[1642] Revlimid 25 mg (REV 25) x 20 Versus 50 mg (REV 50) x 10 q 28 Days with Bridging of 5 mg x 10 Versus 10 mg x 5 as Post-Transplant Salvage Therapy for Multiple Myeloma (MM). Session Type: Poster Session 754-I
Maurizio Zangari, Bart Barlogie, Joth Jacobson, Jerome B. Zeldis, Elias J. Anaissie, Raymond Thertulien, Athanasios Fassas, Choon-Kee Lee, John D. Shaughnessy, Guido J. Tricot Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences, Little Rock, AR, USA; Cancer Research And Biostatistics, Seattle, WA, USA; Celgene Corporation, Warren, NJ, USA
58 patients with advanced and refractory MM were enrolled in this randomized phase II trial. Patient characteristics included age 60 in 54%, abnormal cytogenetics in 54% including del 13 in 33%; prior therapy > 5 years in 41%; prior autotransplants in 86% including tandem transplant in 48%; prior thalidomide exposure in 93% of patients. Cumulative response rates after monthly REV cycles are depicted according to the levels of M protein reduction specified, which were higher with REV 25 than REV 50 (Cycle 8 50% or greater response: 40% vs 15% p=0.041).
Dose limiting toxicity was cytopenia, especially thrombocytopenia with 55% of patients with pre-REV platelet levels ≥ 100,000/µL developing grade > 2 thrombocytopenia (< 50,000/µL) as opposed to 90% when pre-REV platelet levels were < 100,000/µL (p=.001).
REV was not associated with sedative or neurotoxic side effects. Estimated 12-month EFS and OS rates are 30% and 61%, respectively, independent of cytogenetic abnormalities (CA) and REV dose. Serial gene expression profiling (GEP) studies prior to and 48 hr after REV revealed similar but not identical GEP changes as observed after thalidomide. Clinical outcome data will be presented in the context of these GEP data.
Abstract #1642 appears in Blood, Volume 102, issue 11, November 16, 2003
Keywords: Myeloma|Salvage Therapy|Revlimid
Dose limiting toxicity was cytopenia, especially thrombocytopenia with 55% of patients with pre-REV platelet levels ≥ 100,000/µL developing grade > 2 thrombocytopenia (< 50,000/µL) as opposed to 90% when pre-REV platelet levels were < 100,000/µL (p=.001).
REV was not associated with sedative or neurotoxic side effects. Estimated 12-month EFS and OS rates are 30% and 61%, respectively, independent of cytogenetic abnormalities (CA) and REV dose. Serial gene expression profiling (GEP) studies prior to and 48 hr after REV revealed similar but not identical GEP changes as observed after thalidomide. Clinical outcome data will be presented in the context of these GEP data.
Abstract #1642 appears in Blood, Volume 102, issue 11, November 16, 2003
Keywords: Myeloma|Salvage Therapy|Revlimid