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RANDOMIZED CONTROLLED TRIAL
Hervé Avet-Loiseau, Rafael Fonseca, David Siegel, Meletios A Dimopoulos, Ivan Špička, Tamás Masszi, Roman Hájek, Laura Rosiñol, Vesselina Goranova-Marinova, Georgi Mihaylov, Vladimír Maisnar, Maria-Victoria Mateos, Michael Wang, Ruben Niesvizky, Albert Oriol, Andrzej Jakubowiak, Jiri Minarik, Antonio Palumbo, William Bensinger, Vishal Kukreti, Dina Ben-Yehuda, A Keith Stewart, Mihaela Obreja, Philippe Moreau
The presence of certain high-risk cytogenetic abnormalities, such as translocations (4;14) and (14;16) and deletion (17p), are known to have a negative impact on survival in multiple myeloma (MM). The phase 3 study ASPIRE (N = 792) demonstrated that progression-free survival (PFS) was significantly improved with carfilzomib, lenalidomide, and dexamethasone (KRd), compared with lenalidomide and dexamethasone (Rd) in relapsed MM. This preplanned subgroup analysis of ASPIRE was conducted to evaluate KRd vs Rd by baseline cytogenetics according to fluorescence in situ hybridization...
September 1, 2016: Blood
#2
REVIEW
Charles A Clark, Robert F Cornell, Emma C Scott, Jae Chung, Luciano J Costa
Although upfront treatment of multiple myeloma has become more effective, relapses are the norm, often driven by the emergence of a genetically divergent clone selected by the initial therapy. Recent trials have demonstrated the safety and efficacy of combination therapy also in the relapsed and refractory setting and supported the regulatory approval of several new agents including new proteasome inhibitors, immunomodulatory agents, and monoclonal antibodies. We provide a detailed summary of recent practice-changing trials in relapsed and refractory MM and share a practical approach to assimilate disease and patient-features into treatment decision...
October 2016: American Journal of Hematology
#3
JOURNAL ARTICLE
Sameh Gaballa, Rima M Saliba, Samer Srour, Gary Lu, Jonathan E Brammer, Nina Shah, Qaiser Bashir, Krina Patel, Fabian Bock, Simrit Parmar, Chitra Hosing, Uday Popat, Ruby Delgado, Gabriela Rondon, Jatin J Shah, Elisabet E Manasanch, Robert Z Orlowski, Richard Champlin, Muzaffar H Qazilbash
TP53 gene deletion is associated with poor outcomes in multiple myeloma (MM). We report the outcomes of patients with MM with and without TP53 deletion who underwent immunomodulatory drug (IMiD) and/or proteasome inhibitor (PI) induction followed by autologous hematopoietic stem cell transplant (auto-HCT). We identified 34 patients with MM and TP53 deletion who underwent IMiD and/or PI induction followed by auto-HCT at our institution during 2008-2014. We compared their outcomes with those of control patients (n = 111) with MM without TP53 deletion...
October 2016: American Journal of Hematology
#4
JOURNAL ARTICLE
Victor H Jimenez-Zepeda, Peter Duggan, Paola Neri, Fariborz Rashid-Kolvear, Jason Tay, Nizar J Bahlis
BACKGROUND: A variety of validated prognostic markers for multiple myeloma has been described to help inform clinical practice. Recently, a robust system has been introduced for clinical use and is being adopted by the International Myeloma Working Group Revised International Staging System (RISS). The RISS was developed using data from patients enrolled in clinical trials. Consequently, its utility is less clear in unselected patients with myeloma. MATERIALS AND METHODS: All consecutive patients newly diagnosed with multiple myeloma treated and followed up at Tom Baker Cancer Center from January 2004 to October 2015 were included in the present study...
September 2016: Clinical Lymphoma, Myeloma & Leukemia
#5
MULTICENTER STUDY
Saad Z Usmani, Brendan M Weiss, Torben Plesner, Nizar J Bahlis, Andrew Belch, Sagar Lonial, Henk M Lokhorst, Peter M Voorhees, Paul G Richardson, Ajai Chari, A Kate Sasser, Amy Axel, Huaibao Feng, Clarissa M Uhlar, Jianping Wang, Imran Khan, Tahamtan Ahmadi, Hareth Nahi
The efficacy and favorable safety profile of daratumumab monotherapy in multiple myeloma (MM) was previously reported. Here, we present an updated pooled analysis of 148 patients treated with daratumumab 16 mg/kg. Data were combined from part 2 of a first-in-human phase 1/2 study of patients who relapsed after or were refractory to ≥2 prior therapies and a phase 2 study of patients previously treated with ≥3 prior lines of therapy (including a proteasome inhibitor [PI] and an immunomodulatory drug [IMiD]) or were double refractory...
July 7, 2016: Blood
#6
REVIEW
S Vincent Rajkumar, Shaji Kumar
The diagnosis and treatment of multiple myeloma has changed dramatically in the past decade. The disease definition has been updated to include highly specific biomarkers in addition to established markers of end-organ damage. The staging system has been revised to combine both measures of tumor burden and disease biology. Advances in therapy have resulted in a marked improvement in overall survival. New drugs introduced in the past few years include carfilzomib, pomalidomide, panobinostat, ixazomib, elotuzumab, and daratumumab...
January 2016: Mayo Clinic Proceedings
#7
REVIEW
A Spanou, G P Lyritis, E Chronopoulos, S Tournis
Osteonecrosis of the jaw (ONJ) is a serious side effect of bisphosphonate use in patients with osteoporosis, Paget's disease, hypercalcemia of malignancy, metastatic bone disease and multiple myeloma, although recently this complication has also been reported in patients under non-bisphosphonate medication, such as denosumab and bevacizumab. The occurrence of ONJ is higher in oncology patients treated with high-dose iv bisphosphonates than in osteoporosis patients treated with oral bisphosphonates. Although multiple hypotheses have been proposed, the exact pathogenic mechanism of ONJ still remains unclear...
November 2015: Oral Diseases
#8
REVIEW
Massimo Gentile, Ernesto Vigna, Anna Grazia Recchia, Lucio Morabito, Francesco Mendicino, Giovanna Giagnuolo, Fortunato Morabito
The advent of high-dose melphalan with autologous stem-cell transplantation (ASCT), the availability of novel agents such as thalidomide, lenalidomide (immunomodulatory drugs or IMiDs) and bortezomib (proteasome inhibitor) and improvements in supportive care have allowed to increase overall survival in multiple myeloma (MM) patients; nevertheless, MM remains an incurable pathology. For this reason, newer agents are required for continued disease control. Bendamustine is an old drug rediscovered in the last decade...
November 2015: European Journal of Haematology
#9
REVIEW
Holger W Auner, Laurent Garderet, Nicolaus Kröger
High-dose chemotherapy with melphalan followed by autologous haematopoietic cell transplantation (AHCT) is a standard of care in young patients (<65 years) with multiple myeloma. Most myeloma patients, however, are older than 65 years at the time of diagnosis, and the findings of numerous single-centre and registry studies provide evidence that AHCT can be a feasible and effective treatment option in these patients. Nevertheless, AHCT is not generally recommended as standard treatment in the elderly, due to the fact that a benefit of AHCT over conventional-dose therapy has not been demonstrated by prospective randomized trials...
November 2015: British Journal of Haematology
#10
REVIEW
M A Dimopoulos, P Sonneveld, D Siegel, A Palumbo, J San-Miguel
While survival times have increased over the last decade, most patients with multiple myeloma (MM) eventually relapse and become refractory to therapy. The treatment of patients with relapsed and/or refractory MM is frequently further complicated by the presence of pre-existing comorbidities that arise from an advanced disease state and of toxicities stemming from prior antimyeloma treatment. Carfilzomib and pomalidomide have recently been approved for the treatment of patients with relapsed and refractory MM...
November 2015: Annals of Oncology: Official Journal of the European Society for Medical Oncology
#11
REVIEW
W J Chng, A Dispenzieri, C-S Chim, R Fonseca, H Goldschmidt, S Lentzsch, N Munshi, A Palumbo, J S Miguel, P Sonneveld, M Cavo, S Usmani, B G M Durie, H Avet-Loiseau
Multiple myeloma is characterized by underlying clinical and biological heterogeneity, which translates to variable response to treatment and outcome. With the recent increase in treatment armamentarium and the projected further increase in approved therapeutic agents in the coming years, the issue of having some mechanism to dissect this heterogeneity and rationally apply treatment is coming to the fore. A number of robustly validated prognostic markers have been identified and the use of these markers in stratifying patients into different risk groups has been proposed...
February 2014: Leukemia
#12
JOURNAL ARTICLE
Monika Engelhardt, Evangelos Terpos, Martina Kleber, Francesca Gay, Ralph Wäsch, Gareth Morgan, Michele Cavo, Niels van de Donk, Andreas Beilhack, Benedetto Bruno, Hans Erik Johnsen, Roman Hajek, Christoph Driessen, Heinz Ludwig, Meral Beksac, Mario Boccadoro, Christian Straka, Sara Brighen, Martin Gramatzki, Alessandra Larocca, Henk Lokhorst, Valeria Magarotto, Fortunato Morabito, Meletios A Dimopoulos, Hermann Einsele, Pieter Sonneveld, Antonio Palumbo
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)...
February 2014: Haematologica
#13
REVIEW
S Z Usmani, P Rodriguez-Otero, M Bhutani, M-V Mateos, J S Miguel
Multiple myeloma (MM) is more recently being recognized as a heterogeneous group of disease with variability in outcomes based on specific clinical and biologic predictors. MM patients can be broadly categorized into standard, intermediate and high risk for disease relapse, morbidity and mortality. The high-risk features include patient-specific factors such as old age, poor performance status and comorbidities; clinical features such as primary plasma cell leukemia and extramedullary disease; disease-specific biologic features such as deletion 17p, t(4;14) and high-risk gene expression profiling signatures...
November 2015: Leukemia
#14
LETTER
Victor H Jimenez-Zepeda, Peter Duggan, Paola Neri, Ahsan Chaudhry, Karen Murray, Marcia Culham, Joanne Luider, Thomas Fourie, Fariborz Rashid-Kolvear, Nizar J Bahlis
No abstract text is available yet for this article.
2016: Leukemia & Lymphoma
#15
JOURNAL ARTICLE
Evangelos Terpos, Martina Kleber, Monika Engelhardt, Sonja Zweegman, Francesca Gay, Efstathios Kastritis, Niels W C J van de Donk, Benedetto Bruno, Orhan Sezer, Annemiek Broijl, Sara Bringhen, Meral Beksac, Alessandra Larocca, Roman Hajek, Pellegrino Musto, Hans Erik Johnsen, Fortunato Morabito, Heinz Ludwig, Michele Cavo, Hermann Einsele, Pieter Sonneveld, Meletios A Dimopoulos, Antonio Palumbo
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...
October 2015: Haematologica
#16
JOURNAL ARTICLE
Sergio Giralt, Laurent Garderet, Brian Durie, Gordon Cook, Gosta Gahrton, Benedetto Bruno, Paremesweran Hari, Henk Lokhorst, Phillip McCarthy, Amrita Krishnan, Pieter Sonneveld, Harmut Goldschmidt, Sundar Jagannath, Bart Barlogie, Maria Mateos, Peter Gimsing, Orhan Sezer, Joseph Mikhael, Jin Lu, Meletios Dimopoulos, Amitabha Mazumder, Antonio Palumbo, Rafat Abonour, Kenneth Anderson, Michel Attal, Joan Blade, Jenny Bird, Michele Cavo, Raymond Comenzo, Javier de la Rubia, Hermann Einsele, Ramon Garcia-Sanz, Jens Hillengass, Sarah Holstein, Hans Erik Johnsen, Douglas Joshua, Guenther Koehne, Shaji Kumar, Robert Kyle, Xavier Leleu, Sagar Lonial, Heinz Ludwig, Hareth Nahi, Anil Nooka, Robert Orlowski, Vincent Rajkumar, Anthony Reiman, Paul Richardson, Eloisa Riva, Jesus San Miguel, Ingemar Turreson, Saad Usmani, David Vesole, William Bensinger, Muzaffer Qazilbash, Yvonne Efebera, Mohamed Mohty, Christina Gasparreto, James Gajewski, Charles F LeMaistre, Chris Bredeson, Phillipe Moreau, Marcelo Pasquini, Nicolaus Kroeger, Edward Stadtmauer
In contrast to the upfront setting in which the role of high-dose therapy with autologous hematopoietic cell transplantation (HCT) as consolidation of a first remission in patients with multiple myeloma (MM) is well established, the role of high-dose therapy with autologous or allogeneic HCT has not been extensively studied in MM patients relapsing after primary therapy. The International Myeloma Working Group together with the Blood and Marrow Transplant Clinical Trials Network, the American Society of Blood and Marrow Transplantation, and the European Society of Blood and Marrow Transplantation convened a meeting of MM experts to: (1) summarize current knowledge regarding the role of autologous or allogeneic HCT in MM patients progressing after primary therapy, (2) propose guidelines for the use of salvage HCT in MM, (3) identify knowledge gaps, (4) propose a research agenda, and (5) develop a collaborative initiative to move the research agenda forward...
December 2015: Biology of Blood and Marrow Transplantation
#17
JOURNAL ARTICLE
Rafael Ríos-Tamayo, María José Sánchez, José Manuel Puerta, Juan Sáinz, Daysi-Yoe-Ling Chang, Teresa Rodríguez, Pilar López, José María de Pablos, Pilar Navarro, José Luís García de Veas, Antonio Romero, Pilar Garrido, Lucía Moratalla, Carolina Alarcón-Payer, Elisa López-Fernández, Pedro Antonio González, José Juan Jiménez-Moleón, Miguel Ángel Calleja-Hernández, Manuel Jurado
BACKGROUND: Despite the progress made in recent years, multiple myeloma is still considered an incurable disease. Most survival data come from clinical trials. Little is known about the outcome in unselected real-life patients. METHODS: Overall survival was analyzed in a cohort of newly diagnosed symptomatic multiple myeloma patients, over the last three decades, in a single institution population-based study. RESULTS: 582 consecutive myeloma patients were included in the study...
October 2015: Cancer Epidemiology
#18
EDITORIAL
Guy Pratt, Stella Bowcock, Andrew Chantry, Gordon Cook, Graham Jackson, Maggie Lai, Eric Low, Nicola Mulholland, Roger Owen, Neil Rabin, Karthik Ramasamy, John A Snowden, Matthew Streetly, Ashutosh Wechalekar, Kwee Yong, Jenny Bird
In November 2014 the International Myeloma Working Group (IMWG) revised the definition of multiple myeloma, such that asymptomatic patients with newly diagnosed multiple myeloma without any of the traditional 'CRAB' (hypercalcaemia, renal impairment, anaemia, bone disease) end organ damage criteria but with one of three new criteria would be recommended to start treatment. Previously, the standard of care for such patients was expectant management. These three new criteria are: greater than 60% clonal plasma cells on bone marrow biopsy, a serum free light chain (sFLC) ratio of >100 (the involved sFLC must be >100 mg/l) and greater than one unequivocal focal lesion on advanced imaging (low dose whole body computerized tomography, magnetic resonance imaging, (18) F fluorodeoxyglucose positron emission tomography)...
October 2015: British Journal of Haematology
#19
RANDOMIZED CONTROLLED TRIAL
Jesus F San Miguel, Katja C Weisel, Kevin W Song, Michel Delforge, Lionel Karlin, Hartmut Goldschmidt, Philippe Moreau, Anne Banos, Albert Oriol, Laurent Garderet, Michele Cavo, Valentina Ivanova, Adrian Alegre, Joaquin Martinez-Lopez, Christine Chen, Christoph Renner, Nizar Jacques Bahlis, Xin Yu, Terri Teasdale, Lars Sternas, Christian Jacques, Mohamed H Zaki, Meletios A Dimopoulos
Pomalidomide is a distinct oral IMiD(®) immunomodulatory agent with direct antimyeloma, stromal-support inhibitory, and immunomodulatory effects. The pivotal, multicenter, open-label, randomized phase 3 trial MM-003 compared pomalidomide + low-dose dexamethasone vs high-dose dexamethasone in 455 patients with refractory or relapsed and refractory multiple myeloma after failure of bortezomib and lenalidomide treatment. Initial results demonstrated significantly longer progression-free survival and overall survival with an acceptable tolerability profile for pomalidomide + low-dose dexamethasone vs high-dose dexamethasone...
October 2015: Haematologica
#20
COMPARATIVE STUDY
Patrick T Griffin, Viet Q Ho, William Fulp, Taiga Nishihori, Kenneth H Shain, Melissa Alsina, Rachid C Baz
BACKGROUND: Despite the impact of proteasome inhibitors and immunomodulatory agents, infusional chemotherapy regimens continue to be used for patients with multiple myeloma. To the authors' knowledge, contemporary data regarding salvage chemotherapy regimens are sparse, with no direct comparisons. METHODS: The authors performed a single-institution study comparing 3 salvage chemotherapy regimens in 107 patients with recurrent/refractory multiple myeloma: dexamethasone, cyclophosphamide, etoposide, and cisplatin (DCEP) in 52 patients; bortezomib, thalidomide, dexamethasone, cisplatin, doxorubicin, cyclophosphamide, and etoposide (VTD-PACE) in 22 patients; and cyclophosphamide, vincristine, doxorubicin, and dexamethasone (CVAD) in 33 patients...
October 15, 2015: Cancer
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