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2. Health-related quality of life in patients with relapsed or refractory multiple myeloma: treatment with daratumumab, lenalidomide, and dexamethasone in the phase 3 POLLUX trial

Author

Plesner, T. Dimopoulos, M.A. Oriol, A. San-Miguel, J. Bahlis, N.J. Rabin, N. Suzuki, K. Yoon, S.-S. Ben-Yehuda, D. Cook, G. Goldschmidt, H. Grosicki, S. Qin, X. Fastenau, J. Garvin, W. Carson, R. Renaud, T. Gries, K.S.

Subjects
humanities
Abstract

In the phase 3 POLLUX trial, daratumumab in combination with lenalidomide and dexamethasone (D-Rd) significantly improved progression-free survival in patients with relapsed/refractory multiple myeloma (RRMM) compared with lenalidomide and dexamethasone (Rd) alone. Here, we present patient-reported outcomes (PROs) from POLLUX, assessed using the validated European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) and the EuroQol 5-dimensional descriptive system (EQ-5D-5L) questionnaires. Changes from baseline are presented as least-squares mean changes with 95% confidence intervals (CIs) derived from a mixed-effects model. PRO assessment compliance rates were high and similar in both D-Rd and Rd groups through cycle 40 (week 156). In this on-treatment analysis, mean changes from baseline were significantly greater in EORTC QLQ-C30 global health status, physical functioning, and pain scores in the D-Rd group versus the Rd group at multiple time points; however, magnitude of changes was low, suggesting no meaningful impact on health-related quality of life (HRQoL). Subgroup results were similar to those in the overall population. In the POLLUX study, baseline HRQoL was maintained with prolonged D-Rd treatment. These findings complement the sustained and significant improvement in progression-free survival observed with D-Rd and supports its use in patients with RRMM. Clinical trial registration: NCT02076009. © 2021 British Society for Haematology and John Wiley & Sons Ltd.

Published
2021

5. Pembrolizumab plus pomalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma (KEYNOTE-183): a randomised, open-label, phase 3 trial

Author

Mateos, Maria-Victoria, Blacklock, Hilary, Schjesvold, Fredrik, Oriol, Albert, Simpson, David, George, Anupkumar, Goldschmidt, Hartmut, Larocca, Alessandra, Chanan-Khan, Asher, Sherbenou, Daniel, Avivi, Irit, Benyamini, Noam, Iida, Shinsuke, Matsumoto, Morio, Suzuki, Kenshi, Ribrag, Vincent, Usmani, Saad Z, Jagannath, Sundar, Ocio, Enrique M, Rodriguez-Otero, Paula, San Miguel, Jesus, Kher, Uma, Farooqui, Mohammed, Liao, Jason, Marinello, Patricia, Lonial, Sagar, KEYNOTE-183 Investigators, Nicol A, Grigoriadis G, Catalano J, LeBlanc R, Elemary M, Bahlis N, Facon T, Karlin L, Ribrag V, Attal M, Goldschmidt H, Engelhardt M, Weisel K, Mackensen A, Nagler A, Ben Yehuda D, Avivi I, Benyamini N, Magen-Nativ H, Palumbo A, Cavo M, Tobinai K, Iida S, Chou T, Suzuki K, Kosugi H, Taniwaki M, Sunami K, Matsumoto M, Ando K, Ganly P, Blacklock H, Simpson D, George A, Schjesvold F, Gjertsen B, Lahuerta J, Blade J, Oriol Rocafiguera A, Mateos M, Rodriguez-Otero P, Larson S, Atanackovic D, Devarakonda S, Bitran J, Zonder J, Morganstein N, Hay M, Chanan-Khan A, Saylors G, Kio E, Oliff I, Kirkel D, Shtivelband M, Yuen C, Yee A, Shah J, Htut M, Raza S, Chhabra S, Stiff P, Hari P, Bank B, Malek E, Gasparetto C, Faroun Y, Sherbenou D, Kreisle W, Singhal S, Rosenblatt J, Usmani S, Lee W, Safah H, Lutzky J, Suh J, Pan D, Baron A, Manges R, Steis R, Oliveira M, Moreb J, Callander N, Anz B, Raptis A, Stampleman L, Melear J, Boyd T, Garbo L, Klein L, Shao S, Lyons R, McIntyre K, Tarantolo S, Yasenchak C, Yimer H., Mateos, Maria-Victoria, Blacklock, Hilary, Schjesvold, Fredrik, Oriol, Albert, Simpson, David, George, Anupkumar, Goldschmidt, Hartmut, Larocca, Alessandra, Chanan-Khan, Asher, Sherbenou, Daniel, Avivi, Irit, Benyamini, Noam, Iida, Shinsuke, Matsumoto, Morio, Suzuki, Kenshi, Ribrag, Vincent, Usmani, Saad Z, Jagannath, Sundar, Ocio, Enrique M, Rodriguez-Otero, Paula, San Miguel, Jesu, Kher, Uma, Farooqui, Mohammed, Liao, Jason, Marinello, Patricia, Lonial, Sagar, KEYNOTE-183 Investigator, and Nicol A, Grigoriadis G, Catalano J, LeBlanc R, Elemary M, Bahlis N, Facon T, Karlin L, Ribrag V, Attal M, Goldschmidt H, Engelhardt M, Weisel K, Mackensen A, Nagler A, Ben Yehuda D, Avivi I, Benyamini N, Magen-Nativ H, Palumbo A, Cavo M, Tobinai K, Iida S, Chou T, Suzuki K, Kosugi H, Taniwaki M, Sunami K, Matsumoto M, Ando K, Ganly P, Blacklock H, Simpson D, George A, Schjesvold F, Gjertsen B, Lahuerta J, Blade J, Oriol Rocafiguera A, Mateos M, Rodriguez-Otero P, Larson S, Atanackovic D, Devarakonda S, Bitran J, Zonder J, Morganstein N, Hay M, Chanan-Khan A, Saylors G, Kio E, Oliff I, Kirkel D, Shtivelband M, Yuen C, Yee A, Shah J, Htut M, Raza S, Chhabra S, Stiff P, Hari P, Bank B, Malek E, Gasparetto C, Faroun Y, Sherbenou D, Kreisle W, Singhal S, Rosenblatt J, Usmani S, Lee W, Safah H, Lutzky J, Suh J, Pan D, Baron A, Manges R, Steis R, Oliveira M, Moreb J, Callander N, Anz B, Raptis A, Stampleman L, Melear J, Boyd T, Garbo L, Klein L, Shao S, Lyons R, McIntyre K, Tarantolo S, Yasenchak C, Yimer H.

Subjects
Male, medicine.medical_specialty, Pembrolizumab, Antibodies, Monoclonal, Humanized, Dexamethasone, Drug Administration Schedule, 03 medical and health sciences, Pembrolizumab, pomalidomide, dexamethasone, KEYNOTE-183, 0302 clinical medicine, Recurrence, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Progression-free survival, Survival rate, Multiple myeloma, Aged, Proportional Hazards Models, Lenalidomide, Aged, 80 and over, Performance status, business.industry, Hematology, medicine.disease, Pomalidomide, Interim analysis, Progression-Free Survival, Thalidomide, Survival Rate, Myocarditis, Editorial Commentary, Treatment Outcome, Stevens-Johnson Syndrome, 030220 oncology & carcinogenesis, Female, Multiple Myeloma, business, 030215 immunology, medicine.drug
Abstract

Summary Background Pomalidomide and dexamethasone is a standard of care for patients with multiple myeloma in whom bortezomib and lenalidomide treatment has failed. KEYNOTE-183 assessed efficacy and safety of pomalidomide and dexamethasone with or without pembrolizumab in patients with relapsed or refractory multiple myeloma. Here, we present the findings of an unplanned, ad-hoc interim analysis at the request of the US Food and Drug Administration (FDA). Methods KEYNOTE-183 was a randomised, open-label, phase 3 trial done at 97 medical centres across 11 countries (Australia, Canada, France, Germany, Israel, Italy, Japan, New Zealand, Norway, Spain, and USA). Patients aged at least 18 years with multiple myeloma, an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, previously treated with at least two lines of therapy (excluding pomalidomide) and refractory to the last line were randomly assigned 1:1 to the pembrolizumab plus pomalidomide and dexamethasone group or the pomalidomide and dexamethasone group via an interactive voice response or integrated web response system. Patients received oral pomalidomide 4 mg daily on days 1–21 and oral low-dose dexamethasone 40 mg on days 1, 8, 15, and 22 in 28-day cycles, with or without intravenous pembrolizumab 200 mg every 3 weeks. The dual primary endpoints were progression-free survival and overall survival. Efficacy was assessed in all randomly assigned patients and safety was assessed in patients who received at least one dose of study treatment. The trial is registered at ClinicalTrials.gov , number NCT02576977 , and it is closed for accrual. Findings Between Jan 18, 2016, and June 7, 2017, 249 patients were randomly assigned to either the pembrolizumab plus pomalidomide and dexamethasone group (n=125) or the pomalidomide and dexamethasone group (n=124). On July 3, 2017, the FDA established that risks associated with the triple combination outweighed benefits and halted the study. Median follow-up was 8·1 months (IQR 4·5–10·9). Median progression-free survival was 5·6 months (95% CI 3·7–7·5) in the pembrolizumab plus pomalidomide and dexamethasone group versus 8·4 months (5·9–not reached) in the pomalidomide and dexamethasone group; progression-free survival estimates at 6 months were 48% (95% CI 37–58) versus 60% (49–69) at 6 months (hazard ratio [HR] 1·53; 95% CI 1·05–2·22; p=0·98). Median overall survival was not reached (95% CI 12·9–not reached) versus 15·2 months (12·7–not reached; HR 1·61; 95% CI 0·91–2·85; p=0·95); overall survival estimates at 6 months were 82% (95% CI 74–88) versus 90% (82–95). Serious adverse events occurred in 75 (63%) of 120 patients in the pembrolizumab plus pomalidomide and dexamethasone group versus 56 (46%) of 121 patients in the pomalidomide and dexamethasone group. Four (3%) treatment-related deaths occurred in the pembrolizumab plus pomalidomide and dexamethasone group (one each of unknown cause, neutropenic sepsis, myocarditis, and Stevens–Johnson syndrome); myocarditis and Stevens-Johnson syndrome were considered related to pembrolizumab. No treatment-related deaths were reported in the pomalidomide and dexamethasone group. Interpretation The results from this unplanned, FDA-requested, interim analysis showed that the benefit–risk profile of pembrolizumab plus pomalidomide and dexamethasone is unfavourable for patients with relapsed or refractory multiple myeloma. Funding Merck Sharp & Dohme, a subsidiary of Merck & Co (Kenilworth, NJ, USA).

Published
2019

7. Health-related quality-of-life results from the phase 3 OPTIMISMM study: pomalidomide, bortezomib, and low-dose dexamethasone versus bortezomib and low-dose dexamethasone in relapsed or refractory multiple myeloma

Author

Weisel, K. Dimopoulos, M. Moreau, P. Yagci, M. Larocca, A. Kanate, A.S. Vural, F. Cascavilla, N. Basu, S. Johnson, P. Byeff, P. Hus, M. Rodríguez-Otero, P. Muelduer, E. Anttila, P. Hayden, P.J. Krauth, M.-T. Lucio, P. Ben-Yehuda, D. Mendeleeva, L. Guo, S. Yu, X. Grote, L. Biyukov, T. Dhanasiri, S. Richardson, P.

Subjects
humanities
Abstract

In the randomized phase-3 OPTIMISMM study, the addition of pomalidomide to bortezomib and low-dose dexamethasone (PVd) resulted in significant improvement in progression-free survival (PFS) in lenalidomide-pretreated patients with relapsed or refractory multiple myeloma (RRMM), including lenalidomide refractory patients. Here, we report health-related quality of life (HRQoL) results from this trial. Patients received PVd or Vd in 21-day cycles until disease progression or discontinuation. HRQoL was assessed using the EORTC QLQ-C30, QLQ-MY20, and EQ-5D-3L instruments on day 1 of each treatment cycle. Mean score changes for global QoL, physical functioning, fatigue, side effects of treatment domains, and EQ-5D-3L index were generally stable over time across treatment arms. The proportion of patients who experienced clinically meaningful worsening in global QoL and other domains of interest was similar. These HRQoL results with PVd along with previously demonstrated improvement in PFS vs Vd continue to support its use in patients with RRMM. © 2020 Informa UK Limited, trading as Taylor & Francis Group.

Published
2020

12. Pomalidomide, bortezomib, and dexamethasone for patients with relapsed or refractory multiple myeloma previously treated with lenalidomide (OPTIMISMM): a randomised, open-label, phase 3 trial

Author

Richardson, P.G. Oriol, A. Beksac, M. Liberati, A.M. Galli, M. Schjesvold, F. Lindsay, J. Weisel, K. White, D. Facon, T. San Miguel, J. Sunami, K. O'Gorman, P. Sonneveld, P. Robak, P. Semochkin, S. Schey, S. Yu, X. Doerr, T. Bensmaine, A. Biyukov, T. Peluso, T. Zaki, M. Anderson, K. Dimopoulos, M. Abildgaard, N. Adler, H. Altuntas, F. Akay, O.M. Amin, B. Anagnostopoulos, A. Anderson, L. Anttila, P. Araujo, C. Arce-Lara, C. Aydin, Y. Basu, S. Battini, R. Beeker, T. Benboubker, L. Ben-Yehuda, D. Bladé, J. Blau, I.W. Boccia, R. Burke, L. Byeff, P. Cascavilla, N. Cavo, M. Chantry, A. Charles, Y. Chaudhry, A. Corso, A. Coyne, M. De Arriba, F. Delimpasi, S. Desjardins, P. Dhakal, B. Di Bartolomeo, P. Di Raimondo, F. Dürig, J. Engelhardt, M. Escoffre-Barbe, M. Esteves, G. Flogegard, M. Gabrail, N. Gamberi, B. Garrison, M. Gay, J. Gisslinger, H. Goldschmidt, H. Goncalves, C. Gressot, L. Grosicki, S. Hanna, W. Hayden, P. Henriques Bernardo, M.M. Hermann, R. Holden, V. Honkalehto, K. Huben, M. Huffman, J. Hunter, H. Hus, M. Jagasia, M. Jagganath, S. Janakiram, M. Jaiyesimi, I. Jenner, M. João, C. Johnson, P. Jurcyszyn, A. Kalayoğlu Beşişik, S. Kambhampati, S. Kanate, A. Karadoğan, I. Khojasteh, A. Kirkel, D. Komarnicki, M. Krauth, M.-T. Kuriakose, P. Larocca, A. Lauri, B. Leleu, X. Lucio, P. Luppi, M. Mangiacavalli, S. Mariette, C. Matsue, K. Mellqvist, U.-H. Mendeleeva, L. Meshad, M. Miller, C. Mohrbacher, A. Moreau, P. Morelli, A.M. Müldür, E. Naassan, A. Nahi, H. Nair, R. O'Dwyer, M. Öngören Aydin, S. Openshaw, T. O'Rourke, T. Osswald, M. Overton, L. Pati, A. Pavic, M. Pegourie, B. Pehlivan, M. Pierola, A.A. Plesner, T. Pluta, A. Rabin, N. Ramasamy, K. Rambaldi, A. Rodriguez, P. Röllig, C. Rosenblatt, J. Rosenbluth, J. Salomo, M. Samoylova, O. Sastre Moral, J. Sati, H. Selleri, C. Shafeek, S. Shinagawa, A. Sleckman, B. Smith, C. Sonmez, M. Stone, C. Streetly, M. Suzuki, K. Taetle, R. Tafuri, A. Takezako, N. Teke, H.Ü. Vapaatalo, M. Vassilopoulos, G. Verma, A. Vidito, S. Viterbo, L. Vural, F. Wang, X.S. Yağci, M. Yee, A. OPTIMISMM trial investigators

Subjects
hemic and lymphatic diseases
Abstract

Background: As lenalidomide becomes increasingly established for upfront treatment of multiple myeloma, patients refractory to this drug represent a population with an unmet need. The combination of pomalidomide, bortezomib, and dexamethasone has shown promising results in phase 1/2 trials of patients with relapsed or refractory multiple myeloma. We aimed to assess the efficacy and safety of this triplet regimen in patients with relapsed or refractory multiple myeloma who previously received lenalidomide. Methods: We did a randomised, open-label, phase 3 trial at 133 hospitals and research centres in 21 countries. We enrolled patients (aged ≥18 years)with a diagnosis of multiple myeloma and measurable disease, an Eastern Cooperative Oncology Group performance status of 0–2, who received one to three previous regimens, including a lenalidomide-containing regimen for at least two consecutive cycles. We randomly assigned patients (1:1)to bortezomib and dexamethasone with or without pomalidomide using a permutated blocked design in blocks of four, stratified according to age, number of previous regimens, and concentration of β2 microglobulin at screening. Bortezomib (1·3 mg/m2)was administered intravenously until protocol amendment 1 then either intravenously or subcutaneously on days 1, 4, 8, and 11 for the first eight cycles and subsequently on days 1 and 8. Dexamethasone (20 mg [10 mg if age >75 years])was administered orally on the same days as bortezomib and the day after. Patients allocated pomalidomide received 4 mg orally on days 1–14. Treatment cycles were every 21 days. The primary endpoint was progression-free survival in the intention-to-treat population, as assessed by an independent review committee. Safety was assessed in all patients who received at least one dose of study medication. This trial is registered at ClinicalTrials.gov, number NCT01734928; patients are no longer being enrolled. Findings: Between Jan 7, 2013, and May 15, 2017, 559 patients were enrolled. 281 patients were assigned pomalidomide, bortezomib, and dexamethasone and 278 were allocated bortezomib and dexamethasone. Median follow-up was 15·9 months (IQR 9·9–21·7). Pomalidomide, bortezomib, and dexamethasone significantly improved progression-free survival compared with bortezomib and dexamethasone (median 11·20 months [95% CI 9·66–13·73]vs 7·10 months [5·88–8·48]; hazard ratio 0·61, 95% CI 0·49–0·77; p

Published
2019

14. Daratumumab, lenalidomide, and dexamethasone for multiple myeloma

Author

Dimopoulos, M.A. Oriol, A. Nahi, H. San-Miguel, J. Bahlis, N.J. Usmani, S.Z. Rabin, N. Orlowski, R.Z. Komarnicki, M. Suzuki, K. Plesner, T. Yoon, S.-S. Ben Yehuda, D. Richardson, P.G. Goldschmidt, H. Reece, D. Lisby, S. Khokhar, N.Z. O'Rourke, L. Chiu, C. Qin, X. Guckert, M. Ahmadi, T. Moreau, P. POLLUX Investigators

Abstract

BACKGROUND: Daratumumab showed promising efficacy alone and with lenalidomide and dexamethasone in a phase 1-2 study involving patients with relapsed or refractory multiple myeloma. METHODS: In this phase 3 trial, we randomly assigned 569 patients with multiple myeloma who had received one or more previous lines of therapy to receive lenalidomide and dexamethasone either alone (control group) or in combination with daratumumab (daratumumab group). The primary end point was progression-free survival. RESULTS: At a median follow-up of 13.5 months in a protocol-specified interim analysis, 169 events of disease progression or death were observed (in 53 of 286 patients [18.5%] in the daratumumab group vs. 116 of 283 [41.0%] in the control group; hazard ratio, 0.37; 95% confidence interval [CI], 0.27 to 0.52; P

Published
2016

16. International myeloma working group recommendations for the diagnosis and management of myeloma-related renal impairment

Author

Dimopoulos, M.A. Sonneveld, P. Leung, N. Merlini, G. Ludwig, H. Kastritis, E. Goldschmidt, H. Joshua, D. Orlowski, R.Z. Powles, R. Vesole, D.H. Garderet, L. Einsele, H. Palumbo, A. Cavo, M. Richardson, P.G. Moreau, P. Miguel, J.S. Vincent Rajkumar, S. Durie, B.G.M. Terpos, E. Abildgaard, N. Abonour, R. Alsina, M. Anderson, K.C. Attal, M. Avet-Loiseau, H. Badros, A. Bahlis, N.J. Barlogie, B. Bataille, R. Beksaç, M. Belch, A. Ben-Yehuda, D. Bensinger, B. Leif Bergsagel, P. Bhutani, M. Bird, J. Bladé, J. Broijl, A. Boccadoro, M. Caers, J. Chanan-Khan, A. Chari, A. Chen, W.M. Chesi, M. Anthony Child, J. Chim, C.S. Chng, W.-J. Comenzo, R. Cook, G. Crowley, J. Crusoe, E. Dalton, W. Lee Moffitt, H. Davies, F. de la Rubia, J. de Souza, C. Delforge, M. Dhodapkar, M. Dispenzieri, A. Drach, J. Drake, M. Du, J. Dytfeld, D. Facon, T. Fantl, D. Fermand, J.-P. Fernández de Larrea, C. Fonseca, R. Gahrton, G. Garćia-Sanz, R. Gasparetto, C. Gertz, M. Ghobrial, I. Gibson, J. Gimsing, P. Giralt, S. Gu, J. Hajek, R. Hardan, I. Hari, P. Hata, H. Hattori, Y. Heffner, T. Hillengass, J. Ho, J. Hoering, A. Hoffman, J.E. Hou, J. Huang, J. Hungria, V. Ida, S. Jagannath, S. Jakubowiak, A.J. Johnsen, H.E. Jurczyszyn, A. Kaiser, M. Kaufman, J. Kawano, M. Korde, N. Kovacs, E. Krishnan, A. Kristinsson, S. Kröger, N. Kumar, S. Kyle, R.A. Kyriacou, C. Lacy, M. Lahuerta, J.J. Landgren, O. Larocca, A. Laubach, J. da Costa, F.L. Lee, J.-H. Leiba, M. Leleu, X. Lentzsch, S. Lokhorst, H. Lonial, S. Lu, J. Mahindra, A. Maiolino, A. Manasanch, E.E. Mark, T. Mateos, M.-V. Mazumder, A. McCarthy, P. Mehta, J. Mellqvist, U.-H. Mikhael, J. Morgan, G. Munshi, N. Nahi, H. Nawarawong, W. Niesvizky, R. Nouel, A. Novis, Y. Ocio, E. O'Dwyer, M. O'Gorman, P. Orfao, A. Otero, P.R. Paiva, B. Pavlovsky, S. Pilarski, L. Pratt, G. Qui, L. Raje, N. Reece, D. Reiman, A. Remaggi, G. Richter, J. Serra, E.R. Morales, A.R. Romeril, K.R. Roodman, D. Rosiñol, L. Rossi, A. Roussel, M. Russell, S. Schjesvold, F. Schots, R. Sevcikova, S. Sezer, O. Shah, J.J. Shimizu, K. Shustik, C. Siegel, D. Singhal, S. Spencer, A. Stadtmauer, E. Stewart, K. Tan, D. Terragna, C. Tosi, P. Tricot, G. Turesson, I. Usmani, S. Van Camp, B. Van de Donk, N. Van Ness, B. Van Riet, I. Broek, I.V. Vanderkerken, K. Vescio, R. Vij, R. Voorhees, P. Waage, A. Wang, M. Weber, D. Weiss, B.M. Westin, J. Wheatley, K. Zamagni, E. Zonder, J. Zweegman, S.

Abstract

Purpose: The aim of the International Myeloma Working Group was to develop practical recommendations for the diagnosis and management of multiple myeloma–related renal impairment (RI). Methods: Recommendations were based on published data through December 2015, and were developed using the system developed by the Grading of Recommendation, Assessment, Development, and Evaluation Working Group. Recommendations: All patients with myeloma at diagnosis and at disease assessment should have serum creatinine, estimated glomerular filtration rate, and electrolytes measurements as well as free light chain, if available, and urine electrophoresis of a sample from a 24-hour urine collection (grade A). The Chronic Kidney Disease Epidemiology Collaboration, preferably, or the Modification of Diet in Renal Disease formula should be used for the evaluation of estimated glomerular filtration rate in patients with stabilized serum creatinine (grade A). International Myeloma Working Group criteria for renal reversibility should be used (grade B). For the management of RI in patients with multiple myeloma, high fluid intake is indicated along with antimyeloma therapy (grade B). The use of high-cutoff hemodialysis membranes in combination with antimyeloma therapy can be considered (grade B). Bortezomib-based regimens remain the cornerstone of the management of myeloma-related RI (grade A). High-dose dexamethasone should be administered at least for the first month of therapy (grade B). Thalidomide is effective in patients with myeloma with RI, and no dose modifications are needed (grade B). Lenalidomide is effective and safe, mainly in patients with mild to moderate RI (grade B); for patients with severe RI or on dialysis, lena-lidomide should be given with close monitoring for hematologic toxicity (grade B) with dose reduction as needed. High-dose therapy with autologous stem cell transplantation (with melphalan 100 mg/m2 to 140 mg/m2) is feasible in patients with RI (grade C). Carfilzomib can be safely administered to patients with creatinine clearance > 15 mL/min, whereas ixazomib in combination with lenalidomide and dex-amethasone can be safely administered to patients with creatinine clearance > 30 mL/min (grade A). © 2016 by American Society of Clinical Oncology.

Published
2016

17. Practical Considerations for the Use of Daratumumab, a Novel CD38 Monoclonal Antibody, in Myeloma

Author

Moreau, P. Van De Donk, N.W.C.J. Miguel, J.S. Lokhorst, H. Nahi, H. Ben-Yehuda, D. Cavo, M. Cook, G. Delforge, M. Einsele, H. Zweegman, S. Ludwig, H. Driessen, C. Palumbo, A. Facon, T. Plesner, T. Dimopoulos, M. Sondergeld, P. Sonneveld, P. Mateos, M.-V.

Abstract

Monoclonal antibodies (mAbs) are a recent addition to multiple myeloma (MM) therapies and a number of mAbs directed at myeloma cell surface molecules are in development. Daratumumab is a CD38 mAb that has demonstrated substantial activity and good tolerability in four phase I, phase I/II and phase II studies as monotherapy, as well as in combination with current standard treatments in MM. The positive results obtained in the relapsed/refractory setting in patients with advanced-stage disease and in a small number of patients with newly diagnosed disease provide the rationale for the investigation of the agent in a number of ongoing phase III trials. mAbs are generally better tolerated than conventional chemotherapy; however, their use requires other special considerations. Such factors include those common to all mAbs, namely infusion-related reactions, but also factors that are observed with mAbs used in myeloma, such as interference with response assessment, or factors that are related to CD38 mAbs such as daratumumab, for instance blood typing interference. Our review provides an overview of the results from the daratumumab clinical trials conducted to date, as well as practical management considerations for the use of daratumumab based on our experience with the agent. © 2016 Springer International Publishing Switzerland.

Published
2016

19. Carfilzomib, lenalidomide, and dexamethasone for relapsed multiple myeloma

Author

Stewart, Ak, Rajkumar, Sv, Dimopoulos, Ma, Masszi, T, Špička, I, Oriol, A, Hájek, R, Rosiñol, L, Siegel, Ds, Mihaylov, Gg, Goranova Marinova, V, Rajnics, P, Suvorov, A, Niesvizky, R, Jakubowiak, Aj, San Miguel JF, Ludwig, H, Wang, M, Maisnar, V, Minarik, J, Bensinger, Wi, Mateos, Mv, Ben Yehuda, D, Kukreti, V, Zojwalla, N, Tonda, Me, Yang, X, Xing, B, Moreau, P, Palumbo, A, Petrini, Mario, Aspire, Investigators, Laboratory of Molecullar and Cellular Therapy, and Clinical sciences

Subjects
Adult, Male, Oncology, medicine.medical_specialty, Kaplan-Meier Estimate, Dexamethasone, Ixazomib, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Female, Humans, Intention to Treat Analysis, Middle Aged, Multiple Myeloma, Oligopeptides, Recurrence, Thalidomide, Medicine (all), chemistry.chemical_compound, Internal medicine, 80 and over, medicine, Elotuzumab, Multiple myeloma, Lenalidomide, business.industry, General Medicine, Pomalidomide, medicine.disease, Carfilzomib, Surgery, chemistry, business, medicine.drug
Abstract

BACKGROUND: Lenalidomide plus dexamethasone is a reference treatment for relapsed multiple myeloma. The combination of the proteasome inhibitor carfilzomib with lenalidomide and dexamethasone has shown efficacy in a phase 1 and 2 study in relapsed multiple myeloma. METHODS: We randomly assigned 792 patients with relapsed multiple myeloma to carfilzomib with lenalidomide and dexamethasone (carfilzomib group) or lenalidomide and dexamethasone alone (control group). The primary end point was progression-free survival. RESULTS: Progression-free survival was significantly improved with carfilzomib (median, 26.3 months, vs. 17.6 months in the control group; hazard ratio for progression or death, 0.69; 95% confidence interval [CI], 0.57 to 0.83; P=0.0001). The median overall survival was not reached in either group at the interim analysis. The Kaplan-Meier 24-month overall survival rates were 73.3% and 65.0% in the carfilzomib and control groups, respectively (hazard ratio for death, 0.79; 95% CI, 0.63 to 0.99; P=0.04). The rates of overall response (partial response or better) were 87.1% and 66.7% in the carfilzomib and control groups, respectively (P

Published
2015

20. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib:A multicenter international myeloma working group study

Author

Kumar S. K., Lee J. H., Lahuerta J. J., Morgan G., Richardson P. G., Crowley J., Haessler J., Feather J., Hoering A., Moreau P., LeLeu X., Hulin C., Klein S. K., Sonneveld P., Siegel D., Bladé J., Goldschmidt H., Jagannath S., Miguel J. S., Orlowski R., Palumbo A., Sezer O., Rajkumar S. V., Durie B. G. International Myeloma Working Group Abildgaard N, Abonour R, Alexanian R, Alsina M, Anderson KC, Attal M, Avet Loiseau H, Badros A, Baris D, Barlogie B, Bataille R, Beksaç M, Belch A, Ben Yehuda D, Bensinger B, Bergsagel PL, Bird J, Bladé J, Boccadoro M, Chanan Khan A, Chen WM, Child T, Chim J, Chng WJ, Comenzo R, Crowley J, Dalton W, Davies F, de Souza C, Delforge M, Dimopoulos M, Dispenzieri A, Drach J, Drake M, Durie BG, Einsele H, Facon T, Fantl D, Fermand JP, Fonseca R, Gahrton G, García Sanz R, Gasparetto C, Gertz M, Gibson J, Giralt S, Goldschmidt H, Greipp P, Hajek R, Hardan I, Hari P, Harousseau JL, Hata H, Hattori Y, Heffner T, Ho J, Hungria V, Ida S, Jacobs P, Jagannath S, Johnsen HE, Jian H, Joshua D, Jurczyszyn A, Kawano M, Kröger N, Kumar S, Kyle RA, Lacy M, Lahuerta JJ, Landgren O, Laubach J, Lee JH, LeLeu X, Lentzsch S, Lokhorst H, Lonial S, Ludwig H, Maiolino A, Mateos M, Mehta J, Mellqvist UH, Merlini G, Mikhael J, Morales AR, Moreau P, Morgan G, Nahi H, Munshi N, Niesvizky R, Nouel A, Novis Y, Orlowski R, Palumbo A, Pavlovsky S, Pilarski L, Powles R, Raje N, Rajkumar SV, Reece D, Reiman T, Richardson PG, Roodman D, Rosiñol L, San Miguel J, Sezer O, Shah JJ, Shaughnessy J, Shimizu K, Shustik C, Siegel D, Singhal S, Sonneveld P, Spencer A, Stadtmauer E, Stewart K, Terpos E, Tosi P, Tricot G, Turesson I, Van Camp B, Van Ness B, Van Riet I, Vande Broek I, Vanderkerken K, Vescio R, Vesole D, Waage A, Wang M, Weber D, Westin J, Wheatley K, Zonder J., CAVO, MICHELE, Kumar S.K., Lee J.H., Lahuerta J.J., Morgan G., Richardson P.G., Crowley J., Haessler J., Feather J., Hoering A., Moreau P., LeLeu X., Hulin C., Klein S.K., Sonneveld P., Siegel D., Bladé J., Goldschmidt H., Jagannath S., Miguel J.S., Orlowski R., Palumbo A., Sezer O., Rajkumar S.V., Durie B.G. International Myeloma Working Group Abildgaard N, Abonour R, Alexanian R, Alsina M, Anderson KC, Attal M, Avet-Loiseau H, Badros A, Baris D, Barlogie B, Bataille R, Beksaç M, Belch A, Ben-Yehuda D, Bensinger B, Bergsagel PL, Bird J, Bladé J, Boccadoro M, Cavo M, Chanan-Khan A, Chen WM, Child T, Chim J, Chng WJ, Comenzo R, Crowley J, Dalton W, Davies F, de Souza C, Delforge M, Dimopoulos M, Dispenzieri A, Drach J, Drake M, Durie BG, Einsele H, Facon T, Fantl D, Fermand JP, Fonseca R, Gahrton G, García-Sanz R, Gasparetto C, Gertz M, Gibson J, Giralt S, Goldschmidt H, Greipp P, Hajek R, Hardan I, Hari P, Harousseau JL, Hata H, Hattori Y, Heffner T, Ho J, Hungria V, Ida S, Jacobs P, Jagannath S, Johnsen HE, Jian H, Joshua D, Jurczyszyn A, Kawano M, Kröger N, Kumar S, Kyle RA, Lacy M, Lahuerta JJ, Landgren O, Laubach J, Lee JH, LeLeu X, Lentzsch S, Lokhorst H, Lonial S, Ludwig H, Maiolino A, Mateos M, Mehta J, Mellqvist UH, Merlini G, Mikhael J, Morales AR, Moreau P, Morgan G, Nahi H, Munshi N, Niesvizky R, Nouel A, Novis Y, Orlowski R, Palumbo A, Pavlovsky S, Pilarski L, Powles R, Raje N, Rajkumar SV, Reece D, Reiman T, Richardson PG, Roodman D, Rosiñol L, San Miguel J, Sezer O, Shah JJ, Shaughnessy J, Shimizu K, Shustik C, Siegel D, Singhal S, Sonneveld P, Spencer A, Stadtmauer E, Stewart K, Terpos E, Tosi P, Tricot G, Turesson I, Van Camp B, Van Ness B, Van Riet I, Vande Broek I, Vanderkerken K, Vescio R, Vesole D, Waage A, Wang M, Weber D, Westin J, Wheatley K, Zonder J., and Hematology

Subjects
Adult, Male, Oncology, Cancer Research, medicine.medical_specialty, NATURAL HISTORY, Antineoplastic Agents, Context (language use), RELAPSE, Article, Recurrence, Internal medicine, medicine, Humans, Immunologic Factors, Elotuzumab, Survival analysis, Multiple myeloma, Aged, Aged, 80 and over, Isatuximab, Bortezomib, business.industry, Hematology, Middle Aged, Pomalidomide, medicine.disease, Survival Analysis, Surgery, Regimen, SURVIVAL, Disease Progression, Female, Multiple Myeloma, business, medicine.drug
Abstract

Promising new drugs are being evaluated for treatment of multiple myeloma (MM), but their impact should be measured against the expected outcome in patients failing current therapies. However, the natural history of relapsed disease in the current era remains unclear. We studied 286 patients with relapsed MM, who were refractory to bortezomib and were relapsed following, refractory to or ineligible to receive, an IMiD (immunomodulatory drug), had measurable disease, and ECOG PS of 0, 1 or 2. The date patients satisfied the entry criteria was defined as time zero (T-0). The median age at diagnosis was 58 years, and time from diagnosis to T-0 was 3.3 years. Following T-0, 213 (74%) patients had a treatment recorded with one or more regimens (median = 1; range 0-8). The first regimen contained bortezomib in 55 (26%) patients and an IMiD in 70 (33%). A minor response or better was seen to at least one therapy after T0 in 94 patients (44%) including >= partial response in 69 (32%). The median overall survival and event-free survival from T-0 were 9 and 5 months, respectively. This study confirms the poor outcome, once patients become refractory to current treatments. The results provide context for interpreting ongoing trials of new drugs. Leukemia (2012) 26, 149-157; doi:10.1038/leu.2011.196; published online 29 July 2011

Published
2012

22. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib

Author

Kumar, Sk, Lee, Jh, Lahuerta, Jj, Morgan, G, Richardson, Pg, Crowley, J, Haessler, J, Feather, J, Hoering, A, Moreau, P, Leleu, X, Hulin, C, Klein, Sk, Sonneveld, P, Siegel, D, Bladé, J, Goldschmidt, H, Jagannath, S, Miguel, Js, Orlowski, R, Palumbo, Antonio, Sezer, O, Rajkumar, Sv, Durie, Bg, on behalf of the International Myeloma Working Group, International Myeloma Working Group, Abildgaard, N, Abonour, R, Alexanian, R, Alsina, M, Anderson, Kc, Attal, M, Avet Loiseau, H, Badros, A, Baris, D, Barlogie, B, Bataille, R, Beksaç, M, Belch, A, Ben Yehuda, D, Bensinger, B, Leif Bergsagel, P, Bird, J, Boccadoro, M, Cavo, M, Chanan Khan, A, Ming Chen, W, Child, T, Chim, J, Chng, Wj, Comenzo, R, Dalton, W, Davies, F, de Souza, C, Delforge, M, Dimopoulos, M, Dispenzieri, A, Drach, J, Drake, M, Einsele, H, Facon, T, Fantl, D, Fermand, Jp, Fonseca, R, Gahrton, G, García Sanz, R, Gasparetto, C, Gertz, M, Gibson, J, Giralt, S, Greipp, P, Hajek, R, Hardan, I, Hari, P, Harousseau, Jl, Hata, H, Hattori, Y, Heffner, T, Ho, J, Hungria, V, Ida, S, Jacobs, P, Johnsen, H, Jian, H, Joshua, D, Jurczyszyn, A, Kawano, M, Kröger, N, Kumar, S, Kyle, Ra, Lacy, M, Landgren, O, Laubach, J, Lentzsch, S, Lokhorst, H, Lonial, S, Ludwig, H, Maiolino, A, Mateos, M, Mehta, J, Mellqvist, Uh, Merlini, G, Mikhael, J, Morales, Ar, Nari, H, Munshi, N, Niesvizky, R, Nouel, A, Novis, Y, Palumbo, A, Pavlovsky, S, Pilarski, L, Powles, R, Raje, N, Vincent Rajkumar, S, Reece, D, Reiman, T, Roodman, D, Rosiñol, L, Shah, Jj, Shaughnessy, J, Shimizu, K, Shustik, C, Singhal, S, Spencer, A, Stadtmauer, E, Stewart, K, Terpos, E, Tosi, P, Tricot, G, Turesson, I, Van Camp, B, Van Ness, B, Van Riet, I, Broek, Iv, Vanderkerken, K, Vescio, R, Vesole, D, Waage, A, Wang, M, Weber, D, Westin, J, Wheatley, K, and Zonder, J.

Published
2012

24. MELPHALAN/PREDNISONE/LENALIDOMIDE (MPR) VERSUS HIGHDOSEMELPHALAN AND AUTOLOGOUS TRANSPLANTATION (MEL200)IN NEWLY DIAGNOSED MULTIPLE MYELOMA (MM) PATIENTS: APHASE III STUDY

Author

Palumbo, Antonio, Cavallo, Federica, Lupo, B., Nagler, A., Redoglia, V., Cavalli, M., Carella, A., Cafro, A., Patriarca, F., Siniscalchi, A., Rossini, F., Crippa, C., Corradini, P., Cavo, M., Grammatico, S., Stanevsky, A., Ben Yehuda, D., Di Raimondo, F., Caravita Di Toritto, T., and Boccadoro, Mario

Published
2011

25. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: A multicenter international myeloma working group study

Author

Kumar, Sk, Lee, Jh, Lahuerta, Jj, Morgan, G, Richardson, Pg, Crowley, J, Haessler, J, Feather, J, Hoering, A, Moreau, P, Leleu, X, Hulin, C, Klein, Sk, Sonneveld, P, Siegel, D, Bladé, J, Goldschmidt, H, Jagannath, S, Miguel, Js, Orlowski, R, Palumbo, Antonio, Sezer, O, Rajkumar, Sv, Durie, Bg, on behalf of the International Myeloma Working Group, International Myeloma Working Group, Abildgaard, N, Abonour, R, Alexanian, R, Alsina, M, Anderson, Kc, Attal, M, Avet Loiseau, H, Badros, A, Baris, D, Barlogie, B, Bataille, R, Beksaç, M, Belch, A, Ben Yehuda, D, Bensinger, B, Leif Bergsagel, P, Bird, J, Boccadoro, M, Cavo, M, Chanan Khan, A, Ming Chen, W, Child, T, Chim, J, Chng, Wj, Comenzo, R, Dalton, W, Davies, F, de Souza, C, Delforge, M, Dimopoulos, M, Dispenzieri, A, Drach, J, Drake, M, Einsele, H, Facon, T, Fantl, D, Fermand, Jp, Fonseca, R, Gahrton, G, García Sanz, R, Gasparetto, C, Gertz, M, Gibson, J, Giralt, S, Greipp, P, Hajek, R, Hardan, I, Hari, P, Harousseau, Jl, Hata, H, Hattori, Y, Heffner, T, Ho, J, Hungria, V, Ida, S, Jacobs, P, Johnsen, H, Jian, H, Joshua, D, Jurczyszyn, A, Kawano, M, Kröger, N, Kumar, S, Kyle, Ra, Lacy, M, Landgren, O, Laubach, J, Lentzsch, S, Lokhorst, H, Lonial, S, Ludwig, H, Maiolino, A, Mateos, M, Mehta, J, Mellqvist, Uh, Merlini, G, Mikhael, J, Morales, Ar, Nari, H, Munshi, N, Niesvizky, R, Nouel, A, Novis, Y, Palumbo, A, Pavlovsky, S, Pilarski, L, Powles, R, Raje, N, Vincent Rajkumar, S, Reece, D, Reiman, T, Roodman, D, Rosiñol, L, Shah, Jj, Shaughnessy, J, Shimizu, K, Shustik, C, Singhal, S, Spencer, A, Stadtmauer, E, Stewart, K, Terpos, E, Tosi, P, Tricot, G, Turesson, I, Van Camp, B, Van Ness, B, Van Riet, I, Broek, Iv, Vanderkerken, K, Vescio, R, Vesole, D, Waage, A, Wang, M, Weber, D, Westin, J, Wheatley, K, and Zonder, J.

Published
2011

30. P05: DARATUMUMAB PLUS LENALIDOMIDE AND DEXAMETHASONE VERSUS LENALIDOMIDE AND DEXAMETHASONE ALONE IN PATIENTS WITH PREVIOUSLY TREATED MULTIPLE MYELOMA: OVERALL SURVIVAL RESULTS FROM THE PHASE 3 POLLUX TRIAL.

Author

Dimopoulos, MA, Oriol, A, Nahi, H, San‐Miguel, J, Bahlis, NJ, Usmani, SZ, Rabin, N, Orlowski, RZ, Suzuki, K, Plesner, T, Yoon, SS, Ben Yehuda, D, Richardson, PG, Goldschmidt, H, Reece, D, Ahmadi, T, Qin, X, Garvin Mayo, W, Gai, X, and Carey, J

Published
2022
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33. Expression of EBV Encoded Nuclear Small Non-Polyadenylated RNA (EBER) Molecules in 32 Cases of Childhood Burkitt's Lymphoma from Israel.

Author

Peylan-Ramu, N., Diment, J., Krichevsky, S., Ben-Yehuda, D., Bhatia, K., and Magrath, I.T.

Subjects
EPSTEIN-Barr virus diseases, BURKITT'S lymphoma
Abstract

Analyzes the expression of Epstein-Barr virus (EBV) encoded nuclear small non-polyadenylated ribonucleic acid molecules in childhood Burkitt's lymphoma (BL) from Israel. Patient characteristics; Comparison of survival between positive and negative individuals; Association between EBV and BL.

Published
2001
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43. Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma.

Author

Dimopoulos, M. A., Oriol, A., Nahi, H., San-Miguel, J., Bahlis, N. J., Usmani, S. Z., Rabin, N., Orlowski, R. Z., Komarnicki, M., Suzuki, K., Plesner, T., Yoon, S.-S., Ben Yehuda, D., Richardson, P. G., Goldschmidt, H., Reece, D., Lisby, S., Khokhar, N. Z., O'Rourke, L., and Chiu, C.

Subjects
*ANTINEOPLASTIC agents, *DEXAMETHASONE, *TREATMENT effectiveness, *MULTIPLE myeloma treatment, *DISEASE relapse, *PROGRESSION-free survival, *THERAPEUTICS, *CLINICAL trials, *COMPARATIVE studies, *DRUG resistance in cancer cells, *RESEARCH methodology, *MEDICAL cooperation, *MONOCLONAL antibodies, *MULTIPLE myeloma, *PROGNOSIS, *RESEARCH, *THALIDOMIDE, *EVALUATION research, *RANDOMIZED controlled trials, *KAPLAN-Meier estimator
Abstract

Background: Daratumumab showed promising efficacy alone and with lenalidomide and dexamethasone in a phase 1-2 study involving patients with relapsed or refractory multiple myeloma.Methods: In this phase 3 trial, we randomly assigned 569 patients with multiple myeloma who had received one or more previous lines of therapy to receive lenalidomide and dexamethasone either alone (control group) or in combination with daratumumab (daratumumab group). The primary end point was progression-free survival.Results: At a median follow-up of 13.5 months in a protocol-specified interim analysis, 169 events of disease progression or death were observed (in 53 of 286 patients [18.5%] in the daratumumab group vs. 116 of 283 [41.0%] in the control group; hazard ratio, 0.37; 95% confidence interval [CI], 0.27 to 0.52; P<0.001 by stratified log-rank test). The Kaplan-Meier rate of progression-free survival at 12 months was 83.2% (95% CI, 78.3 to 87.2) in the daratumumab group, as compared with 60.1% (95% CI, 54.0 to 65.7) in the control group. A significantly higher rate of overall response was observed in the daratumumab group than in the control group (92.9% vs. 76.4%, P<0.001), as was a higher rate of complete response or better (43.1% vs. 19.2%, P<0.001). In the daratumumab group, 22.4% of the patients had results below the threshold for minimal residual disease (1 tumor cell per 105 white cells), as compared with 4.6% of those in the control group (P<0.001); results below the threshold for minimal residual disease were associated with improved outcomes. The most common adverse events of grade 3 or 4 during treatment were neutropenia (in 51.9% of the patients in the daratumumab group vs. 37.0% of those in the control group), thrombocytopenia (in 12.7% vs. 13.5%), and anemia (in 12.4% vs. 19.6%). Daratumumab-associated infusion-related reactions occurred in 47.7% of the patients and were mostly of grade 1 or 2.Conclusions: The addition of daratumumab to lenalidomide and dexamethasone significantly lengthened progression-free survival among patients with relapsed or refractory multiple myeloma. Daratumumab was associated with infusion-related reactions and a higher rate of neutropenia than the control therapy. (Funded by Janssen Research and Development; POLLUX ClinicalTrials.gov number, NCT02076009 .). [ABSTRACT FROM AUTHOR]

Published
2016
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44. Bortezomib or high-dose dexamethasone for relapsed multiple myeloma.

Author

Richardson PG, Sonneveld P, Schuster MW, Irwin D, Stadtmauer EA, Facon T, Harousseau J, Ben-Yehuda D, Lonial S, Goldschmidt H, Reece D, San-Miguel JF, Bladé J, Boccadoro M, Cavenagh J, Dalton WS, Boral AL, Esseltine DL, Porter JB, and Schenkein D

Published
2005

48. Autologous transplantation and maintenance therapy in multiple myeloma

Author

Antonio Palumbo, Federica Cavallo, Francesca Gay, Francesco Di Raimondo, Dina Ben Yehuda, Maria Teresa Petrucci, Sara Pezzatti, Tommaso Caravita, Chiara Cerrato, Elena Ribakovsky, Mariella Genuardi, Anna Cafro, Magda Marcatti, Lucio Catalano, Massimo Offidani, Angelo Michele Carella, Elena Zamagni, Francesca Patriarca, Pellegrino Musto, Andrea Evangelista, Giovannino Ciccone, Paola Omedé, Claudia Crippa, Paolo Corradini, Arnon Nagler, Mario Boccadoro, Michele Cavo, Palumbo, A, Cavallo, F, Gay, F, Di Raimondo, F, Ben Yehuda, D, Petrucci, Mt, Pezzatti, S, Caravita, T, Cerrato, C, Ribakovsky, E, Genuardi, M, Cafro, A, Marcatti, M, Catalano, L, Offidani, M, Carella, Am, Zamagni, E, Patriarca, F, Musto, P, Evangelista, A, Ciccone, G, Omedé, P, Crippa, C, Corradini, P, Nagler, A, Boccadoro, M, and Cavo, M.

Subjects
Adult, Melphalan, PREDNISONE, medicine.medical_specialty, Neutropenia, PLUS DEXAMETHASONE, BORTEZOMIB, Kaplan-Meier Estimate, Transplantation, Autologous, Disease-Free Survival, Maintenance Chemotherapy, Maintenance therapy, Antineoplastic Combined Chemotherapy Protocols, Humans, Medicine, Combined Modality Therapy, Autologous transplantation, Antineoplastic Agents, Alkylating, ELDERLY-PATIENTS, Multiple myeloma, Aged, Lenalidomide, LENALIDOMIDE, Autologous transplantation, multiple myeloma, business.industry, Hazard ratio, STEM-CELL TRANSPLANTATION, General Medicine, Middle Aged, RANDOMIZED CONTROLLED-TRIAL, medicine.disease, INDUCTION THERAPY, Thalidomide, Surgery, Consolidation Chemotherapy, Transplantation, INITIAL TREATMENT, MELPHALAN, Multiple Myeloma, business, Stem Cell Transplantation, medicine.drug
Abstract

BACKGROUND: This open-label, randomized, phase 3 study compared melphalan at a dose of 200 mg per square meter of body-surface area plus autologous stem-cell transplantation with melphalan-prednisone-lenalidomide (MPR) and compared lenalidomide maintenance therapy with no maintenance therapy in patients with newly diagnosed multiple myeloma. METHODS: We randomly assigned 273 patients 65 years of age or younger to high-dose melphalan plus stem-cell transplantation or MPR consolidation therapy after induction, and 251 patients to lenalidomide maintenance therapy or no maintenance therapy. The primary end point was progression-free survival. RESULTS: The median follow-up period was 51.2 months. Both progression-free and overall survival were significantly longer with high-dose melphalan plus stem-cell transplantation than with MPR (median progression-free survival, 43.0 months vs. 22.4 months; hazard ratio for progression or death, 0.44; 95% confidence interval [CI], 0.32 to 0.61; P

Published
2014

49. International Myeloma Working Group recommendations for global myeloma care

Author

Roman Hájek, R. L. Powles, Artur Jurczyszyn, V. Hungria, Heinz Ludwig, Douglas E. Joshua, W Ming Chen, J. S. Miguel, J. Hou, Suzanne Lentzsch, K. Shimizu, Antonio Palumbo, E. Terpos, A Rodriguez Morales, Elena Zamagni, R. García Sanz, Meletios A. Dimopoulos, Dina Ben-Yehuda, Brian G.M. Durie, Pia Sondergeld, K Romeril, Ludwig, H, Miguel, J, Dimopoulos, Ma, Palumbo, A, Garcia Sanz, R, Powles, R, Lentzsch, S, Ming Chen, W, Hou, J, Jurczyszyn, A, Romeril, K, Hajek, R, Terpos, E, Shimizu, K, Joshua, D, Hungria, V, Rodriguez Morales, A, Ben-Yehuda, D, Sondergeld, P, Zamagni, E, and Durie, B

Subjects
Cancer Research, Pathology, medicine.medical_specialty, business.industry, Treatment outcome, MEDLINE, Hematology, Disease, medicine.disease, Minimal residual disease, Clinical Practice, Treatment Outcome, Oncology, Recurrence, medicine, Humans, business, Intensive care medicine, Multiple Myeloma, Multiple myeloma, Monitoring, Physiologic, multiple myeloma, recommendations
Abstract

Recent developments have led to remarkable improvements in the assessment and treatment of patients with multiple myeloma (MM). New technologies have become available to precisely evaluate the biology and extent of the disease, including information about cytogenetics and genetic abnormalities, extramedullary manifestations and minimal residual disease. New, more effective drugs have been introduced into clinical practice, which enable clinicians to significantly improve the outcome of patients but also pose new challenges for the prevention and management of their specific side effects. Given these various new options and challenges, it is important to identify the minimal requirements for diagnosis and treatment of patients, as access to the most sophisticated advances may vary depending on local circumstances. Here, we propose the minimal requirements and possible options for diagnosis, monitoring and treatment of patients with multiple myeloma.

Published
2014

50. A randomized, open-label, multicentre, phase 2/3 study to evaluate the safety and efficacy of lumiliximab in combination with fludarabine, cyclophosphamide and rituximab versus fludarabine, cyclophosphamide and rituximab alone in subjects with relapsed chronic lymphocytic leukaemia

Author

Awan, Farrukh T, Hillmen, Peter, Hellmann, Andrzej, Robak, Tadeusz, Hughes, Steven G., Trone, Denise, Shannon, Megan, Flinn, Ian W., Byrd, John C., Riveros, Dardo, Pavlovsky, Santiago, Iastrebner, Claudio M., Carney, Dennis A., Deveridge, Sandra, Durrant, Simon, Hahn, Uwe H., Hertzberg, Mark, Leahy, Michael F., David, Ma, Marlton, Paula, Mulligan, Stephen, Opat, Stephen S., Tiley, Campbell, Wickham, Nicholas W., Cannell, Paul, Gatalano, John, Catalano, John, Cull, Gavin, Luen B., To, Hopfinger, Georg, Jager, Ulrich, Linkesch, Werner, Petzer, Andreas, Schwarzmeier, Josef, Steurer, Michael, Greil, Richard, Bememan, Zwi, Bosly, Andre, Bron, Dominique, Janssens, Ann, Offner, Fritz, Van Den Neste, Eric W., Ka Lung, Wu, Van Hoof, Achiel, Maiolino, Angelo, Pinczowski, Helio, Zanichelli, Maria A., Pereira, Juliana, Larratt, Loree, Spaner, David, Howson Jan, Kang, Chen, Christine I., Cantin, Guy, Fernandez, Louis A., Fraser, Graeme, Mayer, Jiri, Trneny, Marek, Jebavy, Ladislav, Bordessoule, Dominique, Lamy, Thierry, Milpied, Noel, Truchan Graczyk, Malgorzata, Eghbali, Houchingue, Karsenti, Jean Michel, Celigny, Philippe Solal, Mans, Le, Cazin, Bruno, Gyan, Emmanuel, Lepretre, Stephane, Bergmann, Lothar, Tsionos, Konstantinos, Lokeshwar, Nilesh M., Agarwal, Mohan B., Ross, Cecil R., Deshmukh, Chetan D., Narayanan, Geetha, Raina, Vinod, Bondarde, Shailesh A., Shah, Bhavin A., Bairey, Osnat, Tikva, Petach, Shvidel, Lev, Ambrosetti, Achille, Rossi, Policlinico G. B., Angelucci, Emanuele, Carella, Angelo M., Massaia, Massimo, Zinzani, Pier L., Caligaris Cappio, Federico, Foa, Roberto, Gaidano, Gianluca, della Caritá, A. O. Maggiore, Leone, Giuseppe, Santoro, Armando, Griskevicius, Laimonas, Jurgutis, Romualdas, Baker, Bartrum W., Hawkins, Timothy, Corbett, Gillian M., Ganly, Peter, D'Souza, Alvyn B., Deptala, Andrzej, Holowiecki, Jerzy, Kloczko, Janusz, Skotnicki, Aleksander, Zdziarska, Barbara, Kyrcz Krzemien, Slawomira, Dmoszynska, Anna, Moreira, Anna, Pereira, Ana P., Colita, Andrei, Moicean, Andreea D., Vasilica, Mariana, Danaila, Catalin, Gheorghita, Emanuil, Pavlov, Vyacheslav V., Rossiev, Viktor A., Konstantinova, Tatiana, Samoilova, Olga S., Novgorod, Nizhniy, Shelekhova, Tatyana, Zaritsky, Andrey Y., Abdulkadyrov, Kudrat M., Zyuzgin, Ilya S., Pristupa, Alexander S., Loscertales, Javier, Vidal, Joan Besalduch, de Mallorca, Palma, Gonzalez, Marcos, Ortuno, Francisco, Giraldo, Pilar, Nathwani, Amit, Agrawal, Samir G., Rule, Simon, Dearden, Claire E., Bloor, Adrian J., Haynes, Andrew, Singer, Charles, Boclek, Robert G., Bosserman, Linda D., Chan, David, Davidson, Sheldon J., Dichmann, Robert A., Farber, Charles, Hart, Lowell, Hermann, Robert, Eddie, Hu, Janakiraman, Nalini, Jonas, William, Liem, Kiem D., Mcintyre, Rosemary E., O'Brien, Susan, Patel, Giribala, Rado, Thomas, Schilder, Russell, Smith, Scott E., Stock, Wendy, Turturro, Francesco, Venugopal, Parameswaran, Anderson, Thomas C., Berry, William, Boyd, Thomas E., Byrd, John, Cooper, Maureen, Flinn, Ian, Gersh, Robert, Gordon, David, Guzley, Gregory J., Wilks, Sharon T., Klein, Andreas, Krauss, John C., Lister, John, Mandell, Lance, Molina, Arthur, Cooper, Barry, Pendergrass, Kelly B., Reeder, Craig, Savin, Michael A., Spitzer, Gary, Tuscano, Joseph M., Vandeventer, Hendrik, Eradat, Herbert A., Masood, Aisha, Mena, Raul, F. T. Awan, P. Hillmen, A. Hellmann, T. Robak, S. G. Hughe, D. Trone, M. Shannon, I. W. Flinn, J. C. Byrd, L. U. 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Subjects
Oncology, Male, Chronic lymphocytic leukaemia, Vascular damage Radboud Institute for Health Sciences [Radboudumc 16], Pharmacology, Antibodies, Monoclonal, Murine-Derived, Recurrence, hemic and lymphatic diseases, Monoclonal, Antineoplastic Combined Chemotherapy Protocols, 80 and over, Medicine, drug therapy, Male, Middle Aged, Recurrence, Vidarabine, Chronic, Aged, 80 and over, Leukemia, Medicine (all), Antibodies, Monoclonal, Hematology, Middle Aged, Adult, Aged, Aged, Lymphocytic, Fludarabine, Tolerability, Small lymphocytic lymphoma, administration /&/ dosage/adverse effects, Female, Humans, Leukemia, Rituximab, Female, Vidarabine, medicine.drug, Adult, Murine-Derived, medicine.medical_specialty, Cyclophosphamide, chemical and pharmacologic phenomena, CD23, Lumiliximab, Aged, Humans, Leukemia, Lymphocytic, Chronic, B-Cell, Antibodies, chronic lymphocytic leukaemia, lumiliximab, small lymphocytic lymphoma, Internal medicine, administration /&/ dosage/adverse effects/analogs /&/ derivatives, 80 and over, Antibodie, Adverse effect, Lymphocytic leukaemia, business.industry, administration /&/ dosage/adverse effects, Antibodie, B-Cell, administration /&/ dosage/adverse effects, Cyclophosphamide, Interim analysis, administration /&/ dosage/adverse effects, Antineoplastic Combined Chemotherapy Protocol, business
Abstract

Item does not contain fulltext Lumiliximab is a chimeric monoclonal antibody that targets CD23 on the surface of chronic lymphocytic leukaemia (CLL) B-cells. Early phase clinical studies with lumiliximab alone and in combination with fludarabine, cyclophosphamide and rituximab (FCR) established its potential efficacy and tolerability. The 152CL201 trial [Lumiliximab with fludarabine, cyclophosphamide and rituximab (FCR) versus FCR alone in subjects with relapsed CLL; LUCID] was a phase 2/3, randomized (1:1), open-label, multicentre study of lumiliximab in combination with FCR versus FCR alone in patients with relapsed CLL. Six hundred and twenty-seven patients were randomized to either arm. Overall the combination of lumiliximab with FCR was not significantly better than FCR alone (overall response rate 71% vs. 72%, complete response rate 16% vs. 15%, median progression-free survival 24.6 vs. 23.9 months respectively, for FCR with and without lumiliximab). There was a slightly increased incidence of adverse events with lumiliximab but these increases did not appear to lead to differences in eventual outcomes. An interim analysis failed to show sufficient efficacy of the combination of lumiliximab with FCR. The study was therefore stopped early for lack of efficacy. Despite the eventual outcome, the LUCID trial is one of the largest studies that provides valuable insight into the efficacy and tolerability of FCR as a therapeutic option for patients with relapsed CLL.

Published
2014

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