Bortezomib and Rituximab for Patients With Waldenstrom's Macroglobulinemia
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|ClinicalTrials.gov Identifier: NCT00492050|
Recruitment Status : Active, not recruiting
First Posted : June 27, 2007
Last Update Posted : May 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Waldenstrom's Macroglobulinemia||Drug: Bortezomib Drug: Rituximab Drug: Valacyclovir||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Primary Treatment of Waldenstrom's Macroglobulinemia With Bortezomib (Velcade) and Rituximab (Rituxan) Followed by Autologous Stem Cell Collection|
|Actual Study Start Date :||August 2006|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2020|
U.S. FDA Resources
Experimental: Bortezomib + Rituximab
Bortezomib 1.6 mg/m^2 IV Weekly on Days 1, 8, 15 and 22. Rituximab 375 mg/m^2 IV on Day 8 and 22. Valacyclovir 500 mg orally daily (or acyclovir 200 mg orally twice daily).
1.6 mg/m^2 IV Weekly on Days 1, 8, 15 and 22.
Other Names:Drug: Rituximab
375 mg/m^2 IV on Day 8 and 22.
Other Name: RituxanDrug: Valacyclovir
500 mg orally daily (or acyclovir 200 mg orally twice daily)
Other Name: Valtrex
- Overall response rate to Bortezomib-Rituximab, and autologous stem cell collection rate after induction therapy with Bortezomib-Rituximab [ Time Frame: Within 1 week prior to the start of each cycle of chemotherapy and every 3 months thereafter until Partial Recovery (PR) achieved ]
The method of Thall, Simon, Estey (1995, 1996) as extended by Thall and Sung (1998) used for trial monitoring.
Partial response (PR) defined as at least > 50 % reduction of serum monoclonal IgM concentration determined by protein electrophoresis, > 50% decrease in adenopathy / organomegaly on physical examination or on CT scan, and no new symptoms or signs of active disease.
Complete response (CR) defined as a disappearance of serum and urine monoclonal protein determined by immunofixation, absence of malignant cells in bone marrow determined by histologic evaluation, resolution of adenopathy/organomegaly (confirmed by computed tomography [CT] scan), and no signs or symptoms attributable to WM.
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): NCT00492050
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Sheeba Thomas, MD||M.D. Anderson Cancer Center|