FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2470833619> ?p ?o ?g. }

• W2470833619 abstract "Abstract Pomalidomide (POM) is a novel IMiD(r) immunomodulatory agent with clinical activity in relapsed / resistant myeloma (RRMM) refractory to both lenalidomide and bortezomib. In prior phase II studies, the clinical activity of POM has been demonstrated using both continuous and intermittent dosing schedules. However the optimal dosing regimen for POM remains to be clarified and prospective data comparing these dosing schedules is limited. Herein we report the results of a randomized phase II clinical trial comparing the two POM dosing schedules. The primary objective was to compare clinical response to therapy (greater than or equal to partial response (PR) according to International Myeloma Working Group (IMWG) criteria). Patients (n=39) with RRMM documented to be refractory to lenalidomide were randomized to therapy with POM 2 mg/day for 28/28 days (Arm A, n=19) or POM 4 mg/day for 21/28 days (Arm B, n=20) of a 28 day cycle. All patients (pts) received POM alone at 2 or 4 mg for cycle 1, followed by the addition of dexamethasone at 40 mg weekly in subsequent cycles in both arms. Aspirin was utilized for thromboprophylaxis in both arms. Toxicity consisted primarily of myelosuppression which was manageable and similar in both cohorts. The incidence of serious adverse events (SAEs) was 36% in arm A and 55% in arm B. Grade 3 or 4 neutropenia (common toxicity criteria v4.0) was the most common toxicity and was observed in 42% and 45% of patients in arm A and arm B respectively. There was no treatment-emergent grade 3 or 4 neuropathy observed in either arm. Only one patient (in arm B) experienced grade 3 / 4 thromboembolic complication. Overall, objective response to therapy (greater than or equal to PR by IMWG criteria) was observed in 21% (4/19 patients) in arm A and 45% (9/20 patients) in arm B (p=0.18). There were no complete remissions in either cohort. Patients in arm B did have greater maximal reduction in measurable disease compared to arm A (percent maximal reduction mean (+ SD) 54% (+ 34%) in arm B versus 28% (+ 35%) in arm A, p=0.02). However both cohorts had comparable event-free survival (EFS) and overall survival (OS). The mean EFS in arm A and arm B was 4.4 months (95% confidence intervals (CI) 2.21 months, 7.67 months) and 5.1 months (95% CI 3.4 months, 9.2 months) respectively (p=0.56). Similarly the median OS in the arm A (17.7 months, 95% CI 10.02, not reached) was similar to that in arm B (17.7 months, 95% CI 9.98, not reached)(p=0.73). These data demonstrate in the context of a prospective randomized controlled clinical trial that both continuous (28/28) and intermittent (21/28) dosing regimens of POM with dexamethasone have remarkable clinical activity in this heavily pretreated MM population. These data provide further support towards the choice of POM at 4 mg/day for 21/28 days for phase III testing. The finding that intermittent dosing at 4 mg/day led to greater maximal cytoreduction of measurable disease compared to continuous dosing at 2 mg/day, without any differences in survival suggests that understanding the biology of residual disease will be essential to further improving outcome in these patients. Disclosures: No relevant conflicts of interest to declare." @default.
• W2470833619 created "2016-07-22" @default.
• W2470833619 creator A5012853410 @default.
• W2470833619 creator A5013461744 @default.
• W2470833619 creator A5021541475 @default.
• W2470833619 creator A5053039908 @default.
• W2470833619 creator A5054360080 @default.
• W2470833619 creator A5068969389 @default.
• W2470833619 creator A5073098256 @default.
• W2470833619 creator A5088696429 @default.
• W2470833619 creator A5090282854 @default.
• W2470833619 date "2013-11-15" @default.
• W2470833619 modified "2023-09-26" @default.
• W2470833619 title "Comparison Of Intermittent and Continuous Dosing Regimens Of Pomalidomide In Relapsed/Refractory Myeloma: Results Of A Phase II Randomized Trial" @default.
• W2470833619 doi "https://doi.org/10.1182/blood.v122.21.3205.3205" @default.
• W2470833619 hasPublicationYear "2013" @default.
• W2470833619 type Work @default.
• W2470833619 sameAs 2470833619 @default.
• W2470833619 citedByCount "0" @default.
• W2470833619 crossrefType "journal-article" @default.
• W2470833619 hasAuthorship W2470833619A5012853410 @default.
• W2470833619 hasAuthorship W2470833619A5013461744 @default.
• W2470833619 hasAuthorship W2470833619A5021541475 @default.
• W2470833619 hasAuthorship W2470833619A5053039908 @default.
• W2470833619 hasAuthorship W2470833619A5054360080 @default.
• W2470833619 hasAuthorship W2470833619A5068969389 @default.
• W2470833619 hasAuthorship W2470833619A5073098256 @default.
• W2470833619 hasAuthorship W2470833619A5088696429 @default.
• W2470833619 hasAuthorship W2470833619A5090282854 @default.
• W2470833619 hasConcept C121332964 @default.
• W2470833619 hasConcept C126322002 @default.
• W2470833619 hasConcept C141071460 @default.
• W2470833619 hasConcept C142424586 @default.
• W2470833619 hasConcept C197934379 @default.
• W2470833619 hasConcept C2776063141 @default.
• W2470833619 hasConcept C2776364478 @default.
• W2470833619 hasConcept C2777063308 @default.
• W2470833619 hasConcept C2777288759 @default.
• W2470833619 hasConcept C2778524551 @default.
• W2470833619 hasConcept C2778850193 @default.
• W2470833619 hasConcept C2781413609 @default.
• W2470833619 hasConcept C29730261 @default.
• W2470833619 hasConcept C71924100 @default.
• W2470833619 hasConcept C87355193 @default.
• W2470833619 hasConceptScore W2470833619C121332964 @default.
• W2470833619 hasConceptScore W2470833619C126322002 @default.
• W2470833619 hasConceptScore W2470833619C141071460 @default.
• W2470833619 hasConceptScore W2470833619C142424586 @default.
• W2470833619 hasConceptScore W2470833619C197934379 @default.
• W2470833619 hasConceptScore W2470833619C2776063141 @default.
• W2470833619 hasConceptScore W2470833619C2776364478 @default.
• W2470833619 hasConceptScore W2470833619C2777063308 @default.
• W2470833619 hasConceptScore W2470833619C2777288759 @default.
• W2470833619 hasConceptScore W2470833619C2778524551 @default.
• W2470833619 hasConceptScore W2470833619C2778850193 @default.
• W2470833619 hasConceptScore W2470833619C2781413609 @default.
• W2470833619 hasConceptScore W2470833619C29730261 @default.
• W2470833619 hasConceptScore W2470833619C71924100 @default.
• W2470833619 hasConceptScore W2470833619C87355193 @default.
• W2470833619 hasLocation W24708336191 @default.
• W2470833619 hasOpenAccess W2470833619 @default.
• W2470833619 hasPrimaryLocation W24708336191 @default.
• W2470833619 hasRelatedWork W1841466874 @default.
• W2470833619 hasRelatedWork W2521830490 @default.
• W2470833619 hasRelatedWork W2531520114 @default.
• W2470833619 hasRelatedWork W2539287384 @default.
• W2470833619 hasRelatedWork W2540650443 @default.
• W2470833619 hasRelatedWork W2547467207 @default.
• W2470833619 hasRelatedWork W2557922010 @default.
• W2470833619 hasRelatedWork W2562289938 @default.
• W2470833619 hasRelatedWork W2564303563 @default.
• W2470833619 hasRelatedWork W2575516876 @default.
• W2470833619 hasRelatedWork W2593294511 @default.
• W2470833619 hasRelatedWork W2606891899 @default.
• W2470833619 hasRelatedWork W2688500010 @default.
• W2470833619 hasRelatedWork W2980037245 @default.
• W2470833619 hasRelatedWork W2980062004 @default.
• W2470833619 hasRelatedWork W2980778150 @default.
• W2470833619 hasRelatedWork W2980900139 @default.
• W2470833619 hasRelatedWork W2981004208 @default.
• W2470833619 hasRelatedWork W2993780843 @default.
• W2470833619 hasRelatedWork W630776279 @default.
• W2470833619 isParatext "false" @default.
• W2470833619 isRetracted "false" @default.
• W2470833619 magId "2470833619" @default.
• W2470833619 workType "article" @default.