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Biobanking and consent to future biospecimen use among adults enrolled in swog trials from 2000 to 2024

Blood cancer journal 2025年第1期15卷 85页

作者： Daniel J Olivieri Alexis Berridge-Green Megan Othus Jerald P Radich Anjali S Advani Harry P Erba Roland B Walter Department of Medicine Internal Medicine Residency Program Department of Medicine University of Washington Seattle WA USA. Public Health Science Division Fred Hutchinson Cancer Center Seattle WA USA. SWOG Statistical and Data Management Center Seattle WA USA. Translational Science and Therapeutics Division Fred Hutchinson Cancer Center Seattle WA USA. Department of Medicine Division of Hematology and Oncology University of Washington Seattle WA USA. Department of Hematologic Oncology and Blood Disorders Cleveland Clinic Cleveland OH USA. Division of Hematologic Malignancies and Cellular Therapy Duke Cancer Institute Durham NC USA. Translational Science and Therapeutics Division Fred Hutchinson Cancer Center Seattle WA USA. rwalter@***. Department of Medicine Division of Hematology and Oncology University of Washington Seattle WA USA. rwalter@***. Department of Laboratory Medicine and Pathology University of Washington Seattle WA USA. rwalter@***.

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Isatuximab in Relapsed AL Amyloidosis: Results of a Prospective Phase II Trial (swog S1702)

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Blood 2024年 144卷 3378-3378页

作者： Terri L. Parker Adam Rosenthal Vaishali Sanchorawala Heather J. Landau Erica L. Campagnaro Prashant Kapoor Natalia Neparidze Saulius Girnius Patrick Hagen Emma C. Scott Antje Hoering Brian G.M. Durie Robert Z. Orlowski Department of Internal Medicine Section of Hematology Yale University School of Medicine and Yale Cancer Center New Haven CT SWOG Statistical and Data Management Center Seattle WA Section of Hematology and Medical Oncology Department of Medicine Boston University Chobanian & Avedisian School of Medicine and Boston Medical Center Boston MA Adult Bone Marrow Transplant Service Department of Medicine Memorial Sloan Kettering Cancer Center New York NY Division of Hematology and Oncology Department of Internal Medicine University of Michigan Ann Arbor MI Division of Hematology Mayo Clinic Rochester MN Trihealth Cancer Institute Cincinnati OH Division of Hematology and Oncology Loyola University Health System Maywood IL Oregon Health and Science University Portland OR Cancer Research And Biostatistics Seattle WA Cedars-Sinai Medical Center Los Angeles CA Department of Lymphoma & Myeloma The University of Texas MD Anderson Cancer Center Houston TX

Background: Isatuximab is an IgG1κ monoclonal antibody that binds with high affinity to CD38 expressed on plasma cells in light chain (AL) amyloidosis. Anti-CD38 antibodies have shown efficacy alone and in combination in a variety of settings for patients with multiple myeloma and light chain (AL) amyloidosis. Here we report the final analysis of a multi-center, cooperative group prospective phase II study of isatuximab in previously treated patients with AL amyloidosis (NCT03499808). Methods: Eligibility included: age ≥18 years, relapsed or refractory systemic AL amyloidosis, ≥1 prior line of therapy, measurable disease, ≥1 organ involved, not refractory to daratumumab, Eastern Cooperative Oncology Group performance status ≤2, creatinine clearance ≥25 mL/min, and NT-proBNP ≤8500 pg/mL. Patients received isatuximab intravenously 20 mg/kg weekly during the first 28-day cycle and every other week during cycles 2 through 24 for a maximum of 24 cycles. The primary objective was hematologic response with secondary objectives of organ response, safety, progression free survival, and overall survival. Results: Forty-three patients were registered, with 35 patients being eligible for response. The median age of the evaluable patients was 70 years (range, 40.1-79.5) with the majority (66%, n=23) having a lambda clonal plasma cell dyscrasia. The most common cytogenetic abnormality using fluorescence in situ hybridization was translocation t(11;14) observed in ten patients (29%). The most common prior treatment was a proteasome inhibitor (94%, n=33) while 46% (n=16) had undergone autologous stem cell transplant. Eighteen patients (51%) had single organ involvement while 17 (49%) had multiple organs involved. The distribution of organ involvement was typical for AL amyloidosis with cardiac involvement in 25 patients (71%) and renal involvement in 14 (40%). As of December 30, 2022, no new safety concerns were identified. The most common treatment related grade ≥3 adverse events

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A Phase III Randomized Trial for Frail Newly Diagnosed Multiple Myeloma Patients Comparing Bortezomib- Lenalidomide-Dexamethasone (VRd-Lite followed by Len maintenance) with Daratumumab-Lenalidomide- Dexamethasone (DRd followed by Len+/- Dara Maintenance): swog S2209

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Blood 2024年 144卷 3381.3-3381.3页

作者： Sikander Ailawadhi Antje Hoering J Christine Ye Brea Lipe Thomas R. Chauncey Krisstina Gowin David Calverley Sarah A. Holstein Erica L. Campagnaro Adam Rosenthal Jack Aiello Saad Z. Usmani Vincent Rajkumar Robert Z. Orlowski Division of Hematology-Oncology Mayo Clinic-Florida Jacksonville FL Cancer Research And Biostatistics Seattle WA Department of Lymphoma & Myeloma UT MD Anderson Cancer Center Houston TX University of Rochester Medical Center Rochester NY Seattle VA Medical Center (111 Onc.) Seattle WA Division of Hematology & Oncology University of Washington Seattle WA University of Arizona Cancer Center UA College of Medicine Tucson AZ OHSU Portland OR Nebraska Medical Center Omaha NE Division of Hematology and Oncology Department of Internal Medicine University of Michigan Ann Arbor MI SWOG Statistical and Data Management Center Seattle WA In memoriam Patient author Southwest Oncology Group San Jose CA Myeloma Service Division of Hematologic Oncology Department of Medicine Memorial Sloan Kettering Cancer Center New York NY Division of Hematology Mayo Clinic Rochester MN Department of Lymphoma & Myeloma The University of Texas MD Anderson Cancer Center Houston TX

Multiple myeloma (MM) is an incurable cancer of plasma cells with nearly 70% of all new diagnoses occurring in adults aged ≥ 65 years. For older adults, medical comorbidities and functional deficits become increasingly more prevalent with increased age and can impact disease outcomes and survival. There are unmet medical needs in this vulnerable patient population who are not eligible for autologous stem cell transplantation to optimize the frontline therapy for better survival and less toxicity. This randomized phase 3 clinical trial is designed to focus on real world patient population to identify an optimal frontline three drug regimen in frail or a subset of intermediate fit newly diagnosed MM patients. Diagnostic criteria and response criteria will be based on IMWG guidelines. Participants must have a calculated myeloma frailty index (Myeloma Frailty Score Calculator (http://***/) categorized as frail or intermediate fit (regardless of age) within 28 days prior to registration (NCT05561387). The two most commonly used induction/maintenance regimens in this patient population will be compared, including RVd-Lite (lenalidomide (R), bortezomib (V), and dexamethasone (dex) followed by R maintenance) and DRd (Daratumumab, lenalidomide, and dex followed by R or R-daratumumab maintenance). The study will include three cohorts: (1) RVd-Lite induction followed by Rev maintenance (2) DRd induction followed by Rev maintenance (3) DRd induction followed by D-R maintenance. Induction phases will be 9 cycles in total of 28 days each, followed by maintenance for cycle 10 and beyond in all cohorts until disease progression: V 1.3 mg/m 2 on days 1, 8, 15, 22, R 15 mg days 1-21, dex 20 mg days 1, 8, 15, 22 for induction phase and R 10 mg days 1-21 for maintenance phase in cohort 1 (VRd-Lite); SubQ Dara 1800 mg (on days 1, 8, 15, 22 for C1-2, on days 1, 15 for C3-6, on day 1 for C7-9), R 15 mg day 1-21, dex 20 mg days 1, 8, 15, 22 for induction p

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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

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Blood 2024年 144卷 3309.1-3309.1页

作者： Patrick Hagen Surbhi Sidana Terri L. Parker Brian A. Walker Vaishali Sanchorawala Jeffrey A. Zonder Taxiarchis Kourelis Anita D'Souza Heather J. Landau Adam Rosenthal Antje Hoering Sikander Ailawadhi Robert Z. Orlowski Division of Hematology and Oncology Loyola University Health System Maywood IL Division of Blood and Marrow Transplantation and Cellular Therapy Stanford University School of Medicine Stanford CA Department of Internal Medicine Section of Hematology Yale University School of Medicine and Yale Cancer Center New Haven CT Center for Computational Biology and Bioinformatics Indiana University School of Medicine Indianapolis IN Amyloidosis Center Boston University Chobanian and Avedisian School of Medicine and Boston Medical Center Boston MA Karmanos Cancer Institute Detroit MI Division of Hematology Mayo Clinic Rochester MN CIBMTR (Center for International Blood and Marrow Transplant Research) Department of Medicine Medical College of Wisconsin Milwaukee WI Center for International Blood and Marrow Transplant Research Department of Medicine Medical College of Wisconsin Milwaukee WI Adult Bone Marrow Transplant Service Department of Medicine Memorial Sloan Kettering Cancer Center New York NY SWOG Statistical and Data Management Center Seattle WA Cancer Research And Biostatistics Seattle WA Division of Hematology-Oncology Mayo Clinic-Florida Jacksonville FL Department of Lymphoma & Myeloma The University of Texas MD Anderson Cancer Center Houston TX

Background and significance: Light chain (AL) amyloidosis is a plasma cell malignancy characterized by the production of amyloidgenic clonal light chains that deposit in various tissues. The addition of daratumumab to bortezomib, cyclophosphamide and dexamethasone (Dara-VCD) has improved the depth of hematologic and organ responses and is an approved induction therapy in newly diagnosed AL amyloid patients (DOI: 10.1056/NEJMoa2028631). However, this approach has not yet demonstrated an overall survival (OS) benefit and follow up remains short. With strict adherence to eligibility criteria, in particular severity of cardiac involvement, autologous stem cell transplantation (ASCT) as consolidative therapy is safe with transplant related mortality on par with multiple myeloma. This approach generates deep and sustained responses, but it is unclear if it offers an additional survival benefit following Dara-VCD induction. The only randomized trial evaluating the role of ASCT in AL amyloid is outdated (DOI: 10.1056/NEJMoa070484) and no randomized data exist to inform the optimal use of ASCT in the era of Dara-VCD induction. Furthermore, multi-organ involvement in AL amyloid drives morbidity and mortality thus the impact of any consolidative therapy on cardiac and renal involvement in addition to overall survival but must be defined. Finally, the approval of Dara-VCD therapy was based on complete hematologic response rates but there is increasing data demonstrating that achieving minimal residual disease (MRD) negativity by either bone marrow next generation flow cytometry (DOI: 10.1002/ajh.26562) or peripheral blood mass spectrometry (DOI: 10.1038/s41408-020-0291-8) generates improved organ response, hematologic progression free survival, and possibly OS. Methods: This randomized phase 3 swog led intergroup trial (S2213; NCT06022939) is being conducted within the United States and will accrue a total of 143 participants per arm. The primary endpoint will compare MOD-PFS (

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