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Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00478218 |
RATIONALE: Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with cyclophosphamide and dexamethasone may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving lenalidomide together with cyclophosphamide and dexamethasone works in treating patients with newly diagnosed multiple myeloma.
Condition | Intervention | Phase |
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Multiple Myeloma and Plasma Cell Neoplasm |
Drug: cyclophosphamide Drug: dexamethasone Drug: lenalidomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial of Revlimid, Cyclophosphamide, and Dexamethasone in Patients With Newly Diagnosed Active Multiple Myeloma |
Estimated Enrollment: | 53 |
Study Start Date: | July 2006 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive oral lenalidomide on days 1-21, oral cyclophosphamide on days 1, 8, and 15, and oral dexamethasone on days 1, 8, 15, and 22.
Treatment repeats every 28 days for 4-12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 6 months for up to 5 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of multiple myeloma
Measurable or evaluable disease, defined by ≥ 1 of the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Arizona | |
Mayo Clinic Scottsdale | |
Scottsdale, Arizona, United States, 85259-5499 | |
United States, Minnesota | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 |
Study Chair: | Shaji K. Kumar, MD | Mayo Clinic |
Investigator: | Craig B. Reeder, MD | Mayo Clinic Scottsdale |
Investigator: | Morie A. Gertz, MD | Mayo Clinic |
Investigator: | Philip R. Greipp, MD | Mayo Clinic |
Investigator: | Thomas E. Witzig, MD | Mayo Clinic |
Investigator: | John A. Lust, MD, PhD | Mayo Clinic |
Investigator: | Martha Q. Lacy, MD | Mayo Clinic |
Investigator: | Angela Dispenzieri, MD | Mayo Clinic |
Investigator: | S. V. Rajkumar, MD | Mayo Clinic |
Investigator: | Steve Zeldenrust, MD | Mayo Clinic |
Investigator: | Suzanne Hayman, MD | Mayo Clinic |
Investigator: | Rafael Fonseca, MD | Mayo Clinic Scottsdale |
Study ID Numbers: | CDR0000546657, MAYO-MC058E, MAYO-06-002786 |
Study First Received: | May 23, 2007 |
Last Updated: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00478218 History of Changes |
Health Authority: | United States: Federal Government |
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 Hemorrhagic Disorders Alkylating Agents Dexamethasone acetate |
Immunoproliferative Disorders Antineoplastic Agents, Hormonal Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Lenalidomide Immunosuppressive Agents Glucocorticoids Multiple Myeloma Antineoplastic Agents, Alkylating Peripheral Nervous System Agents Lymphoproliferative Disorders Antirheumatic Agents Neoplasms, Plasma Cell |
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 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 Gastrointestinal Agents Vascular Diseases Lenalidomide Glucocorticoids Immunosuppressive Agents Pharmacologic Actions Multiple Myeloma |