Presentation on theme: "Final Results From the Registry to Evaluate Novantrone (RENEW) Victor Rivera, Bianca Weinstock-Guttman, Jacquie Beagan, Randy Bennett, Ahmad AL-Sabbagh,"— Presentation transcript:
Final Results From the Registry to Evaluate Novantrone (RENEW) Victor Rivera, Bianca Weinstock-Guttman, Jacquie Beagan, Randy Bennett, Ahmad AL-Sabbagh, Fernando Dangond* September 2009 ECTRIMS Poster Award Presentation *Dr. Dangond is an employee of EMD Serono, Inc.
2 Background Objective To report final cumulative validated data from the Registry to Evaluate Novantrone Effects in Worsening Multiple Sclerosis (RENEW) study Study Design 5-year, phase IV, multicenter, open-label, observational study Intervention Patients received Novantrone IV 12 mg/m 2 q 3 months* Patient Disposition 509 US patients; 46 centers 172 (33.8%) completed the 5-year trial 23 (4.5%) reached a cumulative dose ≥132 mg/m 2 IV=intravenous *Novantrone was administered at the specified dosage until a cumulative dose of 140 mg/m 2 was reached, a decision was made to discontinue therapy, or an adverse event precluded further therapy RENEW
3 Number of Mitoxantrone Infusions Per Patient RENEW Mean infusions: n=6 Mean cumulative dose/patient: 69.8 mg/m 2 n=24 n=38 n=48 n=59 n=50 n=51 n=37 n=104 n=31 n=24 n=12 n=13 n=7 n=6 n=1 n=2 n=0 n=2
4 Cardiac Function, Amenorrhea, and Leukemia Treatment Phase (n=509)Observational Phase (n=250) CHF, n (%) Hospitalization No hospitalization 3 4* 1313 LVEF <50%, n (%)27 (5.3)14 (5.6) LVEF ≥10% relative to baseline 43 (8.4)35 (14.0) Amenorrhea, n/N (%) Persistent Transient 28/128 (22) 5/128 (4) 4/73 (5) 1/73 (1) Leukemia was reported in 3 patients † (0.6%) RENEW n represents the number of patients; CHF=congestive heart failure; LVEF=left ventricular ejection fraction *6 patients total experienced CHF during the treatment phase; values above equal 7 because 1 patient was included in both categories † One case deemed unrelated to mitoxantrone therapy
5 Acknowledgments A special thanks to –Victor Rivera, MD (Houston, TX) and Bianca Weinstock-Guttman, MD (Buffalo, NY) –RENEW Investigators D. Ayres (Lebanon, NH)D. Kerr (Baltimore, MD)V. Rivera (Houston, TX) K. Bashir (Birmingham, AL)P. Kinkel (Williamsville, NY)M. Rizzo (New Haven, CT) R. Baumhefner (Los Angeles, CA)S. Kirzinger (Louisville, KY)L. Rolak (Marshfield, WI) D. Camenga (Duluth, MN)M. Kita (Seattle, WA)S. Sadiq (New York, NY) A. Chaudhry (Spokane, WA)S. Kolar (Indianapolis, IN)R. Sater (High Point, NC) P. Coyle (Stony Brook, NY)K. Kresa-Reahl (Charleston, WV)W. Sheremata (Miami, FL) A. Cross (St. Louis, MO)F. Lublin (New York, NY)R. Shubin (Pasadena, CA) J. DeMatteis (Erie, PA)S. Lynch (Kansas City, KS)J. Simsarian (Fairfax, VA) S. Elias (Detroit, MI)G. McIntosh (Fort Collins, CO)C. Smith (Seattle, WA) C. Ford (Albuquerque, NM)C. Markowitz (Philadelphia, PA)B. Weinstock-Guttman (Buffalo, NY) E. Fox (Round Rock, TX)D. Mattson (Indianapolis, IN)R. Whitham (Portland, OR) A. Goodman (Rochester, NY)D. Mikol (Ann Arbor, MI)D. Wynn (Northbrook, IL) J. Greenstein (Philadelphia, PA)A. Miller (Brooklyn, NY) A. Gupta (Fort Wayne, IN)H. Panitch (Burlington, VT) R. Heyman (Pittsburgh, PA)M. Picone (Teaneck, NJ) J. Huddlestone (Tacoma, WA)A. Rae-Grant (Allentown, PA) B. Hurwitz (Durham, NC)A. Reder (Chicago, IL)