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2. P18 Adjusted Comparison of Teclistamab Versus Real-World Physician’s Choice (RWPC) of Therapy in Patients with Triple-Class Exposed (TCE) Relapsed/Refractory Multiple Myeloma (RRMM)

Author

Mateos, M.V., primary, Chari, A., additional, Usmani, S.Z., additional, Goldschmidt, H., additional, Weisel, K., additional, Qi, K., additional, Londhe, A., additional, Nair, S., additional, Lin, X., additional, Pei, L., additional, Ammann, E., additional, Chastain, K., additional, Parekh, T., additional, Marshall, A., additional, Slavcev, M., additional, and Moreau, P., additional

Published
2023
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4. Impact of Elotuzumab Plus Pomalidomide/Dexamethasone on Health-related Quality of Life for Patients with Relapsed/Refractory Multiple Myeloma: Final Data from the Phase 2 ELOQUENT-3 Trial

Author

Weisel, K. Dimopoulos, M.A. San-Miguel, J. Paner, A. Engelhardt, M. Taylor, F. Lord-Bessen, J. Yip, C. Greenwood, M. Tang, J. Cavo, M. and Weisel, K. Dimopoulos, M.A. San-Miguel, J. Paner, A. Engelhardt, M. Taylor, F. Lord-Bessen, J. Yip, C. Greenwood, M. Tang, J. Cavo, M.

Abstract

Triplet regimens containing immunomodulatory drugs and proteasome inhibitors (PIs) have improved outcomes and extended survival for patients with relapsed/refractory multiple myeloma (RRMM). We evaluated updated health-related quality of life (HRQoL) findings from the phase 2 ELOQUENT-3 clinical trial (NCT02654132) after 4 years of treatment with elotuzumab plus pomalidomide and dexamethasone (EPd) and assessed the impact of the addition of elotuzumab on patients' HRQoL. HRQoL was assessed as an exploratory endpoint using the MD Anderson Symptom Inventory for Multiple Myeloma (MDASI-MM), which evaluates symptom severity, symptom interference, and HRQoL, and the 3-level EQ-5D, a patient-reported measure of health utility and general health. Statistical analyses included descriptive responder, longitudinal mixed-model, and time-to-first-deterioration (TTD) analyses using prespecified minimally important differences and responder definitions. Of 117 randomized patients, 106 (EPd, n = 55; pomalidomide and dexamethasone [Pd], n = 51) were eligible for inclusion in HRQoL analyses. Completion rates at almost all on-treatment visits were ≥80%. The proportion of patients treated with EPd who improved or maintained stable HRQoL until cycle 13 ranged from 82% to 96% for MDASI-MM total symptom score and 64% to 85% for MDASI-MM symptom interference. Across measurements, there were no clinically meaningful differences in changes from baseline between treatment arms, and TTD was not significantly different for EPd versus Pd. In conclusion, HRQoL was not impacted by the addition of elotuzumab to Pd and did not significantly deteriorate in patients with RRMM previously treated with lenalidomide and a PI in ELOQUENT-3. © 2023 Authors. All rights reserved.

Published
2023

5. Prevention and management of adverse events during treatment with bispecific antibodies and CAR T cells in multiple myeloma: a consensus report of the European Myeloma Network

Author

Ludwig, H. Terpos, E. van de Donk, N. Mateos, M.-V. Moreau, P. Dimopoulos, M.-A. Delforge, M. Rodriguez-Otero, P. San-Miguel, J. Yong, K. Gay, F. Einsele, H. Mina, R. Caers, J. Driessen, C. Musto, P. Zweegman, S. Engelhardt, M. Cook, G. Weisel, K. Broijl, A. Beksac, M. Bila, J. Schjesvold, F. Cavo, M. Hajek, R. Touzeau, C. Boccadoro, M. Sonneveld, P. and Ludwig, H. Terpos, E. van de Donk, N. Mateos, M.-V. Moreau, P. Dimopoulos, M.-A. Delforge, M. Rodriguez-Otero, P. San-Miguel, J. Yong, K. Gay, F. Einsele, H. Mina, R. Caers, J. Driessen, C. Musto, P. Zweegman, S. Engelhardt, M. Cook, G. Weisel, K. Broijl, A. Beksac, M. Bila, J. Schjesvold, F. Cavo, M. Hajek, R. Touzeau, C. Boccadoro, M. Sonneveld, P.

Abstract

T-cell redirecting bispecific antibodies (BsAbs) and chimeric antigen receptor T cells (CAR T cells) have revolutionised multiple myeloma therapy, but adverse events such as cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome (ICANS), cytopenias, hypogammaglobulinaemia, and infections are common. This Policy Review presents a consensus from the European Myeloma Network on the prevention and management of these adverse events. Recommended measures include premedication, frequent assessing for symptoms and severity of cytokine release syndrome, step-up dosing for several BsAbs and some CAR T-cell therapies; corticosteroids; and tocilizumab in the case of cytokine release syndrome. Other anti-IL-6 drugs, high-dose corticosteroids, and anakinra might be considered in refractory cases. ICANS often arises concomitantly with cytokine release syndrome. Glucocorticosteroids in increasing doses are recommended if needed, as well as anakinra if the response is inadequate, and anticonvulsants if convulsions occur. Preventive measures against infections include antiviral and antibacterial drugs and administration of immunoglobulins. Treatment of infections and other complications is also addressed. © 2023 Elsevier Ltd

Published
2023

6. P16 HEALTH-RELATED QUALITY OF LIFE FOR FRAIL TRANSPLANT-INELIGIBLE PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA TREATED WITH DARATUMUMAB, LENALIDOMIDE AND DEXAMETHASONE: SUBGROUP ANALYSIS OF MAIA TRIAL

Author

Facon, T., primary, Plesner, T., additional, Usmani, S., additional, Kumar, S., additional, Bahlis, N., additional, Hulin, C., additional, Orlowski, R., additional, Nahi, H., additional, Mollee, P., additional, Ramasamy, K., additional, Roussel, M., additional, Jaccard, A., additional, Delforge, M., additional, Karlin, L., additional, Arnulf, B., additional, Chari, A., additional, Pei, H., additional, Gupta, N., additional, Kaila, S., additional, Matt, K., additional, Gries, K., additional, Carson, R., additional, Borgsten, F., additional, Weisel, K., additional, and Perrot, A., additional

Published
2023
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7. P09 DARATUMUMAB PLUS LENALIDOMIDE AND DEXAMETHASONE (D-RD) VERSUS LENALIDOMIDE AND DEXAMETHASONE (RD) ALONE IN TRANSPLANT-INELIGIBLE PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA (NDMM): UPDATED ANALYSIS OF THE PHASE 3 MAIA STUDY

Author

Weisel, K., primary, Kumar, S., additional, Moreau, P., additional, Bahlis, N., additional, Facon, T., additional, Plesner, T., additional, Orlowski, R., additional, Basu, S., additional, Nahi, H., additional, Hulin, C., additional, Quach, H., additional, Goldschmidt, H., additional, O’Dwyer, M., additional, Perrot, A., additional, Venner, C., additional, Raje, N., additional, Tiab1, M., additional, Macro, M., additional, Frenzel, L., additional, Leleu, X., additional, Pei, H., additional, Krevvata, M, additional, Carson, R, additional, Borgsten, F., additional, and Usmani, S., additional

Published
2023
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11. Phase III trial of bortezomib, cyclophosphamide and dexamethasone (VCD) versus bortezomib, doxorubicin and dexamethasone (PAd) in newly diagnosed myeloma

Author

Mai, E K, Bertsch, U, Dürig, J, Kunz, C, Haenel, M, Blau, I W, Munder, M, Jauch, A, Schurich, B, Hielscher, T, Merz, M, Huegle-Doerr, B, Seckinger, A, Hose, D, Hillengass, J, Raab, M S, Neben, K, Lindemann, H-W, Zeis, M, Gerecke, C, Schmidt-Wolf, I G H, Weisel, K, Scheid, C, Salwender, H, and Goldschmidt, H

Published
2015
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13. S183: NOVEL COMBINATION IMMUNOTHERAPY FOR THE TREATMENT OF RELAPSED/REFRACTORY MULTIPLE MYELOMA: UPDATED PHASE 1B RESULTS FOR TALQUETAMAB (A GPRC5D X CD3 BISPECIFIC ANTIBODY) IN COMBINATION WITH DARATUMUMAB

Author

van de Donk, N. W., primary, Bahlis, N., additional, Mateos, M.-V., additional, Weisel, K., additional, Dholaria, B., additional, Garfall, A. L., additional, Goldschmidt, H., additional, Martin, T. G., additional, Morillo, D., additional, Reece, D. E., additional, Hurd, D., additional, Rodríguez-Otero, P., additional, Bhutani, M., additional, D’Souza, A., additional, Oriol, A., additional, Askari, E., additional, San-Miguel, J. F., additional, Kortüm, K. M., additional, Vishwamitra, D., additional, Xin Wang Lin, S., additional, Prior, T. J., additional, Vandenberk, L., additional, Smit, M.-A. D., additional, Goldberg, J. D., additional, Wäsch, R., additional, and Chari, A., additional

Published
2022
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14. P958: REAL-LIFE CURRENT STANDARD OF CARE IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA: SUBGROUP ANALYSES FROM THE LOCOMMOTION STUDY

Author

Einsele, H., primary, Moreau, P., additional, De Stefano, V., additional, Dytfeld, D., additional, Angelucci, E., additional, Benjamin, R., additional, Goldschmidt, H., additional, van de Donk, N. W., additional, Besemer, B., additional, Scheid, C., additional, Vij, R., additional, ’. Groen-Damen, E. I., additional, Semerjian, M., additional, Strulev, V., additional, Schecter, J. M., additional, Roccia, T., additional, Nesheiwat, T., additional, Wapenaar, R., additional, Weisel, K., additional, and Mateos, M.-V., additional

Published
2022
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15. P972: INDIRECT COMPARISON OF TECLISTIMAB IN MAJESTEC-1 VERSUS PHYSICIAN’S CHOICE OF THERAPY IN LONG-TERM FOLLOW-UP OF TRIPLE-CLASS EXPOSED RELAPSED/REFRACTORY MULTIPLE MYELOMA IN DARATUMUMAB TRIALS

Author

Weisel, K., primary, Chari, A., additional, Usmani, S. Z., additional, Goldschmidt, H., additional, Mateos, M.-V., additional, Qi, K., additional, Londhe, A., additional, Nair, S., additional, Lin, X., additional, Pei, L., additional, Ammann, E., additional, Kobos, R., additional, Smit, J., additional, Parekh, T., additional, Slavcev, M., additional, and Moreau, P., additional

Published
2022
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16. P890: THE OUTCOME OF SECOND PRIMARY MALIGNANCIES DEVELOPING IN MM PATIENTS

Author

Avivi, I., primary, H vesole, D., additional, Dávila Valls, J., additional, Usnarska-Zubkiewicz, L., additional, Milunovic, V., additional, Bogumiła Osękowska, B. B., additional, Kopińska, A., additional, Gentile, M., additional, MARTÍNEZ, B. P., additional, Robak, P., additional, crusoe, E., additional, LUIS GERARDO, R., additional, Gajewska, M., additional, Gergely, V., additional, Delforge, M., additional, Cohen, Y., additional, Alessandro, G., additional, peña, C., additional, Shustik, C., additional, Mikala, G., additional, Žalac, K., additional, Denis, A. H., additional, Peter, B., additional, Weisel, K., additional, martinez lopez, J., additional, Waszczuk-Gajda, A., additional, Krzystanski, M., additional, and Jurczyszyn, A., additional

Published
2022
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18. P959: CILTACABTAGENE AUTOLEUCEL IN LENALIDOMIDE-REFRACTORY PATIENTS WITH PROGRESSIVE MULTIPLE MYELOMA AFTER 1-3 PRIOR LINES OF THERAPY: CARTITUDE-2 BIOLOGICAL CORRELATIVE ANALYSES AND UPDATED CLINICAL DATA

Author

Hillengass, J., primary, Cohen, A. D., additional, Delforge, M., additional, Einsele, H., additional, Goldschmidt, H., additional, Weisel, K., additional, Raab, M.-S., additional, Scheid, C., additional, Schecter, J. M., additional, De Braganca, K. C., additional, Varsos, H., additional, Yeh, T.-M., additional, Mistry, P., additional, Roccia, T., additional, Corsale, C., additional, Akram, M., additional, Pacaud, L., additional, Nesheiwat, T., additional, Agha, M., additional, and Cohen, Y. C., additional

Published
2022
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19. P933: DARATUMUMAB (D) IN COMBINATION WITH VD OR D-RD IN RELAPSED OR REFRACTORY MULTIPLE MYELOMA: SUBGROUP ANALYSIS OF CASTOR AND POLLUX STUDIES IN PATIENTS WITH EARLY OR LATE RELAPSE AFTER INITIAL THERAPY

Author

Spencer, A., primary, Moreau, P., additional, Mateos, M.-V., additional, Goldschmidt, H., additional, Suzuki, K., additional, Levin, M.-D., additional, Sonneveld, P., additional, Yoon, S.-S., additional, Usmani, S. Z., additional, Weisel, K., additional, Reece, D., additional, Ahmadi, T., additional, Pei, H., additional, Garvin Mayo, W., additional, Gai, X., additional, Carey, J., additional, Carson, R., additional, and Dimopoulos, M. A., additional

Published
2022
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20. P1739: HEALTH-RELATED QUALITY OF LIFE IN PATIENTS WITH TRIPLE-CLASS EXPOSED RELAPSED/REFRACTORY MULTIPLE MYELOMA TREATED WITH IBERDOMIDE PLUS DEXAMETHASONE IN A PHASE 1B/2A OPEN-LABEL DOSE ESCALATION STUDY

Author

van de Donk, N. W., primary, Guo, S., additional, Shi, L., additional, Lord-Bessen, J., additional, Tang, D., additional, Karlin, L., additional, Weisel, K., additional, Ramasamy, K., additional, Abad, P. C., additional, Amin, A., additional, Amin, S., additional, and Lonial, S., additional

Published
2022
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21. P930: ISATUXIMAB, LENALIDOMIDE, BORTEZOMIB AND DEXAMETHASONE AS INDUCTION THERAPY FOR NEWLY-DIAGNOSED MULTIPLE MYELOMA PATIENTS WITH HIGH-RISK CYTOGENETICS: A SUBGROUP ANALYSIS FROM THE GMMG-HD7 TRIAL

Author

Mai, E. K., primary, Bertsch, U., additional, Fenk, R., additional, Tichy, D., additional, Besemer, B., additional, Dürig, J., additional, Schroers, R., additional, von Metzler, I., additional, Hänel, M., additional, Mann, C., additional, Asemissen, A. M., additional, Heilmeier, B., additional, Nievergall, E., additional, Huhn, S., additional, Kriegsmann, K., additional, Weinhold, N., additional, Luntz, S., additional, Holderrried, T. A. W., additional, Trautmann-Grill, K., additional, Gezer, D., additional, Klaiber-Hakimi, M., additional, Müller, M., additional, Khandanpour, C., additional, Knauf, W., additional, Scheid, C., additional, Munder, M., additional, Geer, T., additional, Riesenberg, H., additional, Thomalla, J., additional, Hoffmann, M., additional, Raab, M. S., additional, Salwender, H. J., additional, Weisel, K. C., additional, and Goldschmidt, H., additional

Published
2022
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22. P940: SAFETY AND CLINICAL ACTIVITY OF BELANTAMAB MAFODOTIN WITH PEMBROLIZUMAB IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA (RRMM): DREAMM-4 STUDY

Author

Suvannasankha, A., primary, Bahlis, N., additional, Trudel, S., additional, Weisel, K., additional, Koenecke, C., additional, Oriol, A., additional, Voorhees, P. M., additional, Alonso, A. A., additional, Callander, N. S., additional, Mateos Manteca, M. V., additional, Reddy, N., additional, Hakim, S., additional, Patel, N., additional, Williams, D., additional, Jewell, R. C., additional, Zhou, X., additional, Gupta, I., additional, and Nooka, A. K., additional

Published
2022
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23. P960: HEALTH-RELATED QUALITY OF LIFE IN THE LOCOMMOTION STUDY OF REAL-LIFE CURRENT STANDARD OF CARE IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA

Author

Delforge, M., primary, Moreau, P., additional, Einsele, H., additional, De Stefano, V., additional, Lindsey-Hill, J., additional, Vincent, L., additional, Mangiacavalli, S., additional, Perrot, A., additional, Ocio, E., additional, ten Seldam, S., additional, ’. Groen-Damen, E. I., additional, Semerjian, M., additional, Strulev, V., additional, Schecter, J. M., additional, Roccia, T., additional, Gries, K. S., additional, Nesheiwat, T., additional, Wapenaar, R., additional, Mateos, M.-V., additional, and Weisel, K., additional

Published
2022
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24. P879: EXENT AND FLC MASS SPECTROMETRY FOR SEROLOGICAL IDENTIFICATION AND QUANTIFICATION OF MONOCLONAL IMMUNOGLOBULINS IN MULTIPLE MYELOMA

Author

Huhn, S., primary, Poos, A. M., additional, Mai, E. K., additional, Hänel, M., additional, Salwender, H. J., additional, Dürig, J., additional, Blau, I. W., additional, Scheid, C., additional, Weisel, K. C., additional, Munder, M., additional, Berlanga, O., additional, Bertsch, U., additional, Goldschmidt, H., additional, and Weinhold, N., additional

Published
2022
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26. P926: DARATUMUMAB, BORTEZOMIB AND DEXAMETHASONE FOR TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA AND SEVERE RENAL IMPAIRMENT: RESULTS FROM THE PHASE 2 GMMG-DANTE TRIAL

Author

Leypoldt, L., primary, Gavriatopoulou, M., additional, Besemer, B., additional, Salwender, H., additional, Raab, M.-S., additional, Nogai, A., additional, Khandanpour, C., additional, Runde, V., additional, Zago, M., additional, Martus, P., additional, Goldschmidt, H., additional, Bokemeyer, C., additional, Dimopoulos, M., additional, and Weisel, K., additional

Published
2022
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27. P935: REAL WORLD COMPARATIVE ANALYSIS OF THE EFFICACY OF TECLISTAMAB VERSUS CURRENT TREATMENTS IN PATIENTS WITH TRIPLE-CLASS EXPOSED RELAPSED/REFRACTORY MULTIPLE MYELOMA FROM THE LOCOMOTION STUDY

Author

Einsele, H., primary, Moreau, P., additional, Delforge, M., additional, van de Donk, N. W., additional, Ghilotti, F., additional, Diels, J., additional, Elsada, A., additional, Strulev, V., additional, Pei, L., additional, Kobos, R., additional, Smit, J., additional, Slavcev, M., additional, Weisel, K., additional, and Mateos, M.-V., additional

Published
2022
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28. P942: DREAMM-9: PHASE I STUDY OF BELANTAMAB MAFODOTIN PLUS STANDARD OF CARE IN PATIENTS WITH TRANSPLANT-INELIGIBLE NEWLY DIAGNOSED MULTIPLE MYELOMA

Author

Usmani, S. Z., primary, Mielnik, M., additional, Koh, Y., additional, Alonso Alonso, A., additional, Leleu, X., additional, Quach, H., additional, Min, C.-K., additional, Janowski, W., additional, Abdallah, A.-O., additional, Garg, M., additional, Sandhu, I., additional, Ocio San Miguel, E. M., additional, Oriol, A., additional, Rodriquez-Otero, P., additional, Ramasamy, K., additional, Weisel, K., additional, Besemer, B., additional, Cavo, M., additional, Zhou, X. L., additional, Kaisermann, M. C., additional, Bego Marques, C. M., additional, Williams, D., additional, Carreno, F., additional, Kremer, B. E., additional, Gupta, I. V., additional, and Hus, M., additional

Published
2022
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29. P971: ADJUSTED COMPARISON OF PATIENT REPORTED OUTCOMES FROM CARTITUDE-1 AND LOCOMMOTION COMPARING CILTACABTAGENE AUTOLEUCEL VERSUS REAL WORLD CLINICAL PRACTICE IN TRIPLE-CLASS EXPOSED MULTIPLE MYELOMA

Author

Weisel, K., primary, Mateos, M.-V., additional, Vincent, L., additional, Martin, T., additional, Berdeja, J. G., additional, Jakubowiak, A., additional, Jagannath, S., additional, Lin, Y., additional, Thilakarathne, P., additional, Ghilotti, F., additional, Diels, J., additional, Haefliger, B., additional, Hague, C., additional, Gonzalez, A., additional, Schecter, J. M., additional, Gries, K. S., additional, Strulev, V., additional, Nesheiwat, T., additional, Pacaud, L., additional, Einsele, H., additional, and Moreau, P., additional

Published
2022
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30. P936: TIME TO RESPONSE, DURATION OF RESPONSE, AND PATIENT-REPORTED OUTCOMES WITH DARATUMUMAB PLUS RD VS RD ALONE IN TRANSPLANT-INELIGIBLE PATIENTS WITH NDMM: SUBGROUP ANALYSIS OF THE PHASE 3 MAIA STUDY

Author

Facon, T., primary, Kumar, S. K., additional, Plesner, T., additional, Moreau, P., additional, Bahlis, N., additional, Goldschmidt, H., additional, O’Dwyer, M., additional, Perrot, A., additional, Venner, C. P., additional, Weisel, K., additional, Mace, J. R., additional, Raje, N., additional, Tiab, M., additional, Macro, M., additional, Frenzel, L., additional, Leleu, X., additional, Pei, H., additional, Borgsten, F., additional, and Usmani, S. Z., additional

Published
2022
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31. Carfilzomib 56 mg/m2 twice-weekly in combination with dexamethasone and daratumumab (KdD) versus daratumumab in combination with bortezomib and dexamethasone (DVd): a matching-adjusted indirect treatment comparison

Author

Weisel, K. Nooka, A.K. Terpos, E. Spencer, A. Goldschmidt, H. Dirnberger, F. DeCosta, L. Yusuf, A. Kumar, S. and Weisel, K. Nooka, A.K. Terpos, E. Spencer, A. Goldschmidt, H. Dirnberger, F. DeCosta, L. Yusuf, A. Kumar, S.

Abstract

Given the increasing use of frontline lenalidomide-based therapies in multiple myeloma (MM), there is an emerging need for lenalidomide-sparing regimens at relapse. Carfilzomib plus dexamethasone and daratumumab (KdD) and daratumumab plus bortezomib and dexamethasone (DVd) are lenalidomide-sparing triplet regimens that are approved for relapsed and/or refractory MM (R/RMM). In the absence of a head-to-head trial comparing these treatments, a matching-adjusted indirect treatment comparison (MAIC) was conducted to assess the efficacy and safety of KdD versus DVd. Results showed that treatment with KdD decreases the risk of progression or death versus DVd (HR 0.64; 95% confidence interval (CI): 0.46–0.90). Time-dependent analysis demonstrated a larger benefit for KdD after the first eight cycles. Unmatched subgroup analysis indicated that KdD may be particularly effective in lenalidomide-exposed and -refractory patients. The present analysis suggests that KdD improves outcomes compared with DVd in patients with R/RMM and may provide a rationale for a preferential treatment. © 2022 Informa UK Limited, trading as Taylor & Francis Group.

Published
2022

32. Addition of elotuzumab to lenalidomide and dexamethasone for patients with newly diagnosed, transplantation ineligible multiple myeloma (ELOQUENT-1): an open-label, multicentre, randomised, phase 3 trial

Author

Dimopoulos, M.A. Richardson, P.G. Bahlis, N.J. Grosicki, S. Cavo, M. Beksaç, M. Legieć, W. Liberati, A.M. Goldschmidt, H. Belch, A. Magen, H. Larocca, A. Laubach, J.P. Petrucci, M.T. Reece, D. White, D. Mateos, M.-V. Špička, I. Lazaroiu, M. Berdeja, J. Kaufman, J.L. Jou, Y.-M. Ganetsky, A. Popa McKiver, M. Lonial, S. Weisel, K. ELOQUENT-1 investigators and Dimopoulos, M.A. Richardson, P.G. Bahlis, N.J. Grosicki, S. Cavo, M. Beksaç, M. Legieć, W. Liberati, A.M. Goldschmidt, H. Belch, A. Magen, H. Larocca, A. Laubach, J.P. Petrucci, M.T. Reece, D. White, D. Mateos, M.-V. Špička, I. Lazaroiu, M. Berdeja, J. Kaufman, J.L. Jou, Y.-M. Ganetsky, A. Popa McKiver, M. Lonial, S. Weisel, K. ELOQUENT-1 investigators

Abstract

BACKGROUND: Elotuzumab plus lenalidomide and dexamethasone has shown improved progression-free and overall survival versus lenalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma. We aimed to assess these regimens in patients with newly diagnosed multiple myeloma who are ineligible for haematopoietic stem-cell transplantation (HSCT). METHODS: ELOQUENT-1 is an open-label, multicentre, randomised, phase 3 trial conducted at 185 hospitals, oncology practices, and research centres in 19 countries. Eligible patients were aged 18 years or older with newly diagnosed, untreated, symptomatic myeloma and not candidates for high-dose therapy plus HSCT, and an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower. Patients were randomly assigned (1:1) to receive elotuzumab plus lenalidomide and dexamethasone or lenalidomide and dexamethasone using an interactive voice response system, stratified by the International Staging System (ISS; stage I-II vs III), age (<75 years vs ≥75 years), and ECOG performance status (0 vs 1-2). Patients in the elotuzumab plus lenalidomide and dexamethasone group received elotuzumab administered intravenously at 10 mg/kg on days 1, 8, 15, and 22 during cycles 1 and 2, days 1 and 15 during cycles 3-18, and then at 20 mg/kg on day 1 for subsequent cycles. In both treatment groups, patients received 25 mg lenalidomide orally on days 1-21 of each cycle and 40 mg dexamethasone on days 1, 8, 15, and 22 of each cycle. The primary endpoint was progression-free survival, as per the primary definition from European Society for Blood and Marrow Transplantation criteria in all randomly assigned patients (intention-to-treat population). This study is registered with ClinicalTrials.gov, NCT01335399 (completed). FINDINGS: Between Aug 4, 2011, and June 19, 2014, 748 patients were randomly assigned (374 in each treatment group) and 742 patients received treatment (333 (90%) of 371 in the elotuzumab plus lenali

Published
2022

33. Prognostic value of minimal residual disease negativity in myeloma: combined analysis of POLLUX, CASTOR, ALCYONE, and MAIA

Author

Cavo, M. San-Miguel, J. Usmani, S.Z. Weisel, K. Dimopoulos, M.A. Avet-Loiseau, H. Paiva, B. Bahlis, N.J. Plesner, T. Hungria, V. Moreau, P. Mateos, M.-V. Perrot, A. Iida, S. Facon, T. Kumar, S. van de Donk, N.W.C.J. Sonneveld, P. Spencer, A. Krevvata, M. Heuck, C. Wang, J. Ukropec, J. Kobos, R. Sun, S. Qi, M. Munshi, N. and Cavo, M. San-Miguel, J. Usmani, S.Z. Weisel, K. Dimopoulos, M.A. Avet-Loiseau, H. Paiva, B. Bahlis, N.J. Plesner, T. Hungria, V. Moreau, P. Mateos, M.-V. Perrot, A. Iida, S. Facon, T. Kumar, S. van de Donk, N.W.C.J. Sonneveld, P. Spencer, A. Krevvata, M. Heuck, C. Wang, J. Ukropec, J. Kobos, R. Sun, S. Qi, M. Munshi, N.

Abstract

We explored minimal residual disease (MRD) in relapsed/refractory multiple myeloma (RRMM) and transplant-ineligible (TIE) newly diagnosed multiple myeloma (NDMM) using data from 4 phase 3 studies (POLLUX, CASTOR, ALCYONE, and MAIA). Each study previously demonstrated that daratumumab-based therapies improved MRD negativity rates and reduced the risk of disease progression or death by approximately half vs standards of care. We conducted a large-scale pooled analysis for associations between patients achieving complete response or better (≥CR) with MRD-negative status and progression-free survival (PFS). MRD was assessed via next-generation sequencing (10−5 sensitivity threshold). Patient-level data were pooled from all 4 studies and for patients with TIE NDMM and patients with RRMM who received ≤2 prior lines of therapy (≤2 PL). PFS was evaluated by response and MRD status. Median follow-up (months) was 54.8 for POLLUX, 50.2 for CASTOR, 40.1 for ALCYONE, and 36.4 for MAIA. Patients who achieved ≥CR and MRD negativity had improved PFS vs those who failed to reach CR or were MRD positive (TIE NDMM and RRMM hazard ratio [HR] 0.20, P <.0001; TIE NDMM and RRMM ≤2 PL HR 0.20, P <.0001). This benefit occurred irrespective of therapy or disease setting. A time-varying Cox proportional hazard model confirmed that ≥CR with MRD negativity was associated with improved PFS. Daratumumab-based treatment was associated with more patients reaching ≥CR and MRD negativity. These findings represent the first large-scale analysis with robust methodology to support ≥CR with MRD negativity as a prognostic factor for PFS in RRMM and TIE NDMM. These trials were registered at www.clinicaltrials.gov as #NCT02076009, #NCT02136134, #NCT02195479, and #NCT02252172. © 2022 American Society of Hematology

Published
2022

34. Carfilzomib, dexamethasone, and daratumumab versus carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma (CANDOR): updated outcomes from a randomised, multicentre, open-label, phase 3 study

Author

Usmani, S.Z. Quach, H. Mateos, M.-V. Landgren, O. Leleu, X. Siegel, D. Weisel, K. Gavriatopoulou, M. Oriol, A. Rabin, N. Nooka, A. Qi, M. Beksac, M. Jakubowiak, A. Ding, B. Zahlten-Kumeli, A. Yusuf, A. Dimopoulos, M. and Usmani, S.Z. Quach, H. Mateos, M.-V. Landgren, O. Leleu, X. Siegel, D. Weisel, K. Gavriatopoulou, M. Oriol, A. Rabin, N. Nooka, A. Qi, M. Beksac, M. Jakubowiak, A. Ding, B. Zahlten-Kumeli, A. Yusuf, A. Dimopoulos, M.

Abstract

Background: Despite recent advances in therapeutic options, there remains an unmet need for treating patients with relapsed or refractory multiple myeloma, especially in those previously exposed or refractory to lenalidomide. This updated efficacy and safety analysis from the phase 3 CANDOR study compared carfilzomib, daratumumab, and dexamethasone (KdD) with carfilzomib and dexamethasone (Kd) in patients with relapsed or refractory multiple myeloma. Methods: In this updated analysis of the randomised, multicentre, open-label, phase 3 CANDOR study, patients (aged ≥18 years) with relapsed or refractory multiple myeloma, at least a partial response to between one and three previous therapies, and Eastern Cooperative Oncology Group performance status of 0–2, were recruited from 102 medical centres globally and randomly assigned (2:1) by interactive voice or web response software to receive KdD or Kd. Participants were stratified by disease stage, previous proteasome inhibitor or anti-CD38 antibody exposure, and number of previous therapies. All patients received intravenous infusions of carfilzomib twice per week at 56 mg/m2 (20 mg/m2 on days 1 and 2 during cycle 1) on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. Daratumumab (8 mg/kg) was administered intravenously on days 1 and 2 of cycle 1 and at 16 mg/kg weekly for the remaining doses of the first two cycles, then every 2 weeks for four cycles (cycles 3–6), and every 4 weeks thereafter. Patients received 40 mg dexamethasone weekly (20 mg for patients >75 years old). This analysis was a preplanned interim analysis for overall survival; however, at the time of data cutoff, overall survival data were not mature. The primary endpoint was progression-free survival. Here, we provide updated progression-free survival data, assessed centrally by Onyx Response Computer Algorithm in the intention-to-treat population, with 11 months additional follow-up. Adverse events were assessed in the safety population, which

Published
2022

35. Daratumumab plus lenalidomide and dexamethasone in transplant-ineligible newly diagnosed multiple myeloma: frailty subgroup analysis of MAIA

Author

Facon, T, Cook, G, Usmani, SZ, Hulin, C, Kumar, S, Plesner, T, Touzeau, C, Bahlis, NJ, Basu, S, Nahi, H, Goldschmidt, H, Quach, H, Mohty, M, Venner, CP, Weisel, K, Raje, N, Hebraud, B, Belhadj-Merzoug, K, Benboubker, L, Decaux, O, Manier, S, Caillot, D, Ukropec, J, Pei, H, Van Rampelbergh, R, Uhlar, CM, Kobos, R, Zweegman, S, Facon, T, Cook, G, Usmani, SZ, Hulin, C, Kumar, S, Plesner, T, Touzeau, C, Bahlis, NJ, Basu, S, Nahi, H, Goldschmidt, H, Quach, H, Mohty, M, Venner, CP, Weisel, K, Raje, N, Hebraud, B, Belhadj-Merzoug, K, Benboubker, L, Decaux, O, Manier, S, Caillot, D, Ukropec, J, Pei, H, Van Rampelbergh, R, Uhlar, CM, Kobos, R, and Zweegman, S

Abstract

In the phase 3 MAIA study of patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM), daratumumab plus lenalidomide/dexamethasone (D-Rd) improved progression-free survival (PFS) versus lenalidomide/dexamethasone (Rd). We present a subgroup analysis of MAIA by frailty status. Frailty assessment was performed retrospectively using age, Charlson comorbidity index, and baseline Eastern Cooperative Oncology Group performance status score. Patients were classified as fit, intermediate, non-frail (fit + intermediate), or frail. Of the randomized patients (D-Rd, n = 368; Rd, n = 369), 396 patients were non-frail (D-Rd, 196 [53.3%]; Rd, 200 [54.2%]) and 341 patients were frail (172 [46.7%]; 169 [45.8%]). After a 36.4-month median follow-up, non-frail patients had longer PFS than frail patients, but the PFS benefit of D-Rd versus Rd was maintained across subgroups: non-frail (median, not reached [NR] vs 41.7 months; hazard ratio [HR], 0.48; P < 0.0001) and frail (NR vs 30.4 months; HR, 0.62; P = 0.003). Improved rates of complete response or better and minimal residual disease (10-5) negativity were observed for D-Rd across subgroups. The most common grade 3/4 treatment-emergent adverse event in non-frail and frail patients was neutropenia (non-frail, 45.4% [D-Rd] and 37.2% [Rd]; frail, 57.7% and 33.1%). These findings support the clinical benefit of D-Rd in transplant-ineligible NDMM patients enrolled in MAIA, regardless of frailty status.

Published
2022

36. P14: DREAMM-9: PHASE I STUDY OF BELANTAMAB MAFODOTIN PLUS STANDARD OF CARE IN PATIENTS WITH TRANSPLANT-INELIGIBLE NEWLY DIAGNOSED MULTIPLE MYELOMA

Author

Usmani, S, Alonso, A, Quach, H, Koh, Y, Guenther, A, Min, CK, Leleu, X, Abdallah, AO, Oriol, A, Bessemer, B, Garg, M, Sandhu, I, Weisel, K, Ocio San Miguel, E, Cavo, M, Zhou, X, Kaisermann, M, Mis, L, Williams, D, Yeakey, A, Ferron-Brady, G, Figueroa, D, Kremer, B, Gupta, I, Janowski, W, Usmani, S, Alonso, A, Quach, H, Koh, Y, Guenther, A, Min, CK, Leleu, X, Abdallah, AO, Oriol, A, Bessemer, B, Garg, M, Sandhu, I, Weisel, K, Ocio San Miguel, E, Cavo, M, Zhou, X, Kaisermann, M, Mis, L, Williams, D, Yeakey, A, Ferron-Brady, G, Figueroa, D, Kremer, B, Gupta, I, and Janowski, W

Published
2022

37. Anti-CD38 antibody therapy for patients with relapsed/refractory multiple myeloma: differential mechanisms of action and recent clinical trial outcomes

Author

Leleu, X, Martin, T, Weisel, K, Schjesvold, F, Iida, S, Malavasi, F, Manier, S, Min, C-K, Ocio, EM, Pawlyn, C, Perrot, A, Quach, H, Richter, J, Spicka, I, Yong, K, Richardson, PG, Leleu, X, Martin, T, Weisel, K, Schjesvold, F, Iida, S, Malavasi, F, Manier, S, Min, C-K, Ocio, EM, Pawlyn, C, Perrot, A, Quach, H, Richter, J, Spicka, I, Yong, K, and Richardson, PG

Abstract

CD38 is a transmembrane glycoprotein that functions both as a receptor and an ectoenzyme, playing key roles in the regulation of calcium signaling and migration of immune cells to tumor microenvironments. High expression on multiple myeloma (MM) cells and limited expression on normal cells makes CD38 an ideal target for the treatment of MM patients. Two monoclonal antibodies directed at CD38, isatuximab and daratumumab, are available for use in patients with relapsed and/or refractory MM (RRMM); daratumumab is also approved in newly diagnosed MM and light-chain amyloidosis. Clinical experience has shown that anti-CD38 antibody therapy is transforming treatment of MM owing to its anti-myeloma efficacy and manageable safety profile. Isatuximab and daratumumab possess similarities and differences in their mechanisms of action, likely imparted by their binding to distinct, non-overlapping epitopes on the CD38 molecule. In this review, we present the mechanistic properties of these two antibodies and outline available evidence on their abilities to induce adaptive immune responses and modulate the bone marrow niche in MM. Further, we discuss differences in regulatory labeling between these two agents and analyze recent key clinical trial results, including evidence in patients with underlying renal impairment and other poor prognostic factors. Finally, we describe the limited existing evidence for the use of isatuximab or daratumumab after disease progression on prior anti-CD38 mono- or combination therapy, highlighting the need for additional clinical evaluations to define optimal anti-CD38 antibody therapy selection and sequencing in RRMM.

Published
2022

38. P13: CAN PATIENT-REPORTED OCULAR SYMPTOMS GUIDE DOSE MODIFICATIONS IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA RECEIVING BELANTAMAB MAFODOTIN?

Author

Popat, R, primary, Badros, A, additional, Kumar, S, additional, Rodriguez-Otero, P, additional, Cohen, A, additional, Manier, S, additional, Voorhees, P, additional, Gay, F, additional, Rifkin, R, additional, Martin, T, additional, Chari, A, additional, Weisel, K, additional, Farooq, A, additional, Jeng, B, additional, Chng, W, additional, Lee, H, additional, Berdeja, J, additional, Jadhav, V, additional, Tosolini, A, additional, Eliason, L, additional, Palumbo, A, additional, Dimopoulos, M, additional, Lonial, S, additional, Trudel, S, additional, Richardson, P, additional, and Terpos, E, additional

Published
2022
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39. P08: CARTITUDE-2 UPDATE: CILTACABTAGENE AUTOLEUCEL, A B-CELL MATURATION ANTIGEN–DIRECTED CHIMERIC ANTIGEN RECEPTOR T-CELL THERAPY, IN LENALIDOMIDE-REFRACTORY PATIENTS WITH PROGRESSIVE MULTIPLE MYELOMA AFTER 1-3 PRIOR LINES OF THERAPY

Author

Einsele, H, primary, Cohen, AD, additional, Delforge, M, additional, Hillengass, J, additional, Goldschmidt, H, additional, Weisel, K, additional, Raab, M-S, additional, Scheid, C, additional, Schecter, JM, additional, De Braganca, KC, additional, Varsos, H, additional, Yeh, T-M, additional, Wang, L, additional, Vogel, M, additional, Corsale, C, additional, Akram, M, additional, Pacaud, L, additional, Nesheiwat, T, additional, Agha, M, additional, and Cohen, YC, additional

Published
2022
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40. B04: COMBINATION OF SUBCUTANEOUS TECLISTAMAB WITH DARATUMUMAB IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA (RRMM): RESULTS FROM A PHASE 1B MULTICOHORT STUDY

Author

Rodriguez-Otero, P, primary, Dholaria, B, additional, Askari, E, additional, Reece, D, additional, van de Donk, N, additional, Chari, A, additional, Goldschmidt, H, additional, Krishnan, A, additional, Martin, T, additional, Mateos, M, additional, Morillo, D, additional, Rodriguez, C, additional, Rosinol, L, additional, San-Miguel, J, additional, Balari, A, additional, Wäsch, R, additional, Weisel, K, additional, Verona, R, additional, Lin, S, additional, Prior, T, additional, Wade, M, additional, Weiss, B, additional, Goldberg, J, additional, Oriol, A, additional, and Hari, P, additional

Published
2022
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41. P04: DARATUMUMAB PLUS BORTEZOMIB AND DEXAMETHASONE VERSUS BORTEZOMIB AND DEXAMETHASONE ALONE IN PATIENTS WITH PREVIOUSLY TREATED MULTIPLE MYELOMA: OVERALL SURVIVAL RESULTS FROM THE PHASE 3 CASTOR TRIAL

Author

Sonneveld, P, primary, Chanan-Khan, A, additional, Weisel, K, additional, Nooka, AK, additional, Masszi, T, additional, Beksac, M, additional, Spicka, I, additional, Hungria, V, additional, Munder, M, additional, Mateos, MV, additional, Mark, TM, additional, Levin, MD, additional, Ahmadi, T, additional, Qin, X, additional, Garvin Mayo, W, additional, Gai, X, additional, Carey, J, additional, Carson, R, additional, and Spencer, A, additional

Published
2022
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42. P07: RESULTS FROM THE CC-220-MM-001 DOSE-EXPANSION PHASE OF IBERDOMIDE PLUS DEXAMETHASONE IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA

Author

van de Donk, N. W. C. J, primary, Popat, R, additional, Hulin, C, additional, Jagannath, S, additional, Oriol, A, additional, Richardson, P. G, additional, Facon, T, additional, Weisel, K, additional, Larsen, J. T, additional, Minnema, M, additional, Abdallah, A, additional, Badros, A. Z, additional, Knop, S, additional, Stadtmauer, E. A, additional, Chen, M, additional, Nguyen, T. V, additional, Amin, A, additional, Peluso, T, additional, and Lonial, S, additional

Published
2022
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43. B05: RESULTS FROM A META-ANALYSIS OF CILTACABTAGENE AUTOLEUCEL COMPARED TO PHYSICIAN’S CHOICE OF TREATMENT IN PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA

Author

Gay, F, primary, Berdeja, JG, additional, De Stefano, V, additional, Hari, P, additional, Hooper, B, additional, Haltner, A, additional, Kumar, S, additional, Martin, T, additional, Mateos, M-V, additional, Moreau, P, additional, Rosta, E, additional, Samjoo, IA, additional, Usmani, SZ, additional, Weisel, K, additional, Jackson, CC, additional, Olyslager, Y, additional, Schecter, JM, additional, Vogel, M, additional, Garrett, A, additional, Lee, S, additional, Nesheiwat, T, additional, Pacaud, L, additional, Zhou, C, additional, Valluri, S, additional, Costa, LJ, additional, and Lin, Y, additional

Published
2022
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45. Carfilzomib, dexamethasone, and daratumumab versus carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma (CANDOR): updated outcomes from a randomised, multicentre, open-label, phase 3 study

Author

Usmani SZ, Quach H, Mateos MV, Landgren O, Leleu X, Siegel D, Weisel K, Gavriatopoulou M, Oriol A, Rabin N, Nooka A, Qi M, Beksac M, Jakubowiak A, Ding B, Zahlten-Kumeli A, Yusuf A, and Dimopoulos M

Abstract

BACKGROUND: Despite recent advances in therapeutic options, there remains an unmet need for treating patients with relapsed or refractory multiple myeloma, especially in those previously exposed or refractory to lenalidomide. This updated efficacy and safety analysis from the phase 3 CANDOR study compared carfilzomib, daratumumab, and dexamethasone (KdD) with carfilzomib and dexamethasone (Kd) in patients with relapsed or refractory multiple myeloma. METHODS: In this updated analysis of the randomised, multicentre, open-label, phase 3 CANDOR study, patients (aged =18 years) with relapsed or refractory multiple myeloma, at least a partial response to between one and three previous therapies, and Eastern Cooperative Oncology Group performance status of 0-2, were recruited from 102 medical centres globally and randomly assigned (2:1) by interactive voice or web response software to receive KdD or Kd. Participants were stratified by disease stage, previous proteasome inhibitor or anti-CD38 antibody exposure, and number of previous therapies. All patients received intravenous infusions of carfilzomib twice per week at 56 mg/m(2) (20 mg/m(2) on days 1 and 2 during cycle 1) on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. Daratumumab (8 mg/kg) was administered intravenously on days 1 and 2 of cycle 1 and at 16 mg/kg weekly for the remaining doses of the first two cycles, then every 2 weeks for four cycles (cycles 3-6), and every 4 weeks thereafter. Patients received 40 mg dexamethasone weekly (20 mg for patients >75 years old). This analysis was a preplanned interim analysis for overall survival; however, at the time of data cutoff, overall survival data were not mature. The primary endpoint was progression-free survival. Here, we provide updated progression-free survival data, assessed centrally by Onyx Response Computer Algorithm in the intention-to-treat population, with 11 months additional follow-up. Adverse events were assessed in the safety population, which included all participants who received at least one dose of trial treatment. CANDOR is registered with ClinicalTrials.gov, NCT03158688, and is active but not recruiting. FINDINGS: Between June 13, 2017, and June 25, 2018, 466 patients were enrolled, of whom 312 received KdD and 154 received Kd. At data cutoff (June 15, 2020), median follow-up was 27·8 months (IQR 25·6-29·5) for KdD and 27·0 months (13·2-28·6) for Kd. Median progression-free survival was 28·6 months (95% CI 22·7-not estimable [NE]) in the KdD group and 15·2 months (11·1-19·9) in the Kd group (hazard ratio 0·59 [95% CI 0·45-0·78], log-rank p

Published
2022

46. Impact of prior treatment on patients with relapsed multiple myeloma treated with carfilzomib and dexamethasone vs bortezomib and dexamethasone in the phase 3 ENDEAVOR study

Author

Moreau, P, Joshua, D, Chng, W-J, Palumbo, A, Goldschmidt, H, Hjek, R, Facon, T, Ludwig, H, Pour, L, Niesvizky, R, Oriol, A, Rosiñol, L, Suvorov, A, Gaidano, G, Pika, T, Weisel, K, Goranova-Marinova, V, Gillenwater, H H, Mohamed, N, Aggarwal, S, Feng, S, and Dimopoulos, M A

Published
2017
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48. OP24 Clinical efficacy and safety of guselkumab maintenance therapy in patients with moderately to severely active Crohn’s Disease: Week 48 analyses from the phase 2 GALAXI 1 study

Author

Danese, S, primary, Panaccione, R, additional, Rubin, D T, additional, Sands, B E, additional, Reinisch, W, additional, D’Haens, G, additional, Panés, J, additional, Gonzalez, S, additional, Weisel, K, additional, Sahoo, A, additional, Frustaci, M E, additional, Yang, Z, additional, Sandborn, W J, additional, Afzali, A, additional, Hisamatsu, T, additional, Andrews, J M, additional, and Feagan, B, additional

Published
2022
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49. EFFICACY AND SAFETY OF CILTACABTAGENE AUTOLEUCEL (CILTA-CEL), A BCMA-DIRECTED CAR-T CELL THERAPY, IN PATIENTS WITH PROGRESSIVE MULTIPLE MYELOMA (MM) AFTER 1–3 PRIOR LINES OF THERAPY: CARTITUDE-2 PHASE 2 STUDY

Author

Agha, ME, primary, Cohen, AD, additional, Madduri, D, additional, Cohen, YC, additional, Delforge, M, additional, Hillengass, J, additional, Goldschmidt, H, additional, Weisel, K, additional, Raab, M, additional, Scheid, C, additional, Schecter, JM, additional, Braganca, KC, additional, Varsos, H, additional, Wang, L, additional, Vogel, M, additional, Carrasco-Alfonso, MJ, additional, Akram, M, additional, Wu, X, additional, Nesheiwat, T, additional, and Einsele, H, additional

Published
2021
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