Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
M.D. Anderson Cancer Center Millennium Pharmaceuticals, Inc. |
---|---|
Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00492050 |
Primary Objectives:
Secondary Objectives:
Condition | Intervention | Phase |
---|---|---|
Waldenstrom's Macroglobulinemia |
Drug: Bortezomib Drug: Rituximab |
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 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Bortezomib + Rituximab
|
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.
|
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00492050 |
Health Authority: | United States: Institutional Review Board |
Waldenstrom's Macroglobulinemia Macroglobulinemic Lymphoma Stem Cell Collection Bortezomib LDP-341 |
MLN341 PS-341 Velcade Rituximab Rituxan |
Immunoproliferative Disorders Rituximab Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Bortezomib Vascular Diseases Paraproteinemias |
Hemostatic Disorders Lymphatic Diseases Waldenstrom Macroglobulinemia Hemorrhagic Disorders Waldenstrom macroglobulinemia Lymphoproliferative Disorders Lymphoma Neoplasms, Plasma Cell |
Neoplasms by Histologic Type Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Pharmacologic Actions Protease Inhibitors Neoplasms Therapeutic Uses Cardiovascular Diseases Antirheumatic Agents |