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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: | NCT00477750 |
RATIONALE: Drugs used in chemotherapy, such as melphalan, prednisone, and lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of melphalan and lenalidomide when given together with prednisone and to see how well they work in treating patients with newly diagnosed multiple myeloma.
Condition | Intervention | Phase |
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Multiple Myeloma and Plasma Cell Neoplasm |
Drug: lenalidomide Drug: melphalan Drug: prednisone |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I/II Trial of Melphalan, Prednisone Plus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Stem Cell Transplant |
Estimated Enrollment: | 69 |
Study Start Date: | June 2005 |
Estimated Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of melphalan and lenalidomide followed by a phase II study.
Cohorts of 3-6 patients receive escalating doses of melphalan and lenalidomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed every 3 months for 3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of multiple myeloma
Meets 1 of the following criteria:
Measurable disease, defined by any of the following:
PATIENT CHARACTERISTICS:
No other active malignancy except for nonmelanoma skin cancer or carcinoma in situ
PRIOR CONCURRENT THERAPY:
United States, Arizona | |
Mayo Clinic Scottsdale | |
Scottsdale, Arizona, United States, 85259-5499 | |
United States, Florida | |
Mayo Clinic - Jacksonville | |
Jacksonville, Florida, United States, 32224 | |
United States, Minnesota | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 |
Study Chair: | Vivek Roy, MD, FACP | Mayo Clinic |
Investigator: | Philip R. Greipp, MD | Mayo Clinic |
Investigator: | Craig B. Reeder, MD | Mayo Clinic Scottsdale |
Investigator: | Angela Dispenzieri, MD | Mayo Clinic |
Investigator: | Rafael Fonseca, MD | Mayo Clinic Scottsdale |
Investigator: | Morie A. Gertz, MD | Mayo Clinic |
Investigator: | Martha Q. Lacy, MD | Mayo Clinic |
Investigator: | John A. Lust, MD, PhD | Mayo Clinic |
Investigator: | S. V. Rajkumar, MD | Mayo Clinic |
Investigator: | Thomas E. Witzig, MD | Mayo Clinic |
Investigator: | Steve Zeldenrust, MD | Mayo Clinic |
Study ID Numbers: | CDR0000546642, MAYO-MC038A, MAYO-IRB-2387-04 |
Study First Received: | May 23, 2007 |
Last Updated: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00477750 |
Health Authority: | United States: Food and Drug Administration |
stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma |
Melphalan Prednisone Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Lenalidomide Vascular Diseases |
Paraproteinemias Hemostatic Disorders Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Anti-Inflammatory Agents Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Molecular Mechanisms of Pharmacological Action Immune System Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones |
Glucocorticoids Immunosuppressive Agents Pharmacologic Actions Neoplasms Therapeutic Uses Myeloablative Agonists Cardiovascular Diseases Antineoplastic Agents, Alkylating Alkylating Agents |