Objective: Lenalidomide is an effective immunomodulatory derivative drug used in the treatment of multiple myeloma (MM). It is available in original and generic forms in Turkey, but there is no clinical study that has compared the effectiveness and adverse events (AEs) of the generic and original forms of lenalidomide. We compared the effectivity and AEs of generic and original lenalidomide in patients with relapsed/refractory MM (RRMM). Materials and Methods: Patients with RRMM using original or generic lenalidomide were evaluated retrospectively. Overall response (OR), complete response (CR), very good partial response (VGPR), partial response (PR), stable disease, and progressive disease rates and hematologic and nonhematologic AEs were evaluated in these RRMM patients. The results were described as numbers, frequencies, and percentages and were analyzed using PASW 19.0 for Windows with chi-square and Fisher exact tests. Results: The number of patients using original lenalidomide was 55 and the number of patients using generic lenalidomide was 43. The OR rate was 67.2% for patients using original lenalidomide and 60.4% for those on generic lenalidomide. CR and VGPR rates were 14.5% and 45.4% in the original group while the CR and VGPR rates were 20.9% and 18.6%, respectively, in patients using generic lenalidomide. Hematologic AEs were similar in the two groups while some nonhematologic AEs were less common in the original lenalidomide group than the generic group. Only pyrexia as a grade 3-4 AE was more common in the original lenalidomide than the generic lenalidomide group. Conclusion: This study showed that the generic form of lenalidomide has similar efficacy with the original form of lenalidomide in the treatment of RRMM. The AEs of original lenalidomide were generally fewer than those of generic lenalidomide. Further studies involving a larger number of patients with RRMM would be useful for comparing the efficacy and AEs of original and generic lenalidomide.
Objective: Lenalidomide is an effective immunomodulatory derivative drug used in the treatment of multiple myeloma (MM). It is available in original and generic forms in Turkey, but there is no clinical study that has compared the effectiveness and adverse events (AEs) of the generic and original forms of lenalidomide. We compared the effectivity and AEs of generic and original lenalidomide in patients with relapsed/refractory MM (RRMM). Materials and Methods:Patients with RRMM using original or generic lenalidomide were evaluated retrospectively. Overall response (OR), complete response (CR), very good partial response (VGPR), partial response (PR), stable disease, and progressive disease rates and hematologic and nonhematologic AEs were evaluated in these RRMM patients. The results were described as numbers, frequencies, and percentages and were analyzed using PASW 19.0 for Windows with chi-square and Fisher exact tests. Results: The number of patients using original lenalidomide was 55 and the number of patients using generic lenalidomide was 43. The OR rate was 67.2% for patients using original lenalidomide and 60.4% for those on generic lenalidomide. CR and VGPR rates were 14.5% and 45.4% in the original group while the CR and VGPR rates were 20.9% and 18.6%, respectively, in patients using generic lenalidomide. Hematologic AEs were similar in the two groups while some nonhematologic AEs were less common in the original lenalidomide group than the generic group. Only pyrexia as a grade 3-4 AE was more common in the original lenalidomide than the generic lenalidomide group. Conclusion: This study showed that the generic form of lenalidomide has similar efficacy with the original form of lenalidomide in the treatment of RRMM. The AEs of original lenalidomide were generally fewer than those of generic lenalidomide. Further studies involving a larger number of patients with RRMM would be useful for comparing the efficacy and AEs of original and generic lenalidomide.
Authors: Antonio Palumbo; S Vincent Rajkumar; Jesus F San Miguel; Alessandra Larocca; Ruben Niesvizky; Gareth Morgan; Ola Landgren; Roman Hajek; Hermann Einsele; Kenneth C Anderson; Meletios A Dimopoulos; Paul G Richardson; Michele Cavo; Andrew Spencer; A Keith Stewart; Kazuyuki Shimizu; Sagar Lonial; Pieter Sonneveld; Brian G M Durie; Philippe Moreau; Robert Z Orlowski Journal: J Clin Oncol Date: 2014-01-13 Impact factor: 44.544
Authors: Meletios A Dimopoulos; Albert Oriol; Hareth Nahi; Jesus San-Miguel; Nizar J Bahlis; Saad Z Usmani; Neil Rabin; Robert Z Orlowski; Mieczyslaw Komarnicki; Kenshi Suzuki; Torben Plesner; Sung-Soo Yoon; Dina Ben Yehuda; Paul G Richardson; Hartmut Goldschmidt; Donna Reece; Steen Lisby; Nushmia Z Khokhar; Lisa O'Rourke; Christopher Chiu; Xiang Qin; Mary Guckert; Tahamtan Ahmadi; Philippe Moreau Journal: N Engl J Med Date: 2016-10-06 Impact factor: 91.245
Authors: Lotfi Benboubker; Meletios A Dimopoulos; Angela Dispenzieri; John Catalano; Andrew R Belch; Michele Cavo; Antonello Pinto; Katja Weisel; Heinz Ludwig; Nizar Bahlis; Anne Banos; Mourad Tiab; Michel Delforge; Jamie Cavenagh; Catarina Geraldes; Je-Jung Lee; Christine Chen; Albert Oriol; Javier de la Rubia; Lugui Qiu; Darrell J White; Daniel Binder; Kenneth Anderson; Jean-Paul Fermand; Philippe Moreau; Michel Attal; Robert Knight; Guang Chen; Jason Van Oostendorp; Christian Jacques; Annette Ervin-Haynes; Hervé Avet-Loiseau; Cyrille Hulin; Thierry Facon Journal: N Engl J Med Date: 2014-09-04 Impact factor: 91.245
Authors: Brian G M Durie; Antje Hoering; Muneer H Abidi; S Vincent Rajkumar; Joshua Epstein; Stephen P Kahanic; Mohan Thakuri; Frederic Reu; Christopher M Reynolds; Rachael Sexton; Robert Z Orlowski; Bart Barlogie; Angela Dispenzieri Journal: Lancet Date: 2016-12-23 Impact factor: 79.321
Authors: Jesús F San-Miguel; Vania T M Hungria; Sung-Soo Yoon; Meral Beksac; Meletios A Dimopoulos; Ashraf Elghandour; Wieslaw W Jedrzejczak; Andreas Günther; Thanyaphong N Nakorn; Noppadol Siritanaratkul; Robert L Schlossman; Jian Hou; Philippe Moreau; Sagar Lonial; Jae H Lee; Hermann Einsele; Monika Sopala; Bourras-Rezki Bengoudifa; Florence Binlich; Paul G Richardson Journal: Lancet Haematol Date: 2016-10-14 Impact factor: 18.959
Authors: Philippe Moreau; Tamás Masszi; Norbert Grzasko; Nizar J Bahlis; Markus Hansson; Ludek Pour; Irwindeep Sandhu; Peter Ganly; Bartrum W Baker; Sharon R Jackson; Anne-Marie Stoppa; David R Simpson; Peter Gimsing; Antonio Palumbo; Laurent Garderet; Michele Cavo; Shaji Kumar; Cyrille Touzeau; Francis K Buadi; Jacob P Laubach; Deborah T Berg; Jianchang Lin; Alessandra Di Bacco; Ai-Min Hui; Helgi van de Velde; Paul G Richardson Journal: N Engl J Med Date: 2016-04-28 Impact factor: 91.245