Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Millennium Pharmaceuticals, Inc. |
---|---|
Information provided by: | Millennium Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00063726 |
The purpose of this study is to allow patients to receive VELCADE™ (bortezomib) for Injection who experienced progressive disease(PD) while receiving high-dose dexamethasone from the M34101-039 study.
Condition | Intervention | Phase |
---|---|---|
Multiple Myeloma |
Drug: bortezomib |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An International, Non-Comparative, Open-Label Study of PS-341 Administered to Patients With Multiple Myeloma Who Experienced Relapsed or Progressive Disease After Receiving at Least Four Previous Treatment Regimens or Experienced Progressive Disease After Receiving Dexamethasone in Millennium Protocol M34101-039 |
Estimated Enrollment: | 600 |
The rationale for Amendment 2 is 2-fold. First, it is intended that this study serve as a rollover protocol for patients who experience progressive disease (PD) after receiving the comparator treatment, high-dose dexamethasone, in MPI Study M34101-039, thereby ultimately providing all patients who participate in Study M34101-039 and require treatment for their disease access to VELCADE™ (bortezomib) for Injection, formerly known as MLN341, LDP-341 and PS-341.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Baseline visit.):
Study ID Numbers: | M34101-040 |
Study First Received: | July 2, 2003 |
Last Updated: | July 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00063726 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Relapsed Multiple Myeloma Refractory Multiple Myeloma |
Anti-Inflammatory Agents Dexamethasone Immunoproliferative Disorders Antineoplastic Agents, Hormonal Blood Protein Disorders Hematologic Diseases Hormone Antagonists Blood Coagulation Disorders Bortezomib Hormones, Hormone Substitutes, and Hormone Antagonists Vascular Diseases Antiemetics |
Paraproteinemias Hemostatic Disorders Hormones Glucocorticoids Protease Inhibitors Multiple Myeloma Hemorrhagic Disorders Peripheral Nervous System Agents Lymphoproliferative Disorders Dexamethasone acetate Neoplasms, Plasma Cell |
Anti-Inflammatory Agents Dexamethasone Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Hemostatic Disorders Hormones Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Immunoproliferative Disorders |
Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Hematologic Diseases Bortezomib Vascular Diseases Gastrointestinal Agents Enzyme Inhibitors Glucocorticoids Pharmacologic Actions Protease Inhibitors Multiple Myeloma Neoplasms Autonomic Agents Peripheral Nervous System Agents |