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| Sponsor: | Millennium Pharmaceuticals, Inc. |
|---|---|
| Information provided by: | Millennium Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00063713 |
Purpose
The purpose of this study is to find out whether treatment with VELCADE will increase the time it takes for lymphoma to get worse.
| Condition | Intervention | Phase |
|---|---|---|
|
Mantle Cell Lymphoma |
Drug: VELCADE TM (bortezomib) for Injection |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Control: Historical Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2 Study of VELCADE in Subjects With Relapsed or Refractory Mantle Cell Lymphoma |
| Estimated Enrollment: | 152 |
| Study Start Date: | June 2003 |
| Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
VELCADE is approved in multiple myeloma for patients who have received two prior therapies and their disease came back or got worse while on their second therapy. VELCADE is currently being studied in other types of cancers.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Contacts and Locations
Show 35 Study Locations
More Information
| Study ID Numbers: | M34103-053 |
| Study First Received: | July 2, 2003 |
| Last Updated: | February 7, 2008 |
| ClinicalTrials.gov Identifier: | NCT00063713 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Lymphoma, Mantle-Cell Bortezomib Enzyme Inhibitors |
Pharmacologic Actions Protease Inhibitors Lymphatic Diseases Neoplasms Therapeutic Uses Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |