المؤلفون: Chan, Wei Yee, Counsell, Nicholas, de Tute, Ruth, De‐Silva, Dunnya, Phillips, Elizabeth H., Cavenagh, Jamie, Adedayo, Toyin, Braganca, Nivette, Roddie, Claire, Streetly, Matthew, Schey, Stephen, Koh, Mickey B.C., Crowe, Josephine, Morris, Treen C., Cook, Gordon, Clifton‐Hadley, Laura, Rabin, Neil, Owen, Roger G., Popat, Rakesh, Yong, Kwee L.

المصدر: British Journal of Haematology; Feb2022, Vol. 196 Issue 4, pe33-e37, 5p

مصطلحات موضوعية: STEM cell transplantation, MULTIPLE myeloma, DISEASE relapse, DOXORUBICIN, BORTEZOMIB

مستخلص: PADIMAC trial Multiple myeloma, autologous stem cell transplantation, high dose therapy, myeloma therapy Keywords: multiple myeloma; autologous stem cell transplantation; high dose therapy; myeloma therapy EN multiple myeloma autologous stem cell transplantation high dose therapy myeloma therapy e33 e37 5 02/14/22 20220215 NES 220215 Current Phase III trials demonstrate the benefit of up-front autologous stem cell transplant (ASCT) as standard of care for transplant-eligible newly diagnosed patients with multiple myeloma.1-3 Deeper responses and achievement of minimal residual disease (MRD) negativity with current triplet and quadruplet treatments4 has questioned timing and role of ASCT with deferral being preferable for some.5,6 Long-term analysis of the EMN02 trial shows that high-risk patients gain most survival benefit from up-front ASCT3 and such risk-stratified approach to ASCT with standard risk patients receiving deferred ASCT, may be acceptable.7 We previously reported primary results of the Phase II PADIMAC trial, which demonstrated a median progression-free survival (PFS) of 17-0 months [95% confidence interval (CI): 10-5-23-2] for 63 patients who achieved a very good partial response (VGPR) or better post induction and stopped treatment until disease progression.8 MRD-positive patients at day 100 had a median PFS of 9-9 months (95% CI: 5-8-23-2) compared to 24-8 months (95% CI: 18-3-34-2) for MRD-negative patients. [Extracted from the article]

: Copyright of British Journal of Haematology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

المؤلفون: Royle, Kara‐Louise, Gregory, Walter M., Cairns, David A., Bell, Sue E., Cook, Gordon, Owen, Roger G., Drayson, Mark T., Davies, Faith E., Jackson, Graham H., Morgan, Gareth J., Child, J. Anthony

المصدر: British Journal of Haematology; Sep2018, Vol. 182 Issue 6, p816-829, 14p, 3 Charts, 1 Graph

مصطلحات موضوعية: MULTIPLE myeloma treatment, QUALITY of life, ZOLEDRONIC acid, CYCLOPHOSPHAMIDE, STEM cell transplantation, MULTIPLE myeloma

الشركة/الكيان: MEDICAL Research Council (Great Britain)

مستخلص: Summary: In the Medical Research Council (MRC) Myeloma IX trial (ISRCTN684564111) patients were randomised to sodium clodronate or zoledronic acid and induction treatment: cyclophosphamide, vincristine, doxorubicin and dexamethasone (CVAD) or cyclophosphamide, thalidomide and dexamethasone (CTD) followed by autologous stem cell transplant (ASCT) in the intensive pathway; attenuated CTD or melphalan and prednisolone (MP) in the non‐intensive pathway. Subsequent randomisation allocated patients to either thalidomide or observation. The European Organisation for Research and Treatment of Cancer (EORTC) quality of life (QoL) questionnaires, QLQ‐C30 and QLQ‐MY24, were administered at baseline, 3, 6 and 12 months and annually thereafter, enabling the effect of sequential treatment on patient‐reported health‐related QoL (HR‐QoL) to be investigated. The protocol specified four subscales of interest: Pain, Fatigue, Global Health Status/Quality of Life and Physical Functioning at 3, 6 and 12 months that were compared using linear models. The intensive pathway showed significant differences in favour of CTD for Fatigue at 3 months and Physical Functioning at 12 months. The non‐intensive pathway and maintenance phase reported significant differences at 3 months; Pain (improved with attenuated CTD) and Global Health status/Quality of Life (improved with observation). The improved outcomes in MRC Myeloma IX were accompanied by some beneficial and few detrimental effects on HR‐QoL. [ABSTRACT FROM AUTHOR]

: Copyright of British Journal of Haematology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

المؤلفون: Holstein, Sarah A.¹ (AUTHOR) sarah.holstein@unmc.edu, Ye, J Christine² (AUTHOR), Howard, Alan³ (AUTHOR), Bhutani, Manisha⁴ (AUTHOR), Gormley, Nicole⁵ (AUTHOR), Hahn, Theresa⁶ (AUTHOR), Hillengass, Jens⁶ (AUTHOR), Krishnan, Amrita⁷ (AUTHOR), Landgren, C. Ola⁸ (AUTHOR), Munshi, Nikhil C.⁹ (AUTHOR), Oliva, Stefania¹⁰ (AUTHOR), Owen, Roger G.¹¹ (AUTHOR), Pasquini, Marcelo C.¹² (AUTHOR), Puig, Noemi¹³ (AUTHOR), Weinhold, Niels¹⁴ (AUTHOR), Weisel, Katja¹⁵ (AUTHOR), McCarthy, Philip L.⁶ (AUTHOR)

المصدر: Biology of Blood & Marrow Transplantation. Mar2019, Vol. 25 Issue 3, pe89-e97. 9p.

مصطلحات موضوعية: *IMMUNOLOGIC diseases, *TRIAL practice, *STEM cell transplantation, *LONGITUDINAL method, *CLINICAL trials

الشركة/الكيان: AMERICAN Society of Hematology

مستخلص: Highlights • Summary from the second annual BMT CTN Myeloma Intergroup minimal residual disease (MRD)/immune profiling (IP) workshop. • MRD is currently considered a prognostic biomarker from a regulatory perspective. • Additional prospective studies are required to develop MRD as a surrogate endpoint. • Standardization of immunophenotyping/IP studies is needed. Abstract The second annual Blood and Marrow Transplant Clinical Trials Network (BMT CTN) Myeloma Intergroup Workshop on Minimal Residual Disease and Immune Profiling was convened on December 7, 2017, at the American Society of Hematology (ASH) meeting. During this workshop, investigators from around the world presented their latest research involving assessment of minimal residual disease (MRD) and immune profiling (IP) in myeloma. This document summarizes the workshop presentations as well as relevant ASH abstracts and focuses on the regulatory issues involved in the integration of MRD and IP assessment in clinical trial design and practice. [ABSTRACT FROM AUTHOR]