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Sponsors and Collaborators: |
Herbert Irving Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00334932 |
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome and melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving doxorubicin hydrochloride liposome and melphalan together with bortezomib may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of doxorubicin hydrochloride liposome , melphalan, and bortezomib and to see how well they work in treating patients with relapsed or refractory stage I, stage II, or stage III multiple myeloma.
Condition | Intervention | Phase |
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Multiple Myeloma and Plasma Cell Neoplasm |
Drug: bortezomib Drug: melphalan Drug: pegylated liposomal doxorubicin hydrochloride |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I/II Study of Liposomal Doxorubicin (Doxil®)/ Melphalan/Bortezomib (Velcade®) in Relapsed/Refractory Multiple Myeloma |
Estimated Enrollment: | 32 |
Study Start Date: | February 2006 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, phase I, dose-escalation study followed by a phase II study.
Cohorts of 3-6 patients receive escalating doses of doxorubicin HCl liposome, melphalan, and bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 4 of 6 patients experience dose-limiting toxicity after 2 courses of therapy.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: Approximately 32 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of multiple myeloma
Progressive disease, defined as one of the following:
For secretory disease:
For nonsecretory disease:
Must have received ≥ 2 of the following therapeutic regimens for multiple myeloma:
Nonmyeloablative transplantation
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, California | |
UCSF Helen Diller Family Comprehensive Cancer Center | Recruiting |
San Francisco, California, United States, 94115 | |
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222 | |
United States, New York | |
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | Recruiting |
New York, New York, United States, 10032 | |
Contact: Clinical Trials Office - Herbert Irving Comprehensive Cancer C 212-305-8615 |
Principal Investigator: | Ajai Chari, MD | Herbert Irving Comprehensive Cancer Center |
Study ID Numbers: | CDR0000471769, CPMC-AAAB6443 |
Study First Received: | June 7, 2006 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00334932 History of Changes |
Health Authority: | Unspecified |
refractory multiple myeloma stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma |
Melphalan Immunoproliferative Disorders Immunologic Factors Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Bortezomib Vascular Diseases Paraproteinemias Hemostatic Disorders |
Immunosuppressive Agents Doxorubicin Protease Inhibitors Multiple Myeloma Anti-Bacterial Agents 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 Antibiotics, Antineoplastic 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 Doxorubicin Pharmacologic Actions Protease Inhibitors Multiple Myeloma Neoplasms Myeloablative Agonists Antineoplastic Agents, Alkylating Lymphoproliferative Disorders Neoplasms, Plasma Cell |