Bortezomib and Rituximab for Patients With Waldenstrom's Macroglobulinemia
|ClinicalTrials.gov Identifier: NCT00492050|
Recruitment Status : Active, not recruiting
First Posted : June 27, 2007
Last Update Posted : January 9, 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.
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|