scholarly journals Krd Consolidation in Myeloma Patients with a Positive PET-CT after Standard First Line Treatment: A Phase II Study (CONPET)

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 3172-3172 ◽  
Author(s):  
Jakob Nordberg Nørgaard ◽  
Niels Abildgaard ◽  
Anna Lysén ◽  
Mona-Elisabeth R Revheim ◽  
James P Connelly ◽  
...  
Keyword(s):  
Board Of Directors ◽  
Fdg Pet ◽  
Research Funding ◽  
Progression Free Survival ◽  
Line Treatment ◽  
First Line ◽  
Advisory Committees ◽  
Pet Ct ◽  
Fdg Pet Ct ◽  
First Line Treatment

Background: [18F]-Fluorodeoxyglucose positron emission tomography/computed tomography (FDG PET/CT) positivity after first line treatment with autologous stem cell transplantation (ASCT), is strongly correlated with reduced progression free survival and overall survival (Moreau et al., JCO, 2017). However, FDG PET/CT positive patients who obtain FDG PET/CT negativity after treatment can have comparable outcomes to patients who were FDG PET/CT negative at baseline (Davies et al., Haematologica 2018). Aiming for FDG PET/CT negativity may therefore be an important goal in myeloma treatment. The use of FDG PET/CT positivity as an indication for consolidation therapy after ASCT has not been studied before. Methods: This is an ongoing, multicenter phase II study. Patients with multiple myeloma who have received standard first line treatment including ASCT and achieved very good partial response (VGPR) or better, are eligible for the study and examined by FDG PET/CT. Patients who are FDG PET/CT positive defined by the Italian Myeloma criteria for PET USe (IMPETUS) (Nanni C et al., EJNMMI 2016 and 2018) are included in the treatment phase of the study and are assessed for minimal residual disease (MRD) by Euroflow (sensitivity: 10-5) before treatment. The treatment consists of four 28-day cycles of KRd (carfilzomib 36 mg/m2 day 1,2,8,19,15 and 16 (except 20 mg/m2 day 1 and 2 first cycle), lenalidomide 25 mg day 1-21 all cycles and dexamethasone 40 mg day 1,8,15 and 22 all cycles). After four cycles, FDG PET/CT and Euroflow for MRD are repeated for response evaluation. Both patients with FDG PET/CT negativity and patients with FDG PET/CT positivity at baseline are followed for progression free survival (PFS) and overall survival (OS). Results: As of 1st of July 2019, 43 patients have been screened in the study. Sixteen patients (37%) had a positive FDG PET/CT result. Eight of 13 (62%) patients with a FDG PET/CT positive result were MRD negative. Eight patients have completed four cycles of KRD consolidation; two patients were converted into FDG PET/CT negativity; one of the two remained MRD positive, the other remained MRD negative. Three patients had reduced FDG uptake but were still considered FDG PET/CT positive; one of these converted from MRD positive to negative. One had stable disease and two had progression on FDG PET/CT whereof one converted from MRD negative to positive. Conclusion: A significant proportion (37%) of patients treated with standard first line treatment including ASCT with very good partial response or better was considered FDG PET/CT positive. Sixty-two percent of these patients were MRD negative by Euroflow, confirming the complementary features of these two methods. Treatment with four cycles of KRd improved disease status based on FDG PET/CT in 5 of 8 patients (62,5%) and converted 2 out of 8 patients to FDG PET/CT negativity. One patient was converted from MRD positivity to MRD negativity. This study is ongoing and will enroll 50 FDG PET/CT positive patients. Before the ASH 2019 meeting, we plan to screen approximately fifteen additional patients with FDG PET/CT and about five more patients will have completed KRd consolidation therapy. Table Disclosures Nørgaard: Bayer, Astrazeneca: Honoraria. Abildgaard:Janssen: Research Funding; Celgene: Research Funding; Takeda: Research Funding; Amgen: Research Funding. Revheim:South-Eastern Norway Regional Healt Authority: Research Funding. Schjesvold:Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis: Honoraria; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees; MSD: Membership on an entity's Board of Directors or advisory committees; Oncopeptides: Membership on an entity's Board of Directors or advisory committees; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees; SkyliteDX: Honoraria; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding.

scholarly journals Carfilzomib-Lenalidomide-Dexamethasone Consolidation in Myeloma Patients with a Positive FDG PET/CT after Upfront Autologous Stem Cell Transplantation: A Phase II Study (CONPET)

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 3939-3939
Author(s):  
Jakob Nordberg Nørgaard ◽  
Niels Abildgaard ◽  
Anna Lysén ◽  
Galina Tsykunova ◽  
Annette Juul Vangsted ◽  
...  
Keyword(s):  
Board Of Directors ◽  
Fdg Pet ◽  
Research Funding ◽  
Line Treatment ◽  
First Line ◽  
Advisory Committees ◽  
Pet Ct ◽  
Fdg Pet Ct ◽  
First Line Treatment ◽  
Privately Held

Abstract Background: [18F]-Fluorodeoxyglucose positron emission tomography/computed tomography (FDG PET/CT) positivity after first line treatment with autologous stem cell transplantation (ASCT), is strongly correlated with reduced progression free survival and overall survival (Moreau et al., JCO, 2017). However, FDG PET/CT positive patients who obtain FDG PET/CT negativity after treatment seem to have comparable outcomes to patients who were FDG PET/CT negative at baseline (Davies et al., Haematologica 2018). Aiming for FDG PET/CT negativity may therefore be an important goal in myeloma treatment. The use of FDG PET/CT positivity as an indication for consolidation therapy after ASCT has not been studied before. Methods: This is an ongoing, multicenter phase II study. Patients with multiple myeloma who have received standard first line treatment including ASCT and achieved very good partial response (VGPR) or better, are eligible for the study and examined by FDG PET/CT. Patients who are FDG PET/CT positive defined by the Italian Myeloma criteria for PET USe (IMPETUS) (Nanni C et al., EJNMMI 2016 and 2018) are included in the treatment phase of the study and are assessed for minimal residual disease (MRD) by Euroflow (sensitivity: 10 -5) before treatment. FDG PET/CT examinations are centrally read by two experienced nuclear medicine radiologists. The treatment consists of four 28-day cycles of KRd (carfilzomib 36 mg/m 2 day 1,2,8,9,15 and 16 (except 20 mg/m 2 day 1 and 2 first cycle), lenalidomide 25 mg day 1-21 all cycles and dexamethasone 40 mg day 1,8,15 and 22 all cycles). After 4 cycles, FDG PET/CT and Euroflow for MRD are repeated for response evaluation. Both patients with FDG PET/CT negativity and patients with FDG PET/CT positivity at baseline are followed for progression free survival and overall survival. Results: As of the 1st of July 2021, 149 patients have been screened in the study. Fifty-one patients (34%) had a positive FDG PET/CT post-ASCT. Twenty-eight of 50 (56%) patients with positive FDG PET/CT were MRD negative. Forty-four patients have completed four cycles of KRd consolidation; Twelve (27%) patients converted into FDG PET/CT negativity. Nine of them were MRD negative both before and after consolidation; two were MRD positive both before and after consolidation and one turned MRD negative after consolidation. In all patients who were FDG-PET positive before treatment, the rate of MRD negativity after consolidation treatment was 78%. Eleven of twenty (55%) patients who were MRD positive before consolidation treatment turned MRD negative after treatment. Conclusion: A significant proportion (34%) of patients treated with standard first line treatment including ASCT with achieved very good partial response or better was FDG PET/CT positive post-ASCT. Fifty-six percent of them were MRD negative by Euroflow, confirming the complementary features of these two methods. Treatment with four cycles of KRd converted 12 of 44 (27%) patients to FDG PET/CT negativity, and 78% of all patients were MRD negative after treatment. The study is ongoing and we will follow up on data for progression free (PFS) and overall survival (OS). At the congress, complete post-consolidation data for all patients (n=50) will be presented. Figure 1 Figure 1. Disclosures Nørgaard: Bayer: Honoraria; AstraZeneca: Honoraria; Ultimovacs: Current holder of individual stocks in a privately-held company; Targovax: Current holder of individual stocks in a privately-held company; Photocure: Current holder of individual stocks in a privately-held company. Tsykunova: Sobi: Consultancy; Ablynx: Consultancy; Janssen: Consultancy, Honoraria, Research Funding; Amgen: Consultancy, Honoraria; Sanofi: Consultancy. João: Janssen: Consultancy; Amgen: Consultancy, Membership on an entity's Board of Directors or advisory committees; BMS: Consultancy, Membership on an entity's Board of Directors or advisory committees; GSK: Membership on an entity's Board of Directors or advisory committees; Gilead: Membership on an entity's Board of Directors or advisory committees, Research Funding; Takeda: Consultancy, Research Funding. Schjesvold: Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees; GSK: Research Funding; Nordics Nanovector: Current holder of individual stocks in a privately-held company; Sanofi: Consultancy, Honoraria, Research Funding; Oncopeptides: Consultancy, Current holder of individual stocks in a privately-held company, Honoraria, Research Funding; Janssen: Consultancy, Honoraria, Research Funding; Celgene/BMS: Consultancy, Honoraria, Research Funding; SkyliteDX: Honoraria; AbbVie: Honoraria; Bayer: Consultancy; Adaptive Biotechnologies: Consultancy; Schain: Honoraria; Amgen: Consultancy, Honoraria, Research Funding; Novartis: Consultancy, Honoraria.

scholarly journals Clinical and Biological Characteristics and Outcomes of Richter Transformation : A French Multicenter Study from the Filo Group

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 4112-4112
Author(s):  
Charline Moulin ◽  
Romain Morizot ◽  
Thomas Remen ◽  
Hélène Augé ◽  
Florian Bouclet ◽  
...  
Keyword(s):  
Board Of Directors ◽  
Research Funding ◽  
Intermediate Risk ◽  
Line Treatment ◽  
First Line ◽  
Advisory Committees ◽  
Long Term Survivors ◽  
First Line Treatment

Introduction: About 2 to 10% of patients (pts) diagnosed with Chronic Lymphocytic Leukemia (CLL) develop diffuse large B-cell lymphoma (DLBCL, so-called Richter transformation (RT)) over long-term follow-up. The outcomes of pts with RT are variable and poorly understood and there is no consensus on the best therapeutic approach. The aim of this study was to analyze the clinical characteristics, outcomes and factors predictive of survival in a large series of RT from the French Innovative Leukemia Organization (FILO). Methods: Biopsy-confirmed RT (limited to DLBCL and excluding Hodgkin lymphoma) diagnosed from 2001 to 2018 were identified from eight FILO centers. Clinical and biological characteristics of CLL and RT at diagnosis, including cytogenetics, clonal relation with the pre-existing CLL, Epstein-Barr virus (EBV) status, cell of origin (COO) analyzed by immunohistochemistry and RT score (Tsimberidou AM et al, J Clin Oncol, 2006) were analyzed as well as treatment and outcomes. Overall survivals (OS) were defined as time from CLL and RT diagnosis to death from any cause and analyzed using the Kaplan-Meier method. Statistical analyses were performed with SAS version 9.4. Results: A total of 70 CLL pts who developed RT were identified. The median age at CLL diagnosis was 62 years old (range 35-82), and 50 (71.4 %) were male. The median time to transformation was 5.5 years (range 0 to 22 years), with 12 simultaneous diagnosis of CLL and RT. Prior to RT, 20 (29%) pts had not been treated for CLL, 50 received one (n=21) or more (n= 29) line of treatment ; 6 pts had received a novel agent (ibrutinib, idelalisib or venetoclax). The median age at RT diagnosis was 68 years old (range 42-88). All biopsies were centrally reviewed; 38/58 pts (66%) had elevated LDH (>1.5N) ; 35/65 pts (54 %) had bulky disease (≥ 5 cm); 10/54 (18.5%) pts had del(17p) or TP53 mutation ; 9/42 pts (21%) had a complex karyotype (at least 3 abnormalities). The CLL and RT were clonally related in 27/27 (100%) tested pts. COO by Hans algorithm was non germinal center B cell-like (GCB) in 26/28 pts (93%). EBV was positive or detected in 5/40 (12.5%) pts. The median of Ki67 positivity was 70% (range 30% to 100%). The RT score (based at RT diagnosis on ECOG performance status 2-4, LDH >1.5 x normal, platelets<100 x 109/L, tumor size >5 cm and >1 prior therapy for CLL) was : low risk in 17 pts (31%), low-intermediate risk in 10 pts (19%), high-intermediate risk in 14 pts (25%) and high risk in 14 pts (25%). The most common first-line treatment of RT was immunochemotherapy (n=57, 87%) including R-CHOP-like regimen (n=48, 73%). Autologous or allogeneic transplantation was performed for 7 pts (11%). Response to first-line treatment was complete or partial response in 26 pts (40%), and stable disease or progression in 39 pts (60%). After a median follow-up of 8 years, 51/64 pts (80%) have died. The main causes of death were progressive DLBCL (n=36, 71%), infection (n=8, 16%) or progressive CLL (n=2, 4%). The median OS of the cohort from CLL and RT diagnosis (Figure 1) were 7.8 years and 9.5 months, respectively. In univariate analysis, patients with TP53 disruption at CLL stage, low platelets count, elevated LDH, elevated beta2-microglobulin, high ECOG score, high RT score, EBV positivity and absence of response to first-line RT treatment had worse OS. The ECOG score, platelets count and TP53 disruption remain significant in multivariate Cox-regression. Last, we compared the clinical and biological parameters of two Richter groups defined as: (i) short-term survivors (<12 months, n = 34) and (ii) long-term survivors (>48 months, n = 18). Long survival was significantly associated with elevated platelets count, low LDH, low ECOG, low RT score and response to RT first-line treatment. Discussion: The clinical outcomes of RT patients is poor and novel treatment options are needed. However, a group of long-term survivors was identified, characterized by elevated platelets count, low LDH, low ECOG, low RT score and response to immunochemotherapy. Disclosures Leblond: Astra Zeneca: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Gilead: Honoraria, Speakers Bureau; Roche: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Abbvie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Amgen: Honoraria, Speakers Bureau. Thieblemont:Roche: Honoraria, Research Funding; Gilead: Honoraria; Novartis: Honoraria; Kyte: Honoraria; Janssen: Honoraria; Celgene: Honoraria; Cellectis: Membership on an entity's Board of Directors or advisory committees. Cymbalista:Janssen: Honoraria; Gilead: Honoraria; AstraZeneca: Honoraria; Sunesis: Research Funding; Roche: Research Funding; Abbvie: Honoraria. Guièze:Abbvie: Honoraria; Janssen: Honoraria; Gilead: Honoraria; Roche: Honoraria. Broseus:Janssen: Honoraria; Gilead: Honoraria; Novartis: Research Funding. Feugier:gilead: Honoraria, Research Funding, Speakers Bureau; janssen: Honoraria, Research Funding, Speakers Bureau; abbvie: Honoraria, Research Funding, Speakers Bureau; roche: Honoraria, Research Funding, Speakers Bureau.

Major Improvement of Invasive Aspergillosis Outcome Is Not Enough to Improve Overall Survival In Allogeneic Hematopoietic Stem Cell Transplant Recipients: Results From a Single-Center Retrospective Analysis

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 1244-1244
Author(s):  
Géraldine Salmeron ◽  
Raphaël Porcher ◽  
Anne Bergeron ◽  
Marie Robin ◽  
Regis Peffault de Latour ◽  
...  
Keyword(s):  
Overall Survival ◽  
Board Of Directors ◽  
Cumulative Incidence ◽  
Research Funding ◽  
Line Treatment ◽  
First Line ◽  
Advisory Committees ◽  
Hematopoietic Stem ◽  
Risk Of Death ◽  
First Line Treatment

Abstract Abstract 1244 Background. Voriconazole (V) treatment has been shown to improve the 12 week (W) survival rate of hematological patients (pts) with invasive aspergillosis (IA), including recipients of allogeneic hematopoietic stem cell transplants (HSCT). We investigated whether this early survival advantage could translate into a significant increase in overall survival. Methods. We retrospectively reviewed all consecutive pts who received a transplant between Sept. 1997 and Dec. 2008 at Saint-Louis Hospital and were diagnosed as having IA. The temporal origin of the study was the date of IA diagnosis for each patient. Factors associated with survival were analyzed using Cox proportional hazard models. Separate models were estimated for survival up to 12 W and for survival between 12 W and 24 months (M) in pts surviving longer than 12 W. The deaths of pts with and without IA were analyzed with a competing risk framework. Cumulative incidence curves were compared using Gray's tests. Results. Our study examined 89 IA pts. The median follow-up was 70 M (range, 11–130 M). Two pts did not receive any antifungal treatment and were excluded from subsequent analyses. Of the 87 pts, 42 received first-line V and 45 primarily received a lipid formulation of amphotericin B (n=25), amphotericin B deoxycholate (n=10), caspofungin (n=8) or itraconazole (n=2). The primary characteristics of pts with IA and their causes of death, separated by V as first-line treatment, are shown in the table below. The median survival was 2.6 M, and the overall survival at 24 M was 19% (95% CI 12–30 M) (see figure). Overall, the survival rates of the two groups were significantly different (P= 0.010). However, the differences in survival were quite dramatic prior to 10 M, whereas both survival curves became very close after one year. At 18 M, the numbers of surviving pts were almost identical in the two groups [19% (95% CI: 11–34%) in pts who did not receive V as first-line treatment vs. 21% (95% CI 11–38%) in pts who did]. Pts who did not receive V as a first-line treatment displayed a higher probability of dying from IA than those who did (P=0.004), whereas opposite results were found for mortality in pts without IA (P=0.006). The 24-M cumulative incidence of death from IA was 47% (95% CI 31–61%) in the no V group and 19% (95% CI 9–33%) in the group treated with V. The 24-M cumulative incidence of death in pts without IA was 4% (95% CI 7–14%) in the no V group and 27% (95% CI 14–42%) in pts treated with V. The probability of death from another cause, with IA, was similar in both groups (29% vs. 36% at 24 M; P=0.46). After adjusting for donor type, conditioning regimen, progressive GVHD at diagnosis of IA and cumulated steroid dose (mg/kg) in the W preceding IA diagnosis, administration of V as first-line treatment was found to decrease the risk of death during the first 12 W by approximately 70% [HR=0.31 (95% CI 0.16–0.60); P=0.0005]. Conversely, analysis of mortality between 12 W and 24 M failed to identify any significant predictor of risk of death; however, only 24 pts died during this period. Conclusions. The finding that first-line treatment with V, which is associated with a tremendous improvement in IA outcome, does not translate into an increase in overall survival (even in the context of early diagnosis) is striking. Diagnosis of IA following HSCT, whatever the outcome, appears to be a strong marker for poor long-term prognosis. Disclosures: Bergeron: Pfizer: Speakers Bureau, none; Merck: Speakers Bureau, none; Schering: Speakers Bureau, none. Sulahian:Pfizer: Research Funding, non; Merck: Research Funding, none. Ribaud:Pfizer: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau, none; Schering: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau, none; Gilead: Speakers Bureau, none.

Clinicopathological Features of Nodular Sclerosis-Type Classical Hodgkin Lymphoma In the Elderly: Multicenter Study of Hodgkin Lymphoma In Japan

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 2677-2677
Author(s):  
Naoko Asano ◽  
Tomohiro Kinoshita ◽  
Koichi Ohshima ◽  
Tadashi Yoshino ◽  
Nozomi Niitsu ◽  
...  
Keyword(s):  
Board Of Directors ◽  
Hodgkin Lymphoma ◽  
Research Funding ◽  
The Elderly ◽  
Clinicopathological Features ◽  
Line Treatment ◽  
Classical Hodgkin Lymphoma ◽  
First Line ◽  
Advisory Committees ◽  
First Line Treatment

Abstract Abstract 2677 Background: Classical Hodgkin lymphoma (CHL), which is characterized by the presence of Hodgkin and Reed Sternberg (H-RS) cells in a background of non-neoplastic inflammatory cells, is divided into four histological subgroups, nodular sclerosis (NSCHL), mixed cellularity (MCCHL), lymphocyte-rich, and lymphocyte depletion. While NSCHL in young adults is characterized by a mediastinal mass and good prognosis, the clinicopathological characteristics of NSCHL in the elderly (NSCHL-e) remain uncertain. Patients and methods: Enrolled patients were diagnosed with CHL between 1986 and 2006 as part of the Hodgkin Lymphoma's Multicenter Study Group. To better characterize NSCHL-e, we compared the clinicopathological profiles of 84 NSCHL-e patients aged 50 or over with 237 NSCHL-y patients aged 49 or younger and 302 with MCCHL. Results: The total of 743 CHL patients consisted of 496 men and 247 women with a median age of 48 years (range, 15– 89 years). The pathological diagnoses were NSCHL in 324 patients (43%) and MCCHL in 303 (41%). NSCHL patients showed a bimodal age distribution, with an initial peak in their 20s and a second small peak in their 60s. We categorized the former as NSCHL-y (49 or younger) and the latter as NSCHL-e (50 and over). NSCHL-e patients were characterized by male predominance and a more advanced clinical stage (53%) than NSCHL-y. Immunophenotypically, H-RS cells had the prototypic immunophenotype of CD15+ CD30+ and Pax5+. NSCHL-e cases showed a significantly higher rate of CD20 (24%) than NSCHL-y (8%, P = 0.001). Furthermore, H-RS cells in 29 of 75 (39%) patients with NSCHL-e were positive for EBV RNA transcripts by in situ hybridization, whereas only 7% of NSCHL-y cases were EBER-positive (P < 0.0001) (Table). Regarding NSCHL-e and MCCHL, no significant difference between these patients was seen in clinical characteristics. Immunophenotypically, NSCHL-e patients showed significantly higher rates for CD3 and TIA-1, while MCCHL patients showed higher EBV positivity (75%). Fifty-five of 63 patients received systemic multi-agent chemotherapy as first-line treatment, consisting of doxorubicin, bleomycin, vinblastine, and dacarbacin (ABVD) in 38 patients; CHOP in 8; C-MOPP in 8; and BEACOPP in 1. Overall, 51 patients responded to first-line treatment, 39 with complete response and 12 with partial response. Disease-specific survival of NSCHL-e was poorer than that of NSCHL-y (P < 0.001) but similar to that of MCCHL (P = 0.43) (Figure). Conclusion: NSCHL-e is characterized by an unfavorable prognosis and different clinicopathological features to NSCHL-y, which is considered as typical NSCHL. A number of cases of NSCHL-e might have been associated with MCCHL, with most being EBV-positive. These results suggest the limitations of current histological subgroupings for CHL. Disclosures: Matsushita: Pfizer CO.: Membership on an entity's Board of Directors or advisory committees, Research Funding; Baxter Co.: Membership on an entity's Board of Directors or advisory committees, Research Funding.

Predictors of Early Relapse Following Initial Therapy for Systemic Immunoglobulin Light Chain Amyloidosis

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 2082-2082
Author(s):  
Nidhi Tandon ◽  
Surbhi Sidana ◽  
Morie A. Gertz ◽  
Angela Dispenzieri ◽  
Martha Q. Lacy ◽  
...  
Keyword(s):  
Board Of Directors ◽  
Light Chain ◽  
Research Funding ◽  
Initial Therapy ◽  
Al Amyloidosis ◽  
Line Treatment ◽  
First Line ◽  
Advisory Committees ◽  
Early Relapse ◽  
First Line Treatment

Abstract Introduction Immunoglobulin light chain amyloidosis (AL Amyloidosis) is a monoclonal plasma cell proliferative disorder that is characterized by tissue deposits of misfolded insoluble κ or λ light chain derived amyloid fibrils, leading to organ dysfunction. The prognosis of patients depends on the number and severity of organ involvement, especially cardiac involvement. Autologous stem cell transplant (ASCT), if eligible, alkylator (melphalan) and novel drugs like proteasome inhibitors (PI) and immunomodulators (IMiD) have improved the overall survival (OS) during the past decades. But still, nearly half of the patients die within a year of diagnosis. We analyzed the factors predicting early relapse / progression or death (within 12 months) after first line therapy for systemic AL amyloidosis. Methods Clinical and laboratory data of all consecutive patients with systemic AL amyloidosis seen at Mayo Clinic within 90 days of their diagnosis, between 2006 and 2015, was collected by chart review and analyzed retrospectively. Patients who died within 3 months of starting the first line treatment were excluded from analysis. Early relapse (ER) was defined as relapse / progression requiring treatment change / re-institution or death within 12 months of starting first line treatment. Patients in the cohort with ER were compared with patients with a follow up of more than 12 months who had a relapse / progression beyond 12 months or had continuing response at the time of analysis. Categorical variables were analyzed using chi - square and Fisher's exact test and continuous variables using Kruskal- Wallis test and Wilcoxon rank sum test. Multivariate analysis was done using logistic regression model. Results Seven hundred and eighty six patients with newly diagnosed systemic AL amyloidosis met the study criteria and were included in the analysis. Among these, 230 (29.3%) patients had ER within 12 months of starting initial therapy while 556 (70.7%) patients either relapsed after 1 year or had continuing response at the time of analysis. Baseline demographics, organ involvement and type of first line therapy are presented in Table1. The median estimated follow up for the entire cohort from start of initial therapy was 62.9 months (95% CI; 59.9, 67.3). The variables included in the univariate and multivariate analyses for factors predicting ER were age at diagnosis (≤ vs > 70 years ), revised mayo stage (I and II vs III and IV), bone marrow plasma cell percentage (BMPC; ≤ 10% vs > 10%), presence of any chromosomal abnormalities, trisomies or IgH translocations by fluorescence in situ hybridization (FISH), multiorgan involvement [(>1 vs 1) (heart, liver, kidney, gastrointestinal tract, autonomic neuropathy), incorporation of ASCT in initial therapy. In univariate analysis, mayo stage (p<0.0001), multiorgan involvement (p=0.0008) and inclusion of ASCT as part of initial therapy (p<0.0001) were significantly associated with ER, while age (p=0.06), BMPC(p=0.9), FISH abnormalities (p=0.2) were not. However, in multivariate analysis, only mayo stage (III + IV vs I + II; p=0.01) and non-inclusion of ASCT in first line treatment (p=0.0001) were significantly predictive of ER. Conclusions Despite the introduction of ASCT and novel drugs, the early mortality in systemic AL amyloidosis remains high. This study demonstrates that patients with ER are older with higher prevalence of cardiac involvement and multiorgan involvement and higher Mayo stage (III and IV). Incorporation of ASCT as part of the initial therapy was associated with reduced early relapse, but it is difficult to separate the influence of the eligibility for ASCT from the effect of ASCT itself. This will help us in characterizing these patients to better understand their mechanisms of resistance to therapy and gives an insight to the type of initial therapy that benefits them. Disclosures Dispenzieri: GSK: Membership on an entity's Board of Directors or advisory committees; Jannsen: Research Funding; Prothena: Membership on an entity's Board of Directors or advisory committees; Celgene: Research Funding; Takeda: Membership on an entity's Board of Directors or advisory committees, Research Funding; Alnylam: Research Funding; pfizer: Research Funding. Kapoor:Takeda: Research Funding; Amgen: Research Funding; Celgene: Research Funding. Kumar:Celgene: Consultancy, Research Funding; Kesios: Consultancy; BMS: Consultancy; Sanofi: Consultancy, Research Funding; Noxxon Pharma: Consultancy, Research Funding; Glycomimetics: Consultancy; Millennium: Consultancy, Research Funding; Array BioPharma: Consultancy, Research Funding; Onyx: Consultancy, Research Funding; AbbVie: Research Funding; Skyline: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy, Research Funding.

scholarly journals Management of Steroid-Refractory Graft-Versus-Host Disease - a Survey By the Transplant Complications Working Party of the EBMT

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 2884-2884
Author(s):  
Zinaida Peric ◽  
Helene Schoemans ◽  
Christophe Peczynski ◽  
Christian Koenecke ◽  
Ivan S. Moiseev ◽  
...  
Keyword(s):  
Board Of Directors ◽  
Research Funding ◽  
Working Party ◽  
Line Treatment ◽  
Second Line ◽  
Clinical Practices ◽  
First Line ◽  
Advisory Committees ◽  
Prospective Trials ◽  
First Line Treatment

Abstract Introduction: As there is limited evidence to guide management of patients with steroid-refractory graft-versus-host disease (SR-GVHD) there is a broad variability of clinical practices. To document the current practice and assess the impact of emerging new drugs in SR-GVHD, Transplant Complications Working Party (TCWP) of the EBMT performed a survey among EBMT centers that covered specific treatment decisions on first- and second-line treatment of acute and chronic GVHD (aGVHD and cGVHD). Methods: The survey was conducted from December 2020 to March 2021 among EBMT centers. A questionnaire was developed by the study authors and used for data collection. It consisted of 40 questions focused on general approach in the first-line treatment, preferred second-line treatment in SR-GVHD and ancillary care in aGVHD and cGVHD. Results: 145 centers from 33 countries agreed to participate and responded to the questionnaire. First-line treatment of aGVHD was reported as rather homogenous; with most centers (68%) starting with lower doses of corticosteroids (CS) (&lt;2mg/kg) in lower grade aGVHD (grade 2a) and most centers (88%) starting with higher doses (2mg/kg) in aGVHD grades &gt;2b. On the other hand, the evaluation of response to CS was more heterogeneous: at 3 days in 33%, at 5 days in 30%, at 7 days in 15% of centers and depending on severity of aGVHD in most other centers. In the presence of SR-aGVHD, 50% of centers consider inclusion of patients in clinical trials. Although as much as 85% of centers reported to have a standard operating procedure (SOP) for SR-aGVHD management, only 45% (n=66) have an established one or 2-agent second-line treatment; most frequently ruxolitinib (n=46) and/or extracorporeal photopheresis (ECP) (n=29). All other centers reported a very heterogeneous practice and listed multiple agents (range, 3-10) as second-line treatment options. In total, the most used agents for SR-aGVHD as shown in Figure 1A are ruxolitinib in 68%, ECP in 59%, mycophenolate-mofetil (MMF) in 27%, calcineurin inhibitors (CNI) in 25%, high-dose CS (&gt;2mg/kg) in 15%, mesenchymal stem cells (MSC) in 14%, etanercept in 13%, infliximab in 11% and anti-thymocyte globulin (ATG) in 10% of centers. Clinical practice in first-line treatment of cGVHD again appeared relatively homogeneous; 58% of centers reported to treat mild forms with topical treatment only, unless affected organs could not be reached topically. In moderate/severe cGVHD, the majority (71%) of centers start with 0.5-1mg/kg of CS, in 45% with addition of CNI, while others use higher doses of CS +/- other agents. The evaluation of response was done before 4 weeks in 41% of centers, between 5-8 weeks in 41%, while a minority performed later response assessment or based the latter on organ affection/severity. In case of SR-cGVHD, 56% of centers would consider the inclusion in clinical trials, while only 65% have a SOP on management of these patients. One third of centers (35%) has an established multidisciplinary cGVHD team. Practices for SR-cGVHD again varied significantly, with most centers reporting on the use of more than 2 agents (range, 3-13) as second-line and with most applied agents as depicted in Figure 1B; ruxolitinib and ECP in 68% of centers, CNI in 40%, MMF in 37%, rituximab in 27%, imatinib in 25%, mTOR inhibitors in 23%, ibrutinib and methotrexate (MTX) in 19%, pulse of CS in 17%, MSC in 12% and PUVA therapy in 10% of centers. Conclusions:In summary, this survey revealed a rather homogenous first-line management of aGVHD and cGVHD based on steroids in the majority of centers. However, when first-line fails, the definition of SR-GVHD remains highly variable and SR-GVHD is still treated with a seemingly "trial and error" approach as demonstrated by significant variability of clinical practices among EBMT centers for second-line treatment. However, in line with recently published prospective trials, ruxolitinib comes forth as one of the most used therapeutic modalities in both SR-aGVHD and cGVHD, together with already widely administered ECP. On the contrary, ibrutinib has not emerged as standard of care in this setting. Future efforts should be invested in finding a standardized approach in SR-GVHD by directly comparing most applied second-line agents in prospective trials as well as evidence-based personalized treatment approaches. Figure 1 Figure 1. Disclosures Peric: Therakos, Servier, MSD, Astellas, Novartis, Abbvie, Pfizer: Honoraria. Schoemans: Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: personal fees , Research Funding; Incyte: Membership on an entity's Board of Directors or advisory committees, Other: Travel grants and personal fees; Gilead: Other: travel grants; CIBMTR: Consultancy, Other: travel grants; Janssen: Membership on an entity's Board of Directors or advisory committees; BHS: Membership on an entity's Board of Directors or advisory committees, Other: travel grants and personal fees , Research Funding; Jazz Pharmaceuticals: Other: personal fees; Takeda: Other: personal fees. Koenecke: Novartis: Consultancy; Janssen: Consultancy; BMS/Celgene: Consultancy; Kite/Gilead: Consultancy; EUSA Pharm: Consultancy. Basak: Saventic Health: Current holder of individual stocks in a privately-held company. Greinix: Celgene: Consultancy; Novartis: Consultancy; Sanofi: Consultancy; Takeda: Consultancy; Therakos: Consultancy. Penack: Omeros: Consultancy; Shionogi: Consultancy; Priothera: Consultancy; Incyte: Research Funding; Takeda: Research Funding; Therakos: Honoraria; Pfizer: Honoraria; Neovii: Honoraria; Novartis: Honoraria; MSD: Honoraria; Jazz: Honoraria; Gilead: Honoraria; Astellas: Honoraria.

scholarly journals Prospective Evaluation of 18F-FDG PET/CT As Predictor of Prognosis in Newly Diagnosed Transplant Eligible Multiple Myeloma (MM) Patients: Results from the Imaging Sus-Study of the EMN02/HO95 MM Randomized Phase III Trial

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 992-992
Author(s):  
Elena Zamagni ◽  
Cristina Nanni ◽  
Paola Tacchetti ◽  
Annibale Versari ◽  
Stephane Chauvie ◽  
...  
Keyword(s):  
Board Of Directors ◽  
Fdg Pet ◽  
Research Funding ◽  
Advisory Board ◽  
Response To Therapy ◽  
Phase Iii ◽  
Newly Diagnosed ◽  
Advisory Committees ◽  
Pet Ct ◽  
Fdg Pet Ct

Abstract F-18-fluorodeoxyglucose positron emission tomography integrated with computed tomography (FDG-PET/CT) enables to detect with relatively high sensitivity and specificity myeloma bone disease and extramedullary sites of metabolically active clonal plasma cells. FDG-PET/CT has also been used to assess and monitor the metabolic response to therapy and to predict the prognosis. One of the major limitation of PET/CT is the lack of standardized image criteria and of inter-observer reproducibility in interpreting the results. Aim of the present sub-study was to prospectively evaluate FDG-PET/CT at diagnosis, after 4 cycles of induction therapy and prior to maintenance therapy in a sub-group of patients enrolled into EMN02/HO95 MM international phase III trial. In particular, the two primary end-points were firstly to assess the prognostic significance of PET/CT at diagnosis and after therapy and secondly to standardize PET/CT evaluation by centralized imaging and revision and definition of criteria for interpretation. Seven hundred and 18 patients with newly diagnosed transplant-eligible symptomatic MM have been prospectively randomized in Italy from February 2011 through April 2014 to receive 4 cycles of bortezomib-melphalan-prednisone (VMP) vs high-dose melphalan and single or double autologous stem cell transplantation (ASCT) as intensification following induction with bortezomib-cyclophosphamide-dexamethasone (VCD). Consolidation therapy with bortezomib-lenalidomide-dexamethasone vs no consolidation was planned after VMP or ASCT(s), followed by lenalidomide maintenance until progression or toxicity. One hundred and three patients were included in the PET/CT imaging sub-study, and followed for a median of 24 months. By study design, PET/CT was performed and analysed in each of the 8 participating centres at baseline, after induction therapy and prior to the start of maintenance (EOT). Each PET scan was a posteriori re-interpreted in a blinded independent central review process, managed by WIDEN®, by a panel of 5 expert nuclear medicine physicians. They described the following characteristics: bone marrow metabolic state (BM), number (Fx) and score (Fs) of focal PET positive lesions, osteolysis (Lx), presence and site of extramedullary disease (EM), and fractures(Fr), according to the IMPeTUs criteria (Nanni et al, EJNM 2015). Moreover, a global score (GS), from 1 to 5, was given to each patient, considering the highest score among BM, Fx, Fs and EM. Concordance among reviewers on different metrics was calculated using Krippendorf's alpha (AK) coefficient Baseline characteristics of the patients were the following: median age 58 years, ISS and R-ISS stage III 15% and 10%, high-risk cytogenetics (t(4;14) ± del(17p) ±del (1p)±1q gain detected by FISH) 42%. At baseline, 78% of the patients had FLs, with a median SUVmax of 6.0. The percentages of PET positive patients for the different characteristics are summarized in table 1. The agreement among reviewer was good for BM (AK=0.49), Fx (AK=0.65), Fs (AK=0.62), Lx (AK=0.62) and EM (AK=0.40). Of all parameters, only Fx ≥ 4 was associated with worse PFS and OS (P = 0.06) Following 4 cycles of VCD, PET/CT remained positive in 59% of the patients, with a median SUVmax of 3.7. Of all parameters, only Fs ≥ 4 was predictive of worse OS (P= 0.05). Prior to maintenance therapy, PET/CT remained positive in 34% of the patients, with a median SUVmax of 3.4. Normal PET/CT findings before maintenance (66%) were associated with a significant improvement in PFS, in particular the following: presence of FLs (P=0.03), Fx ≥ 4 (P=0.001), Fs ≥2 (P=0.03), 3 (P=0.03) and 4 (P=0.006) and SUVmax ≥ 3.4 (p=0.002). GS was also predictive for PFS if ≥ 3 (P=0.033), 4 (P=0.0001) and 5 (P=0.004). The same parameters were also predictive for OS. The prognostic relevance of pre-maintenance PET/CT was retained across the randomization arm (VMP or ASCT), in terms of PFS and OS. In conclusion, PET/CT was confirmed to be a reliable predictor of outcome in newly diagnosed transplant eligible MM patients, whatever the treatment. Normalization of PET/CT before maintenance was associated with a significant improvement for PFS and OS. FDG-PET/CT is by now the preferred imaging technique for evaluating and monitoring response to therapy. Acknowledgments: this study was partially supported by a grant to Elena Zamagni from Fondazione del Monte di Bologna e Ravenna Table 1 Table 1. Disclosures Gay: Amgen: Honoraria; Bristol-Myers Squibb: Honoraria; Celgene: Honoraria; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Membership on an entity's Board of Directors or advisory committees; Mundipharma: Membership on an entity's Board of Directors or advisory committees. Larocca:Bristol-Myers Squibb: Honoraria; Janssen-Cilag: Honoraria; Celgene: Honoraria; Amgen: Honoraria. Sonneveld:Celgene: Other: Advisory board, Research Funding; Onyx: Other: Advisory board, Research Funding; Millennium: Other: Advisory board, Research Funding; Janssen-Cilag: Other: Advisory board, Research Funding. Cavo:Amgen: Honoraria; Celgene: Honoraria, Research Funding; Janssen: Honoraria, Research Funding; Takeda: Honoraria; Bristol-Myers Squibb: Honoraria.

An Open-Label, Randomized Study of Bendamustine and Rituximab (BR) Compared with Rituximab, Cyclophosphamide, Vincristine, and Prednisone (R-CVP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in First-Line Treatment of Patients with Advanced Indolent Non-Hodgkin's Lymphoma (NHL) or Mantle Cell Lymphoma (MCL): The Bright Study

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 902-902 ◽  
Author(s):  
Ian W. Flinn ◽  
Richard H. Van der Jagt ◽  
Brad S. Kahl ◽  
Peter Wood ◽  
Tim E. Hawkins ◽  
...  
Keyword(s):  
Respiratory Failure ◽  
Board Of Directors ◽  
Research Funding ◽  
Standard Treatment ◽  
Line Treatment ◽  
First Line ◽  
Advisory Committees ◽  
Pharmaceutical Industries ◽  
Grade 3 ◽  
First Line Treatment

Abstract Abstract 902 Background Bendamustine (B) is an active agent for relapsed and refractory indolent NHL, both as monotherapy and combined with rituximab (R), results recently updated by the StiL study group. This study compared efficacy and safety of BR with standard treatment regimens of R-CHOP and R-CVP as first-line treatment for indolent NHL or MCL. Methods Patients were randomized to 6–8 cycles of BR or R-CHOP/R-CVP (R-CHOP or R-CVP determined by investigator prior to randomization). BR regimen was B 90 mg/m2/day on days 1 and 2 plus R 375 mg/m2on day 1 of a 28-day cycle. Standard dosing and 21 day cycles were used for R-CHOP and R-CVP. Primary objective was to demonstrate noninferiority of complete response (CR) rate of BR vs standard treatment (noninferiority margin [ratio] 0.88). Secondary measures included overall response rate (ORR), progression-free survival, and overall survival. Tumor response was determined by a blinded independent review committee (IRC) using International Working Group revised response criteria for malignant lymphoma. Investigator assessments were compared with those of the IRC. Results Of 447 randomized patients, 436 received treatment (BR n=221; R-CHOP/R-CVP n=215 [R-CHOP n=99; R-CVP n=116]) and were evaluable for safety. Of these, 419 patients (BR n=213; R-CHOP/R-CVP n=206 [R-CHOP 97; R-CVP n=109]) were evaluable for efficacy. The randomized groups were well matched for age (median 60 and 58 years), sex (male, 61% and 59%), ECOG status (64% performance status 0, both groups), lymphoma type (83% indolent NHL, both groups), and Ann Arbor stage (62% stage IV, both groups). Among randomized patients and efficacy evaluable patients, the IRC-assessed CR rate was numerically higher for BR than R-CHOP/R-CVP and statistically noninferior (Table). In the randomized groups, CR rates for indolent NHL were numerically similar between BR and R-CHOP/R-CVP; however, in MCL, BR was statistically superior (P=0.018) (Table). Investigator-assessed response in randomized patients found superiority of BR vs R-CHOP/R-CVP (P=0.0013). IRC and investigator assessments differed mainly in quality of response (CR vs partial) rather than in whether a patient was a responder. For randomized patients, the ORR was 94% for BR and 84% for R-CHOP/R-CVP. Time-to-event data are immature and will be analyzed later. At time of data cut-off, 8% of the BR group had progressed, relapsed, or died, compared with 4% of R-CHOP/R-CVP group. Most patients completed 6 cycles (92% for BR and 91% for R-CHOP/R-CVP), with high relative dose intensity (>96%). Dose delays were more common for BR-treated patients (35% vs 19%), and dose reductions were less common (22% vs 29%). Most common AEs for BR and R-CHOP/R-CVP, respectively, were nausea (139 vs 102 patients), fatigue (113 vs 107), neutropenia (76 vs 85), constipation (65 vs 90), and alopecia (8 vs 74). Laboratory grade 3/4 hematologic toxicities for BR and R-CHOP/R-CVP were lymphopenia (137 vs 64), neutropenia (98 vs 151), leukopenia (84 vs 116), thrombocytopenia (16 vs 15), and anemia (6 vs 9), respectively. The most frequent investigator-reported nonhematologic grade 3/4 AEs for BR and R-CHOP/R-CVP were infusion-related reaction (13 vs 8 patients). Granulocyte colony stimulating factors were given at investigator discretion (per ASCO recommendations) to 29% of the BR group and 43% of the R-CHOP/R-CVP group. Fatal AEs occurred in 6 BR patients (pneumonia, respiratory failure, and sepsis; acute respiratory failure; cardiac arrest; pneumonia; chronic obstructive pulmonary disease; lung cancer) and 1 R-CHOP/R-CVP patient (sepsis). Conclusion In patients with advanced indolent NHL and MCL, BR produces a CR rate that is noninferior to that of R-CHOP/R-CVP. In the subgroup of patients with MCL, BR produces a significantly higher CR rate (51% vs 24%). High ORRs were attained in both treatment groups. The AE profile of BR was distinct from that of R-CHOP/R-CVP. Support: Teva Pharmaceutical Industries Ltd. Disclosures: Flinn: Teva Pharmaceuticals : Research Funding. Off Label Use: Bendamustine is FDA-approved for adults with chronic lymphocytic leukemia or indolent B-cell non-Hodgkin's lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Van der Jagt:Celgene: Consultancy, Research Funding, Sponsorship Other; Novartis: Consultancy, Research Funding, sponsorship, sponsorship Other; Roche: Consultancy, sponsorship, sponsorship Other; Cephalon: Consultancy, Research Funding; Incyte: Research Funding; Xanthus: Research Funding; Bristol-Myers Squibb : Consultancy. Kahl:Roche: Membership on an entity's Board of Directors or advisory committees, Research Funding; Genentech: Membership on an entity's Board of Directors or advisory committees, Research Funding; Teva Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees. MacDonald:Lundbeck: Membership on an entity's Board of Directors or advisory committees; Roche: Membership on an entity's Board of Directors or advisory committees, Research Funding. Munteanu:Teva Pharmaceutical Industries Ltd.: Employment. Clementi:Teva Pharmaceutical Industries Ltd.: Employment. Chen:Teva Pharmaceutical Industries Ltd.: Employment. Burke:Spectrum Pharmaceuticals: Consultancy.

PET/CT Evaluation As a Prognostic Indicator In Relapsed Or Refractory Multiple Myeloma

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 1878-1878
Author(s):  
Adriana C Rossi ◽  
Tomer M Mark ◽  
Kevin Wood ◽  
Roger N Pearse ◽  
Faiza Zafar ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Board Of Directors ◽  
Fdg Pet ◽  
Research Funding ◽  
Advisory Committees ◽  
Refractory Multiple Myeloma ◽  
Extramedullary Disease ◽  
Pet Ct ◽  
Lytic Lesions ◽  
Fdg Pet Ct

Abstract Background Conventional radiography remains the gold standard imaging modality for staging multiple myeloma (MM). Other imaging modalities have been evaluated in recent years, and been shown to provide additional information about disease burden and location. FDG-PET/CT has proven to be useful in the identification of extramedullary disease and in monitoring patients with non-secretory myeloma. In addition to diagnostic utility, FDG-PET/CT has also been shown to predict time to relapse in the setting of newly diagnosed MM. However, to our knowledge its utility as a prognostic indicator in relapsed or refractory disease has not been studied. Methods We conducted a retrospective analysis of 61 patients with relapsed or refractory multiple myeloma (RRMM) who underwent PET/CT imaging prior to receiving salvage chemotherapy on a therapeutic trial of ClaPD (clarithromycin, pomalidomide, dexamethasone). Patients were heavily pre-treated, having received a minimum of 3 prior lines of therapy (range 3-15). All imaging was performed on the same PET/CT system at a single institution. Each PET/CT was evaluated in blinded fashion by two independent nuclear medicine physicians, with attention to the number and type of lesion, maximum SUV, and presence or absence of extramedullary disease. Disease response evaluation was performed monthly, and measured according to the international uniform response criteria. Multivariate analysis was performed to assess relationships of the above variables to depth of response, progression free survival (PFS), and overall survival (OS). Results Of 61 evaluable patients, 23 (38%) had no lytic lesions, 12 (20%) had <5 lytic lesions, and 26 (42%) had >5 lytic lesions on FDG-PET/CT. It is worth noting that 10 patients (16%) were found to have extramedullary disease, 8 of whom had >5 lytic bone lesions. There was no correlation between FDG-PET/CT findings and depth of response or median PFS, however patients with >5 lytic lesions had a median OS of 5.8 months, while it has not yet been reached for the other groups. At a median follow up of 13.2 months, 17 patients (74%) with no lytic lesions and 7 (58%) of those with <5 lytic lesions are alive. Conclusions The presence of >5 lesions on PET/CT at time of relapse is associated with poor prognosis in our cohort of heavily pre-treated patients with relapsed or refractory multiple myeloma receiving salvage chemotherapy with ClaPD. The presence of extramedullary disease, seen mostly in patients with >5 lesions, may contribute to our findings. Further studies in patients with relapsed or refractory MM are needed to evaluate the prognostic utility of FDG-PET/CT in this setting, as well as to extend these findings to other salvage regimens. Disclosures: Rossi: Celgene: Speakers Bureau. Mark:Celgene: Consultancy, Honoraria, Membership on an entity’s Board of Directors or advisory committees, Research Funding, Speakers Bureau; Millennium: Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau; Onyx: Research Funding, Speakers Bureau. Zafar:Celgene: Speakers Bureau; Millennium: Speakers Bureau; Onyx: Speakers Bureau. Pekle:Celgene: Speakers Bureau; Millennium: Speakers Bureau. Niesvizky:Millennium: The Takeda Oncology Company: Consultancy, Honoraria, Membership on an entity’s Board of Directors or advisory committees, Research Funding, Speakers Bureau; Onyx: Consultancy, Honoraria, Research Funding, Speakers Bureau; Celgene: Consultancy, Honoraria, Membership on an entity’s Board of Directors or advisory committees, Research Funding, Speakers Bureau.

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