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Sponsors and Collaborators: |
Emory University Millennium Pharmaceuticals, Inc. |
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Information provided by: | Emory University |
ClinicalTrials.gov Identifier: | NCT00793650 |
The goal of this study is to evaluate the safety of melphalan and autologous PBSCT (peripheral blood stem cell transplantation - stem cells that come from your own body) in combination with bortezomib, a new FDA approved drug used to treat myeloma.
Condition | Intervention | Phase |
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Cancer Multiple Myeloma |
Drug: Bortezomib |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety Study |
Official Title: | Combination High Dose Melphalan and Autologous PBSC Transplant With Bortezomib for Multiple Myeloma: A Dose and Schedule Finding Study |
Estimated Enrollment: | 40 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm A: Active Comparator
Bortezomib before HD melphalan
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Drug: Bortezomib
Escalating doses of bortezomib 1.0, 1.3, or 1.6 mg/m2 in Arm A and Arm B.
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Arm B: Active Comparator
Bortezomib after HD melphalan
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Drug: Bortezomib
Escalating doses of bortezomib 1.0, 1.3, or 1.6 mg/m2 in arm A and arm B.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Georgia | |
Emory University Winship Cancer Institute | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: Sagar Lonial, MD 888-946-7447 sloni01@emory.edu | |
Principal Investigator: Sagar Lonial, MD |
Principal Investigator: | Sagar Lonial, MD | Emory University Winship Cancer Institute |
Responsible Party: | Emory University Winship Cancer Institute ( Sagar Lonial, MD ) |
Study ID Numbers: | 080-2005 |
Study First Received: | November 17, 2008 |
Last Updated: | November 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00793650 |
Health Authority: | United States: Institutional Review Board |
Cancer Multiple Myeloma Peripheral Blood Stem Cell Transplant |
Melphalan Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Bortezomib Vascular Diseases Paraproteinemias |
Hemostatic Disorders Multiple Myeloma Signs and Symptoms Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Cardiovascular Diseases Pharmacologic Actions Protease Inhibitors |