PMID- 33342205
OWN - NLM
STAT- MEDLINE
DCOM- 20210727
LR  - 20210727
IS  - 1308-5263 (Electronic)
IS  - 1300-7777 (Print)
IS  - 1300-7777 (Linking)
VI  - 38
IP  - 1
DP  - 2021 Feb 25
TI  - Original Versus Generic Lenalidomide in Patients with Relapsed/Refractory 
      Multiple Myeloma: Comparison of Efficacy and Adverse Events.
PG  - 41-48
LID - 10.4274/tjh.galenos.2020.2020.0169 [doi]
AB  - 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.
FAU - Bolaman, Ali Zahit
AU  - Bolaman AZ
AUID- ORCID: 0000-0003-0651-5462
AD  - Aydin Adnan Menderes University Faculty of Medicine, Department of Hematology, 
      Aydin, Turkey
FAU - Turgutkaya, Atakan
AU  - Turgutkaya A
AUID- ORCID: 0000-0001-8428-4730
AD  - Aydin Adnan Menderes University Faculty of Medicine, Department of Hematology, 
      Aydin, Turkey
FAU - Sahip, Birsen
AU  - Sahip B
AUID- ORCID: 0000-0001-5375-6432
AD  - Zonguldak Bulent Ecevit University Faculty of Medicine, Division of Hematology, 
      Zonguldak, Turkey
FAU - Selim, Cem
AU  - Selim C
AUID- ORCID: 0000-0002-2717-8306
AD  - Aydin Adnan Menderes University Faculty of Medicine, Department of Hematology, 
      Aydin, Turkey
FAU - Eroglu Kucukerdiler, Hilal
AU  - Eroglu Kucukerdiler H
AUID- ORCID: 0000-0002-2604-3127
AD  - Aydin Adnan Menderes University Faculty of Medicine, Department of Hematology, 
      Aydin, Turkey
FAU - Ertop, Sehmus
AU  - Ertop S
AUID- ORCID: 0000-0001-8771-7343
AD  - Zonguldak Bulent Ecevit University Faculty of Medicine, Division of Hematology, 
      Zonguldak, Turkey
FAU - Sargin, Gokhan
AU  - Sargin G
AUID- ORCID: 0000-0002-3778-8351
AD  - Aydin Adnan Menderes University Faculty of Medicine, Department of 
      Immunology-Rheumatology, Aydin, Turkey
FAU - Yavasoglu, Irfan
AU  - Yavasoglu I
AUID- ORCID: 0000-0003-1703-2175
AD  - Aydin Adnan Menderes University Faculty of Medicine, Department of Hematology, 
      Aydin, Turkey
LA  - eng
PT  - Comparative Study
PT  - Journal Article
DEP - 20201221
PL  - Turkey
TA  - Turk J Haematol
JT  - Turkish journal of haematology : official journal of Turkish Society of 
      Haematology
JID - 9606065
RN  - 0 (Drugs, Generic)
RN  - F0P408N6V4 (Lenalidomide)
SB  - IM
MH  - Aged
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/therapeutic use
MH  - Disease Progression
MH  - Drug Resistance, Neoplasm
MH  - Drugs, Generic/administration & dosage/adverse effects/*therapeutic use
MH  - Female
MH  - Humans
MH  - Lenalidomide/administration & dosage/adverse effects/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Multiple Myeloma/diagnosis/*drug therapy/mortality
MH  - Neoplasm Grading
MH  - Neoplasm Staging
MH  - Odds Ratio
MH  - Recurrence
MH  - Retreatment
MH  - Treatment Outcome
PMC - PMC7927438
OTO - NOTNLM
OT  - Lenalidomide
OT  - Treatment
OT  - Original
OT  - Generic
OT  - Adverse effect
COIS- Conflict of Interest: No conflict of interest was declared by the authors.
EDAT- 2020/12/22 06:00
MHDA- 2021/07/28 06:00
PMCR- 2021/03/01
CRDT- 2020/12/21 03:28
PHST- 2020/12/21 03:28 [entrez]
PHST- 2020/12/22 06:00 [pubmed]
PHST- 2021/07/28 06:00 [medline]
PHST- 2021/03/01 00:00 [pmc-release]
AID - 44784 [pii]
AID - 10.4274/tjh.galenos.2020.2020.0169 [doi]
PST - ppublish
SO  - Turk J Haematol. 2021 Feb 25;38(1):41-48. doi: 
      10.4274/tjh.galenos.2020.2020.0169. Epub 2020 Dec 21.