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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00124579 |
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as thalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. It may also stop the growth of cancer by blocking blood flow to the cancer. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with thalidomide and dexamethasone may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with thalidomide and dexamethasone works in treating patients with relapsed or refractory multiple myeloma.
Condition | Intervention | Phase |
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Multiple Myeloma and Plasma Cell Neoplasm |
Drug: bortezomib Drug: dexamethasone Drug: thalidomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Bortezomib (Velcade™, PS-341), Thalidomide, and Dexamethasone in Patients With Refractory Multiple Myeloma |
Estimated Enrollment: | 90 |
Study Start Date: | August 2005 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients achieving confirmed CR, R, or PR who reach a plateau prior to receiving the maximum 8 courses of induction therapy OR who achieve confirmed CR, R, or PR after receiving the maximum 8 courses of induction therapy proceed to maintenance therapy. Patients achieving stable disease after receiving the maximum 8 courses of induction therapy either proceed to maintenance therapy or receive further treatment with bortezomib, thalidomide, and dexamethasone off-study.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 18 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of multiple myeloma (MM)
Relapsed or refractory disease after ≥ 1 prior therapy for MM, that may have included autologous or allogeneic stem cell transplantation
Relapse is defined as the occurrence of any of the following during or after prior treatment:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Investigator: | Gordan Srkalovic, MD, PhD | Sparrow Regional Cancer Center |
Investigator: | Mohamad A. Hussein, MD | The Cleveland Clinic |
Study ID Numbers: | CDR0000435925, SWOG-S0417 |
Study First Received: | July 26, 2005 |
Last Updated: | November 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00124579 History of Changes |
Health Authority: | United States: Federal Government |
stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma refractory multiple myeloma |
Dexamethasone Anti-Inflammatory Agents Thalidomide Immunologic Factors Blood Protein Disorders Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Hemostatic Disorders Hormones Anti-Bacterial Agents Hemorrhagic Disorders Dexamethasone acetate |
Immunoproliferative Disorders Antineoplastic Agents, Hormonal Hematologic Diseases Blood Coagulation Disorders Bortezomib Vascular Diseases Angiogenesis Inhibitors Glucocorticoids Immunosuppressive Agents Protease Inhibitors Multiple Myeloma Peripheral Nervous System Agents Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Anti-Inflammatory Agents Dexamethasone Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Thalidomide Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Hemostatic Disorders Hormones Anti-Bacterial Agents |
Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Growth Inhibitors Angiogenesis Modulating Agents Dexamethasone acetate Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Hematologic Diseases Growth Substances Bortezomib Gastrointestinal Agents Vascular Diseases |