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1. 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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2. 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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3. 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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4. 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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5. 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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6. 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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8. 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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9. 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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10. 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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11. 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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12. 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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13. 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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14. 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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16. 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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17. 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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18. 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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19. 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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20. 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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21. 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

22. 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

23. 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

24. 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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25. 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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26. 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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27. 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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28. 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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29. 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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30. 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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31. 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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33. 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

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 (

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.

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 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

35. 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

36. 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.

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

37. 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.

Subjects
hemic and lymphatic diseases
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

Published
2022

38. 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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40. Updated interim analysis of the GMMG-CONCEPT trial investigating Isatuximab, Carfilzomib, Lenalidomide, and Dexamethasone (Isa-KRd) in front-line treatment of high-risk Multiple Myeloma

Author

Leypoldt, L., Besemer, B., Asemissen, A. M., Hänel, M., Blau, I. W., Görner, M., Ko, Y. -D., Reinhardt, H. Christian, Staib, P., Mann, C., Lutz, R., Munder, M., Graeven, U., Peceny, Rudolf, Salwender, H., Jauch, A., Zago, M., Benner, A., Tichy, D., Bokemeyer, C., Goldschmidt, H., and Weisel, K.

Subjects
Medizin
Published
2021

45. Recommendations for vaccination in multiple myeloma: a consensus of the European Myeloma Network

Author

Ludwig, H. Boccadoro, M. Moreau, P. San-Miguel, J. Cavo, M. Pawlyn, C. Zweegman, S. Facon, T. Driessen, C. Hajek, R. Dimopoulos, M.A. Gay, F. Avet-Loiseau, H. Terpos, E. Zojer, N. Mohty, M. Mateos, M.-V. Einsele, H. Delforge, M. Caers, J. Weisel, K. Jackson, G. Garderet, L. Engelhardt, M. van de Donk, N. Leleu, X. Goldschmidt, H. Beksac, M. Nijhof, I. Abildgaard, N. Bringhen, S. Sonneveld, P.

Abstract

Vaccination is one of the most successful medical interventions that has saved the life of millions of people. Vaccination is particularly important in patients with multiple myeloma, who have an increased risk of infections due to the disease-inherent immune suppression, and because of the immune suppressive effects of therapy. Hence, all appropriate measures should be exploited, to elicit an effective immune response to common pathogens like influenza, pneumococci, varicella zoster virus, and to those bacteria and viruses (haemophilus influenzae, meningococci, and hepatitis) that frequently may pose a significant risk to patients with multiple myeloma. Patients after autologous, and specifically after allogeneic transplantation have severely reduced antibody titers, and therefore require a broader spectrum of vaccinations. Response to vaccination in myeloma often is less vigorous than in the general population, mandating either measurement of the postvaccination antibody titers and/or repeating the vaccination. Here, we compile the existing data on vaccination in multiple myeloma and provide recommendations for clinical practice. © 2020, The Author(s).

Published
2021

46. Pomalidomide, bortezomib, and dexamethasone for multiple myeloma previously treated with lenalidomide (OPTIMISMM): outcomes by prior treatment at first relapse

Author

Dimopoulos, M. Weisel, K. Moreau, P. Anderson, L.D., Jr. White, D. San-Miguel, J. Sonneveld, P. Engelhardt, M. Jenner, M. Corso, A. Dürig, J. Pavic, M. Salomo, M. Casal, E. Srinivasan, S. Yu, X. Nguyen, T.V. Biyukov, T. Peluso, T. Richardson, P.

Subjects
hemic and lymphatic diseases
Abstract

In the phase 3 OPTIMISMM trial, pomalidomide, bortezomib, and dexamethasone (PVd) demonstrated superior efficacy vs bortezomib and dexamethasone (Vd) in patients with relapsed or refractory multiple myeloma previously treated with lenalidomide, including those refractory to lenalidomide. This analysis evaluated outcomes in patients at first relapse (N = 226) by lenalidomide-refractory status, prior bortezomib exposure, and prior stem cell transplant (SCT). Second-line PVd significantly improved PFS vs Vd in lenalidomide-refractory (17.8 vs 9.5 months; P = 0.0276) and lenalidomide-nonrefractory patients (22.0 vs 12.0 months; P = 0.0491), patients with prior bortezomib (17.8 vs 12.0 months; P = 0.0068), and patients with (22.0 vs 13.8 months; P = 0.0241) or without (16.5 vs 9.5 months; P = 0.0454) prior SCT. In patients without prior bortezomib, median PFS was 20.7 vs 9.5 months (P = 0.1055). Significant improvement in overall response rate was also observed with PVd vs Vd in lenalidomide-refractory (85.9% vs 50.8%; P < 0.001) and lenalidomide-nonrefractory (95.7% vs 60.0%; P < 0.001) patients, with similar results regardless of prior bortezomib or SCT. No new safety signals were observed. These data demonstrate the benefit of PVd at first relapse, including immediately after upfront lenalidomide treatment failure and other common first-line treatments. © 2020, The Author(s).

Published
2021

47. Treatment of relapsed and refractory multiple myeloma: recommendations from the International Myeloma Working Group

Author

Moreau, P. Kumar, S.K. San Miguel, J. Davies, F. Zamagni, E. Bahlis, N. Ludwig, H. Mikhael, J. Terpos, E. Schjesvold, F. Martin, T. Yong, K. Durie, B.G.M. Facon, T. Jurczyszyn, A. Sidana, S. Raje, N. van de Donk, N. Lonial, S. Cavo, M. Kristinsson, S.Y. Lentzsch, S. Hajek, R. Anderson, K.C. João, C. Einsele, H. Sonneveld, P. Engelhardt, M. Fonseca, R. Vangsted, A. Weisel, K. Baz, R. Hungria, V. Berdeja, J.G. Leal da Costa, F. Maiolino, A. Waage, A. Vesole, D.H. Ocio, E.M. Quach, H. Driessen, C. Bladé, J. Leleu, X. Riva, E. Bergsagel, P.L. Hou, J. Chng, W.J. Mellqvist, U.-H. Dytfeld, D. Harousseau, J.-L. Goldschmidt, H. Laubach, J. Munshi, N.C. Gay, F. Beksac, M. Costa, L.J. Kaiser, M. Hari, P. Boccadoro, M. Usmani, S.Z. Zweegman, S. Holstein, S. Sezer, O. Harrison, S. Nahi, H. Cook, G. Mateos, M.-V. Rajkumar, S.V. Dimopoulos, M.A. Richardson, P.G.

Abstract

This Policy Review presents the International Myeloma Working Group's clinical practice recommendations for the treatment of relapsed and refractory multiple myeloma. Based on the results of phase 2 and phase 3 trials, these recommendations are proposed for the treatment of patients with relapsed and refractory disease who have received one previous line of therapy, and for patients with relapsed and refractory multiple myeloma who have received two or more previous lines of therapy. These recommendations integrate the issue of drug access in both low-income and middle-income countries and in high-income countries to help guide real-world practice and thus improve patient outcomes. © 2021 Elsevier Ltd

Published
2021

49. Daratumumab, lenalidomide, and dexamethasone versus lenalidomide and dexamethasone alone in newly diagnosed multiple myeloma (MAIA): overall survival results from a randomised, open-label, phase 3 trial

Author

Facon, T, Kumar, SK, Plesner, T, Orlowski, RZ, Moreau, P, Bahlis, N, Basu, S, Nahi, H, Hulin, C, Quach, H, Goldschmidt, H, O'Dwyer, M, Perrot, A, Venner, CP, Weisel, K, Mace, JR, Raje, N, Tiab, M, Macro, M, Frenzel, L, Leleu, X, Ahmadi, T, Wang, J, Van Rampelbergh, R, Uhlar, CM, Tromp, B, Delioukina, M, Vermeulen, J, Usmani, SZ, Facon, T, Kumar, SK, Plesner, T, Orlowski, RZ, Moreau, P, Bahlis, N, Basu, S, Nahi, H, Hulin, C, Quach, H, Goldschmidt, H, O'Dwyer, M, Perrot, A, Venner, CP, Weisel, K, Mace, JR, Raje, N, Tiab, M, Macro, M, Frenzel, L, Leleu, X, Ahmadi, T, Wang, J, Van Rampelbergh, R, Uhlar, CM, Tromp, B, Delioukina, M, Vermeulen, J, and Usmani, SZ

Abstract

BACKGROUND: In the primary analysis of the phase 3 MAIA trial (median follow-up 28·0 months), a significant improvement in progression-free survival was observed with daratumumab plus lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone in transplantation-ineligible patients with newly diagnosed multiple myeloma. Here, we report the updated efficacy and safety results from a prespecified interim analysis for overall survival. METHODS: MAIA is an ongoing, multicentre, randomised, open-label, phase 3 trial that enrolled patients at 176 hospitals in 14 countries across North America, Europe, the Middle East, and the Asia-Pacific region. Eligible patients were aged 18 years or older, had newly diagnosed multiple myeloma, had an Eastern Cooperative Oncology Group performance status score of 0-2, and were ineligible for high-dose chemotherapy with autologous stem-cell transplantation because of their age (≥65 years) or comorbidities. Patients were randomly assigned (1:1) using randomly permuted blocks (block size 4) by an interactive web response system to receive 28-day cycles of intravenous daratumumab (16 mg/kg, once per week during cycles 1-2, once every 2 weeks in cycles 3-6, and once every 4 weeks thereafter) plus oral lenalidomide (25 mg on days 1-21 of each cycle) and oral dexamethasone (40 mg on days 1, 8, 15, and 22 of each cycle; daratumumab group) or lenalidomide and dexamethasone alone (control group). Randomisation was stratified by International Staging System disease stage, geographical region, and age. Neither patients nor investigators were masked to treatment assignment. The primary endpoint was progression-free survival, which was centrally assessed, and a secondary endpoint was overall survival (both assessed in the intention-to-treat population). The safety population included patients who received at least one dose of the study treatment. The results presented here are from a prespecified interim analysis for overall survival

Published
2021

50. Belantamab mafodotin in combination with novel agents in relapsed/refractory multiple myeloma: DREAMM-5 study design

Author

Nooka, AK, Weisel, K, van de Donk, NWCJ, Routledge, D, Otero, PR, Song, K, Quach, H, Callander, N, Minnema, MC, Trudel, S, Jackson, NA, Ahlers, CM, Im, E, Cheng, S, Smith, L, Hareth, N, Ferron-Brady, G, Brouch, M, de Oca, RM, Paul, S, Holkova, B, Gupta, I, Kremer, BE, Richardson, P, Nooka, AK, Weisel, K, van de Donk, NWCJ, Routledge, D, Otero, PR, Song, K, Quach, H, Callander, N, Minnema, MC, Trudel, S, Jackson, NA, Ahlers, CM, Im, E, Cheng, S, Smith, L, Hareth, N, Ferron-Brady, G, Brouch, M, de Oca, RM, Paul, S, Holkova, B, Gupta, I, Kremer, BE, and Richardson, P

Abstract

Belantamab mafodotin (belamaf) is a BCMA-targeted antibody-drug conjugate recently approved as monotherapy for adults with relapsed/refractory multiple myeloma who have received ≥4 prior therapies. Belamaf binds to BCMA and eliminates myeloma cells by multimodal mechanisms of action. The cytotoxic and potential immunomodulatory properties of belamaf have led to novel combination studies with other anticancer therapies. Here, we describe the rationale and design of DREAMM-5, an ongoing Phase I/II platform study evaluating the safety and efficacy of belamaf combined with novel agents, including GSK3174998 (OX40 agonist), feladilimab (an ICOS; GSK3359609), nirogacestat (a gamma-secretase inhibitor; PF-03084014) and dostarlimab (a PD-1 blocker) versus belamaf monotherapy for patients with relapsed/refractory multiple myeloma. Clinical trial registration: NCT04126200 (ClinicalTrials.gov).

Published
2021

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