Generic Lenalidomide Rivelime Versus Brand-name Revlimid® in the Treatment of Relapsed/Refractory Multiple Myeloma: A Retrospective Single-center Experience on Efficacy, Safety and Survival Outcome

In this retrospective observational study, relapsed/refractory multiple myeloma patients receiving singlet, doublet (Rd) or triplet (Rd plus carfilzomib, ixazomib or bortezomib) lenalidomide containing regimens were evaluated in terms of efficacy, safety and survival outcome with original brand-name lenalidomide (Revlimid (R)) vs. generic equivalent (Rivelime (R)). Our findings revealed similar efficacy and safety profile and similar survival outcome between original and generic lenalidomide.Background: This study aimed to compare use of original brand-name lenalidomide (Revlimid (R)) vs. generic equivalent (Rivelime (R)) in terms of efficacy, safety and survival outcome in patients with relapsed/refractory multiple myeloma (RRMM) Patients and Methods: A total of 184 patients RRMM (median age: 62 years, 60.9% were males) who received singlet, doublet or triplet lenalidomide-containing regimens including either Revlimid (R) (n = 74) or Rivelime (R) (n = 110) were included in this study. Treatment response was based on evaluation of objective response to treatment (ORR) including the sum of patients who achieved partial response (PR), very good partial responses (VGPR) or complete response (CR) to therapy. Progression-free survival (PFS), overall survival (OS) and safety data were also recorded. Results: Revlimid (R) and Rivelime (R) groups were similar in terms of ORR (54.1 vs. 60.0%), CR (22.5 vs. 28.8%), VGPR (55.0 vs. 50.0%) and PR (22.5 vs. 21.2%) rates. Median (SE) PFS time were similar between Rivelime (R) vs. Revlimid (R) treated patients who were in the 2nd line (30.3(3.8) vs. 22.7(7.0) months, p = 0.827) or 3rd line of therapy (38.1(12.1) vs. 20.1(0.9) months, p = 0.147) at lenalidomide initiation. Two groups also had similar OS rate (83.8 vs. 73.6%) and OS time (mean 122.3 vs. 123.5 months). Side effects were manageable in both groups. Conclusion: In conclusion, replacing Revlimid (R) with its generic version Rivelime (R) in singlet, doublet or triplet lenalidomide containing RRMM regimens seems not to compromise the efficacy of treatment, and to yield a similarly improved response rates and survival outcome and no additional toxic effects, enabling a long-term therapy.