Maintenance treatment with interferon alpha-2b in multiple myeloma: a prospective randomized study from PETHEMA (Program for the Study and Treatment of Hematological Malignancies, Spanish Society of Hematology)

Bladé, Joan; Miguel, Jesús F. San; Ml, Escudero; Fontanillas, Montserrat; Besalduch, Juan; Gardella, Santiago; Arias, Jesús; Garcı́a-Conde, J; Carnero, M; Marti, JM; Rozmán, C; Vila, Jordi; Montserrat, Emili

doi:10.1038/sj.leu.2401039

Cited by 26 publications

(11 citation statements)

References 23 publications

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“…4, 5). Results from the PETHEMA study 38 indicate a longer disease-free duration for patients treated with maintenance therapy compared with patients who did not receive this treatment (Fig. 6).…”

Section: Immunotherapy Of Multiple Myelomamentioning

confidence: 99%

A review of the cytokine network in multiple myeloma

Lauta

2003

Cancer

197

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Because many studies have focused on growth factors in multiple myeloma, the study of the cytokine network appears to be useful for this purpose. Interleukin-6 (IL-6) and IL-2 with their soluble receptors (IL-3, IL-4, IL-10, and IL-11) have been examined. Plasma cells may produce IL-6 by an autocrine mechanism whereas a paracrine mechanism is believed to be involved in the production of IL-6 by bone However, the concomitant evaluation of all immunologic parameters could be more useful than the value of a single IL. Serum levels of IL-6, sIL-6R, sIL-2R, and the expression of membrane-bound IL-2 receptors, both on bone marrow plasma cells and on peripheral blood mononuclear cells, are correlated with disease activity and disease stage. In addition, IL-6 and sIL-6R serum levels are believed to be correlated with the duration of disease-free survival because a high serum level at the time of diagnosis is believed to be correlated with a short duration of survival. However, some laboratory parameters may express the same prognostic value as high ␤ 2 microglobulin and lactate dehydrogenase (LDH) serum levels together with a high plasma cell labeling index are correlated with disease activity.Furthermore, if the evaluation is performed at the time of diagnosis, high values of these parameters are correlated with a short disease-free survival. A correlation between laboratory parameters and the serum level of several cytokines was demonstrated. Hence, the real advantage of the prognostic evaluation of cytokines is reserved for patients who do not exhibit uniform results with regard to ␤ 2 microglobulin and LDH serum levels, or, better, for borderline cases. With regard to the differential diagnosis, all immunologic parameters should be evaluated concomitantly rather than separately to confer a real prognostic value to results. Furthermore, a particular relation was found between a high sIL-6R serum level and a poor response to chemotherapy, therefore suggesting the possibility of identifying in advance a subset of patients with a high risk of treatment failure, as has already been demonstrated in other hematologic malignancies.Finally, the majority of studies indicate that interferons are used mainly in the immunotherapy for multiple myeloma, whereas many clinical trials should still be required for the evaluation of the effectiveness of anti-I-L6 antibodies or antiidiotypic vaccines in reference to the eligible patients for these particular therapies.

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Section: Immunotherapy Of Multiple Myelomamentioning

confidence: 99%

A review of the cytokine network in multiple myeloma

Lauta

2003

Cancer

197

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“…Toxicity was recorded according to the Seattle regimenrelated toxicity grading 28 and the diagnosis of VOD was established using both the Seattle 29 and Baltimore 30 criteria. Disease response was assessed post-induction and 90 days post-transplant using European Group for Blood and Marrow Transplantation (EBMT) criteria, 31 modified to include near complete response. The reference M-protein level for each patient was that recorded at initiation of induction therapy.…”

Section: End-pointsmentioning

confidence: 99%

Busulfan 12 mg/kg plus melphalan 140 mg/m2 versus melphalan 200 mg/m2 as conditioning regimens for autologous transplantation in newly diagnosed multiple myeloma patients included in the PETHEMA/GEM2000 study

Lahuerta¹,

Mateos²,

Martínez‐López³

et al. 2010

Haematologica

103

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BackgroundThe aim of this study was to compare the long-term safety and efficacy of oral busulfan 12 mg/kg plus melphalan 140 mg/m 2 and melphalan 200 mg/m 2 as conditioning regimens for autologous stem cell transplantation in newly diagnosed patients with multiple myeloma in the GEM2000 study. Design and MethodsThe first 225 patients received oral busulfan 12 mg/kg plus melphalan 140 mg/m 2 ; because of a high frequency of veno-occlusive disease, the protocol was amended and a further 542 patients received melphalan 200 mg/m 2 . ResultsEngraftment and hospitalization times were similar in both groups. Oral busulfan 12 mg/kg plus melphalan 140 mg/m 2 resulted in higher transplant-related mortality (8.4% versus 3.5%; P=0.002) due to the increased frequency of veno-occlusive disease in this group. Response rates were similar in both arms. With respective median follow-ups of 72 and 47 months, the median progression-free survival was significantly longer with busulfan plus melphalan (41 versus 31 months; P=0.009), although survival was similar to that in the melphalan 200 mg/m 2 group. However, access to novel agents as salvage therapy after relapse/progression was significantly lower for patients receiving busulfan plus melphalan (43%) than for those receiving melphalan 200 mg/m 2 (58%; P=0.01). ConclusionsConditioning with oral busulfan 12 mg/kg plus melphalan 140 mg/m 2 was associated with longer progression-free survival but equivalent survival to that achieved with melphalan 200 mg/m 2 but this should be counterbalanced against the higher frequency of veno-occlusive disease-related deaths. This latter fact together with the limited access to novel salvage therapies in patients conditioned with oral busulfan 12 mg/kg plus melphalan 140 mg/m 2 may explain the absence of a survival difference. Oral busulfan was used in the present study; use of the intravenous formulation may reduce toxicity and result in greater efficacy, and warrants further investigation in myeloma patients. (Clinicaltrials.gov identifier: NCT00560053).Key words: multiple myeloma, melphalan, oral busulfan, conditioning regimens, autologous stem cell transplantation, survival, progression-free survival. . Haematologica 2010;95(11):1913-1920. doi:10.3324/haematol.2010 Citation

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“…The ideal maintenance therapy should improve not only PFS and OS, but also quality of life, and therefore have few side effects and be easy to administer. Until now, only three anti-neoplastic agents-α-interferon (α-IFN), glucocorticoids, and thalidomide-have been adequately studied [77][78][79][80][81][82][83][84][85][86][87][88][89][90][91][92][93][94]. Maintenance with α-IFN is of only marginal benefit after either standard therapy or ASCT.…”

Section: Maintenancementioning

confidence: 99%

“…Maintenance with α-IFN is of only marginal benefit after either standard therapy or ASCT. A number of studies showed a trend toward improved response duration and relapse-free survival [77][78][79][80][81], but others failed to corroborate these findings [82][83][84], and OS was not prolonged by IFN treatment after standard therapy [77][78][79][80][81][82][83][84]. Furthermore, when administered after ASCT, the value of α-IFN-maintenance is similarly controversial, with only one study showing a PFS and OS benefit [61].…”

Section: Maintenancementioning

confidence: 99%

Consensus statement from European experts on the diagnosis, management, and treatment of multiple myeloma: from standard therapy to novel approaches

Engelhardt

Kleber

Udi

et al. 2010

Leukemia & Lymphoma

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Original Citation:Consensus statement from European experts on the diagnosis, management, and treatment of multiple myeloma: from standard therapy to novel approaches. Terms of use:Open Access (Article begins on next page) Anyone can freely access the full text of works made available as "Open Access". Works made available under a Creative Commons license can be used according to the terms and conditions of said license. Use of all other works requires consent of the right holder (author or publisher) if not exempted from copyright protection by the applicable law. Availability: This is the author's manuscriptThis version is available http://hdl.handle.net/2318/81898 since This is an author version of the contribution published on: Questa è la versione dell'autore dell'opera: [August 2010, Vol. 51, No. 8 , Pages 1424-1443 (doi:10.3109/10428194.2010 ABSTRACTTreatment for multiple myeloma (MM) has changed beyond recognition over the past two decades. During the early 1980s, MM inevitably resulted in a slow progressive decline in quality of life until death after about 2 years, while today patients can expect a 50% chance of achieving a complete remission, median survival of 5 years, and a 20% chance of surviving longer than 10 years. An international expert opinion meeting (including members of the GIMEMA and DSMM study groups) was held in 2009. One of the outcomes of the meeting was the development of a consensus statement outlining contemporary optimal clinical practice for the treatment of MM. The international panel recommended that the state of the art therapy for MM should comprise: (a) evidence-based supportive care, (b) effective and well-tolerated chemotherapeutic regimens, (c) autologous hematopoietic stem cell transplant (ASCT) for patients suitable for intensive conditioning therapy, and (d) evidence-based incorporation of novel anti-MM agents. Maintenance strategies have also become increasingly important for the prolongation of remission after front-line therapies. In addition, improved understanding of the biology of MM has led to the development of novel biological therapeutic agents such as thalidomide, lenalidomide, bortezomib, and others. These agents specifically target intracellular mechanisms and interactions, such as those within the bone marrow microenvironment, and have been integrated into MM treatment. This report reviews recent clinical advances in the treatment strategies available for MM and provides an overview of the state of the art management of patients with MM.

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Maintenance treatment with interferon alpha-2b in multiple myeloma: a prospective randomized study from PETHEMA (Program for the Study and Treatment of Hematological Malignancies, Spanish Society of Hematology)

Cited by 26 publications

References 23 publications

A review of the cytokine network in multiple myeloma

A review of the cytokine network in multiple myeloma

Busulfan 12 mg/kg plus melphalan 140 mg/m2 versus melphalan 200 mg/m2 as conditioning regimens for autologous transplantation in newly diagnosed multiple myeloma patients included in the PETHEMA/GEM2000 study

Consensus statement from European experts on the diagnosis, management, and treatment of multiple myeloma: from standard therapy to novel approaches

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