Efficacy Of Lenalidomide Dexamethasone Research Articles

Real-world outcomes for the treatment of relapsed/refractory multiple myeloma patients with lenalidomide-dexamethasone combinations in a Latin American country. A retrospective cohort study from grupo argentino de mieloma múltiple

ABSTRACT Objectives We compared the efficacy of lenalidomide-dexamethasone (Rd) based treatments for relapsed/refractory multiple myeloma patients (pts), in a real-world setting. In addition, we evaluated adverse events (AE), progression-free survival (PFS) and overall survival (OS). Methods In our retrospective, multicentric study, 156 pts with RRMM were included. 74/156 pts (47%) were refractory to bortezomib (V) and 43/156 (27%) pts to lenalidomide (R), with 24/156 (15%) of pts double refractory. Eighty-six pts (55%) received Rd with carfilzomib (KRd), 30 pts (19%) bortezomib (VRd), 30 pts (19%) daratumumab (DRd), and 10 pts (6%) ixazomib (IRd). Results The overall response (ORR) (≥ partial response) for the entire cohort was 71%, with a very good partial response rate or better (≥VGPR) of 35%. We found no significant differences in CR or ≥VGRP rates between treatments (p:0.229). Regardless of the combination received, those patients who achieved CR had significantly improved PFS (p: 0.007). The most frequent cause of treatment discontinuation was disease progression in 55/156 pts (35%). 8 pts (5%) discontinued treatment due to treatment-related adverse events (AE). Conclusion This is the first report of Rd combinations for the treatment of RRMM in Latin America. All combinations proved to be effective with an acceptable toxicity.

A prospective comparative study of efficacy of lenalidomide plus dexamethasone combination therapy versus VAD (vincristine, doxorubicin and dexamethasone) regimen in the treatment of multiple myeloma

Background: Lenalidomide plus Dexamethasone (Len-Dex) and VAD (Vincristine, Doxorubicin and Dexamethasone) regimen are the two common drug therapies employed in the treatment of Multiple myeloma.Objectives: To compare the efficacy of Len-Dex versus VAD regimen based on complete remission achieved with treatment in newly diagnosed cases of multiple myeloma in a tertiary care hospital in Kerala.Methods: Eighty patients (forty in each group) of newly diagnosed cases of multiple myeloma, who were willing to give the informed consent, were included in the study. Patients were allocated by the treating physician to two groups; one group was given Len-Dex (lenalidomide + dexamethasone) regimen and the other VAD (Vincristine, Adriamycin, Dexamethasone) regimen. A total of six cycles were given for both groups. Their baseline investigations and follow up investigations were collected at regular intervals, based on these values, the outcome was classified as partial remission and complete remission and the results were compared and analyzed.Results: Among the forty patients in each group, 17 (38%) on VAD regimen and 28 (62%) on Len-Dex regimen achieved complete remission. The statistical analysis was done using chi square test (χ2= 6.13, df= 1, p= 0.01) which showed statistically significant difference.Conclusions: The study showed that the efficacy of Lenalidomide-Dexamethasone (Len-Dex) combination therapy is clearly higher than that of VAD regimen among the study population. The overall efficacy of Len-Dex combination is 70% and that of VAD regimen is only 42.5%.

A randomized Southwest Oncology Group study comparing dexamethasone (D) to lenalidomide + dexamethasone (LD) as treatment of newly-diagnosed multiple myeloma (NDMM): Impact of cytogenetic abnormalities on efficacy of LD, and updated overall study results

8521 Background: We recently reported superior 1-yr prog. free survival (PFS) for pts with NDMM treated with LD vs D alone. High-risk cytogenetic abnormalities (HRCA) confer poor prognosis with standard therapies, including high dose melphalan. It is unknown if pts on LD with HRCA will also have inferior results. We prospectively examined the impact of abnormal karyotype (AK) and HRCA (defined as deletion of chromosomes 13 and/or 17 by FISH) on 1-yr PFS and overall survival (OS), as well as updated overall study results. Methods: 198 pts with NDMM were randomized to L 25 mg/day (28 of 35 days x 3 cycles, then 21 of 28 days as maintenance) + D (40 mg d1–4, 9–12, 17–20 induction; d1–4, 15–18 maintenance) or D (same induction and maintenance schedules) + placebo. Cross-over to LD was allowed for progressive disease on D. Aspirin 325 mg/d was mandated. Pts had a baseline bone marrow aspirate for karyotypic analysis and FISH for deletions of chromosomes 13 and 17. The response rate (RR) by IMWG criteria, PFS, and OS of pts in each study arm were updated. The impact of AK and HRCA by FISH on PFS and OS was assessed by log-rank analysis. Results: Informative baseline karyotypes and FISH results were available for 103 and 80 pts, respectively. AK were seen in 10/52 samples from pts on D, and 11/51 on LD. Twelve of 45 samples from pts on D and 8/35 on LD had HRCA. For pts on LD without AK, 1-yr PFS and OS were 86% and 97% respectively, vs 55% (p=0.13) and 82% (p=0.02) in pts with AK. Pts on D alone with AK had 1-yr PFS and OS of 33% and 77% (p=NS). 1-yr PFS and OS for pts on LD were both 100% with HRCA vs 73% and 92% without HRCA (p=NS). Conclusions: In this sub-group analysis, pts with NDMM on LD with AK had lower PFS and OS compared to those without AK. HRCA as defined in this study did not seem to account for this difference, but sample size limited the statistical power of the analysis. Pts with AK treated with LD had higher PFS and OS compared to those on D alone. Further characterization of observed karyotypic and FISH abnormalities, as well as extended follow-up for PFS, OS, and RR (including ≥VGPR rates) for S0232 will be presented at ASCO. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Celgene, Millennium Celgene, Millennium