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Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00849251 |
RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin and cyclophosphamide, 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 and by blocking blood flow to the cancer. Giving liposomal doxorubicin together with bortezomib, cyclophosphamide, and dexamethasone may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects of giving liposomal doxorubicin together with bortezomib, cyclophosphamide, and dexamethasone and to see how well it works in treating patients with multiple myeloma.
Condition | Intervention | Phase |
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Multiple Myeloma and Plasma Cell Neoplasm |
Drug: bortezomib Drug: cyclophosphamide Drug: dexamethasone Drug: pegylated liposomal doxorubicin hydrochloride |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Combination Pegylated Liposomal Doxorubicin, Bortezomib, Cyclophosphamide, and Dexamethasone for Multiple Myeloma (PLD-BCD) |
Estimated Enrollment: | 45 |
Study Start Date: | July 2009 |
Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive cyclophosphamide IV over 1 hour, bortezomib IV over 3 minutes, and dexamethasone orally or IV on days 1, 8, and 15. Patients also receive pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 8. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of multiple myeloma meeting one of the following criteria:
Relapsed or refractory disease (phase I)
Newly diagnosed, previously untreated disease (phase II)
PATIENT CHARACTERISTICS:
No other malignancy within the past 3 years, except for the following:
PRIOR CONCURRENT THERAPY:
No prior cumulative dose of doxorubicin hydrochloride ≥ 400 mg/m^2
United States, Washington | |
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Recruiting |
Seattle, Washington, United States, 98109-1024 | |
Contact: Clinical Trials Office - Fred Hutchinson Cancer Research Cente 800-804-8824 |
Principal Investigator: | Pamela S. Becker, MD, PhD | University of Washington |
Responsible Party: | University of Washington School of Medicine ( Pamela S. Becker ) |
Study ID Numbers: | CDR0000634802, UWCC-6817, IR-6817, FHCRC-6817 |
Study First Received: | February 20, 2009 |
Last Updated: | August 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00849251 History of Changes |
Health Authority: | Unspecified |
refractory multiple myeloma stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma |
Anti-Inflammatory Agents Dexamethasone Immunologic Factors Blood Protein Disorders Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Cyclophosphamide Hemostatic Disorders Hormones Anti-Bacterial Agents Hemorrhagic Disorders Alkylating Agents Dexamethasone acetate |
Immunoproliferative Disorders Antineoplastic Agents, Hormonal Hematologic Diseases Blood Coagulation Disorders Bortezomib Vascular Diseases Immunosuppressive Agents Glucocorticoids Doxorubicin Protease Inhibitors Multiple Myeloma Antineoplastic Agents, Alkylating Peripheral Nervous System Agents Lymphoproliferative Disorders Antirheumatic Agents |
Anti-Inflammatory Agents Dexamethasone Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Cyclophosphamide Antibiotics, Antineoplastic Hemostatic Disorders Hormones Hemorrhagic Disorders |
Therapeutic Uses Cardiovascular Diseases Alkylating Agents Dexamethasone acetate Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Hematologic Diseases Bortezomib Gastrointestinal Agents Vascular Diseases Enzyme Inhibitors Glucocorticoids Immunosuppressive Agents |