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Sponsors and Collaborators: |
University of Wisconsin, Madison National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00410605 |
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Bevacizumab and lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Dexamethasone may stimulate the immune system in different ways and stop cancer cells from growing. Giving bevacizumab together with lenalidomide and dexamethasone may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with lenalidomide and dexamethasone works in treating patients with relapsed or refractory stage II or stage III multiple myeloma.
Condition | Intervention | Phase |
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Multiple Myeloma and Plasma Cell Neoplasm |
Biological: bevacizumab Drug: dexamethasone Drug: lenalidomide Genetic: fluorescence in situ hybridization Genetic: polymorphism analysis Other: immunoenzyme technique Other: immunohistochemistry staining method Other: laboratory biomarker analysis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of Bevacizumab Combined With Lenalidomide and Dexamethasone (BEV/REV/DEX) in Relapsed or Refractory Multiple Myeloma |
Estimated Enrollment: | 33 |
Study Start Date: | November 2006 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, open-label study.
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, oral lenalidomide on days 1-21, and oral dexamethasone on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline and before courses 2 and 4. Blood samples are examined for vascular endothelial growth factor (VEGF) and VEGF receptor (VEGFR) polymorphisms by pyrosequencing and VEGF, VEGFR1, VEGFR2, interleukin-6, and macrophage inflammatory protein 1 by immunoenzyme techniques. Relationships between plasma cell myeloma and stroma and the effect of study treatment on these relationships are examined in tissue sections of bone marrow before and after treatment utilizing microvessel density measurements, VEGF staining, and STAT3 staining (by immunohistochemistry and fluorescent in situ hybridization [FISH]).
After completion of study treatment, patients are followed periodically for at least 5 years.
PROJECTED ACCRUAL: A total of 33 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:
Histologically or cytologically confirmed symptomatic multiple myeloma
PATIENT CHARACTERISTICS:
ECOG performance status (PS) 0-2 OR Karnofsky PS 70-100%
No proteinuria (i.e., albuminuria) > 1,000 mg/24 hours unless related to the diagnosis of multiple myeloma
PRIOR CONCURRENT THERAPY:
More than 7 days since prior minor surgical procedures, fine-needle aspirations, or core biopsies
Concurrent full-dose anticoagulants allowed provided all of the following criteria are met:
United States, Pennsylvania | |
Veterans Affairs Medical Center - Pittsburgh | Recruiting |
Pittsburgh, Pennsylvania, United States, 15240 | |
Contact: Clinical Trials Office - Veterans Affairs Medical Center - Pit 412-688-6104 | |
United States, Wisconsin | |
Aurora Sinai Medical Center | Recruiting |
Milwaukee, Wisconsin, United States, 53201-0342 | |
Contact: Nancy Briggs 414-219-6591 | |
Gundersen Lutheran Center for Cancer and Blood | Recruiting |
La Crosse, Wisconsin, United States, 54601 | |
Contact: Clinical Trials Office - Gundersen Lutheran Cancer Center 608-775-2385 cancerctr@gundluth.org | |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Recruiting |
Madison, Wisconsin, United States, 53792-6164 | |
Contact: Clinical Trials Office - University of Wisconsin Paul P. Carbo 608-262-5223 | |
St. Vincent Hospital Regional Cancer Center | Recruiting |
Green Bay, Wisconsin, United States, 54307-3508 | |
Contact: Clinical Trials Office - St. Vincent Hospital Regional Cancer 920-433-8889 | |
University of Wisconcin Cancer Center at Aspirus Wausau Hospital | Recruiting |
Wausau, Wisconsin, United States, 54401 | |
Contact: Clinical Trials Office - University of Wisconsin Cancer Center 608-262-5223 | |
Medical Consultants, Limited | Recruiting |
Milwaukee, Wisconsin, United States, 53215-3690 | |
Contact: Nancy Briggs 414-385-3086 |
Study Chair: | Natalie S. Callander, MD | University of Wisconsin, Madison |
Responsible Party: | University of Wisconsin Paul P. Carbone Comprehensive Cancer Center ( Natalie S. Callander ) |
Study ID Numbers: | CDR0000521546, WCCC-HO06401 |
Study First Received: | December 11, 2006 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00410605 History of Changes |
Health Authority: | Unspecified |
refractory multiple myeloma stage II multiple myeloma stage III multiple myeloma |
Anti-Inflammatory Agents Dexamethasone Immunoproliferative Disorders Antineoplastic Agents, Hormonal Blood Protein Disorders Hematologic Diseases Hormone Antagonists Blood Coagulation Disorders Hormones, Hormone Substitutes, and Hormone Antagonists Lenalidomide Vascular Diseases Antiemetics |
Paraproteinemias Bevacizumab Hemostatic Disorders Angiogenesis Inhibitors Hormones Glucocorticoids Multiple Myeloma Hemorrhagic Disorders Peripheral Nervous System Agents Lymphoproliferative Disorders Dexamethasone acetate Neoplasms, Plasma Cell |
Anti-Inflammatory Agents Dexamethasone Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Bevacizumab Hemostatic Disorders Hormones 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 Gastrointestinal Agents Vascular Diseases Lenalidomide Angiogenesis Inhibitors Glucocorticoids Pharmacologic Actions Multiple Myeloma |