ALBERT

Description: We conducted a prospective, multicenter, single-arm, open-label, non-randomized, phase II study to evaluate the efficacy and safety of 90Y Ibritumomab Tiuxetan of a new approach combining induction chemotherapy with oral Fludarabine and Mitoxantrone (FM) followed by consolidation with 90Y Ibritumomab Tiuxetan for patients with previously untreated FL. Patient eligibility was represented by: age ≥ 18 years with biopsy-proven, untreated; stage II – IV FL grade I–II; WHO performance status of 0 to 2. All patients signed a written informed consent. Patients were treated with standard FM chemotherapy (Fludarabine was administered orally at the dose 40 mg/m2/day for 3 consecutive days) every 28 days for 6 cycles. Patients were restaged 4 to 8 weeks after completion of the sixth cycle of FM. Patients achieving at least a PR after 6 cycles of FM chemotherapy were eligible for consolidation with 90Y Ibritumomab Tiuxetan provided the granulocyte count was 〉 1500/μL, the platelet count 〉100.000/μL, lymphocytes expressing the CD20 antigen and the bone marrow examination at the completion of FM demonstrated 〈 25% involvement with lymphoma. All patients were to receive a single dose of 90Y Ibritumomab Tiuxetan 14.8 MBq/kg (0.4 mCi/kg) up to a maximum dose of 1184 MBq (32 mCi). At data reporting for this abstract, 62 patients were enrolled and 41 were evaluable for response. Of these 41 patients, all are evaluable for induction FM regimen and 19 of them also are evaluable after 90Y Ibritumomab Tiuxetan treatment. 15 were male and 26 female; the median age was 52.5 years (range 36–70); 5 were stage II, 12 stage III, and 24 stage IV. After the FM treatment the OR rate was 100%, including 73% complete remissions (CR + CRu) and 27% PR. Time to event analyses, including TTP and duration of response are pending further follow-up. Treatment was well tolerated; grade ≥ 3 AEs were seen in 20 patients; the most common grade ≥ 3 AEs was neutropenia. Among the actual 19 evaluable patients subsequentially treated with 90Y Ibritumomab Tiuxetan, 3/5 (60%) patients improved their remission status from PR to CR. The 90Y Ibritumomab Tiuxetan toxicity included grade ≥ 3 hematologic AEs in 12 patients. These preliminary data indicate: 1) FM regimen including oral fludarabine presents the same activity of i.v. formulation one without significant gastrointestinal toxicity and with a better patient compliance; 2) feasibility, tolerability, and efficacy of the FM plus 90Y Ibritumomab Tiuxetan regimen for untreated FL. Final efficacy and safety data will be presented.

Description: Abstract 3879 Purpose. The use of early (interim) positron emission tomography (PET) restaging during front-line therapy in Hodgkin's lymphoma (HL) has considerably increased in clinical practice as an early recognition of treatment failure allows patients to be addressed to more intensive treatment regimens. Patients and Methods. Between June 1997 and June 2009, 304 newly-diagnosed Hodgkin's lymphoma patients (147 early-stage and 157 advanced-stage) were treated with the ABVD regimen at two Italian institutions. Patients underwent to a PET staging and restaging at baseline, after 2 cycles of therapy and at the end of the treatment. Results. 53 patients showed a positive interim PET and only 13/53 (24.5%) achieved a complete response (CR), whereas 251 patients showed a negative PET and 231/251 (92%) remained in CR. Comparison between interim PET-positive and interim PET-negative patients indicated a significant association between PET findings and 9-year progression-free survival (p=0.0000) and 9-year overall survival (p=0.0000), with a median follow-up of 31 months. Among the early-stage patients, 19 had a positive interim PET and only 4 (21%) achieved a CR; among the 128 negative interim PET patients, 122 (97.6%) obtained a CR. In the advanced-stage subset, 34 patients showed a persistently positive PET (with only 9/34, 26.4% in CR), whereas 123 showed a negative interim PET, with 109 (88.6%) remaining in CR. Conclusions. Our results confirm the role of early PET as a significant step forward for the management of both early and advanced-stage HL patients, offering the potential for an immediate switch to high-dose treatments, if required. Disclosures: No relevant conflicts of interest to declare.

Description: Abstract 369 F-18-fluorodeoxyglucose positron emission tomography integrated with computed tomography (FDG-PET/CT) has been reported to be a careful technique for a widespread screening of myelomatous lesions, both medullary and extramedullary, at the onset of multiple myeloma (MM). By the opposite, the role of FDG-PET/CT in assessing and monitoring response to therapy and the prognostic value of this imaging technique is less explored. Aim of the present study was to prospectively evaluate the prognostic significance of FDG-PET/CT at diagnosis and after therapy in an homogeneous population of patients with newly diagnosed MM who received up-front single or double autologous stem cell transplantation (ASCT). By study design, all patients were studied with FDG-PET/CT at baseline, 3 months after ASCT, every year during the maintenance/follow-up phase and at time of relapse. Bone marrow involvement was described as negative, diffuse or focal. The number of focal lesions (FL), as well as their size and associated standardized uptake values (SUV) were recorded. Extramedullary disease, if present, was described by location, size, number of lesions and SUV. A total of 146 patients who actually received the planned treatment program and were followed for a median of 39 months were analyzed. Their median age was 58 years. ISS stage was as follows: 48% stage I, 31% stage II, 14% stage III. Six per cent of the patients had renal failure, related to the presence of hypercalcemia at diagnosis. Del (13q), t(4;14) and del(17p), detected by FISH, were present in 47%, 25% and 10% of the patients, respectively. Induction treatment prior to ASCT included an IMiD in 55% of the patients, bortezomib in 34% and chemotherapy in 11% of the cases. The best overall response rate, including CR and at least VGPR, was 56% and 82%, respectively. Median PFS of the entire population was 55 months and the 5-year projected OS rate was 85%. At baseline, 22% of the patients had a negative PET/CT, 27% presented less than 3 FL and 51% 3 or more FL or a diffuse bone marrow uptake of FDG. In 44% of the cases the SUV was low (〈 3.9) while in 56% was 4 or more. In 6% of the patients extramedullary disease was present. No significant differences between patients with positive or negative PET/CT were found regarding baseline characteristics and response to therapy. The entity of PET/CT involvement at baseline influenced clinical outcomes. In particular, patients with more than 3 FL and/or SUV 〉 3.9 had a significantly shorter OS in comparison with patients with FL 〈 3 and/or SUV 〈 3.9 (5-year projected OS: 92% vs 75%, respectively, P=0.04). After 3 months from ASCT, PET/CT was negative in 65% of the patients and remained positive, either unchanged or with a reduction in the SUV, in 35% of them. A correlation between PET/CT findings and response to ASCT was evident; in particular, among patients with negative PET/CT the rate of CR and VGPR was significantly higher than among patients with positive PET/CT (CR: 68% vs 38%; P= 0.001) (VGPR: 90% vs 76%; P= 0.008). Complete FDG suppression at PET/CT after ASCT conferred superior PFS and OS than persistence of FL (PFS: median 58 vs 45 months, respectively, P=0.05; 5-year projected OS: 92% vs 79%, respectively, P=0.004). In conclusion, involvement of PET/CT at diagnosis in terms of number of FL and intensity of tumour metabolism (SUV) predicted survival outcome. Complete FDG suppression after ASCT was strictly related with achievement of high-quality response and was prognostically relevant for durable disease control and longer OS. Disclosures: Cavo: Jansen-Cilag: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau, no; Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau, no; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau, no.

Description: We conducted a prospective, single-arm, open-label, non-randomized, multicenter, phase II to evaluate the efficacy and safety of 90Y Ibritumomab Tiuxetan of a novel new approach combining induction chemotherapy with Fludarabine and Mitoxantrone (FM) followed by consolidation with 90Y Ibritumomab Tiuxetan for patients with previously untreated indolent non-follicular lymphoma (indolent non-FL). Patient eligibility was represented by: patients age 18 years or older with biopsy-proven, untreated, bidimensionally measurable stage II, stage III, or stage IV indolent non-FL expressing the CD20 antigen; WHO performance status of 0 to 2. All patients were notified of the investigational nature of this study and signed a written informed consent approved in accordance with institutional guidelines, including the Declaration of Helsinki. The study was approved by the institutional review boards. Patients were treated with standard FM chemotherapy every 28 days for 6 cycles. Patients were restaged 4 to 8 weeks after completion of the sixth cycle of FM chemotherapy. Patients achieving at least a partial response after 6 cycles of FM chemotherapy were eligible for consolidation with 90Y Ibritumomab Tiuxetan provided the granulocyte count was greater than 1500/μL, the platelet count exceeded 100.000/μL, and the bone marrow examination at the completion of FM chemotherapy demonstrated no more than 25% involvement with lymphoma. All patients were to receive a single dose of 90Y Ibritumomab Tiuxetan 14.8 MBq/kg (0.4 mCi/kg) up to a maximum dose of 1184 MBq (32 mCi). At data reporting for this abstract, 29 patients were enrolled and 26 were evaluable for response. Of these 26 patients, all are evaluable for induction chemotherapy FM regimen and 17 of them also are evaluable after 90Y Ibritumomab Tiuxetan treatment. Histologically, 11 had marginal zone lymphoma, 10 had lymphoplasmacytic lymphoma, and 5 had small lymphocytic lymphoma; 10 were male and 16 female; the median age was 61 years (range 45–82); 4 were stage III, and 21 stage IV. After the FM treatment the overall response rate was 81%, including 50% CR and 31% PR. Time to event analyses, including TTP and duration of response are pending further follow-up. Treatment was well tolerated; grade ≥ 3 AEs were seen in 13 patients; the most common grade ≥ 3 AEs was neutropenia. Among the actual 17 evaluable patients subsequentially treated with 90Y Ibritumomab Tiuxetan, 2/4 (50%) patients improved their remission status from PR to CR. The 90Y Ibritumomab Tiuxetan toxicity included grade ≥ 3 hematologic AEs in 15 patients; the most common grade ≥ 3 AEs were neutropenia (10 patients) and thrombocytopenia (15 patients). Transfusions of red cells and/or platelets were given to 6 patients. These preliminary data indicate the feasibility, tolerability, and efficacy of the FM plus 90Y Ibritumomab Tiuxetan regimen for patients with untreated indolent non-FL. Final efficacy and safety data will be presented.

Description: Abstract 3019 Background: Radioimmunotherapy (RIT) is an effective and manageable treatment option for those patients (pts) affected by follicular B-cell lymphoma (FL) who experience disease relapse. The results of RIT in the setting of first line consolidation are also very promising in terms of progression free and overall survival. On the other hand autologous stem cell transplantation (ASCT) is a suitable treatment option for relapsed FL patients. Although major concerns about the widespread use of RIT early in the disease course are the long term hematologic toxicity and the theoretical possible irreparable damage to bone marrow function with impairment of peripheral stem cell harvest, very few data are available about mobilization rates after Zevalin exposure. Methods: The aim of this monocentric study was to analyze the impact of prior Zevalin administration on peripheral blood stem cells (PBSC) mobilization and on the outcome of subsequent ASCT. Moreover the impact of different prior treatment regimens [Cyclophosphamide, Doxorubicin, Vincristine, Prednisone plus Rituximab (R-CHOP) or CHOP-like regimens vs Fludarabine, Mitoxantrone plus Rituximab (FM-R) vs Zevalin] and number of previous lines of therapy given earlier in the disease course, was prospectively evaluated in all FL patients (n=100) who underwent stem cell mobilization from January 2005 to March 2012. Results: At the time of mobilization, 68 pts had received R-CHOP or CHOP-like regimens, 20 pts FM-R, 12 pts RIT with Zevalin earlier in the disease course. Characteristics of pts such as age, weight and number of prior therapies, were well balanced in the 3 groups. Sixty one pts had received one prior therapy, 31 pts 2 therapies, 8 pts ≥ 3 lines of therapy. All pts received chemotherapy plus granulocyte colony stimulating factor (G-CSF) 5 μg/kg (n=94) or G-CSF alone (10 μg/kg) (n=6) as mobilization regimen. Mean CD34+ cells yield was 8.9 × 106/kg in the CHOP group, vs 5.8 × 106 CD34 + cells/kg in the FM-R group, vs 2.7 × 106 CD34 + cells/kg in the Zevalin group (p=0.05 CHOP vs FM-R; p20000/μL) was 10 and 11 days in all groups respectively. Only one pt in the CHOP group and one in the FM-R group did not undergo ASCT because of insufficient CD34+ harvest. Considering the Zevalin group (n=12), median age was 51 years (range 36–66). Seven pts received Zevalin as first line consolidation, 5 patients at disease relapse. Median number of prior therapies was 2 (range 1–4). Ten pts received chemotherapy plus G-CSF as initial mobilization regimen, 2 pts received G-CSF alone. Median time from RIT to mobilization was 13 months (4–60 months). Five pts (42%) reached the collection yield of 〉 2.0 × 106 CD34 + cells/kg with the first mobilization attempt. Considering the remaining 7 pts who failed (CD34+ cells below 10/mL before apheresis, or cell harvest below 2.0 × 106 CD34 + cells/kg), a surgical procedure was attempted in 4 pts, G-CSF + Plerixafor (240 μg/kg) in 3 pts. Remarkably the second harvest allowed 5 additional pts (3 pts after surgery, 2 pts after G-CSF + Plerixafor) to undergo ASCT. Finally ASCT was succesfully performed in 9 pts (75%). Median number of reinfused CD34+ cells was 2.3 × 106 CD34 + cells/kg (0.4–4.2). Three pts did not undergo ASCT, one because of disease progression, 2 pts because of insufficient CD34+ harvest. Conclusions: The type of previous therapy may significantly influence the mobilization rate in FL pts. Although mobilization was significantly impaired in pts previously treated with Zevalin compared to other chemotherapy regimens, stem cell harvest after RIT was feasible and the vast majority of patients retained the possibility to undergo ASCT with a second stem cell harvest, with no significant impact on engraftment. The use of Plerixafor seems to be particularly promising for those patients previously exposed to RIT who failed the first mobilization. Disclosures: No relevant conflicts of interest to declare.

Description: In the last 20 years, the major improvement over the use of CHOP has been the addition of anti-CD20 immunotherapy (Rituximab). This advancement was first demonstrated in a randomized trial in elderly patients with diffuse large B-cell lymphoma (DLBCL). Single-agent radioimmunotherapy activity, in particular Yttrium 90 (90Y) Ibritumomab Tiuxetan (Zevalin®), has been demonstrated in heavily pretreated DLBCL patients. Recently, the preliminary data of a phase II trial have showed that 90Y Ibritumomab Tiuxetan have useful activity in the treatment of relapsed/refractory elderly DLBCL (Morschhauser et al, Blood 2004, 104: 41a), with no unexpected toxicities observed. The results of this study support a further evaluation of 90Y Ibritumomab Tiuxetan in combination with chemotherapy earlier in the time course of elderly DLBCL. We conducted a prospective, single-arm, open-label, non-randomized, phase II to evaluate the efficacy and safety of 90Y Ibritumomab Tiuxetan of a novel new approach combining induction chemotherapy with CHOP followed by consolidation with 90Y Ibritumomab Tiuxetan for patients with previously untreated elderly DLBCL. Patient eligibility was represented by: patients older than 60 years with biopsy-proven, untreated, bidimensionally measurable stage II, stage III, or stage IV DLBCL expressing the CD20 antigen; WHO performance status of 0 to 2. All patients signed a written informed consent approved in accordance with institutional guidelines. The study was approved by the institutional review board. Patients were treated with standard CHOP chemotherapy every 21 days for 6 cycles. Patients were restaged 4 to 6 weeks after completion of the sixth cycle of CHOP chemotherapy. Patients achieving at least a partial response after 6 cycles of CHOP chemotherapy were eligible for consolidation with 90Y Ibritumomab Tiuxetan provided the granulocyte count was greater than 1500/μL, the platelet count exceeded 100.000/μL, and the bone marrow examination at the completion of CHOP chemotherapy demonstrated no more than 25% involvement with lymphoma. All patients were to receive a single dose of 90Y Ibritumomab Tiuxetan 14.8 MBq/kg (0.4 mCi/kg) up to a maximum dose of 1184 MBq (32 mCi). A total of 20 patients have been enrolled: 12 were male and 8 female; the median age was 68 years (range 61–84); 6 were stage II, 14 stage III-IV. After the CHOP treatment the overall response rate was 100%, including 15 (75%) CR and 5 (25%) PR. Treatment was well tolerated; grade ≥ 3 AEs were seen in 13 patients; the most common grade ≥ 3 AEs was neutropenia. After the treatment of all 20 patients with 90Y Ibritumomab Tiuxetan, 4/5 (80%) patients improved their remission status from PR to CR. The 90Y Ibritumomab Tiuxetan toxicity included grade ≥ 3 hematologic AEs in 11/20 patients; the most common grade ≥ 3 AEs were neutropenia (11 patients) and thrombocytopenia (7 patients). Transfusions of red cells and/or platelets were given to 2 patients. Time to event analyses, including TTP and duration of response are pending further follow-up. These preliminary data indicate the feasibility, tolerability, and efficacy of the CHOP plus 90Y Ibritumomab Tiuxetan regimen for patients with untreated elderly DLBCL.

Description: Background: 18F-FDG-PET/CT is currently the standard technique to define minimal residual disease (MRD) status outside the bone marrow (BM) in multiple myeloma (MM) patients. A joined analysis of two prospective randomized trials in newly diagnosed transplant-eligible MM (NDTEMM) patients applied for the first time the Deauville Scores (DS) to focal lesions (FS) and bone marrow uptake (BMS) and showed the liver background (DS 〈 4) to be the best cut-off to define PET negativity after therapy (Zamagni et al, ASH 2018). Multiparameter Flow cytometry (MFC) at the sensitivity level of 10-5 is one of the standardized methods to assess MRD in the BM (Kumar SK, Lancet Oncol 2016). In this analysis, we aimed at comparing MRD data by PET/TC assessment and MFC in the multicenter phase II randomized FORTE trial for NDTEMM patients. Methods: NDTEMM patients ≤65 years were randomized to receive carfilzomib, lenalidomide, dexamethasone (KRD) induction - autologous stem cell transplantation (ASCT) intensification-KRd consolidation (arm A); KRd12 (arm B) and carfilzomib, cyclophosphamide, dexamethasone (KCd) induction-ASCT intensification-KCd consolidation (arm C). Thereafter, patients were randomized to maintenance with lenalidomide alone or lenalidomide plus carfilzomib. MRD evaluation was performed by 8-color second-generation flow cytometry (sensitivity 10-5) in patients who achieved at least VGPR before maintenance (Gay F, ASCO 2019). PET/CT scans were performed locally at baseline (B) and prior to the start of maintenance (PM) and the DS were applied both in the BM and FLs as previously described. Cramér's V coefficient was used to measure the concordance between PET/TC and MFC; Fisher or X2 tests were adopted, where appropriate, to evaluate the statistical significance, at the level of 0.05. Results: 182 out of the 474 global patients enrolled in the trial had a matched PET/CT and MFC evaluation available and were included in the present analysis. Baseline characteristics of the patients were as follows: median age 57 years, ISS and R-ISS stage III 18% and 10%, respectively, high-risk cytogenetics (t(4;14) ± del(17p) ± t(14;16), detected by FISH) 26%, reflecting baseline clinical features of the entire FORTE population. At B, 92% of the patients had FLs, with a median maximum standardized uptake value (SUVmax) of 5.7 [IQR: 4.1-8.1], 11% presented extra-medullary lesions and nearly all the patients had increased BM uptake, with a median SUVmax of 3.3 [IQR: 2.8-4.3]. FS and BMS ≥4 were present in 87% and 59% of the patients, respectively. A higher FS at B was significantly correlated with ISS stage III (P= 0.04), while higher BMS with lower hemoglobin level (P= 0.002) and higher free light chain ratio (P= 0.004). At PM, PET/TC negativity according to DS 〈 4, was present in 78% in the FLs and 85% in the BM, respectively. No significant correlations between PET/CT negativity after therapy and baseline prognostic factors or PET/CT characteristics were found. 95% and 67.5% of the patients achieved ≥ VGPR and CR as best response, respectively, while 75% of them achieved MFC MRD negativity. The achievement of a best CR significantly correlated with BMS 〈 4 at PM (P= 0.013). We analyzed the concordance between MRD results by the two techniques and Cramér's V coefficient measured a strong association, with a value of 0.76 (p

Description: F-18-fluorodeoxyglucose positron emission tomography integrated with computed tomography (FDG-PET/CT) is actually considered as the standard technique to assess and monitor the metabolic response to therapy and to define minimal residual disease (MRD) status outside the bone marrow (BM) in multiple myeloma (MM) patients. In this regard, standardization of image criteria and definition of cut-offs for positivity/negativity is of highly importance. Aim of the present study was to prospectively evaluate FDG-PET/CT at diagnosis and prior to maintenance therapy in a joined analysis of a sub-group of patients with newly diagnosed transplant-eligible MM, enrolled in 2 independent European randomized phase III trials (EMN02/HO95 and IFM2009) (Cavo M et al, Blood 2017 abs; Attal M et al, NEJM 2017). The primary end-point was to standardize PET/CT evaluation by centralized imaging and revision and to define criteria for PET negativity after therapy (MRD definition). 236 patients (102 and 134 from the EMN02 and IFM2009 trial, respectively) were enrolled in the PET/CT imaging sub-studies and followed for a median of 62.9 (IQR: 44.9-67.9) months. By study design, PET/CT scans were performed locally at baseline (B) and prior to the start of maintenance (PM), uploaded in a central website and re-interpreted a-posteriori in a blinded independent central review process, by a panel of expert nuclear medicine physicians. According to the IMPeTUs criteria (Nanni C et al, EJNM 2017), the five-point Deauville scores (between 1 and 5) were applied to the following parameters: bone marrow (BM), focal lesions (FLs), extramedullary disease (EMD). The impact of each parameter on outcomes was evaluated by landmark analyses at PM; the univariate and multivariate analyses were stratified by trial to smooth out differences between the 2 studies. Baseline characteristics of the patients were generally homogeneous between the 2 trials and as follows: median age 59 years, ISS and R-ISS stage III 15.8% and 11.5%, respectively, high-risk cytogenetics (t(4;14) ± del(17p) ± t(14;16) detected by FISH) 14%. Fifty seven percent of the patients were randomized in the transplant arm, and 43% in the bortezomib-intensification arm, with a higher percentage in the IFM2009 vs EMN02 trial (54% vs 24%, respectively). At baseline, 80% of the patients had FLs, with a median maximum standardized uptake value (SUVmax) of 5. Median BM SUVmax was 3. Both median FLs and BM SUVmax were slightly higher in the IFM2009 vs the EMN02 trial (5.7 vs 4.2 and 3.7 vs 2.68, respectively), while reference SUVmean (mediastinal blood pool and liver) did not differ between the 2 studies. FLs Deauville score (FS) and BM Deauville score (BMS) 〉 3 (higher than the liver) were present in 79.8% and 35.5% of the patients, respectively, with no difference between the 2 trials. EMD was present in 11% of the patients. Prior to maintenance therapy, median FLs and BM SUVmax were 3.6 and 2.3, respectively, with 53.5% and 71.2% of the patients obtaining a FS and BMS ≤ 2 and 79% and 91.4% ≤ 3, respectively. In univariate analysis, at Landmark time prior to maintenance, attaining a FS and BMS ≤ 3 was the strongest predictor for prolonged PFS (FS≤ 3 vs 〉3: median 40 vs 26.6 months, HR 0.6, CI 0.39-0.98, P= 0.0019; BMS≤ 3 vs 〉3: median 39.8 vs 26.6 months, HR 0.47, CI 0.24-0.91, P= 0.024, respectively) and OS (FS≤ 3 vs 〉3: estimate at 63 months 73% vs 63.6% months, HR 0.51, CI 0.26-0.98, P= 0.028; BMS≤ 3 vs 〉3: estimate at 75.5% vs 49.7%, HR 0.28, CI 0.12-0.64, P= 0.002, respectively) and could be identified as the most representative cut-off values for PET negativity after therapy. Of the two PM scores, only FS ≤ 3 retained prognostic relevance in the subgroup of patients not receiving transplant, in terms of PFS. In Cox multivariable analysis, FS and BMS ≤ 3 at PM were independent predictors of prolonged PFS (FS: HR 0.58, CI 0.35-0.96, P= 0.036; BMS HR 0.41, CI 0.20-0.84, P= 0.014) and OS (FS: HR 0.36, CI 0.17-0.74, P= 0.005; BMS HR 0.24, CI 0.09-0.63, P= 0.004). In conclusion, FDG PET/CT was confirmed to be a reliable predictor of outcomes in newly diagnosed MM, regardless of treatment. Reduction of FDG uptake lower than the liver after therapy, both in the FLs and in the BM (FS and BMS), was an independent predictor for improved PFS and OS. Findings from this analysis could be proposed as standardized criteria to define PET negativity after therapy, confirming the value of Deauville scores in MM. Disclosures Zamagni: Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees; BMS: Honoraria, Membership on an entity's Board of Directors or advisory committees. Tacchetti:Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Honoraria; Janssen: Honoraria; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees; BMS: Honoraria. Gallamini:Takeda: Consultancy, Speakers Bureau. Patriarca:Jazz: Other: Travel, accommodations, expenses; Medac: Other: Travel, accommodations, expenses; Celgene: Other: Advisory Role; Travel, accommodations, expenses; Janssen: Other: Advisory role; MSD Italy: Other: Advisory Role. Macro:Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Financial support for congress; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Financial support for congress; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Financial support for congress; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Financial support for congress. Boccadoro:Bristol-Myers Squibb: Honoraria, Research Funding; AbbVie: Honoraria; Novartis: Honoraria, Research Funding; Janssen: Honoraria, Research Funding; Amgen: Honoraria, Research Funding; Celgene: Honoraria, Research Funding; Sanofi: Honoraria, Research Funding; Mundipharma: Research Funding. Garderet:Takeda: Consultancy; Amgen: Consultancy; Celgene: Consultancy. Perrot:Takeda: Honoraria; Sanofi: Honoraria; Amgen: Honoraria; Janssen: Honoraria; Celgene: Honoraria. Sonneveld:Amgen: Honoraria, Research Funding; BMS: Honoraria, Research Funding; Karyopharm: Honoraria, Research Funding; Janssen: Honoraria, Research Funding; Celgene: Honoraria, Research Funding. Karlin:Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: travel support; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: travel support. Cavo:Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; AbbVie: Honoraria, Membership on an entity's Board of Directors or advisory committees; GlaxoSmithKline: Honoraria, Membership on an entity's Board of Directors or advisory committees; Bristol-Myers Squibb: Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Adaptive Biotechnologies: Honoraria, Membership on an entity's Board of Directors or advisory committees. Moreau:Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Abbvie: Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees.