMJE | January 17, 2007 | |||
Results First Submitted Date | December 27, 2017 | |||
Results First Posted Date | January 26, 2018 | |||
Last Update Posted Date | January 26, 2018 | |||
Actual Study Start Date ICMJE | August 30, 2006 | |||
Actual Primary Completion Date | October 9, 2015 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
|
|||
Original Primary Outcome Measures ICMJE |
Assess the response rate of bortezomib and rituximab (VR) in patients with relapsed or refractory WM. | |||
Change History | Complete list of historical versions of study NCT00422799 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
|
|||
Original Secondary Outcome Measures ICMJE |
|
|||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Combination Bortezomib and Rituximab in Patients With Waldenstrom's Macroglobulinemia | |||
Official Title ICMJE | 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 |
|
|||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
|||
Condition ICMJE | Waldenstrom's Macroglobulinemia | |||
Intervention ICMJE |
|
|||
Study Arms | Experimental: bortezomib and rituximab
bortezomib and rituximab
Interventions:
|
|||
Publications * | Ghobrial IM, Hong F, Padmanabhan S, Badros A, Rourke M, Leduc R, Chuma S, Kunsman J, Warren D, Harris B, Sam A, Anderson KC, Richardson PG, Treon SP, Weller E, Matous J. Phase II trial of weekly bortezomib in combination with rituximab in relapsed or relapsed and refractory Waldenstrom macroglobulinemia. J Clin Oncol. 2010 Mar 10;28(8):1422-8. doi: 10.1200/JCO.2009.25.3237. Epub 2010 Feb 8. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
63 | |||
Original Enrollment ICMJE |
45 | |||
Actual Study Completion Date | October 9, 2015 | |||
Actual Primary Completion Date | October 9, 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||
Sex/Gender |
|
|||
Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00422799 | |||
Other Study ID Numbers ICMJE | 06-008 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Irene Ghobrial, MD, Dana-Farber Cancer Institute | |||
Study Sponsor ICMJE | Dana-Farber Cancer Institute | |||
Collaborators ICMJE | Millennium Pharmaceuticals, Inc. | |||
Investigators ICMJE |
|
|||
PRS Account | Dana-Farber Cancer Institute | |||
Verification Date | December 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |