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2. Phase III trial of postoperative cisplatin, interferon alpha-2b, and 5-FU combined with external radiation treatment versus 5-FU alone for patients with resected pancreatic adenocarcinoma – CapRI: study protocol [ISRCTN62866759]

Author

Schmitz-Winnenthal H, Lindel K, Seiler C, Hoffmann K, Schmidt J, Märten A, Knaebel HP, Fritz S, Herrmann T, Goldschmidt H, Krempien R, Mansmann U, Debus J, Diehl V, and Büchler MW

Subjects
Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract After surgical intervention with curative intention in specialised centres the five-year survival of patients with carcinoma of the exocrine pancreas is only 15%. The ESPAC-1 trial showed an increased five-year survival of 21% achieved with adjuvant chemotherapy. Investigators from the Virginia Mason Clinic have reported a 5-year survival rate of 55% in a phase II trial evaluating adjuvant chemotherapy, immunotherapy and external-beam radiation. Design The CapRI study is an open, controlled, prospective, randomised multi-centre phase III trial. Patients in study arm A will be treated as outpatients with 5-Fluorouracil; Cisplatin and 3 million units Interferon alpha-2b for 5 1/2 weeks combined with external beam radiation. After chemo-radiation the patients receive continuous 5-FU infusions for two more cycles. Patients in study arm B will be treated as outpatients with intravenous bolus injections of folinic acid, followed by intravenous bolus injections of 5-FU given on 5 consecutive days every 28 days for 6 cycles. A total of 110 patients with specimen-proven R0 or R1 resected pancreatic adenocarcinoma will be enrolled. An interim analysis for patient safety reasons will be done one year after start of recruitment. Evaluation of the primary endpoint will be performed two years after the last patients' enrolment. Discussion The aim of this study is to evaluate the overall survival period attained by chemo-radiotherapy including interferon alpha 2b administration with adjuvant chemotherapy. The influence of interferon alpha on the effectiveness of the patients' chemoradiation regimen, the toxicity, the disease-free interval and the quality of life are analysed. Different factors are tested in terms of their potential role as predictive markers.

Published
2005
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4. 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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9. 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. In vivo Reproduzierbarkeit von Radiomics-Merkmalen zwischen verschiedenen MRT-Geräten bei Patienten mit monoklonalen Plasmazellerkrankungen – eine prospektive Bi-institutionelle Studie.

Author

Wennmann, M, additional, Bauer, F, additional, Neher, P, additional, Grözinger, M, additional, Rotkopf, L, additional, Goldschmidt, H, additional, Weber, T F, additional, Delorme, S, additional, Maier-Hein, K, additional, Schlemmer, H P, additional, and Götz, M, additional

Published
2023
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12. Deep learning zur automatischen Messung des Scheinbaren Diffusionskoeffizienten (ADC) aus multizentrischen retrospektiven Ganzkörper-MRT Daten bei Patienten mit Multiplem Myelom

Author

Stanczyk, N, additional, Wennmann, M, additional, Neher, P, additional, Kahl, K C, additional, Horger, M, additional, Goldschmidt, H, additional, Schlemmer, H P, additional, Weber, T F, additional, Delorme, S, additional, Kurz, F T, additional, and Maier-Hein, K, additional

Published
2023
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13. Deep Learning und Radiomics zur automatischen, objektiven, umfassenden Knochenmarkscharakterisierung aus Ganzkörper-MRTs – eine multizentrische Machbarkeitsstudie

Author

Wennmann, M, additional, Klein, A, additional, Bauer, F, additional, Chmelik, J, additional, Uhlenbrock, C, additional, Grözinger, M, additional, Weber, T F, additional, Goldschmidt, H, additional, Delorme, S, additional, Maier-Hein, K, additional, and Schlemmer, H P, additional

Published
2023
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14. Identification of novel genetic loci for risk of multiple myeloma by functional annotation.

Author

Macauda, A., Briem, K., Clay-Gilmour, A., Cozen, W., Försti, A., Giaccherini, M., Corradi, C., Sainz, J., Niazi, Y., Horst, R. ter, Li, Y., Netea, M.G., Vogel, U., Hemminki, K., Slager, S.L., Varkonyi, J., Andersen, V., Iskierka-Jazdzewska, E., Mártinez-Lopez, J., Zaucha, J., Camp, N.J., Rajkumar, S.V., Druzd-Sitek, A., Bhatti, P., Chanock, S.J., Kumar, S.K., Subocz, E., Mazur, G., Landi, S., Machiela, M.J., Jerez, A., Norman, A.D., Hildebrandt, M.A., Kadar, K., Berndt, S.I., Ziv, E., Buda, G., Nagler, A., Dumontet, C., Raźny, M., Watek, M., Butrym, A., Grzasko, N., Dudzinski, M., Rybicka-Ramos, M., Matera, E.L., García-Sanz, R., Goldschmidt, H., Jamroziak, K., Jurczyszyn, A., Clavero, E., Giles, G.G., Pelosini, M., Zawirska, D., Kruszewski, M., Marques, H., Haastrup, E., Sánchez-Maldonado, J.M., Bertsch, U., Rymko, M., Raab, M.S., Brown, E.E., Hofmann, J.N., Vachon, C., Campa, D., Canzian, F., Macauda, A., Briem, K., Clay-Gilmour, A., Cozen, W., Försti, A., Giaccherini, M., Corradi, C., Sainz, J., Niazi, Y., Horst, R. ter, Li, Y., Netea, M.G., Vogel, U., Hemminki, K., Slager, S.L., Varkonyi, J., Andersen, V., Iskierka-Jazdzewska, E., Mártinez-Lopez, J., Zaucha, J., Camp, N.J., Rajkumar, S.V., Druzd-Sitek, A., Bhatti, P., Chanock, S.J., Kumar, S.K., Subocz, E., Mazur, G., Landi, S., Machiela, M.J., Jerez, A., Norman, A.D., Hildebrandt, M.A., Kadar, K., Berndt, S.I., Ziv, E., Buda, G., Nagler, A., Dumontet, C., Raźny, M., Watek, M., Butrym, A., Grzasko, N., Dudzinski, M., Rybicka-Ramos, M., Matera, E.L., García-Sanz, R., Goldschmidt, H., Jamroziak, K., Jurczyszyn, A., Clavero, E., Giles, G.G., Pelosini, M., Zawirska, D., Kruszewski, M., Marques, H., Haastrup, E., Sánchez-Maldonado, J.M., Bertsch, U., Rymko, M., Raab, M.S., Brown, E.E., Hofmann, J.N., Vachon, C., Campa, D., and Canzian, F.

Abstract

Contains fulltext : 299996.pdf (Publisher’s version ) (Open Access), 01 november 2023

Published
2023

15. Large T cell clones expressing immune checkpoints increase during multiple myeloma evolution and predict treatment resistance

Author

Botta, C, Perez, C, Larrayoz, M, Puig, N, Cedena, M, Termini, R, Goicoechea, I, Rodriguez, S, Zabaleta, A, Lopez, A, Sarvide, S, Blanco, L, Papetti, D, Nobile, M, Besozzi, D, Gentile, M, Correale, P, Siragusa, S, Oriol, A, González-Garcia, M, Sureda, A, de Arriba, F, Rios Tamayo, R, Moraleda, J, Gironella, M, Hernandez, M, Bargay, J, Palomera, L, Pérez-Montaña, A, Goldschmidt, H, Avet-Loiseau, H, Roccaro, A, Orfao, A, Martinez-Lopez, J, Rosiñol, L, Lahuerta, J, Blade, J, Mateos, M, San-Miguel, J, Martinez Climent, J, Paiva, B, Botta, Cirino, Perez, Cristina, Larrayoz, Marta, Puig, Noemi, Cedena, Maria-Teresa, Termini, Rosalinda, Goicoechea, Ibai, Rodriguez, Sara, Zabaleta, Aintzane, Lopez, Aitziber, Sarvide, Sarai, Blanco, Laura, Papetti, Daniele M, Nobile, Marco S, Besozzi, Daniela, Gentile, Massimo, Correale, Pierpaolo, Siragusa, Sergio, Oriol, Albert, González-Garcia, Maria Esther, Sureda, Anna, de Arriba, Felipe, Rios Tamayo, Rafael, Moraleda, Jose-Maria, Gironella, Mercedes, Hernandez, Miguel T, Bargay, Joan, Palomera, Luis, Pérez-Montaña, Albert, Goldschmidt, Hartmut, Avet-Loiseau, Hervé, Roccaro, Aldo, Orfao, Alberto, Martinez-Lopez, Joaquin, Rosiñol, Laura, Lahuerta, Juan-José, Blade, Joan, Mateos, Maria-Victoria, San-Miguel, Jesús F, Martinez Climent, Jose-Angel, Paiva, Bruno, Botta, C, Perez, C, Larrayoz, M, Puig, N, Cedena, M, Termini, R, Goicoechea, I, Rodriguez, S, Zabaleta, A, Lopez, A, Sarvide, S, Blanco, L, Papetti, D, Nobile, M, Besozzi, D, Gentile, M, Correale, P, Siragusa, S, Oriol, A, González-Garcia, M, Sureda, A, de Arriba, F, Rios Tamayo, R, Moraleda, J, Gironella, M, Hernandez, M, Bargay, J, Palomera, L, Pérez-Montaña, A, Goldschmidt, H, Avet-Loiseau, H, Roccaro, A, Orfao, A, Martinez-Lopez, J, Rosiñol, L, Lahuerta, J, Blade, J, Mateos, M, San-Miguel, J, Martinez Climent, J, Paiva, B, Botta, Cirino, Perez, Cristina, Larrayoz, Marta, Puig, Noemi, Cedena, Maria-Teresa, Termini, Rosalinda, Goicoechea, Ibai, Rodriguez, Sara, Zabaleta, Aintzane, Lopez, Aitziber, Sarvide, Sarai, Blanco, Laura, Papetti, Daniele M, Nobile, Marco S, Besozzi, Daniela, Gentile, Massimo, Correale, Pierpaolo, Siragusa, Sergio, Oriol, Albert, González-Garcia, Maria Esther, Sureda, Anna, de Arriba, Felipe, Rios Tamayo, Rafael, Moraleda, Jose-Maria, Gironella, Mercedes, Hernandez, Miguel T, Bargay, Joan, Palomera, Luis, Pérez-Montaña, Albert, Goldschmidt, Hartmut, Avet-Loiseau, Hervé, Roccaro, Aldo, Orfao, Alberto, Martinez-Lopez, Joaquin, Rosiñol, Laura, Lahuerta, Juan-José, Blade, Joan, Mateos, Maria-Victoria, San-Miguel, Jesús F, Martinez Climent, Jose-Angel, and Paiva, Bruno

Abstract

Tumor recognition by T cells is essential for antitumor immunity. A comprehensive characterization of T cell diversity may be key to understanding the success of immunomodulatory drugs and failure of PD-1 blockade in tumors such as multiple myeloma (MM). Here, we use single-cell RNA and T cell receptor sequencing to characterize bone marrow T cells from healthy adults (n = 4) and patients with precursor (n = 8) and full-blown MM (n = 10). Large T cell clones from patients with MM expressed multiple immune checkpoints, suggesting a potentially dysfunctional phenotype. Dual targeting of PD-1 + LAG3 or PD-1 + TIGIT partially restored their function in mice with MM. We identify phenotypic hallmarks of large intratumoral T cell clones, and demonstrate that the CD27− and CD27+ T cell ratio, measured by flow cytometry, may serve as a surrogate of clonal T cell expansions and an independent prognostic factor in 543 patients with MM treated with lenalidomide-based treatment combinations.

Published
2023

16. Transcriptional diversity in specific synaptic gene sets discriminates cortical neuronal identity

Author

Roig Adam, A., Martínez-López, J., van der Spek, S., Achsel, T., Andres-Alonso, M., Bagni, C., Bayés, À., Biederer, T., Brose, N., Chua, J., Coba, M., Cornelisse, L., de Juan-Sanz, J., Goldschmidt, H., Gundelfinger, E., Huganir, R., Imig, C., Jahn, R., https://orcid.org/0000-0003-1542-3498, Jung, H., Kaeser, P., Kim, E., Koopmans, F., Kreutz, M., Lipstein, N., MacGillavry, H., McPherson, P., O’Connor, V., Pielot, R., Ryan, T., Sala, C., Sheng, M., Smalla, K., Thomas, P., Toonen, R., van Weering, J., Verpelli, C., Sullivan, P., Smit, A., Verhage, M., and Hjerling-Leffler, J.

Abstract

Synapse diversity has been described from different perspectives, ranging from the specific neurotransmitters released, to their diverse biophysical properties and proteome profiles. However, synapse diversity at the transcriptional level has not been systematically identified across all synapse populations in the brain. To quantify and identify specific synaptic features of neuronal cell types we combined the SynGO (Synaptic Gene Ontology) database with single-cell RNA sequencing data of the mouse neocortex. We show that cell types can be discriminated by synaptic genes alone with the same power as all genes. The cell type discriminatory power is not equally distributed across synaptic genes as we could identify functional categories and synaptic compartments with greater cell type specific expression. Synaptic genes, and specific SynGO categories, belonged to three different types of gene modules: gradient expression over all cell types, gradient expression in selected cell types and cell class- or type-specific profiles. This data provides a deeper understanding of synapse diversity in the neocortex and identifies potential markers to selectively identify synapses from specific neuronal populations.

Published
2023

18. Natural history of relapsed myeloma, refractory to immunomodulatory drugs and proteasome inhibitors: a multicenter IMWG study

Author

Kumar, S K, Dimopoulos, M A, Kastritis, E, Terpos, E, Nahi, H, Goldschmidt, H, Hillengass, J, Leleu, X, Beksac, M, Alsina, M, Oriol, A, Cavo, M, Ocio, E M, Mateos, M V, O'Donnell, E K, Vij, R, Lokhorst, H M, van de Donk, N W C J, Min, C, Mark, T, Turesson, I, Hansson, M, Ludwig, H, Jagannath, S, Delforge, M, Kyriakou, C, Hari, P, Mellqvist, U, Usmani, S Z, Dytfeld, D, Badros, A Z, Moreau, P, Kim, K, Otero, P R, Lee, J H, Shustik, C, Waller, D, Chng, W J, Ozaki, S, Lee, J-J, de la Rubia, J, Eom, H S, Rosinol, L, Lahuerta, J J, Sureda, A, Kim, J S, and Durie, B G M

Published
2017
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19. Genome-wide association study of immunoglobulin light chain amyloidosis in three patient cohorts: comparison with myeloma

Author

da Silva Filho, M I, Försti, A, Weinhold, N, Meziane, I, Campo, C, Huhn, S, Nickel, J, Hoffmann, P, Nöthen, M M, Jöckel, K-H, Landi, S, Mitchell, J S, Johnson, D, Morgan, G J, Houlston, R, Goldschmidt, H, Jauch, A, Milani, P, Merlini, G, Rowcieno, D, Hawkins, P, Hegenbart, U, Palladini, G, Wechalekar, A, Schönland, S O, and Hemminki, K

Published
2017
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22. Corrigendum to “Corrigendum to ‘Multiple myeloma: EHA-ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up’”

Author

Dimopoulos, M.A., primary, Moreau, P., additional, Terpos, E., additional, Mateos, M.V., additional, Zweegman, S., additional, Cook, G., additional, Delforge, M., additional, Hájek, R., additional, Schjesvold, F., additional, Cavo, M., additional, Goldschmidt, H., additional, Facon, T., additional, Einsele, H., additional, Boccadoro, M., additional, San-Miguel, J., additional, Sonneveld, P., additional, and Mey, U., additional

Published
2022
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32. 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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34. 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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35. 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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36. P963: EVOLUTION OF TREATMENT PATTERNS AND OVERALL SURVIVAL IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA RECEIVING A SECOND LINE OF THERAPY BETWEEN 2012 AND 2020: ANALYSIS OF THE PREAMBLE COHORT

Author

Kuter, D., primary, Goldschmidt, H., additional, Cella, D., additional, Petrucci, M. T., additional, Moreau, P., additional, Durie, B., additional, Juarez-Garcia, A., additional, Trong, L., additional, Gu, J., additional, Hernandez Rivera, G., additional, Dhanasiri, S., additional, Marshall, T., additional, Wang, J., additional, Lacoin, L., additional, Ramasamy, K., additional, and Vij, R., additional

Published
2022
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37. 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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38. 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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39. 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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40. 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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41. 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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42. 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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43. 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

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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47. 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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