Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute Millennium Pharmaceuticals, Inc. |
---|---|
Information provided by: | H. Lee Moffitt Cancer Center and Research Institute |
ClinicalTrials.gov Identifier: | NCT00307086 |
The primary objectives of this study are to:
The secondary objectives of this study are to:
Condition | Intervention | Phase |
---|---|---|
Multiple Myeloma Plasma Cell Leukemia |
Drug: Bortezomib Drug: Melphalan Procedure: stem cell transplant |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Evaluation of Bortezomib (VelcadeR ) Followed by High-Dose Melphalan and Bortezomib (VelcadeR) as Conditioning Regimen for Tandem Peripheral Blood Stem Cell Transplants in Patients With Primary Refractory Multiple Myeloma and Plasma Cell Leukemia |
Estimated Enrollment: | 51 |
Study Start Date: | June 2005 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Patients with primary refractory multiple myeloma or plasma cell leukemia either newly diagnosed or previously treated will receive 2-cycles of standard dose bortezomib followed by high-dose melphalan and bortezomib as a conditioning regimen prior to a tandem autologous peripheral blood stem cell transplantation. Following treatment with two cycles of standard dose bortezomib, sequential cohorts of patients will be given escalating bortezomib doses combined with standard and constant conditioning regimen doses of melphalan. Once the MTD of bortezomib is reached, that dose will be administered in combination with melphalan as conditioning prior to peripheral blood stem cell rescue.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Christine Simonelli, RN | 813-745-1822 | christine.simonelli@moffitt.org |
United States, Florida | |
H. Lee Moffitt Cancer Center & Research Institute | Recruiting |
Tampa, Florida, United States, 33612 | |
Contact: Melissa Alsina, MD 813-745-7202 Melissa.Alsina@moffitt.org | |
Contact: Christine Simonelli, RN 813-745-7202 Christine.McIsaac@moffitt.org | |
Principal Investigator: Melissa Alsina, MD | |
Principal Investigator: Todd Aleksun, MD | |
Sub-Investigator: Claudio Anasetti, MD | |
Sub-Investigator: Ernesto Ayala, MD | |
Sub-Investigator: William Dalton, PhD, MD | |
Sub-Investigator: Ben Djulbegovic, MD, PhD | |
Sub-Investigator: Teresa Field, MD | |
Sub-Investigator: William Janssen, PhD | |
Sub-Investigator: Dawn Kettner, PA-C | |
Sub-Investigator: Lia Perez, MD | |
Sub-Investigator: Janelle Perkins, PharmD | |
Sub-Investigator: Daniel Sullivan, MD | |
Sub-Investigator: Mohamed kharfan-Dabaja, MD | |
Sub-Investigator: Hugo Fernandez, MD | |
Sub-Investigator: Jyoti Raychaudhuri, MD | |
Sub-Investigator: Jose Leonel Ochoa-Bayona, MD |
Principal Investigator: | Melissa Alsina, MD | H. Lee Moffitt Cancer Center and Research Institute |
Principal Investigator: | Todd Alekshun, MD | H. Lee Moffitt Cancer Center and Research Institute |
Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute ( Melissa Alsina, MD ) |
Study ID Numbers: | MCC-14184, X05174 |
Study First Received: | March 23, 2006 |
Last Updated: | June 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00307086 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Melphalan Immunoproliferative Disorders Immunologic Factors Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Bortezomib Plasma Cell Leukemia Vascular Diseases Paraproteinemias Hemostatic Disorders |
Immunosuppressive Agents Protease Inhibitors Multiple Myeloma Leukemia Hemorrhagic Disorders Antineoplastic Agents, Alkylating Leukemia, Plasma Cell Lymphoproliferative Disorders Alkylating Agents Neoplasms, Plasma Cell |
Melphalan Molecular Mechanisms of Pharmacological Action Immunologic Factors Blood Protein Disorders Antineoplastic Agents Physiological Effects of Drugs Paraproteinemias Hemostatic Disorders Leukemia Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Leukemia, Plasma Cell Alkylating Agents Immunoproliferative Disorders |
Neoplasms by Histologic Type Immune System Diseases Hematologic Diseases Bortezomib Vascular Diseases Enzyme Inhibitors Immunosuppressive Agents Pharmacologic Actions Protease Inhibitors Multiple Myeloma Neoplasms Myeloablative Agonists Antineoplastic Agents, Alkylating Lymphoproliferative Disorders Neoplasms, Plasma Cell |