scholarly journals Efficacy and Tolerability of Once‐Weekly Selinexor, Bortezomib, and Dexamethasone in Comparison with Standard Twice‐Weekly Bortezomib and Dexamethasone in Previously Treated Multiple Myeloma with Renal Impairment: Subgroup Analysis from the BOSTON Study

2021 ◽  
Author(s):  
Sosana Delimpasi ◽  
Maria Victoria Mateos ◽  
Holger W. Auner ◽  
Maria Gavriatopoulou ◽  
Meletios A. Dimopoulos ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Renal Impairment ◽  
Subgroup Analysis ◽  
Boston Study ◽  
Previously Treated

scholarly journals Isatuximab plus carfilzomib and dexamethasone versus carfilzomib and dexamethasone in relapsed multiple myeloma patients with renal impairment: IKEMA subgroup analysis

Haematologica ◽  
2021 ◽  
Author(s):  
Marcelo Capra ◽  
Thomas Martin ◽  
Philippe Moreau ◽  
Ross Baker ◽  
Ludek Pour ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Renal Function ◽  
Glomerular Filtration Rate ◽  
Renal Impairment ◽  
Glomerular Filtration ◽  
Subgroup Analysis ◽  
Filtration Rate ◽  
Estimated Glomerular Filtration Rate ◽  
Phase 3 ◽  
New Therapies

Renal impairment (RI) is common in patients with multiple myeloma (MM) and new therapies that can improve renal function are needed. The Phase 3 IKEMA study (NCT03275285) investigated isatuximab (Isa) with carfilzomib and dexamethasone (Kd) vs Kd in relapsed MM. This subgroup analysis examined results from patients with RI, defined as estimated glomerular filtration rate

scholarly journals Isatuximab plus pomalidomide and dexamethasone in relapsed/refractory multiple myeloma patients with renal impairment: ICARIA-MM subgroup analysis

Leukemia ◽  
2020 ◽  
Author(s):  
Meletios A. Dimopoulos ◽  
Xavier Leleu ◽  
Philippe Moreau ◽  
Paul G. Richardson ◽  
Anna Marina Liberati ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Renal Impairment ◽  
Subgroup Analysis ◽  
Refractory Multiple Myeloma

Effect of isatuximab plus pomalidomide/dexamethasone on renal impairment in relapsed/refractory multiple myeloma: ICARIA-MM study subgroup analysis

2019 ◽  
Vol 19 (10) ◽  
pp. e254 ◽  
Author(s):  
Meletios A. Dimopoulos ◽  
Xavier Leleu ◽  
Philippe Moreau ◽  
Michel Attal ◽  
Paul G. Richardson ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Renal Impairment ◽  
Subgroup Analysis ◽  
Refractory Multiple Myeloma

scholarly journals Effect of prior treatments on selinexor, bortezomib, and dexamethasone in previously treated multiple myeloma

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Maria V. Mateos ◽  
Maria Gavriatopoulou ◽  
Thierry Facon ◽  
Holger W. Auner ◽  
Xavier Leleu ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Peripheral Neuropathy ◽  
Adverse Events ◽  
Randomized Study ◽  
Progression Free Survival ◽  
Autologous Stem Cell Transplant ◽  
Cell Transplant ◽  
Prior Therapy ◽  
Boston Study ◽  
Previously Treated

AbstractTherapeutic regimens for previously treated multiple myeloma (MM) may not provide prolonged disease control and are often complicated by significant adverse events, including peripheral neuropathy. In patients with previously treated MM in the Phase 3 BOSTON study, once weekly selinexor, once weekly bortezomib, and 40 mg dexamethasone (XVd) demonstrated a significantly longer median progression-free survival (PFS), higher response rates, deeper responses, a trend to improved survival, and reduced incidence and severity of bortezomib-induced peripheral neuropathy when compared with standard twice weekly bortezomib and 80 mg dexamethasone (Vd). The pre-specified analyses described here evaluated the influence of the number of prior lines of therapy, prior treatment with lenalidomide, prior proteasome inhibitor (PI) therapy, prior immunomodulatory drug therapy, and prior autologous stem cell transplant (ASCT) on the efficacy and safety of XVd compared with Vd. In this 1:1 randomized study, enrolled patients were assigned to receive once weekly oral selinexor (100 mg) with once weekly subcutaneous bortezomib (1.3 mg/m2) and 40 mg per week dexamethasone (XVd) versus standard twice weekly bortezomib and 80 mg per week dexamethasone (Vd). XVd significantly improved PFS, overall response rate, time-to-next-treatment, and showed reduced all grade and grade ≥ 2 peripheral neuropathy compared with Vd regardless of prior treatments, but the benefits of XVd over Vd were more pronounced in patients treated earlier in their disease course who had either received only one prior therapy, had never been treated with a PI, or had prior ASCT. Treatment with XVd improved outcomes as compared to Vd regardless of prior therapies as well as manageable and generally reversible adverse events. XVd was associated with clinical benefit and reduced peripheral neuropathy compared to standard Vd in previously treated MM. These results suggest that the once weekly XVd regimen may be optimally administered to patients earlier in their course of disease, as their first bortezomib-containing regimen, and in those relapsing after ASCT.Trial registration: ClinicalTrials.gov (NCT03110562). Registered 12 April 2017. https://clinicaltrials.gov/ct2/show/NCT03110562.

Comparison of lenalidomide in combination with dexamethasone to dexamethasone alone in patients who have received prior thalidomide in relapsed or refractory multiple myeloma

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 7522-7522 ◽  
Author(s):  
M. Wang ◽  
R. Knight ◽  
M. Dimopoulos ◽  
D. Siegel ◽  
S. V. Rajkumar ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Subgroup Analysis ◽  
Phase Iii ◽  
Significant Variable ◽  
Refractory Multiple Myeloma ◽  
Prior Therapy ◽  
Pooled Data ◽  
Phase Iii Trials ◽  
Previously Treated ◽  
The Impact

7522 Background: Lenalidomide (len), an analog of thalidomide (thal) is a novel, oral immunomodulatory agent that is effective against multiple myeloma (MM). Two randomized, Phase III trials (MM009 and MM010) have recently demonstrated superior responses and overall survival (OS) for patients (pts) treated with len and dexamethasone (dex) in comparison with dex-placebo. This is a prospective subgroup analysis to assess the impact of prior therapy with thal on the sensitivity of MM to subsequent lenalidomide. Methods: We evaluated 692 pts from both trials (MM009 and MM010). The pts had relapsed/refractory MM, were not refractory to dex and were randomized to receive either len (25 mg daily for 3 weeks (wks) every 4 wks) plus dex (40 mg on days 1–4, 9–12, 17–20 every 4 wks for 4 cycles, then 40 mg on days 1–4 every subsequent cycle) or placebo plus dex. Standard criteria were used to evaluate response and TTP. Results: Pooled data from 692 pts showed superior median TTP (48.1 vs 20.1 wks) and OR (59.2% vs 22.5%) in pts treated with len/dex compared to dex-placebo (p <0.001). Although subgroup analysis of pts with prior thal therapy revealed that pts who received len/dex had significantly improved OR, PR CR and median TTP than pts who received dex-placebo, OR, CR and TTP were highest in len/dex pts not previously treated with thal. Multivariate analysis indicates that after controlling for the treatment factor and baseline disease characteristics, whether or not pt had prior exposure to thal is a marginally significant variable to predict TTP. The risk of deep venous thrombosis and pulmonary embolism in these subgroups will be updated on further analysis. Conclusions: Lenalidomide in combination with dexamethasone is more effective than dexamethasone-placebo regardless of prior thalidomide in relapsed/refractory multiple myeloma. [Table: see text] [Table: see text]

Plateau is a prognostic factor of lenalidomide therapy for previously treated multiple myeloma

2021 ◽  
Author(s):  
Teruhito Takakuwa ◽  
Kensuke Ohta ◽  
Eiji Nakatani ◽  
Tomoki Ito ◽  
Hitomi Kaneko ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Prognostic Factor ◽  
Previously Treated

Detection of renal impairment as one specific comorbidity factor in multiple myeloma: multicenter study in 198 consecutive patients

2009 ◽  
Vol 83 (6) ◽  
pp. 519-527 ◽  
Author(s):  
Martina Kleber ◽  
Gabriele Ihorst ◽  
Barbara Deschler ◽  
Christian Jakob ◽  
Peter Liebisch ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Renal Impairment ◽  
Multicenter Study
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