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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: | NCT00772915 |
RATIONALE: Lenalidomide and dexamethasone may stop the growth of multiple myeloma by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well lenalidomide works with or without dexamethasone in treating patients with newly diagnosed multiple myeloma.
Condition | Intervention | Phase |
---|---|---|
Multiple Myeloma and Plasma Cell Neoplasm |
Drug: dexamethasone Drug: lenalidomide Procedure: bone marrow aspiration Procedure: flow cytometry Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis Procedure: pharmacological study Procedure: staining method |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial of Revlimid® and "On Demand" Dexamethasone Dosing in Patients With Newly Diagnosed Symptomatic Multiple Myeloma |
Estimated Enrollment: | 39 |
Study Start Date: | December 2008 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: Patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for up to 18 courses in the absence of second disease progression or unacceptable toxicity. Beginning in course 4, patients experiencing stable or progressive disease also receive concurrent oral dexamethasone once daily on days 1, 8, 15, and 22 and for all subsequent courses.
Blood and bone marrow samples are collected periodically for pharmacological and correlative studies. Samples are analyzed for parameters of immune activation, cell proliferation and apoptosis, and circulating tumor cells via flow cytometry; global impact of therapy on immune cell subsets via immunophenotype analysis; and angiogenesis via CD34 staining.
After completion of study therapy, patients are followed periodically for up to 3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Newly diagnosed multiple myeloma, meeting the following criteria:
Measurable or evaluable disease, defined by ≥ 1 of the following:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No prior corticosteroids (≥ 160 mg of dexamethasone or equivalent) for this disease
United States, Minnesota | |
Mayo Clinic Cancer Center | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 |
Study Chair: | Shaji K. Kumar, MD | Mayo Clinic |
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: | Francis K. Buadi, MD | Mayo Clinic |
Investigator: | David Dingli, MD | Mayo Clinic |
Investigator: | Stephen J. Russell, MD, PhD | Mayo Clinic |
Responsible Party: | Mayo Clinic Cancer Center ( Clinical Trials Office ) |
Study ID Numbers: | CDR0000616057, MAYO-MC0884, MAYO-08-002093 |
Study First Received: | October 12, 2008 |
Last Updated: | December 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00772915 |
Health Authority: | Unspecified |
stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma |
Dexamethasone Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Lenalidomide Vascular Diseases Paraproteinemias |
Hemostatic Disorders Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Dexamethasone acetate Neoplasms, Plasma Cell |
Anti-Inflammatory Agents Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Gastrointestinal Agents Antiemetics |
Hormones Glucocorticoids Pharmacologic Actions Neoplasms Autonomic Agents Therapeutic Uses Cardiovascular Diseases Peripheral Nervous System Agents Central Nervous System Agents |