2024
The Association between Glucagon-like Peptide-1 Receptor Agonist and Major Adverse Cardiac and Cerebrovascular Events in Monoclonal Gammopathy of Undetermined Significance: A Propensity-Score Analysis
Song J, Deshpande S, Chang Y, Chiang C, Ahn J, Lessa A, Soni A, Gonzales A, Lee P, Chang Y, Parker T, Kwan J, Chi K, Nanna M. The Association between Glucagon-like Peptide-1 Receptor Agonist and Major Adverse Cardiac and Cerebrovascular Events in Monoclonal Gammopathy of Undetermined Significance: A Propensity-Score Analysis. Blood 2024, 144: 6869. DOI: 10.1182/blood-2024-194867.Peer-Reviewed Original ResearchReal-World Efficacy and Patient-Reported Quality of Life Outcomes with Daratumumab Regimens in Multiple Myeloma
Browning S, Li F, Theprungsirikul P, Parker T, Bar N, Giri S, Anderson T, Stevens E, Gorshein E, Sabbath K, Wei C, Ali S, Witt D, Persico J, Talsania A, Rahmat L, Kidwai W, Legare R, LaSala J, Austin M, Neparidze N. Real-World Efficacy and Patient-Reported Quality of Life Outcomes with Daratumumab Regimens in Multiple Myeloma. Blood 2024, 144: 7831. DOI: 10.1182/blood-2024-204150.Peer-Reviewed Original ResearchRelapsed/refractory multiple myelomaInternational Myeloma Working GroupAdverse eventsGlobal health statusFunctional scalesMultiple symptom scalesPartial responseProteasome inhibitorsMultiple myelomaHealth statusEastern Cooperative Oncology Group performance statusClinical trialsMonoclonal antibody targeting CD38Median progression free survivalRelapsed/refractory multiple myeloma patientsIntroduction of novel therapiesHealth-related quality of lifeClinical response assessmentDaratumumab-based regimensProgression free survivalInfusion-related reactionsLines of therapyPatient-reported quality of life outcomesMean fatigue scoreHealth-related qualityA Phase III, Randomized Study of Daratumumab, Cyclophosphamide, Bortezomib and Dexamethasone (DARA-VCD) Induction Followed By Autologous Stem Cell Transplant or Dara-VCD Consolidation and Daratumumab Maintenance in Patients with Newly Diagnosed AL Amyloidosis
Hagen P, Sidana S, Parker T, Walker B, Sanchorawala V, Zonder J, Kourelis T, D'Souza A, Landau H, Rosenthal A, Hoering A, Ailawadhi S, Orlowski R. A Phase III, Randomized Study of Daratumumab, Cyclophosphamide, Bortezomib and Dexamethasone (DARA-VCD) Induction Followed By Autologous Stem Cell Transplant or Dara-VCD Consolidation and Daratumumab Maintenance in Patients with Newly Diagnosed AL Amyloidosis. Blood 2024, 144: 3309.1-3309.1. DOI: 10.1182/blood-2024-208227.Peer-Reviewed Original ResearchAutologous stem cell transplantationNext generation flow cytometryStem cell transplantationOverall survivalConsolidation therapyAL amyloidCell transplantationASCT armLight chain (AL) amyloidosisSeverity of cardiac involvementFlow cytometryAL amyloid patientsDaratumumab to bortezomibTransplant related mortalityProgression free survivalHematologic response rateTwo-sided significance levelPlasma cell malignancyMulti-organ involvementDaratumumab maintenanceInduction therapyMRD negativityFree survivalIntergroup trialCardiac involvementIsatuximab in Relapsed AL Amyloidosis: Results of a Prospective Phase II Trial (SWOG S1702)
Parker T, Rosenthal A, Sanchorawala V, Landau H, Campagnaro E, Kapoor P, Neparidze N, Girnius S, Hagen P, Scott E, Hoering A, Durie B, Orlowski R. Isatuximab in Relapsed AL Amyloidosis: Results of a Prospective Phase II Trial (SWOG S1702). Blood 2024, 144: 3378-3378. DOI: 10.1182/blood-2024-208341.Peer-Reviewed Original ResearchMedian time to responseRelapsed AL amyloidosisTime to responseAL amyloidosisPartial responseHematologic responseComplete responseCardiac involvementOverall survivalRenal involvementOrgan involvementEastern Cooperative Oncology Group performance statusRate of hematologic responseAutologous stem cell transplantationProspective phase II trialLight chain (AL) amyloidosisDistribution of organ involvementProgression free survivalHematologic complete responseHematologic response rateStem cell transplantationPhase II trialAnti-CD38 antibodiesSystemic AL amyloidosisRate of patientsP-088 Evaluating T-cell Fitness Pre B-Cell Maturation Antigen (BCMA)-Targeted T-Cell Redirection Therapies (TRT) as a Predictive Marker for Efficacy/Toxicity in Relapsed/Refractory Multiple Myeloma (RRMM)
Theprungsirikul P, Yu M, Liu Y, Rall K, Matthews M, Neparidze N, Parker T, Browning S, Anderson T, Stevens E, Foss F, Gowda L, Pillai M, Isufi I, Seropian S, Mirza S, Bar N. P-088 Evaluating T-cell Fitness Pre B-Cell Maturation Antigen (BCMA)-Targeted T-Cell Redirection Therapies (TRT) as a Predictive Marker for Efficacy/Toxicity in Relapsed/Refractory Multiple Myeloma (RRMM). Clinical Lymphoma Myeloma & Leukemia 2024, 24: s92-s93. DOI: 10.1016/s2152-2650(24)01991-8.Peer-Reviewed Original ResearchPrevalence of metabolic comorbidities and viral co-infections in monoclonal gammopathy: a retrospective analysis
Muradashvili T, Yu M, Browning S, Bar N, Gorshein E, Parker T, Neparidze N. Prevalence of metabolic comorbidities and viral co-infections in monoclonal gammopathy: a retrospective analysis. Leukemia 2024, 38: 2281-2283. PMID: 39164408, DOI: 10.1038/s41375-024-02380-x.Peer-Reviewed Original ResearchAssociations of T-cell fitness prior to B-cell maturation antigen (BCMA)–targeted chimeric antigen receptor T-cell (CART) and bispecific T-cell engager (BiTE) therapies and efficacy/toxicity in relapsed/refractory multiple myeloma (RRMM).
Theprungsirikul P, Yu M, Rall K, Matthews M, Neparidze N, Parker T, Browning S, Anderson T, Stevens E, Foss F, Gowda L, Pillai M, Isufi I, Seropian S, Mirza S, Bar N. Associations of T-cell fitness prior to B-cell maturation antigen (BCMA)–targeted chimeric antigen receptor T-cell (CART) and bispecific T-cell engager (BiTE) therapies and efficacy/toxicity in relapsed/refractory multiple myeloma (RRMM). Journal Of Clinical Oncology 2024, 42: 7549-7549. DOI: 10.1200/jco.2024.42.16_suppl.7549.Peer-Reviewed Original ResearchChimeric antigen receptor T cellsRelapsed/refractory multiple myelomaT cell fitnessHigh-risk cytogeneticsCytokine release syndromeNon-respondersExtramedullary diseaseT cellsPeripheral blood prior to treatmentInternational Myeloma Working Group criteriaNR groupBlood prior to treatmentBispecific T-cell engagerMedian follow-up timeMedian prior linesT-cell therapyPost-treatment follow-upT-cell engagersT cell influxT-cell %Working Group criteriaYale Cancer CenterMann-Whitney U testResponse to disease progressionIdecabtagene vicleucelA phase III, randomized study of daratumumab, cyclophosphamide, bortezomib and dexamethasone (DARA-VCD) induction followed by autologous stem cell transplant or DARA-VCD consolidation and daratumumab maintenance in patients with newly diagnosed AL amyloidosis.
Hagen P, Sidana S, Parker T, Walker B, Hoering A, Sanchorawala V, Zonder J, Kourelis T, D'Souza A, Landau H, Rosenthal A, Ailawadhi S, Orlowski R. A phase III, randomized study of daratumumab, cyclophosphamide, bortezomib and dexamethasone (DARA-VCD) induction followed by autologous stem cell transplant or DARA-VCD consolidation and daratumumab maintenance in patients with newly diagnosed AL amyloidosis. Journal Of Clinical Oncology 2024, 42: tps7575-tps7575. DOI: 10.1200/jco.2024.42.16_suppl.tps7575.Peer-Reviewed Original ResearchAutologous stem cell transplantationProgression free survivalStem cell transplantationOverall survivalCell transplantationASCT armNext generation flow cytometryLight chain (AL) amyloidosisDaratumumab to bortezomibDiagnosed AL amyloidosisTwo-sided significance levelPlasma cell malignancyShort follow-upDaratumumab maintenanceMRD negativityFree survivalInduction therapyIntergroup trialMultiple myelomaAL amyloidosisHematologic responseRenal responseRandomized studyCell malignancyFollow-upA Phase III, Randomized Study of Daratumumab, Cyclophosphamide, Bortezomib and Dexamethasone (DARA-VCD) Induction Followed by Autologous Stem Cell Transplant or DARA-VCD Consolidation and Daratumumab Maintenance in patients with Newly Diagnosed AL Amyloidosis PA145 (#114)
Hagen P, Hoering A, Sidana S, Parker T, Walker B, Sanchorawala V, Zonder J, Kourelis T, D’Souza A, Landau H, Rosenthal A, Ailawadhi S, Z. R. A Phase III, Randomized Study of Daratumumab, Cyclophosphamide, Bortezomib and Dexamethasone (DARA-VCD) Induction Followed by Autologous Stem Cell Transplant or DARA-VCD Consolidation and Daratumumab Maintenance in patients with Newly Diagnosed AL Amyloidosis PA145 (#114). 2024 DOI: 10.26226/m.65f9bf89e6f73964e1d4eb32.Peer-Reviewed Original Research
2021
Outcomes Among Primary Refractory Multiple Myeloma Patients in the Era of Monoclonal Antibodies: The Yale Experience
Liu Y, Kywe B, Crawford L, Lora F, Bar N, Browning S, Gorshein E, Parker T, Neparidze N. Outcomes Among Primary Refractory Multiple Myeloma Patients in the Era of Monoclonal Antibodies: The Yale Experience. Blood 2021, 138: 1635. DOI: 10.1182/blood-2021-146619.Peer-Reviewed Original ResearchAutologous stem cell transplantMedian overall survivalInternational Staging System stage IIRefractory multiple myeloma patientsOverall survivalMultiple myeloma patientsMultiple myelomaInduction therapyPartial responsePrimary refractoryInduction regimenMyeloma patientsMonoclonal antibodiesPlasma cellsInternational Myeloma Working Group criteriaYale New Haven Health SystemStage IIHigh-risk cytogeneticsGood partial responseRetrospective cohort studyMajority of patientsMRD-negative statusMonoclonal antibody therapyStem cell transplantImportant prognostic valueUse of Denosumab after Zoledronic Acid in Patients with Multiple Myeloma: Real-World Experience from 2015 to 2019 at Yale Cancer Center
Dosani T, Poteraj A, Parker T, Bar N, Browning S, Gorshein E, Anderson T, Insogna K, Neparidze N. Use of Denosumab after Zoledronic Acid in Patients with Multiple Myeloma: Real-World Experience from 2015 to 2019 at Yale Cancer Center. Blood 2021, 138: 4756. DOI: 10.1182/blood-2021-147466.Peer-Reviewed Original ResearchBone-modifying agentsUse of denosumabYale Cancer CenterZoledronic acidMultiple myelomaMM patientsCancer CenterMedian numberPhysician preferenceCommon reasonClinical practiceNew fracturesNuclear factor kappa-B ligandStudy periodApproval of denosumabEfficacy of denosumabIncidence of SREsMain treatment centreSmilow Cancer HospitalSuppress bone turnoverPatient's renal functionBone resorption markersCohort of patientsGlomerular filtration rateDate of diagnosis
2020
Cost-Effectiveness of Once-Weekly Selinexor, Bortezomib, and Dexamethasone (SVd) Versus Twice-Weekly Bortezomib and Dexamethasone (Vd) in Relapsed or Refractory Multiple Myeloma
Patel K, Parker T, Di M, Bar N, Huntington S, Giri S. Cost-Effectiveness of Once-Weekly Selinexor, Bortezomib, and Dexamethasone (SVd) Versus Twice-Weekly Bortezomib and Dexamethasone (Vd) in Relapsed or Refractory Multiple Myeloma. Blood 2020, 136: 51-52. DOI: 10.1182/blood-2020-141972.Peer-Reviewed Original ResearchIncremental cost-effectiveness ratioQuality-adjusted life yearsBest supportive careRefractory multiple myelomaMultiple myelomaSupportive careProbabilistic sensitivity analysesDisease progressionIncremental effectivenessIncremental costPost-progression therapyTwice-weekly bortezomibLarge randomized trialsProgression-free survivalUS payer perspectiveIncremental lifetime costOne-way sensitivity analysesCost-effectiveness ratioQuality of lifeCost of treatmentCost-effectiveness analysisVD progressionAnnual discount rateAdverse eventsHazard ratioA Phase II Study of Isatuximab (SAR650984) (NSC-795145) for Patients with Previously Treated AL Amyloidosis (SWOG S1702; NCT#03499808)
Parker T, Rosenthal A, Sanchorawala V, Landau H, Campagnaro E, Kapoor P, Neparidze N, Hagen P, Sarosiek S, Scott E, Hoering A, Durie B, Usmani S, Orlowski R. A Phase II Study of Isatuximab (SAR650984) (NSC-795145) for Patients with Previously Treated AL Amyloidosis (SWOG S1702; NCT#03499808). Blood 2020, 136: 20-21. DOI: 10.1182/blood-2020-143180.Peer-Reviewed Original ResearchPhase II studyAL amyloidosisJanssen BiotechEligible patientsCardiac involvementII studyComplete responsePartial responseGrade IAnti-CD38 monoclonal antibody therapyCommon drug-related AEsECOG performance status 0Overall hematologic response rateAutologous stem cell transplantMonoclonal antibodiesAdvisory CommitteeDrug-related AEsHematologic response ratePerformance status 0Relapsed refractory myelomaGood partial responseHigh-dose therapyProgression-free survivalRefractory multiple myelomaStage III diseaseCarfilzomib or bortezomib in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma without intention for immediate autologous stem-cell transplantation (ENDURANCE): a multicentre, open-label, phase 3, randomised, controlled trial
Kumar SK, Jacobus SJ, Cohen AD, Weiss M, Callander N, Singh AK, Parker TL, Menter A, Yang X, Parsons B, Kumar P, Kapoor P, Rosenberg A, Zonder JA, Faber E, Lonial S, Anderson KC, Richardson PG, Orlowski RZ, Wagner LI, Rajkumar SV. Carfilzomib or bortezomib in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma without intention for immediate autologous stem-cell transplantation (ENDURANCE): a multicentre, open-label, phase 3, randomised, controlled trial. The Lancet Oncology 2020, 21: 1317-1330. PMID: 32866432, PMCID: PMC7591827, DOI: 10.1016/s1470-2045(20)30452-6.Peer-Reviewed Original ResearchConceptsAutologous stem cell transplantationProgression-free survivalStem cell transplantationVRd regimenInduction therapyMultiple myelomaVRd groupDay 1Oral lenalidomideOral dexamethasoneOverall survivalEastern Cooperative Oncology Group performance statusMedian progression-free survivalNon-haematological adverse eventsSecond planned interim analysisNext-generation proteasome inhibitorsHigh-risk multiple myelomaCommon grade 3Treatment-related deathsMedian overall survivalPhase 2 trialCommunity oncology practicesStandard of careKey inclusion criteriaPhase 3Carfilzomib, lenalidomide, and dexamethasone (KRd) versus bortezomib, lenalidomide, and dexamethasone (VRd) for initial therapy of newly diagnosed multiple myeloma (NDMM): Results of ENDURANCE (E1A11) phase III trial.
Kumar S, Jacobus S, Cohen A, Weiss M, Callander N, Singh A, Parker T, Menter A, Yang X, Parsons B, Kumar P, Kapoor P, Rosenberg A, Zonder J, Faber E, Lonial S, Richardson P, Orlowski R, Wagner L, Rajkumar S. Carfilzomib, lenalidomide, and dexamethasone (KRd) versus bortezomib, lenalidomide, and dexamethasone (VRd) for initial therapy of newly diagnosed multiple myeloma (NDMM): Results of ENDURANCE (E1A11) phase III trial. Journal Of Clinical Oncology 2020, 38: lba3-lba3. DOI: 10.1200/jco.2020.38.18_suppl.lba3.Peer-Reviewed Original ResearchProgression-free survivalPhase III trialsInitial therapyIII trialsHazard ratioMedian progression-free survivalRandomized phase 3 trialRandomized phase III trialNext-generation proteasome inhibitorsDexamethasone Versus BortezomibStandard initial therapyPhase 3 trialPhase II trialPlasma cell leukemiaISS stageLen-DexLens maintenanceNeuropathy ratesInduction regimenFree survivalII trialPFS eventsMedian ageMultiple myelomaRenal toxicityIntegrated safety profile of selinexor in multiple myeloma: experience from 437 patients enrolled in clinical trials
Gavriatopoulou M, Chari A, Chen C, Bahlis N, Vogl DT, Jakubowiak A, Dingli D, Cornell RF, Hofmeister CC, Siegel D, Berdeja JG, Reece D, White D, Lentzsch S, Gasparetto C, Huff CA, Jagannath S, Baz R, Nooka AK, Richter J, Abonour R, Parker TL, Yee AJ, Moreau P, Lonial S, Tuchman S, Weisel KC, Mohty M, Choquet S, Unger TJ, Li K, Chai Y, Li L, Shah J, Shacham S, Kauffman MG, Dimopoulos MA. Integrated safety profile of selinexor in multiple myeloma: experience from 437 patients enrolled in clinical trials. Leukemia 2020, 34: 2430-2440. PMID: 32094461, PMCID: PMC7449872, DOI: 10.1038/s41375-020-0756-6.Peer-Reviewed Original ResearchConceptsWeeks of treatmentSide effectsMultiple myelomaNuclear export protein exportin 1Integrated safety profileSupportive care measuresThrombopoietin receptor agonistsGastrointestinal side effectsGranulocyte-colony stimulating factorConstitutional side effectsColony-Stimulating FactorAdverse eventsSupportive carePlatelet transfusionsSafety profileReceptor antagonistCare measuresReceptor agonistSolid malignanciesClinical trialsSmall molecule inhibitorsSelinexorDemonstrated activityStimulating factorWeight loss
2019
Daratumumab in the Clinic, a Real-Word Experience at Yale Cancer Center
Browning S, Parker T, Bar N, Seropian S, Lee A, Anderson T, Neparidze N. Daratumumab in the Clinic, a Real-Word Experience at Yale Cancer Center. Blood 2019, 134: 5569. DOI: 10.1182/blood-2019-130134.Peer-Reviewed Original ResearchSmilow Cancer HospitalMultiple myelomaRefractory MMInfusion reactionsSpeakers bureauCancer HospitalReal-word experienceReal-world practice patternsAnti-plasma cell therapyTransplant-eligible patientsYale Cancer CenterInfusion-related reactionsAdverse event profileLeukotriene receptor antagonistsProgression-free survivalRefractory multiple myelomaPatient-reported qualityManagement of patientsOverall response rateJanssen Scientific AffairsClonal plasma cellsExcellent safety profileMulti-center studyDrug combination regimensInfusion reaction ratesOral Selinexor-Dexamethasone for Triple-Class Refractory Multiple Myeloma.
Chari A, Vogl DT, Gavriatopoulou M, Nooka AK, Yee AJ, Huff CA, Moreau P, Dingli D, Cole C, Lonial S, Dimopoulos M, Stewart AK, Richter J, Vij R, Tuchman S, Raab MS, Weisel KC, Delforge M, Cornell RF, Kaminetzky D, Hoffman JE, Costa LJ, Parker TL, Levy M, Schreder M, Meuleman N, Frenzel L, Mohty M, Choquet S, Schiller G, Comenzo RL, Engelhardt M, Illmer T, Vlummens P, Doyen C, Facon T, Karlin L, Perrot A, Podar K, Kauffman MG, Shacham S, Li L, Tang S, Picklesimer C, Saint-Martin JR, Crochiere M, Chang H, Parekh S, Landesman Y, Shah J, Richardson PG, Jagannath S. Oral Selinexor-Dexamethasone for Triple-Class Refractory Multiple Myeloma. The New England Journal Of Medicine 2019, 381: 727-738. PMID: 31433920, DOI: 10.1056/NEJMoa1903455.Peer-Reviewed Original Research
2018
Antigen-mediated regulation in monoclonal gammopathies and myeloma
Nair S, Sng J, Boddupalli CS, Seckinger A, Chesi M, Fulciniti M, Zhang L, Rauniyar N, Lopez M, Neparidze N, Parker T, Munshi NC, Sexton R, Barlogie B, Orlowski R, Bergsagel L, Hose D, Flavell RA, Mistry PK, Meffre E, Dhodapkar MV. Antigen-mediated regulation in monoclonal gammopathies and myeloma. JCI Insight 2018, 3: e98259. PMID: 29669929, PMCID: PMC5931125, DOI: 10.1172/jci.insight.98259.Peer-Reviewed Original ResearchConceptsMultiple myelomaPlasma cellsGaucher diseaseAntigenic stimulationMonoclonal gammopathyAntigen-driven stimulationMonoclonal IgClonal IgB cell receptorSingle tumor cellsPatient cohortUndetermined significanceVivo responsivenessMalignant cloneGammopathyTumor growthMonoclonal tumorsCell receptorTumor cellsAntigenGene expression profilingStimulationClonal natureMyelomaTumorsSelective Inhibition of Nuclear Export With Oral Selinexor for Treatment of Relapsed or Refractory Multiple Myeloma.
Vogl DT, Dingli D, Cornell RF, Huff CA, Jagannath S, Bhutani D, Zonder J, Baz R, Nooka A, Richter J, Cole C, Vij R, Jakubowiak A, Abonour R, Schiller G, Parker TL, Costa LJ, Kaminetzky D, Hoffman JE, Yee AJ, Chari A, Siegel D, Fonseca R, Van Wier S, Ahmann G, Lopez I, Kauffman M, Shacham S, Saint-Martin JR, Picklesimer CD, Choe-Juliak C, Stewart AK. Selective Inhibition of Nuclear Export With Oral Selinexor for Treatment of Relapsed or Refractory Multiple Myeloma. Journal Of Clinical Oncology : Official Journal Of The American Society Of Clinical Oncology 2018, 36: 859-866. PMID: 29381435, PMCID: PMC6905485, DOI: 10.1200/JCO.2017.75.5207.Peer-Reviewed Original Research