Matches in SemOpenAlex for { <https://semopenalex.org/work/W3096690841> ?p ?o ?g. }
- W3096690841 endingPage "2" @default.
- W3096690841 startingPage "1" @default.
- W3096690841 abstract "Introduction: Single-agent belamaf (GSK2857916), a B-cell maturation antigen-targeting antibody-drug conjugate, induced deep and durable responses in patients with RRMM, with a manageable safety profile with 13 months of follow-up (DREAMM-2; NCT03525678; Lonial et al, ASCO 2020, Poster 436). A platform trial design allows efficient evaluation of belamaf in combination with other anti-myeloma agents, such as a humanized wild-type IgG1 anti-OX40 agonist, an IgG4-inducible T-cell co-stimulator (ICOS) agonist, a gamma-secretase inhibitor, and a humanized programmed cell death (PD)-1 antagonist. The unique, multimodal mechanisms of action (MoAs) of belamaf, in combination with MoAs of these agents, has the potential to achieve synergistic effects in RRMM to further enhance anti-myeloma activity without compromising safety. Methods: DREAMM-5 (NCT04126200) is a Phase I/II study that utilizes a master protocol with separate substudies comprised of sequential dose-exploration (DE) and cohort-expansion (CE) phases, to identify promising, effective belamaf combinations when compared with a shared single-agent belamaf control arm (CE phase only). The DE phase consists of multiple dosing cohorts with belamaf combinations in which patients are assigned to treatment slots by a predetermined algorithmic approach (N≤10 per cohort). A recommended Phase II dose (RP2D) for each combination treatment will be identified based on the safety and preliminary efficacy in the DE phase. At the end of the DE phase, an interim analysis of safety, pharmacokinetic, and efficacy data will also be performed for each substudy treatment combination to determine whether the combination should move forward at the RP2D to the CE phase. Patients in the CE phase (N≥35 per cohort) will be randomized to a substudy and within a substudy to either combination treatment or the belamaf monotherapy control arm; patients will also be stratified by number of prior therapies). Eligible patients will have RRMM and will have received ≥3 prior therapy lines, which includes a prior immunomodulatory agent, proteasome inhibitor, and anti-CD38 antibody; all patients will provide informed consent for participation. The primary objectives of the study are to identify the RP2D (DE phase) and the overall response rate (≥partial response, CE phase), along with safety and tolerability, for each combination treatment. Substudies 1 (combination with GSK3174998, OX40 agonist antibody), 2 (combination with GSK3359609, ICOS agonist antibody), and 3 (combination with nirogacestat [PF-03084014; SpringWorks Therapeutics], gamma-secretase inhibitor) are currently open to enrollment. Substudy 4 (combination with dostarlimab; PD-1 antagonist antibody) is under review. Additional substudies will be explored based on scientific rationale and/or preclinical combination study results. Funding: GSK (Study 208887); belamaf drug linker technology licensed from Seattle Genetics; belamaf monoclonal antibody produced using POTELLIGENT Technology licensed from BioWa; nirogacestat gamma-secretase inhibitor produced by and used in collaboration with SpringWorks Therapeutics. Figure: DREAMM-5 study design Figure 1 Disclosures Richardson: Celgene/BMS, Oncopeptides, Takeda, Karyopharm: Research Funding. Nooka:GlaxoSmithKline: Consultancy, Honoraria, Other: Personal Fees: Travel/accomodations/expenses, Research Funding; Karyopharm Therapeutics, Adaptive technologies: Consultancy, Honoraria, Research Funding; Janssen: Consultancy, Honoraria, Research Funding; Spectrum Pharmaceuticals: Consultancy; Adaptive Technologies: Consultancy, Honoraria; Sanofi: Consultancy, Honoraria; Oncopeptides: Consultancy, Honoraria; Celgene: Consultancy, Honoraria, Research Funding; Takeda: Consultancy, Honoraria, Research Funding; Amgen: Consultancy, Honoraria, Research Funding; Bristol-Myers Squibb: Consultancy, Honoraria, Research Funding. Quach:Amgen, sanofi, celgene, Karyopharm, GSK: Research Funding; Amgen, Celgene, karyopharm, GSK, Janssen Cilag, Sanofi.: Membership on an entity's Board of Directors or advisory committees; GlaxoSmithKline, Karyopharm, Amgen, Celgene, Janssen Cilag: Consultancy; GlaxoSmithKline, Karyopharm, Amgen, Celgene, Janssen Cilag: Honoraria. Trudel:Celgene, Janssen, Takeda, Sanofi, Karyopharm, Amgen Canada: Honoraria; Celgene, Amgen, GSK: Consultancy, Research Funding; GSK, Celgene, Janssen, Amgen, Genentech: Research Funding. Routledge:Celgene, Sandoz: Consultancy; Amgen, BMS, Celgene, Sandoz: Honoraria. Song:Otsuka: Honoraria; Janssen: Honoraria, Research Funding; Amgen, Celgene,Takeda: Consultancy, Honoraria; Sanofi: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Gilead: Honoraria, Membership on an entity's Board of Directors or advisory committees; GlaxoSmithKline: Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene/BMS: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees. Paul:GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company. Khan:GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company. Brouch:GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company. Ferron-Brady:GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company. Yeakey:GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company. Shelton:GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company. Montes de Oca:GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company. Smith:SpringWorks: Current Employment, Current equity holder in publicly-traded company. Im:GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company. Ahlers:GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company. Paul:GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company. Holkova:GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company. Gupta:GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company; Novartis: Current equity holder in publicly-traded company. Kremer:GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company. Rodriguez-Otero:GlaxoSmithKline: Consultancy, Current Employment, Current equity holder in publicly-traded company, Honoraria; Kite: Consultancy, Honoraria; Abbvie: Consultancy, Honoraria; Oncopeptides: Consultancy, Honoraria; Amgen: Consultancy, Honoraria; Medscape: Membership on an entity's Board of Directors or advisory committees; Celgene/Bristol-Myers Squibb: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company); Janssen: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company); Sanofi: Consultancy, Honoraria." @default.
- W3096690841 created "2020-11-09" @default.
- W3096690841 creator A5001985488 @default.
- W3096690841 creator A5016138981 @default.
- W3096690841 creator A5018048721 @default.
- W3096690841 creator A5021098925 @default.
- W3096690841 creator A5021528356 @default.
- W3096690841 creator A5022520524 @default.
- W3096690841 creator A5027768129 @default.
- W3096690841 creator A5034602382 @default.
- W3096690841 creator A5043526996 @default.
- W3096690841 creator A5047132939 @default.
- W3096690841 creator A5047384785 @default.
- W3096690841 creator A5049230560 @default.
- W3096690841 creator A5052046806 @default.
- W3096690841 creator A5053503856 @default.
- W3096690841 creator A5058384217 @default.
- W3096690841 creator A5066814550 @default.
- W3096690841 creator A5080959881 @default.
- W3096690841 creator A5082712392 @default.
- W3096690841 creator A5086115833 @default.
- W3096690841 creator A5086403929 @default.
- W3096690841 creator A5089930850 @default.
- W3096690841 creator A5091396091 @default.
- W3096690841 date "2020-11-05" @default.
- W3096690841 modified "2023-09-28" @default.
- W3096690841 title "Dreamm-5 Platform Trial: Belantamab Mafodotin (Belamaf) in Combination with Four Different Novel Agents in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)" @default.
- W3096690841 doi "https://doi.org/10.1182/blood-2020-139182" @default.
- W3096690841 hasPublicationYear "2020" @default.
- W3096690841 type Work @default.
- W3096690841 sameAs 3096690841 @default.
- W3096690841 citedByCount "2" @default.
- W3096690841 countsByYear W30966908412021 @default.
- W3096690841 countsByYear W30966908412023 @default.
- W3096690841 crossrefType "journal-article" @default.
- W3096690841 hasAuthorship W3096690841A5001985488 @default.
- W3096690841 hasAuthorship W3096690841A5016138981 @default.
- W3096690841 hasAuthorship W3096690841A5018048721 @default.
- W3096690841 hasAuthorship W3096690841A5021098925 @default.
- W3096690841 hasAuthorship W3096690841A5021528356 @default.
- W3096690841 hasAuthorship W3096690841A5022520524 @default.
- W3096690841 hasAuthorship W3096690841A5027768129 @default.
- W3096690841 hasAuthorship W3096690841A5034602382 @default.
- W3096690841 hasAuthorship W3096690841A5043526996 @default.
- W3096690841 hasAuthorship W3096690841A5047132939 @default.
- W3096690841 hasAuthorship W3096690841A5047384785 @default.
- W3096690841 hasAuthorship W3096690841A5049230560 @default.
- W3096690841 hasAuthorship W3096690841A5052046806 @default.
- W3096690841 hasAuthorship W3096690841A5053503856 @default.
- W3096690841 hasAuthorship W3096690841A5058384217 @default.
- W3096690841 hasAuthorship W3096690841A5066814550 @default.
- W3096690841 hasAuthorship W3096690841A5080959881 @default.
- W3096690841 hasAuthorship W3096690841A5082712392 @default.
- W3096690841 hasAuthorship W3096690841A5086115833 @default.
- W3096690841 hasAuthorship W3096690841A5086403929 @default.
- W3096690841 hasAuthorship W3096690841A5089930850 @default.
- W3096690841 hasAuthorship W3096690841A5091396091 @default.
- W3096690841 hasBestOaLocation W30966908411 @default.
- W3096690841 hasConcept C112705442 @default.
- W3096690841 hasConcept C121332964 @default.
- W3096690841 hasConcept C126322002 @default.
- W3096690841 hasConcept C142424586 @default.
- W3096690841 hasConcept C143998085 @default.
- W3096690841 hasConcept C197934379 @default.
- W3096690841 hasConcept C22979827 @default.
- W3096690841 hasConcept C2776063141 @default.
- W3096690841 hasConcept C2776364478 @default.
- W3096690841 hasConcept C2777288759 @default.
- W3096690841 hasConcept C2778524551 @default.
- W3096690841 hasConcept C535046627 @default.
- W3096690841 hasConcept C61943457 @default.
- W3096690841 hasConcept C71924100 @default.
- W3096690841 hasConcept C87355193 @default.
- W3096690841 hasConcept C98274493 @default.
- W3096690841 hasConceptScore W3096690841C112705442 @default.
- W3096690841 hasConceptScore W3096690841C121332964 @default.
- W3096690841 hasConceptScore W3096690841C126322002 @default.
- W3096690841 hasConceptScore W3096690841C142424586 @default.
- W3096690841 hasConceptScore W3096690841C143998085 @default.
- W3096690841 hasConceptScore W3096690841C197934379 @default.
- W3096690841 hasConceptScore W3096690841C22979827 @default.
- W3096690841 hasConceptScore W3096690841C2776063141 @default.
- W3096690841 hasConceptScore W3096690841C2776364478 @default.
- W3096690841 hasConceptScore W3096690841C2777288759 @default.
- W3096690841 hasConceptScore W3096690841C2778524551 @default.
- W3096690841 hasConceptScore W3096690841C535046627 @default.
- W3096690841 hasConceptScore W3096690841C61943457 @default.
- W3096690841 hasConceptScore W3096690841C71924100 @default.
- W3096690841 hasConceptScore W3096690841C87355193 @default.
- W3096690841 hasConceptScore W3096690841C98274493 @default.
- W3096690841 hasIssue "Supplement 1" @default.
- W3096690841 hasLocation W30966908411 @default.
- W3096690841 hasOpenAccess W3096690841 @default.
- W3096690841 hasPrimaryLocation W30966908411 @default.
- W3096690841 hasRelatedWork W2021159149 @default.
- W3096690841 hasRelatedWork W2039196526 @default.
- W3096690841 hasRelatedWork W2051764329 @default.
- W3096690841 hasRelatedWork W2059075557 @default.