Lenalidomide plus Dexamethasone for Relapsed Multiple Myeloma in North America

• Published in: The New England journal of medicine Vol. 357; no. 21; pp. 2133 - 2142
• Main Authors: Weber, Donna M, Chen, Christine, Niesvizky, Ruben, Wang, Michael, Belch, Andrew, Stadtmauer, Edward A, Siegel, David, Borrello, Ivan, Rajkumar, S. Vincent, Chanan-Khan, Asher Alban, Lonial, Sagar, Yu, Zhinuan, Patin, John, Olesnyckyj, Marta, Zeldis, Jerome B, Knight, Robert D
• Format: Journal Article
• Language: English
• Published: Boston, MA Massachusetts Medical Society 22.11.2007
• Subjects: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Bone marrow; Dexamethasone - therapeutic use; Disease Progression; Double-Blind Method; Drug dosages; Female; General aspects; Glucocorticoids - therapeutic use; Humans; Immunodeficiencies. Immunoglobulinopathies; Immunoglobulinopathies; Immunologic Factors - therapeutic use; Immunopathology; Male; Medical sciences; Medical treatment; Middle Aged; Multiple Myeloma - drug therapy; Multiple Myeloma - mortality; Proteins; Recurrence; Survival Analysis; Thalidomide - adverse effects; Thalidomide - analogs & derivatives; Thalidomide - therapeutic use; Transplants & implants; North America; America; Canada; United States > US; Corticosteroid; Immunopathology; Drug combination; Relapse; Dexamethasone; Lenalidomide; Steroid hormone; Antiinflammatory agent; Malignant hemopathy; Myeloma; Immunomodulator; Medicine; Immunoglobulinopathy; Lymphoproliferative syndrome; Cancer
• ISSN: 0028-4793; 1533-4406
• DOI: 10.1056/NEJMoa070596

This randomized trial compared lenalidomide plus dexamethasone with a placebo plus dexamethasone in patients in the United States and Canada who had multiple myeloma that was resistant to one or more other treatments. The addition of lenalidomide improved the time to progression and overall survival in these patients. Important adverse events were severe neutropenia and venous thromboembolism. The addition of lenalidomide improved the time to progression and overall survival in patients with multiple myeloma. Multiple myeloma causes nearly 11,000 deaths annually in the United States. 1 Treatment with the immunomodulatory agent thalidomide or the proteasome inhibitor bortezomib has improved response rates, time to progression, and survival, but the side effects of fatigue, neuropathy, constipation, and thrombotic events remain a concern. 2 – 6 In nearly all patients who receive these drugs or other chemotherapy, the disease eventually relapses and is subsequently resistant to treatment. Lenalidomide is a thalidomide derivative that down-regulates interleukin-6 and nuclear factor κ-B and activates caspase 8 in vitro. The drug is up to 50,000 times as potent as its parent molecule in inhibiting . . .