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Sponsors and Collaborators: |
Mayo Clinic Scottsdale National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00790842 |
RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. 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 lenalidomide together with dexamethasone may kill more cancer cells. Lenalidomide and dexamethasone may have different effects in patients who have changes in their kidney function.
PURPOSE: This phase I/II trial is studying the side effects and best dose of lenalidomide when given together with low-dose dexamethasone and to see how well they work in treating patients with relapsed or refractory multiple myeloma and kidney dysfunction.
Condition | Intervention | Phase |
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Multiple Myeloma and Plasma Cell Neoplasm |
Drug: dexamethasone Drug: lenalidomide Procedure: pharmacological study |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I/II Study of the Tolerability of Lenalidomide and Low Dose Dexamethasone in Multiple Myeloma Patients With Impaired Renal Function. |
Estimated Enrollment: | 135 |
Study Start Date: | December 2008 |
Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a phase I, dose-escalation study of lenalidomide followed by a phase II study. Patients are stratified according to degree of renal dysfunction (moderate [creatinine clearance 30-50 mL/min] vs severe [creatinine clearance < 30 mL/min and does not require dialysis] vs end-stage renal disease [creatinine clearance < 30 mL/min and requires dialysis]).
Patients receive oral lenalidomide on days 1-21 and low-dose oral dexamethasone on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients enrolled in the phase II portion of the study undergo blood sample collection periodically for pharmacokinetic analysis of lenalidomide.
After completion of study treatment, patients are followed every 6 months for up to 3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of symptomatic multiple myeloma
Measurable or evaluable disease, as defined by one of the following:
PATIENT CHARACTERISTICS:
No concurrent uncontrolled illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
No other concurrent anticancer agents or treatments except for the following:
United States, Arizona | |
Mayo Clinic Scottsdale | Recruiting |
Scottsdale, Arizona, United States, 85259-5499 | |
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
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: | Joseph R. Mikhael, MD | Mayo Clinic Scottsdale |
Investigator: | Suzanne Hayman, MD | Mayo Clinic |
Responsible Party: | Mayo Clinic Scottsdale ( Clinical Trials Office ) |
Study ID Numbers: | CDR0000617813, MAYO-MC0885, MAYO-08-003156, CELGENE-RV-MM-PI-0394 |
Study First Received: | November 13, 2008 |
Last Updated: | December 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00790842 |
Health Authority: | Unspecified |
refractory multiple myeloma 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 |