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

Author

Ludwig, H. (Heinz), Boccadoro, M. (Mario), Moreau, P., San-Miguel, J. (Jesus), Cavo, M. (Michele), Pawlyn, C. (Charlotte), Zweegman, S. (Sonja), Facon, T. (Thierry), Driessen, C. (Christoph), Hajek, R. (Roman), Dimopoulos, M.A. (Melitios A.), Gay, F. (Francesca), Avet-Loiseau, H., Terpos, E. (Evangelos), Zojer, N. (Niklas), Mohty, M. (Mohamad), Mateos, M.V., Einsele, H. (Hermann), Delforge, M. (Michel), Caers, J. (Jo), Weisel, K. (Katja), Jackson, G. (Graham), Garderet, L. (Laurent), Engelhardt, M. (Monika), Donk, N.W.C.J. (Niels) van de, Leleu, X., Goldschmidt, H. (Hartmut), Beksaç, M. (Meral), Nijhof, I. (Inger), Abildgaard, N. (Niels), Bringhen, S. (Sara), Sonneveld, P. (Pieter), Ludwig, H. (Heinz), Boccadoro, M. (Mario), Moreau, P., San-Miguel, J. (Jesus), Cavo, M. (Michele), Pawlyn, C. (Charlotte), Zweegman, S. (Sonja), Facon, T. (Thierry), Driessen, C. (Christoph), Hajek, R. (Roman), Dimopoulos, M.A. (Melitios A.), Gay, F. (Francesca), Avet-Loiseau, H., Terpos, E. (Evangelos), Zojer, N. (Niklas), Mohty, M. (Mohamad), Mateos, M.V., Einsele, H. (Hermann), Delforge, M. (Michel), Caers, J. (Jo), Weisel, K. (Katja), Jackson, G. (Graham), Garderet, L. (Laurent), Engelhardt, M. (Monika), Donk, N.W.C.J. (Niels) van de, Leleu, X., Goldschmidt, H. (Hartmut), Beksaç, M. (Meral), Nijhof, I. (Inger), Abildgaard, N. (Niels), Bringhen, S. (Sara), and Sonneveld, P. (Pieter)

Abstract

Vaccination is one of the most successful medical interventions that has saved the life of millions of peo

Published
2020
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2. Daratumumab, bortezomib, and dexamethasone in relapsed or refractory multiple myeloma: subgroup analysis of CASTOR based on cytogenetic risk

Author

Weisel, K. (Katja), Spencer, A. (Andrew), Lentzsch, S. (Suzanne), Avet-Loiseau, H., Mark, T.M. (Tomer M.), Spicka, I. (Ivan), Masszi, T. (Tamás), Lauri, B. (Birgitta), Levin, M.-D. (Mark-David), Bosi, A. (Alberto), Hungria, V., Cavo, M. (Michele), Lee, J.-J. (Je-Jung), Nooka, A.K. (Ajay), Quach, H. (Hang), Munder, M. (Markus), Lee, C. (Cindy), Barreto, W. (Wolney), Corradini, P. (P.), Min, C.-K. (Chang-Ki), Chanan-Khan, A. (Asher Alban), Horvath, N. (Noemi), Capra, M. (Marcelo), Beksaç, M. (Meral), Ovilla, R. (Roberto), Jo, J.-C. (Jae-Cheol), Shin, H.-J. (Ho-Jin), Sonneveld, P. (Pieter), Casneuf, T. (Tineke), DeAngelis, N. (Nikki), Amin, H. (Himal), Ukropec, J. (Jon), Kobos, R. (Rachel), Mateos, M.V., Weisel, K. (Katja), Spencer, A. (Andrew), Lentzsch, S. (Suzanne), Avet-Loiseau, H., Mark, T.M. (Tomer M.), Spicka, I. (Ivan), Masszi, T. (Tamás), Lauri, B. (Birgitta), Levin, M.-D. (Mark-David), Bosi, A. (Alberto), Hungria, V., Cavo, M. (Michele), Lee, J.-J. (Je-Jung), Nooka, A.K. (Ajay), Quach, H. (Hang), Munder, M. (Markus), Lee, C. (Cindy), Barreto, W. (Wolney), Corradini, P. (P.), Min, C.-K. (Chang-Ki), Chanan-Khan, A. (Asher Alban), Horvath, N. (Noemi), Capra, M. (Marcelo), Beksaç, M. (Meral), Ovilla, R. (Roberto), Jo, J.-C. (Jae-Cheol), Shin, H.-J. (Ho-Jin), Sonneveld, P. (Pieter), Casneuf, T. (Tineke), DeAngelis, N. (Nikki), Amin, H. (Himal), Ukropec, J. (Jon), Kobos, R. (Rachel), and Mateos, M.V.

Abstract

BACKGROUND: Multiple myeloma (MM) patients with high cytogenetic risk have poor outcomes. In CASTOR, daratumumab plus bortezomib/dexamethasone (D-Vd) prolonged progression-free survival (PFS) versus bortezomib/dexamethasone (Vd) alone and exhibited tolerability in patients with relapsed or refractory MM (RRMM). METHODS: This subgroup analysis evaluated D-Vd versus Vd in CASTOR based on cytogenetic risk, determined using fluorescence in situ hybridization and/or karyotype testing performed locally. High-risk patients had t(4;14), t(14;16), and/or del17p abnormalities. Minimal residual disease (MRD; 10-5 sensitivity threshold) was assessed via the clonoSEQ® assay V2.0. Of the 498 patients randomized, 40 (16%) in the D-Vd group and 35 (14%) in the Vd group were categorized as high risk. RESULTS: After a median follow-up of 40.0 months, D-Vd prolonged median PFS versus Vd in patients with standard (16.6 vs 6.6 months; HR, 0.26; 95% CI, 0.19-0.37; P < 0.0001) and high (12.6 vs 6.2 months; HR, 0.41; 95% CI, 0.21-0.83; P = 0.0106) cytogenetic risk. D-Vd achieved deep responses, including higher rates of MRD negativity and sustained MRD negativity versus Vd, regardless of cytogenetic risk. The safety profile was consistent with the overall population of CASTOR. CONCLUSION: These updated data reinforce the effectiveness and tolerability of daratumumab-based regimens for RRMM, regardless of cytogenetic risk status. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02136134 . Registered 12 May 2014.

Published
2020
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3. Insights on Multiple Myeloma Treatment Strategies

Author

Mateos, M.V., Ludwig, H. (Heinz), Bazarbachi, A. (Ali), Beksaç, M. (Meral), Blade, J., Boccadoro, M. (Mario), Cavo, M. (Michele), Delforge, M. (Michel), Dimopoulos, M.A. (Meletios), Facon, T. (Thierry), Geraldes, C. (Catarina), Goldschmidt, H. (Hartmut), Hájek, R. (Roman), Hansson, M. (Markus), Jamroziak, K. (Krzysztof), Leiba, M. (Merav), Masszi, T. (Tamás), Mendeleeva, L. (Larisa), O'Dwyer, M. (Michael), Plesner, T. (Torben), San-Miguel, J.F. (Jesús F.), Straka, C. (Christian), Donk, N.W.C.J. (Niels) van de, Yong, K. (Kwee), Zver, S. (Samo), Moreau, P., Sonneveld, P. (Pieter), Mateos, M.V., Ludwig, H. (Heinz), Bazarbachi, A. (Ali), Beksaç, M. (Meral), Blade, J., Boccadoro, M. (Mario), Cavo, M. (Michele), Delforge, M. (Michel), Dimopoulos, M.A. (Meletios), Facon, T. (Thierry), Geraldes, C. (Catarina), Goldschmidt, H. (Hartmut), Hájek, R. (Roman), Hansson, M. (Markus), Jamroziak, K. (Krzysztof), Leiba, M. (Merav), Masszi, T. (Tamás), Mendeleeva, L. (Larisa), O'Dwyer, M. (Michael), Plesner, T. (Torben), San-Miguel, J.F. (Jesús F.), Straka, C. (Christian), Donk, N.W.C.J. (Niels) van de, Yong, K. (Kwee), Zver, S. (Samo), Moreau, P., and Sonneveld, P. (Pieter)

Abstract

The introduction of new agents and management strategies over the past decade has resulted in a major step change in treatment outcomes with deepening responses and increased survival for patients with multiple myeloma. In daily clinical practice, healthcare professionals are now faced with challenges including, optimal treatment sequencing and changing treatment goals. In light of this, a group of experts met to discuss diagnostic and treatment guidelines, examine current clinical practice, and consider how new clinical trial data may be integrated into the management of multiple myeloma in the future.

Published
2019
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4. Prevention and management of adverse events of novel agents in multiple myeloma: A consensus of the European Myeloma Network

Author

Ludwig, H. (Heinz), Delforge, M. (Michel), Facon, T. (Thierry), Einsele, H. (Hermann), Gay, F. (Francesca), Moreau, P., Avet-Loiseau, H. (Hervé), Boccadoro, M. (Mario), Hàjek, R. (Roman), Mohty, M. (Mohamad), Cavo, M. (Michele), Dimopoulos, M.A. (Meletios), San-Miguel, J.F. (Jesús F.), Terpos, E. (Evangelos), Zweegman, S. (Sonja), Garderet, L. (Laurent), Mateos, M.V., Cook, G. (Gordon), Leleu, X., Goldschmidt, H. (Hartmut), Jackson, G. (Graham), Kaiser, M.F. (Martin F.), Weisel, K. (Katja), Donk, N.W.C.J. (Niels) van de, Waage, A. (Anders), Beksaç, M. (Meral), Mellqvist, U.H. (U. H.), Engelhardt, M. (Monika), Caers, J. (Jo), Driessen, C. (Christoph), Blade, J., Sonneveld, P. (Pieter), Ludwig, H. (Heinz), Delforge, M. (Michel), Facon, T. (Thierry), Einsele, H. (Hermann), Gay, F. (Francesca), Moreau, P., Avet-Loiseau, H. (Hervé), Boccadoro, M. (Mario), Hàjek, R. (Roman), Mohty, M. (Mohamad), Cavo, M. (Michele), Dimopoulos, M.A. (Meletios), San-Miguel, J.F. (Jesús F.), Terpos, E. (Evangelos), Zweegman, S. (Sonja), Garderet, L. (Laurent), Mateos, M.V., Cook, G. (Gordon), Leleu, X., Goldschmidt, H. (Hartmut), Jackson, G. (Graham), Kaiser, M.F. (Martin F.), Weisel, K. (Katja), Donk, N.W.C.J. (Niels) van de, Waage, A. (Anders), Beksaç, M. (Meral), Mellqvist, U.H. (U. H.), Engelhardt, M. (Monika), Caers, J. (Jo), Driessen, C. (Christoph), Blade, J., and Sonneveld, P. (Pieter)

Abstract

During the last few years, several new drugs have been introduced for treatment of patients with multiple myeloma, which have significantly improved the treatment outcome. All of these novel substances differ at least in part in their mode of action from similar drugs of the same drug class, or are representatives of new drug classes, and as such present with very specific side effect profiles. In this review, we summarize these adverse events, provide information on their prevention, and give practical guidance for monitoring of patients and for management of adverse events.

Published
2018
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5. Phase 3 randomised study of daratumumab, bortezomib and dexamethasone (DVd) vs bortezomib and dexamethasone (Vd) in patients (pts) with relapsed or refractory multiple myeloma (RRMM): CASTOR

Author

Weisel, K. (Katja), Palumbo, A. (Antonio), Chanan-Khan, A. (Asher Alban), Nooka, A.K. (Ajay), Spicka, I. (Ivan), Masszi, T. (Tamás), Beksaç, M. (Meral), Hungria, V., Munder, M. (Markus), Mateos, M.V., Mark, T.M. (Tomer M.), Spencer, A. (Andrew), Qi, M. (Ming), Schecter, J. (Jordan), Amin, H. (Himal), Qin, X. (X.), Deraedt, W. (William), Ahmadi, T. (Tahamtan), Sonneveld, P. (Pieter), Weisel, K. (Katja), Palumbo, A. (Antonio), Chanan-Khan, A. (Asher Alban), Nooka, A.K. (Ajay), Spicka, I. (Ivan), Masszi, T. (Tamás), Beksaç, M. (Meral), Hungria, V., Munder, M. (Markus), Mateos, M.V., Mark, T.M. (Tomer M.), Spencer, A. (Andrew), Qi, M. (Ming), Schecter, J. (Jordan), Amin, H. (Himal), Qin, X. (X.), Deraedt, W. (William), Ahmadi, T. (Tahamtan), and Sonneveld, P. (Pieter)

Published
2016
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6. European myeloma network guidelines for the management of multiple myeloma-related complications

Author

Terpos, E. (Evangelos), Kleber, M. (Martina), Engelhardt, M. (Monika), Zweegman, S. (Sonja), Gay, F. (Francesca), Kastritis, E. (Efstathios), Donk, N.W.C.J. (Niels) van de, Bruno, B. (Benedetto), Sezer, O., Broij, A. (Annemiek), Bringhen, S. (Sara), Beksaç, M. (Meral), Larocca, A. (Alessandra), Hàjek, R. (Roman), Musto, P. (Pellegrino), Johnsen, H.E. (Hans), Morabito, F. (Fortunato), Ludwig, H. (Heinz), Cavo, M. (Michele), Einsele, H. (Hermann), Sonneveld, P. (Pieter), Dimopoulos, M.A. (Meletios), Palumbo, A. (Antonio), Terpos, E. (Evangelos), Kleber, M. (Martina), Engelhardt, M. (Monika), Zweegman, S. (Sonja), Gay, F. (Francesca), Kastritis, E. (Efstathios), Donk, N.W.C.J. (Niels) van de, Bruno, B. (Benedetto), Sezer, O., Broij, A. (Annemiek), Bringhen, S. (Sara), Beksaç, M. (Meral), Larocca, A. (Alessandra), Hàjek, R. (Roman), Musto, P. (Pellegrino), Johnsen, H.E. (Hans), Morabito, F. (Fortunato), Ludwig, H. (Heinz), Cavo, M. (Michele), Einsele, H. (Hermann), Sonneveld, P. (Pieter), Dimopoulos, M.A. (Meletios), and Palumbo, A. (Antonio)

Abstract

The European Myeloma Network provides recommendations for the management of the most common complications of multiple myeloma. Whole body low-dose computed tomography is more sensitive than conventional radiography in depicting osteolytic disease and thus we recommend it as the novel standard for the detection of lytic lesions in myeloma (grade 1A). Myeloma patients with adequate renal function and bone disease at diagnosis should be treated with zoledronic acid or pamidronate (grade 1A). Symptomatic patients without lytic lesions on conventional radiography can be treated with zoledronic acid (grade 1B), but its advantage is not clear for patients with no bone involvement on computed tomography or magnetic resonance imaging. In asymptomatic myeloma, bisphosphonates are not recommended (grade 1A). Zoledronic acid should be given continuously, but it is not clear if patients who achieve at least a very good partial response benefit from its continuous use (grade 1B). Treatment with erythropoietic-stimulating agents may be initiated in patients with persistent symptomatic anemia (hemoglobin <10g/dL) in whom other causes of anemia have been e

Published
2015
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7. Phase 2 study of dovitinib in patients with relapsed or refractory multiple myeloma with or without t(4;14) translocation

Author

Scheid, C. (Christof), Reece, D. (Donna), Beksaç, M. (Meral), Spencer, A. (Andrew), Callander, N. (Natalie), Sonneveld, P. (Pieter), Kalimi, G. (Ghulam), Cai, C. (Can), Shi, M. (Michael), Scott, J.W. (Jeffrey W.), Stewart, A.K. (Keith), Scheid, C. (Christof), Reece, D. (Donna), Beksaç, M. (Meral), Spencer, A. (Andrew), Callander, N. (Natalie), Sonneveld, P. (Pieter), Kalimi, G. (Ghulam), Cai, C. (Can), Shi, M. (Michael), Scott, J.W. (Jeffrey W.), and Stewart, A.K. (Keith)

Abstract

Objectives: Approximately 15% of patients with multiple myeloma (MM) exhibit a t(4;14) translocation, which often results in constitutive activation of the receptor tyrosine kinase (RTK) fibroblast growth factor receptor 3 (FGFR3). This study evaluated the efficacy and safety of dovitinib, an RTK inhibitor with in vitro inhibitory activity against FGFR, in patients with re

Published
2015
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8. Retrospective matched-pairs analysis of bortezomib plus dexamethasone versus bortezomib monotherapy in relapsed multiple myeloma

Author

Dimopoulos, M.A. (Meletios), Orlowski, R.Z. (Robert), Facon, T. (Thierry), Sonneveld, P. (Pieter), Anderson, K.C. (Kenneth), Beksaç, M. (Meral), Benboubker, L. (Lotfi), Roddie, H. (Huw), Potamianou, A. (Anna), Couturier, C. (Catherine), Ataman, O. (Ozlem), Velde, H. (Helgi) van de, Richardson, P.G. (Paul Gerard), Dimopoulos, M.A. (Meletios), Orlowski, R.Z. (Robert), Facon, T. (Thierry), Sonneveld, P. (Pieter), Anderson, K.C. (Kenneth), Beksaç, M. (Meral), Benboubker, L. (Lotfi), Roddie, H. (Huw), Potamianou, A. (Anna), Couturier, C. (Catherine), Ataman, O. (Ozlem), Velde, H. (Helgi) van de, and Richardson, P.G. (Paul Gerard)

Abstract

Bortezomib-dexamethasone is widely used for relapsed myeloma in routine clinical practice, but comparative data versus single-agent bortezomib are lacking. This retrospective analysis compared second-line treatment with bortezomib- dexamethasone and bortezomib using 109 propensity score-matched pairs of patients treated in three clinical trials: MMY-2045, APEX, and DOXIL-MMY-3001. Propensity scores were estimated using logistic regression analyses incorporating 13 clinical variables related to drug exposure or clinical outcome. Patients received intravenous bortezomib 1.3 mg/m2 on days 1, 4, 8, and 11, in 21-day cycles, alone or with oral dexamethasone 20 mg on the days of/after bortezomib dosing. Median bortezomib cumulative dose (27.02 and 28.60 mg/m2) and treatment duration (19.6 and 17.6 weeks) were similar with bortezomib-dexamethasone and bortezomib, respectively. The overall response rate was higher (75% vs. 41%; odds ratio=3.467; P<0.001), and median time-to-progression (13.6 vs. 7.0 months; hazard ratio [HR]=0.394; P=0.003) and progression-free survival (11.9 vs. 6.4 months; HR=0.595; P=0.051) were longer with bortezomib-dexamethasone versus bortezomib, respectively. Rates of anygrade adverse events, most common grade 3 or higher adverse events, and discontinuations due to adverse events appeared similar between the groups. Two patients per group died of treatment-related adverse events. These data indicate the potential benefit of bortezomib-dexamethasone compared with single-agent bortezomib at first relapse in myeloma. The MMY-2045, APEX, and DOXIL-MMY-3001 clinical trials were registered at, respectively, clinicaltrials.gov identifier: 00908232, 00048230, and 00103506.

Published
2014
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9. European myeloma network recommendations on the evaluation and treatment of newly diagnosed patients with multiple myeloma

Author

Engelhardt, M. (Monika), Terpos, E. (Evangelos), Kleber, M. (Martina), Gay, F. (Francesca), Wäsch, R. (Ralph), Morgan, G. (Gareth), Cavo, M. (Michele), Donk, N.W.C.J. (Niels) van de, Beilhack, A. (Andreas), Bruno, B. (Benedetto), Johnsen, H.E. (Hans), Hajek, R. (Roman), Driessen, C. (Christoph), Ludwig, H. (Heinz), Beksaç, M. (Meral), Boccadoro, M. (Mario), Straka, C. (Christian), Brighen, S. (Sara), Gramatzki, M. (Martin), Larocca, A. (Alessandra), Lokhorst, H.M. (Henk), Magarotto, V. (Valeria), Morabito, F. (Fortunato), Dimopoulos, M.A. (Meletios), Einsele, H. (Hermann), Sonneveld, P. (Pieter), Palumbo, A. (Antonio), Engelhardt, M. (Monika), Terpos, E. (Evangelos), Kleber, M. (Martina), Gay, F. (Francesca), Wäsch, R. (Ralph), Morgan, G. (Gareth), Cavo, M. (Michele), Donk, N.W.C.J. (Niels) van de, Beilhack, A. (Andreas), Bruno, B. (Benedetto), Johnsen, H.E. (Hans), Hajek, R. (Roman), Driessen, C. (Christoph), Ludwig, H. (Heinz), Beksaç, M. (Meral), Boccadoro, M. (Mario), Straka, C. (Christian), Brighen, S. (Sara), Gramatzki, M. (Martin), Larocca, A. (Alessandra), Lokhorst, H.M. (Henk), Magarotto, V. (Valeria), Morabito, F. (Fortunato), Dimopoulos, M.A. (Meletios), Einsele, H. (Hermann), Sonneveld, P. (Pieter), and Palumbo, A. (Antonio)

Abstract

Multiple myeloma management has undergone profound changes in the past thanks to advances in our understanding of the disease biology and improvements in treatment and supportive care approaches. This article presents recommendations of the European Myeloma Network for newly diagnosed patients based on the GRADE system for level of evidence. All patients with symptomatic disease should undergo risk stratification to classify patients for International Staging System stage (level of evidence: 1A) and for cytogenetically defined high- versus standard-risk groups (2B). Novel-agent-based induction and up-front autologous stem cell transplantation in medically fit patients remains the standard of care (1A). Induction therapy should include a triple combination of bortezomib, with either adriamycin or thalidomide and dexamethasone (1A), or with cyclophosphamide and dexamethasone (2B). Currently, allogeneic stem cell transplantation may be considered for young patients with high-risk disease and preferably in the context of a clinical trial (2B). Thalidomide (1B) or lenalidomide (1A) maintenance increases progression-free survival and possibly overall survival (2B). Bortezomib-based regimens are a valuable consolidation option, especially for patients who failed excellent response after autologous stem cell transplantation (2A). Bortezomib-melphalan-prednisone or melphalan-prednisone-thalidomide are the standards of care for transplant-ineligible patients (1A). Melphalan-prednisone-lenalidomide with lenalidomide maintenance increases progression-free survival, but overall survival data are needed. New data from the phase III study (MM-020/IFM 07-01) of lenalidomide-low-dose dexamethasone reached its primary end point of a statistically significant improvement in progression-free survival as compared to melphalan-prednisone-thalidomide and provides further evidence for the efficacy of lenalidomide-low-dose dexamethasone in transplant-ineligible patients (2B).

Published
2014
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10. Safety of thalidomide in newly diagnosed elderly myeloma patients: A meta-analysis of data from individual patients in six randomized trials

Author

Palumbo, A. (Antonio), Waage, A. (Anders), Hulin, C., Beksaç, M. (Meral), Zweegman, S. (Sonja), Gay, F. (Francesca), Gimsing, P. (Peter), Leleu, X., Wijermans, P.W. (Pierre), Sucak, G. (Gülsan), Pezzatti, S. (Sara), Juliusson, G. (Gunnar), Pégourié, B. (Brigitte), Schaafsma, M.R. (Martijn), Galli, M. (Matilde), Turesson, I., Kolb, B. (Brigitte), Holt, B. (Bronno) van der, Baldi, I. (Ileana), Rolke, J. (Jürgen), Ciccone, G. (Giovannino), Wetterwald, M. (Marc), Lokhorst, H.M. (Henk), Boccadoro, M. (Mario), Rodon, J. (Jordi), Sonneveld, P. (Pieter), Palumbo, A. (Antonio), Waage, A. (Anders), Hulin, C., Beksaç, M. (Meral), Zweegman, S. (Sonja), Gay, F. (Francesca), Gimsing, P. (Peter), Leleu, X., Wijermans, P.W. (Pierre), Sucak, G. (Gülsan), Pezzatti, S. (Sara), Juliusson, G. (Gunnar), Pégourié, B. (Brigitte), Schaafsma, M.R. (Martijn), Galli, M. (Matilde), Turesson, I., Kolb, B. (Brigitte), Holt, B. (Bronno) van der, Baldi, I. (Ileana), Rolke, J. (Jürgen), Ciccone, G. (Giovannino), Wetterwald, M. (Marc), Lokhorst, H.M. (Henk), Boccadoro, M. (Mario), Rodon, J. (Jordi), and Sonneveld, P. (Pieter)

Abstract

Treatment with melphalan-prednisone-thalidomide improves the outcome of patients with multiple myeloma and is now considered a standard of care for patients not eligible for transplantation. However, this treatment is a major source of morbidity. A meta-analysis of data from individual patients (n=1680) in six randomized trials was performed, comparing the effects of melphalan-prednisone-thalidomide versus melphalan-prednisone. The main objective was to estimate the risk of serious adverse events and their impact on outcome. The primary endpoints were the 2-year cumulative incidence of grade 3-4 hematologic and non-hematologic toxicities. At least 75% of the grade 3-4 toxicities occurred during the first 6 months of treatment in both treatment groups. The cumulative incidence of grade 3-4 hematologic toxicities was higher in the melphalan-prednisone-thalidomide group than in the melphalan-prednisone group (28% versus 22%; HR 1.32, 95% CI 1.05-1.66) as was the cumulative incidence of non-hematologic toxicities (39% versus 17%, HR 2.78, 95% CI 2.21-3.50). Grade 3-4 non-hematologic toxicities were significantly increased in patients with poor Performance Status. Occurrence of grade 3-4 non-hematologic toxicities had a negative impact on both progression-free survival (HR 1.24, 95% CI 1.07-1.45) and overall survival, (HR 1.23, 95% CI 1.03-1.47). Besides toxicities, progression-free and overall survival were also negatively affected by advanced International Staging System stage, high creatinine levels and poor Performance Status. Age had a negative impact on survival as well. Although melphalan-prednisone-thalidomide improved outcome, it increased toxicities, especially non-hematologic ones. Serious non-hematologic toxicities, older age, poor Performance Status, and high creatinine levels negatively affected survival.

Published
2013
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11. IMWG consensus on maintenance therapy in multiple myeloma

Author

Ludwig, H. (Heinz), Durie, B.G.M. (Brian), McCarthy, P. (Philip), Palumbo, A. (Antonio), San Miguel, J.F. (Jesús Fernando), Barlogie, B. (Bart), Morgan, G. (Gareth), Sonneveld, P. (Pieter), Spencer, A. (Andrew), Andersen, K.C. (Kenneth), Facon, T. (Thierry), Stewart, A.K. (Keith), Einsele, H. (Hermann), Mateos, M.V., Wijermans, P.W. (Pierre), Waage, A. (Anders), Beksaç, M. (Meral), Richardson, P.G. (Paul Gerard), Hulin, C., Niesvizky, R., Lokhorst, H.M. (Henk), Landgren, O., Bergsagel, P.L. (Leif), Orlowski, R.Z. (Robert), Hinke, A. (Axel), Cavo, M. (Michele), Attal, M. (Michel), Ludwig, H. (Heinz), Durie, B.G.M. (Brian), McCarthy, P. (Philip), Palumbo, A. (Antonio), San Miguel, J.F. (Jesús Fernando), Barlogie, B. (Bart), Morgan, G. (Gareth), Sonneveld, P. (Pieter), Spencer, A. (Andrew), Andersen, K.C. (Kenneth), Facon, T. (Thierry), Stewart, A.K. (Keith), Einsele, H. (Hermann), Mateos, M.V., Wijermans, P.W. (Pierre), Waage, A. (Anders), Beksaç, M. (Meral), Richardson, P.G. (Paul Gerard), Hulin, C., Niesvizky, R., Lokhorst, H.M. (Henk), Landgren, O., Bergsagel, P.L. (Leif), Orlowski, R.Z. (Robert), Hinke, A. (Axel), Cavo, M. (Michele), and Attal, M. (Michel)

Published
2012
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12. Myeloma in patients younger than age 50 years presents with more favorable features and shows better survival: An analysis of 10 549 patients from the International Myeloma Working Group

Author

Ludwig, H. (Heinz), Durie, B.G.M. (Brian), Bolejack, V. (Vanessa), Turesson, I., Kyle, R. (Robert), Bladé, J. (Joan), Fonseca, R. (Rafael), Dimopoulos, M.A. (Meletios), Shimizu, K., San Miguel, J.F. (Jesús Fernando), Westin, J. (Johan), Harousseau, J-L. (Jean-Luc), Beksaç, M. (Meral), Boccadoro, M. (Mario), Palumbo, A. (Antonio), Barlogie, B. (Bart), Shustik, C. (Chaim), Cavo, M. (Michele), Greipp, P. (Philip), Joshua, D., Attal, M. (Michel), Sonneveld, P. (Pieter), Crowley, J. (John), Ludwig, H. (Heinz), Durie, B.G.M. (Brian), Bolejack, V. (Vanessa), Turesson, I., Kyle, R. (Robert), Bladé, J. (Joan), Fonseca, R. (Rafael), Dimopoulos, M.A. (Meletios), Shimizu, K., San Miguel, J.F. (Jesús Fernando), Westin, J. (Johan), Harousseau, J-L. (Jean-Luc), Beksaç, M. (Meral), Boccadoro, M. (Mario), Palumbo, A. (Antonio), Barlogie, B. (Bart), Shustik, C. (Chaim), Cavo, M. (Michele), Greipp, P. (Philip), Joshua, D., Attal, M. (Michel), Sonneveld, P. (Pieter), and Crowley, J. (John)

Abstract

We analyzed the presenting features and survival in 1689 patients with multiple myeloma aged younger than 50 years compared with 8860 patients 50 years of age and older. Of the total 10 549 patients, 7765 received conventional therapy and 2784 received high-dose therapy. Young patients were more frequently male, had more favorable features such as low International Staging System (ISS) and Durie-Salmon stage as well as less frequently adverse prognostic factors including high C-reactive protein (CRP), low hemoglobin, increased serum creatinine, and poor performance status. Survival was significantly longer in young patients (median, 5.2 years vs 3.7 years; P< .001) both after conventional (median, 4.5 years vs 3.3 years; P < .001) or high-dose therapy (median, 7.5 years vs 5.7 years; P = .04). The 10-year survival rate was 19% after conventional therapy and 43% after high-dose therapy in young patients, and 8% and 29%, respectively, in older patients. Multivariate analysis revealed age as an independent risk factor during conventional therapy, but not after autologous transplantation. A total of 5 of the 10 independent risk factors identified for conventional therapy were also relevant for autologous transplantation. After adjusting for normal mortality, lower ISS stage and other favorable prognostic features seem to account for the significantly longer survival of young patients with multiple myeloma with age remaining a risk factor during conventional therapy.

Published
2008
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13. Report of the European Myeloma Network on multiparametric flow cytometry in multiple myeloma and related disorders

Author

Rawstron, A.C., Orfao, A. (Alberto), Beksaç, M. (Meral), Bezdickova, L. (Ludmila), Brooimans, R.A. (Rik), Bumbea, H. (Horia), Dalva, K. (Klara), Fuhler, G.M. (Gwenny), Gratama, J.W. (Jan-Willem), Hose, D. (Dirk), Kovarova, L. (Lucie), Lioznov, M. (Michael), Mateo, G. (Gema), Morilla, R. (Ricardo), Mylin, A.K. (Anne), Omedé, P. (Paola), Pellat-Deceunynck, C. (Catherine), Andres, M.P., Petrucci, M. (Maria), Ruggeri, M. (Marina), Rymkiewicz, G. (Grzegorz), Schmitz, A., Schreder, M. (Martin), Seynaeve, C.M. (Caroline), Spacek, M. (Martin), Tute, R.M. (Ruth) de, Valckenborgh, E. (Els) van, Weston-Bell, N. (Nicky), Owen, R.G. (Roger), San Miguel, J.F. (Jesús Fernando), Sonneveld, P. (Pieter), Johnsen, H.E. (Hans), Rawstron, A.C., Orfao, A. (Alberto), Beksaç, M. (Meral), Bezdickova, L. (Ludmila), Brooimans, R.A. (Rik), Bumbea, H. (Horia), Dalva, K. (Klara), Fuhler, G.M. (Gwenny), Gratama, J.W. (Jan-Willem), Hose, D. (Dirk), Kovarova, L. (Lucie), Lioznov, M. (Michael), Mateo, G. (Gema), Morilla, R. (Ricardo), Mylin, A.K. (Anne), Omedé, P. (Paola), Pellat-Deceunynck, C. (Catherine), Andres, M.P., Petrucci, M. (Maria), Ruggeri, M. (Marina), Rymkiewicz, G. (Grzegorz), Schmitz, A., Schreder, M. (Martin), Seynaeve, C.M. (Caroline), Spacek, M. (Martin), Tute, R.M. (Ruth) de, Valckenborgh, E. (Els) van, Weston-Bell, N. (Nicky), Owen, R.G. (Roger), San Miguel, J.F. (Jesús Fernando), Sonneveld, P. (Pieter), and Johnsen, H.E. (Hans)

Abstract

The European Myeloma Network (EMN) organized two flow cytometry workshops. The first aimed to identify specific indications for flow cytometry in patients with monoclonal gammopathies, and consensus technical approaches through a questionnaire-based review of current practice in participating laboratories. The second aimed to resolve outstanding technical issues and develop a consensus approach to analysis of plasma cells. The primary clinical applications identified were: differential diagnosis of neoplastic plasma cell disorders from reactive plasmacytosis; identifying risk of progression in patients with MGUS and detecting minimal residual disease. A range of technical recommendations were identified, including: 1) CD38, CD138 and CD45 should all be included in at least one tube for plasma cell identification and enumeration. The primary gate should be based on CD38 vs. CD138 expression; 2) after treatment, clonality assessment is only likely to be informative when combined with immunophenotype to detect abnormal cells. Flow cytometry is suitable for demonstrating a stringent complete remission; 3) for detection of abnormal plasma cells, a minimal panel should include CD19 and CD56. A preferred panel would also include CD20, CD117, CD28 and CD27; 4) discrepancies between the percentage of plasma cells detected by flow cytometry and morphology are primarily r

Published
2008
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