Elotuzumab plus pomalidomide and dexamethasone in relapsed/refractory multiple myeloma: Extended follow‐up of a multicenter, retrospective real‐world experience with 321 cases outside of controlled clinical trials

Author:

Martino Enrica Antonia1,Palmieri Salvatore2ORCID,Galli Monica3,Derudas Daniele4,Mina Roberto5,Della Pepa Roberta6ORCID,Zambello Renato78,Vigna Ernesto1,Bruzzese Antonella1ORCID,Mangiacavalli Silvia9,Zamagni Elena1011,Califano Catello12,Musso Maurizio13,Conticello Concetta14,Cerchione Claudio15,Mele Giuseppe16ORCID,Di Renzo Nicola17,Offidani Massimo18ORCID,Tarantini Giuseppe19ORCID,Casaluci Gloria Margiotta20,Rago Angela21,Ria Roberto2223ORCID,Uccello Giuseppina24,Barilà Gregorio25ORCID,Palumbo Gaetano26,Pettine Loredana27ORCID,Vincelli Iolanda Donatella28ORCID,Brunori Marino29,Accardi Fabrizio30ORCID,Amico Valeria31,Amendola Angela32,Fontana Raffaele33,Bongarzoni Velia34,Rossini Bernardo35,Cotzia Emilia36,Gozzetti Alessandro37,Rizzi Rita3839,Sgherza Nicola38,Reddiconto Giovanni17,Maroccia Antonio40,Franceschini Luca41,Bertuglia Giuseppe42ORCID,Nappi Davide15,Barbieri Emiliano43ORCID,Gamberi Barbara43,Petrucci Maria Teresa44,Di Raimondo Francesco14,Neri Antonino45,Morabito Fortunato46,Musto Pellegrino3839,Gentile Massimo147

Affiliation:

1. Department of Onco‐hematology Hematology Unit Azienda Ospedaliera Annunziata Cosenza Italy

2. Hematology Unit, Ospedale Cardarelli Napoli Italy

3. Hematology and Bone Marrow Transplant Unit ASST Papa Giovanni Bergamo Italy

4. Department of Hematology Businco Hospital Cagliari Italy

5. Division of Hematology AOU Città della Salute e della Scienza di Torino University of Torino Torino Italy

6. Department of Clinical Medicine and Surgery Hematology Unit University of Naples "Federico II" Naples Italy

7. Department of Medicine University of Padova Hematology Unit Padova Italy

8. Veneto Institute of Molecular Medicine Padova Italy

9. Division of Hematology IRCCS Fondazione Policlinico San Matteo Pavia Italy

10. IRCCS Azienda Ospedaliero‐Universitaria di Bologna Istituto di Ematologia "Seràgnoli" Bologna Italy

11. Dipartimento di Scienze Mediche e Chirurgiche Università di Bologna Bologna Italy

12. Onco‐Hematology Unit "A. Tortora" Hospital Pagani Italy

13. Department of Oncology Onco‐Hematology Unit and TMO U.O.C. Palermo Italy

14. Division of Hematology Azienda Policlinico‐S. Marco University of Catania Catania Italy

15. Hematology Unit IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" Meldola Italy

16. Department of Hematology Hospital Perrino Brindisi Italy

17. Department of Hematology Hospital Vito Fazzi Lecce Italy

18. Hematology Unit AOU delle Marche Ancona Italy

19. Hematology Unit "Dimiccoli" Hospital Barletta (BAT) Italy

20. Division of Hematology Department of Translational Medicine University of Eastern Piedmont Novara Italy

21. UOSD Ematologia Rome Italy

22. Department of Precision and Regenerative Medicine and Ionian Area (DiMePRe‐J) University of Bari Aldo Moro Medical School Internal Medicine “G. Baccelli”; CITEL Bari Italy

23. Interdepartmental Centre for Research in Telemedicine University of Bari Aldo Moro Bari Italy

24. Hematology Department G. Garibaldi Hospital Catania Italy

25. Hematology Unit Ospedale San Bortolo Vicenza Italy

26. Department of Hematology Hospital University Riuniti Foggia Italy

27. Hematology Unit Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano Italy

28. Department of Hemato‐Oncology and Radiotherapy Hematology Unit Great Metropolitan Hospital "Bianchi‐Melacrino‐Morelli" Reggio Calabria Italy

29. Internal Medicine Ospedale Santa Croce Fano Italy

30. Department of Hematology I Azienda Ospedaliera Ospedali Riuniti Villa Sofia‐Cervello Palermo Italy

31. UOSD Ematologia, AORN San Pio Benevento Italy

32. Hematology Unit Azienda Ospedaliera Regionale "San Carlo" Potenza Italy

33. Hematology and Transplant Center University Hospital "San Giovanni di Dio e Ruggi d'Aragona" Salerno Italy

34. Department of Hematology San Giovanni‐Addolorata Hospital Rome Italy

35. Hematology and Cell Therapy Unit IRCCS Istituto Tumori "Giovanni Paolo II" Bari Bari Italy

36. Section of Hematology‐ Ospedale E. Muscatello‐Augusta Siracusa Italy

37. Hematology Azienda Ospedaliera Universitaria Senese University of Siena Siena Italy

38. Unit of Hematology and Stem Cell Transplantation AOUC Policlinico Bari Bari Italy

39. Department of Precision and Regenerative Medicine and Ionian Area "Aldo Moro" University School of Medicine Bari Italy

40. Hematology Unit ‐ Ospedale dell'Angelo Azienda ULSS n.3 Serenissima Venezia Mestre Italy

41. Lymphoproliferative Diseases Unit Tor Vergata University Hospital Rome Italy

42. Dipartimento di Oncologia ed Ematologia SC Ematologia 1 A.O. Citta' della Salute e della Scienza di Torino P.O. Molinette Torino Italy

43. Clinical and Experimental Medicine PhD Program University of Modena and Reggio Emilia Modena Italy

44. Department of Translational and Precision Medicine Hematology Azienda Policlinico Umberto I Sapienza University of Rome Rome Italy

45. Scientific Directorate Azienda USL‐IRCCS di Reggio Emilia Reggio Emilia Italy

46. Gruppo Amici Dell'Ematologia Foundation‐GrADE Reggio Emilia Italy

47. Department of Pharmacy Health and Nutritional Science University of Calabria Rende Italy

Abstract

AbstractThe ELOQUENT‐3 trial demonstrated the superiority of the combination of elotuzumab, pomalidomide, and dexamethasone (EloPd) in terms of efficacy and safety, compared to Pd in relapsed/refractory multiple myeloma (RRMM), who had received at least two prior therapies, including lenalidomide and a proteasome inhibitor. The present study is an 18‐month follow‐up update of a previously published Italian real‐life RRMM cohort of patients treated with EloPd. This revised analysis entered 319 RRMM patients accrued in 41 Italian centers. After a median follow‐up of 17.7 months, 213 patients (66.4%) experienced disease progression or died. Median progression‐free survival (PFS) and overall survival (OS) were 7.5 and 19.2 months, respectively. The updated multivariate analysis showed a significant reduction of PFS benefit magnitude both in advanced International Staging System (ISS) (II and III) stages and previous exposure to daratumumab cases. Instead, advanced ISS (II and III) stages and more than 2 previous lines of therapy maintained an independent prognostic impact on OS. Major adverse events included grade three‐fourths neutropenia (24.9%), anemia (13.4%), lymphocytopenia (15.5%), and thrombocytopenia (10.7%), while infection rates and pneumonia were 19.3% and 8.7%, respectively. A slight increase in the incidence of neutropenia and lymphocytopenia was registered with longer follow‐up. In conclusion, our real‐world study still confirms that EloPd is a safe and possible therapeutic choice for RRMM. Nevertheless, novel strategies are desirable for those patients exposed to daratumumab.

Publisher

Wiley

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