Pharmacokinetics and safety of elotuzumab combined with lenalidomide and dexamethasone in patients with multiple myeloma and various levels of renal impairment: Results of a phase Ib study

AbstractIntroductionThe present study evaluated the pharmacokinetics and safety of elotuzumab, a humanized IgG1 monoclonal antibody against signaling lymphocyte activation molecule-F7, combined with lenalidomide and dexamethasone, in patients with multiple myeloma (MM) and renal impairment.Patients and MethodsPatients with MM and normal renal function (NRF) (creatinine clearance [CrCl] ≥ 90 mL/min), severe renal impairment (SRI) (CrCl < 30 mL/min, not requiring dialysis), or end-stage renal disease (ESRD) (requiring dialysis) were enrolled in this open-label, phase Ib study. Elotuzumab (10 mg/kg), lenalidomide (5-25 mg), and dexamethasone (40 mg) were administered in 28-day cycles until disease progression or unacceptable toxicity developed. The primary endpoint was single-dose elotuzumab pharmacokinetics.ResultsA total of 26 patients (median age, 63 years) were treated (NRF, n = 8; SRI, n = 9; ESRD, n = 9). The median baseline CrCl was 105 mL/min (range, 84-146 mL/min) for those with NRF and 26 mL/min (range, 15-33 mL/min) for those with SRI. Twenty-three patients (89%) had received previous therapy (median, 2 regimens; range, 1-7). Treatment was discontinued in 6 patients with NRF, 4 with SRI, and 5 with ESRD, primarily because of disease progression. The mean elotuzumab serum concentrations were comparable across groups (n = 23). No statistically significant differences were observed in the maximum observed serum concentration, area under the concentration–time curve from time 0 to the last quantifiable serum concentration, or area under the concentration–time curve from time 0 to infinity when the SRI and ESRD groups were compared with the NRF group (P > .05). All patients had ≥ 1 adverse event (AE). Of the 8 patients with NRF, 9 with SRI, and 9 with ESRD, 7, 8, and 7 experienced grade 3 to 4 AEs. The overall response rates were 75% in the NRF, 67% in the SRI, and 56% in the ESRD groups.ConclusionThe results of the present study support the use of elotuzumab for the treatment of patients with MM and renal dysfunction without dose adjustment

The Grizzly, November 5, 1991

Red and Gold Day • Changes for Education Majors • Golf Cart Stolen • Unrest in the Quad • Alcohol Update • Fourth Annual Grizzly Network Career Day • U.S.G.A. Minutes • Chemical Awareness • Biology Department Update • Environmental Notes • Fraternities Experience Humanity of Habitat • The Winner Is: Mudslinger #1 • The Harm of Rumors • Priorities in College Athletics • Feed Your Mind • Halloween Flop • Soviet Art at Ursinus • The Quad Peacock • College Choir Performs Requiem • Senior Barn Bash • Goodfellas • Bears Rush by the Mules in 13-9 Upset • Volleyball Ends Season with a Loss • Field Hockey Passes by Princeton • Senior Runners Reflect on Seasonhttps://digitalcommons.ursinus.edu/grizzlynews/1282/thumbnail.jp

The Grizzly, April 16, 1991

Alcohol Policy Changes Discussed • Reimert Fire Breaks Up Sorority Rush: Deliberate or Accidental Still Unknown • Faculty Evaluates Frat Pledges Performance • Economics Conference Held • U.S.G.A. Minutes • Conflict and Creativity: ProTheatre Does it Again • Is Rock and Roll Really Dead? • REM: Out of Time • The Cider House Rules, Revisited • Religious Significance of David • Plaza Suite in Wismer • Jack Spinella Named New Basketball Coach • Men\u27s Track Falls to Hopkins • Men\u27s Lax Goes 1 and 1 This Week • Women Run Over Muhlenberg • Softball Splits • Golf Below Par • Student Input on Alcohol Policy Inadequate • Schafer Demands Opinion • Hold on to Your Key Money? • Letters: Apathy Dialog Proposed; Sorry, Harley; Thanks, Judd!; Weakly not Weekly • The Cutting Edge of Surgery • Electron Microscope to be Purchased With Kresge Grant • Help for Chronic Fatigue Sufferershttps://digitalcommons.ursinus.edu/grizzlynews/1276/thumbnail.jp

The Grizzly, February 26, 1990

UC Airband Gets Respect It Deserves • Student Abortion Debate To Heat Campus • Letters: Hey, Don\u27t be so Rude; Pledging: A Test; Don\u27t Blame Townies • Olin Topped In Style • New Day For Grizzly • Bears End Season With a Win • Bear Pack Paces To Second • Smith\u27s Super Season • Men Finish Sixth Aquabears Make a Splash • Grapplers To MAC\u27s • Haircuts Work Well • Richter Rips Alum • Trees Vanish In Northwest • Skateboarders Unite! • Rising Standards For Prospective Ursinus Students • Speaker Chosen • Martial Law Declared: Identification Now! • Hey Congress: Pass It, Man! • The King Of History • Bomberger Concert a Hit • Randolph Promoted • Bush Bugs Druggieshttps://digitalcommons.ursinus.edu/grizzlynews/1253/thumbnail.jp

The Grizzly, October 22, 1991

Alumni Return for Homecoming Celebration • Phi Beta Kappa Charter Approved for Ursinus • Thomas Confirmed to Supreme Court • Gibson to Speak at Ursinus • GALA Seeks Recognition • U.S.G.A. Minutes • GALA Comes Out • Modern Medical Imaging • The Vision of Science Through Art • Beware of Bad Moods • Woman Fixing Her Hair? • Critics\u27 Corner: The Fisher King; Sleeping With the Enemy • Giggles Night Club Comedians • Letters: In Defense of Harley; Harassment Response; An Appeal for the Trees • Apples and Oranges • Dining Turf • Bears Blank the Bullets in Homecoming Game • Cross Country Runs to Victory • Field Hockey Strikes Back, Raises Record to 5-5-2 • Volleyball Spikes Cabrini • Lady Bears Cruise to 1st Place • Winds Fill Ursinus\u27 Sails • Soccer Bounces Back with Three Straight Winshttps://digitalcommons.ursinus.edu/grizzlynews/1280/thumbnail.jp

The Grizzly, October 8, 1991

1991 Parents\u27 Day a Great Success • Homecoming Festivities Planned • Is the Soviet Union Dead? • Teacher Appreciation Dinner a Success • Tortorelli at NASA • What About Recycled Paper? • Movie Review: Misery • Jane Powell Returns • Saffire: Uppity Blues Women • The Aggressive Couple • Homecoming Queen Nominees • Ethnic Degradation • Unsafe City • Appreciate Today • Construction Blues • Letter: Come On, Harley! • Bears Maul Swarthmore • Lady Bears Run to Victory • Volleyball Gets Spiked • Field Hockey Drives for Victory • Too Early to Tell? No Way • Cross Country Takes 2nd • Soccer Team Struggles Among Tough Competition • Flag Football Follieshttps://digitalcommons.ursinus.edu/grizzlynews/1279/thumbnail.jp

The Grizzly, October 29, 1991

Charles Gibson Speaks to Crowd • Blood Drive a Success • Pledging Ends • Clergy Assembly for Professional Development on Campus Next Week • Hood Speaks on Morals at Tri-Lambda Meeting • The Environmental Corner • The Experience of a Lifetime • Environmental Chemistry and its Price • Trimming the Fat • Snoopy • Berman Opens Two New Exhibits • Dating Game a Success • Carlin Captivates at Valley Forge • ProTheatre Presents ... The Crucible • Haunted Hayride • Silence of the Lambs • Thought Organization • America: A Nation of Sissies • Letters: Clarification of GALA; Put Your Mouth Where Your Money Is • Bears Have a Devil of a Time with FDU • Lady Bears Finish 4th at PAIAW • Field Hockey Sticks it to St. Joe\u27s • Lady \u27Mers Swim to Victory at Ship Relays • Men\u27s Lacrosse Defeats St. Joseph\u27s • Flag Football • Men Swimmers Start Season • Cross Country Runs Widener Ragged • Golf Scores • Farleigh-Dickinson and Haverford Bounce by Ursinushttps://digitalcommons.ursinus.edu/grizzlynews/1281/thumbnail.jp

The Grizzly, November 12, 1991

Evaluations Show Drop in Pledge Grades • SAC Changes to AFAC • Voters Choose Wofford • Tri-Lamba Meets • Salk to Speak on Founders\u27 Day • Haley Visits Nearby High School • Crucible Captivates • WVOU at Music Marathon • Environmental Corner • Bench Art • Killer CAB Comedy • Fantasia • National Chemistry Week Unveils The Alchemist • Changing Life\u27s Blueprints • The Trouble With Wofford • The Black Hole of Greek Life • Face Off: Pros and Cons of GALA • Adopt a Flower Bed • IFC and The Illusion of Good Faith • Bears Squeak by King\u27s Point • Lady Bears Run Strong • Field Hockey Ends Season with a Tie • \u27Mers Submerge • Lady Swimmers Defeat Dickinsonhttps://digitalcommons.ursinus.edu/grizzlynews/1283/thumbnail.jp

The Grizzly, March 19, 1991

New U.S.G.A Officers Appointed • Pennsylvania Pro-Life Convention Held • Rare Israeli Exhibition Arrives Safely • Village Idiots Compete at Pitt • Tenure Candidates Approved for Next Year • Alcohol Recovery Group to Start • Seniors Prepare for Graduation • Just Do It -- The Nautilus Connection • Flags: The Collegeville Connection • U.S.G.A Minutes • The Knack is Bnack! • Ursinus Students in Indonesia for a Day • Julian\u27s House • Meistersingers • Talking With Betty Boop • Bowie: Something Old and Something New • City of David at Berman • Men\u27s Lacrosse Club Wins Season Opener • Tennis Teams Begin Season • Five Named to MAC Honor Roll • Softball Starts Season • Baseball World Tour \u2791 • Indoor Track Finishes Season • Letter: On Teaching Catalan • Student Apathy is Growing • Consider Women\u27s Studies Next Semesterhttps://digitalcommons.ursinus.edu/grizzlynews/1273/thumbnail.jp

The Grizzly, January 28, 1991

Policies and Statistics, A Security Concern: New Quad Regulations; Crime Report Released • Sonia Sanchez: Poet for Peace • Gulf Dialogue Continues • Independence Dogs • Financial Aid Month • You Asked for it: You Got It!! • New Quad Policy • Presidency Symposium • When is Dr. Martin Luther King, Jr.\u27s Birthday? • Who\u27s Who Announced • Mission Conference Held • Back to the Basics • The Innocent • Swimmers on Win Streak • Women Hope for Good Things to Come • A Roller Coaster Season for the Hoopsters • Women Rounding-out Season • The Dream Lives On • Letter: Bundle Up! • Researchers Psyched Out • The Technology of War • A Wasted Solution?https://digitalcommons.ursinus.edu/grizzlynews/1268/thumbnail.jp