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Sponsored by: |
Hackensack University Medical Center |
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Information provided by: | Hackensack University Medical Center |
ClinicalTrials.gov Identifier: | NCT00784823 |
The purpose of this study is to determine the tolerance and potential efficacy of combining dose intense melphalan with escalating doses of bortezomib in patients with multiple myeloma undergoing autologous stem cell transplantation.
Condition | Intervention | Phase |
---|---|---|
Multiple Myeloma |
Drug: Bortezomib Drug: Melphalan |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Study of Escalating Doses of Bortezomib in Conjunction With High Dose Melphalan as a Conditioning Regimen for Autologous Peripheral Blood Stem Cell Transplantation in Patients With Multiple Myeloma |
Estimated Enrollment: | 24 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Multiple myeloma is the second most common hematological malignancy that has affected approximately 40,000 Americans.Conventional chemotherapy has achieved limited control of this disease but studies have reported improved response rates for patients who are treated with dose-intense therapy and autologous hematopoietic stem cell transplantation. This Phase I/II study will investigate the potential of combination therapy of dose-intense melphalan with escalating doses of bortezomib.
Ages Eligible for Study: | 18 Years to 76 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Show progression of disease after a previous cycle of dose-intense melphalan, or less than 25% decrease in paraprotein measured at 8 weeks after a prior cycle of dose-intense melphalan
Availability of >2x10^6 autologous peripheral blood CD34+ cells/kg or a syngeneic donor meeting eligibility criteria for syngeneic donation
Exclusion Criteria:
Organ dysfunction
Contact: Marie DelFavero, RN | 201-996-5834 | mdelfavero@humed.com |
Contact: Janet Specia, RN | 201-996-5834 | jspecia@humed.com |
United States, New Jersey | |
Hackensack University Medical Center | Recruiting |
Hackensack, New Jersey, United States, 07601 | |
Contact: Marie Del Favero, RN 201-996-5843 ext 5843 mdelfavero@humed.com | |
Principal Investigator: Scott D Rowley, MD, FACP | |
Principal Investigator: David S Siegel, MD, Ph.d | |
Sub-Investigator: Michele Donato, MD | |
Sub-Investigator: Tatiana Feldman, MD | |
Sub-Investigator: Stuart Goldberg, MD | |
Sub-Investigator: Andre Goy, MD | |
Sub-Investigator: Thea Friedman, Ph.D | |
Sub-Investigator: Robert Korngold, Ph.D |
Principal Investigator: | Scott D Rowley, MD | Director-Blood and Marrow Transplantation Program |
Responsible Party: | The Cancer Center at Hackensack University Medical Center ( Scott Rowley MD ) |
Study ID Numbers: | 06.05.109B |
Study First Received: | October 31, 2008 |
Last Updated: | November 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00784823 History of Changes |
Health Authority: | United States: Institutional Review Board |
Melphalan Immunoproliferative Disorders Immunologic Factors Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Bortezomib Vascular Diseases Paraproteinemias |
Hemostatic Disorders Immunosuppressive Agents Protease Inhibitors Multiple Myeloma Hemorrhagic Disorders Antineoplastic Agents, Alkylating 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 Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases 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 |