|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Millennium Pharmaceuticals, Inc. |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00492050 |
Purpose
Primary Objectives
To assess response rate in newly diagnosed patients with Waldenstrom's Macroglobulinemia treated with bortezomib and rituximab.
To assess ability to collect stem cells after treatment with bortezomib and rituximab in newly diagnosed patients with Waldenstrom's Macroglobulinemia.
Secondary Objectives
To assess overall response rate to treatment with bortezomib and rituximab followed by cladribine, cyclophosphamide and rituximab in newly diagnosed patients with Waldenstrom's Macroglobulinemia
To assess time to progression and time to retreatment, following treatment with bortezomib and rituximab followed by cladribine, cyclophosphamide and rituximab in newly diagnosed patients with Waldenstrom's Macroglobulinemia
To assess toxicity of treatment with bortezomib and rituximab in newly diagnosed patients with Waldenstrom's Macroglobulinemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Waldenstrom's Macroglobulinemia |
Drug: Bortezomib Drug: Rituximab Drug: Valacyclovir |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Primary Treatment of Waldenstrom's Macroglobulinemia With Bortezomib (Velcade) and Rituximab (Rituxan) Followed by Autologous Stem Cell Collection |
| Estimated Enrollment: | 38 |
| Study Start Date: | August 2006 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Bortezomib + Rituximab: Experimental |
Drug: Bortezomib
1.6 mg/m^2 IV Weekly on Days 1, 8, 15 and 22.
Drug: Rituximab
375 mg/m^2 IV on Day 8 and 22.
Drug: Valacyclovir
500 mg orally daily (or acyclovir 200 mg orally twice daily)
|
Show Detailed Description
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Sheeba Thomas, MD | 713-792-2860 |
| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Sheeba Thomas, MD | |
| Principal Investigator: | Sheeba Thomas, MD | U.T.M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T.M.D. Anderson Cancer Center ( Sheeba K. Thomas, MD/Assistant Professor ) |
| Study ID Numbers: | 2005-0733 |
| Study First Received: | June 26, 2007 |
| Last Updated: | December 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00492050 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Waldenstrom's Macroglobulinemia Macroglobulinemic Lymphoma Stem Cell Collection Bortezomib LDP-341 |
MLN341 PS-341 Velcade Rituximab Rituxan |
|
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Paraproteinemias Hemostatic Disorders Valacyclovir Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases |
Hematologic Diseases Rituximab Bortezomib Vascular Diseases Enzyme Inhibitors Antiviral Agents Pharmacologic Actions Protease Inhibitors Lymphatic Diseases Neoplasms Waldenstrom Macroglobulinemia Lymphoproliferative Disorders Antirheumatic Agents Neoplasms, Plasma Cell |