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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Millennium Pharmaceuticals, Inc. |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00492050 |
Purpose
The main goal of this clinical research study is to learn if Velcade ® (bortezomib) given with rituximab can help to control waldenstrom's macroglobulinemia (WM). This drug combination will allow researchers to collect your stem cells in case it is possible to transplant the stem cells as treatment if your WM gets worse. Researchers will also look at the safety and tolerability of this drug combination followed by treatment with other drug combinations.
| Condition | Intervention | Phase |
|---|---|---|
|
Waldenstrom's Macroglobulinemia |
Drug: Bortezomib Drug: Rituximab Drug: Valacyclovir |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Bortezomib + Rituximab |
Drug: Bortezomib
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: Rituxan
Drug: Valacyclovir
500 mg orally daily (or acyclovir 200 mg orally twice daily)
Other Name: Valtrex
|
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 | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Sheeba Thomas, MD | |
| Principal Investigator: | Sheeba Thomas, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00492050 History of Changes |
| Other Study ID Numbers: | 2005-0733 |
| Study First Received: | June 26, 2007 |
| Last Updated: | January 5, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
Waldenstrom's Macroglobulinemia Macroglobulinemic Lymphoma Stem Cell Collection Bortezomib LDP-341 |
MLN341 PS-341 Velcade Rituximab Rituxan |
|
Waldenstrom Macroglobulinemia Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Valacyclovir Rituximab Bortezomib Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |