ALBERT

Description: Backround: Arsenic trioxide (ATO) has been shown to be synergistic with melphalan both in vitro and in vivo. We conducted a phase I/II trial to determine the safety and efficacy of a combination of arsenic trioxide, melphalan and ascorbic acid (AA) as preparative regimen in patients undergoing high-dose therapy (HDT) and autologous hematopoietic progenitor cell transplantation for multiple myeloma (MM). We also assessed the impact ATO levels on melphalan pharmacokinetics (PK), engraftment and toxicity. Methods: Forty-eight patients with secretory myeloma (23 females, 25 males; median age: 54, range: 3570) were treated between 4/04 and 8/05. All patient received melphalan 100 mg/m2 IV on days -4 and -3 and AA 1000 mg/day IV on days -9 to -3. Patients were randomized to 3 arms; no ATO (arm 1), ATO 0.15 mg/kg IV on days -9 to -3 (arm 2) and ATO 0.25 mg/kg IV on days -9 to -3 (arm 3). Twelve patients had disease progression or relapse after a prior autograft. Median CD34 cells dose infused was 4.5 x 106/kg (range 2.3–10.9). Results: Patients in all 3 arms were evenly matched. With a median F/U of 14.0 months (range 6–25) post autograft, no dose-limiting toxicity or non-relapse mortality was seen. Toxicity was limited to grade I or II nausea, vomiting and diarrhea. Median ATO levels on day 0 in arms 1, 2 and 3 were 0.2, 26.3 and 46.2 ng/ml, respectively. Melphalan PK was not altered by ATO pretreatment. Median time to neutrophil engraftment (ANC 〉500/ dl) was 9 days. There were no engraftment failures or delays in the ATO arms. CR rate for the entire group was 23%, and total response rate (CR + PR) was 75%. 1-year Progression-free survival (PFS) and overall survival (OS) were 75% and 95%, respectively. There was no significant difference in CR, RR, PFS or OS between the 3 arms (p = 0.9, 0.9, 0.4 and 0.6, respectively). A prior autologous transplant (p = 0.02) and abnormal cytogenetics at transplant (p = 0.04) were associated with a significantly shorter remission. Conclusions: ATO + melphalan + ascorbic acid is a safe, effective and well tolerated preparative regimen for patients with multiple myeloma undergoing an autotransplant. A longer follow up is needed to assess the impact of ATO on progression-free and overall survival.

Description: Background: Allogeneic hematopoietic stem cell transplantation (allo SCT) has two potential advantages over autologous SCT: a tumor-free graft and graft-versus-myeloma (GVM) effect. Allo SCT’s potential to induce long term remission has, however, been offset by high rates of transplant-related non-relapse mortality (TRM). Reduced-intensity conditioning (RIC) regimens for allo SCT are associated with lower TRM without compromising the GVM effect. Methods: We retrospectively analyzed our experience in 69 patients (30 females and 39 males) with heavily pretreated, relapsed myeloma, who received allo SCT at our institution between1985 and 2007. Eighteen patients received myeloablative regimens (MA), while 51 received RIC regimens. MA regimens were TBI-based in 5 patients, high-dose busulfan-containing in 6 patients and high-dose melphalan containing (180–200 mg/m2) in 7 patients. RIC regimens were a combination of fludarabine (90–120 mg/m2) and melphalan (100–140 mg/m2). Median age of patients at allo SCT in both groups was 51 years. Median interval from diagnosis to allo SCT was 35.4 months in MA group, and 34.2 months in RIC group. Eight (44%) patients in MA group and 36 (70%) patients in RIC group had prior autologous SCT. Six patients (33%) in the MA group and 11 (25%) in the RIC group received allo SCT from unrelated donors (p=0.3). Median number of prior treatment regimens were 5 (range 1–10) in both groups. Stem cell source was peripheral blood in 3 patients in MA group and 41 patients in the RIC group (p=0.0001). Results: Median follow-up in surviving patients was 27 months (3–98). All patients achieved engraftment. Cumulative TRM at 1 year was 56% in the MA group and 25% in the RIC group (p=0.03). Overall response rates in evaluable patients were 69% (CR=15%, PR= 54%) in MA group, and 79% (CR=23%, PR=56%) in the RIC group (p=0.47). Disease progression at 2 years was seen in 8 patients (44%) in the MA group and 25 patients (49%) in the RIC group (p=0.78). Median progression-free survival (PFS) in MA vs. RIC groups was 4.1 and 6.8 months, respectively (p=0.003) and median overall survival (OS) ) in MA vs. RIC group was 5.3 and 13.9 months, respectively (p=0.001). Cumulative Incidence of grade II–IV acute graft-vs.-host (GVHD) in MA vs. RIC groups disease was 33 vs. 27% (p=0.76); cumulative incidence of chronic GVHD in MA vs. RIC group was 54% vs. 47% (p=0.41) in evaluable patients. At the time of this analysis, 13 patients (25%) were still alive in RIC group, 7 of whom (14%) were in remission for up to 6 years post allo SCT. The most common causes of death were recurrent disease (30 patients; 43%), acute or chronic GVHD (16 patients; 23%) and opportunistic infections (5 patients: 7%). Conclusions: Allo SCT after RIC regimens is associated with longer PFS and OS and lower TRM. There was no increase in the risk of relapse, or acute or chronic GVHD. These regimens can safely replace MA regimens and may offer greater benefit if utilized earlier in the course of disease. Figure Figure

Description: Background: Allogeneic transplantation is a potentially curative approach in patients with myeloma. The potential benefit is offset by a higher risk of transplant-related mortality (TRM), graft-vs.host disease (GVHD) and opportunistic infections. The success of reduced intensity conditioning approaches has renewed interest in allogeneic transplantation. In this randomized phase II trial we evaluated whether lowering the dose of melphalan in a nonablative preparative regimen can lower the toxicity and TRM. Two reduced intensity regimens: fludarabine + melphalan 140 mg/m2 (FM 140) and fludarabine + melphalan 100 mg/m2 (FM 100) were compared in patients undergoing allogeneic stem cell transplantation. Methods: We enrolled 22 patients, 11 in each arm, who were 70 years of age or younger and had an HLA-identical sibling donor. Patients underwent allogeneic transplantation between April 2002 and January 2007. Median age was 52.5 years (Range: 32–63). GVHD prophylaxis consisted of tacrolimus and methotrexate 5mg/m2 on days 1, 3, 6 and 11. Median interval between diagnosis and transplant was 28 months (9–232). Only 6 patients (27%) received transplant for the consolidation of first remission, the rest had relapsed or refractory disease (73%). Twenty-one patients had a prior autotransplant; 3 of these had 2 prior autotransplants. Median number of prior treatment regimens was 5 (1–10). Cytogenetic abnormalities were observed in 8/22 patients (36%). Results: The 2 groups were comparable in terms of age, disease status, prior therapy and other prognostic factors. Median time to neutrophil engraftment in both arms was 12 days. TRM in the first 100 days was zero in both arms. Response rate (CR 18% + PR 64%) was 82%, with no significant difference between the 2 arms. After a median follow up of 25 months (26 months in FM 100, 21 months in FM 140), Kaplan-Meier estimates of 2-year PFS in FM 100 vs. FM 140 were 41% vs. 42%, respectively. Kaplan-Meier estimates of 2-year OS in FM 100 vs. FM 140 were 60 vs. 36%, (p=0.4), respectively. There was no significant difference in the incidence of grade II-IV acute GVHD (27 vs. 36%) or chronic GVHD (50 vs. 43%) between the 2 arms. There was a decrease in overall grade II-IV toxicity in the FM 100 arm (45% vs. 73%) that did not reach statistical significance (p=0.2) Patients transplanted in relapse had shorter PFS (0.09). Conclusions: The dose of melphalan in preparative regimen can be safely reduced without adversely impacting the engraftment in this heavily pretreated patient population. There was a trend towards lower grade II-IV toxicity and prolonged OS in the FM 100 arm. This approach may be more beneficial when used early in the course of treatment.

Description: Background: There is a role of novel preparative regimens to further improve the outcome after high-dose chemotherapy and autologous hematopoietic stem cell transplantation (ASCT) in multiple myeloma. Arsenic trioxide (ATO) has synergistic activity with melphalan and ascorbic acid (AA) both in vitro and in vivo, and this 3-drug combination was found to be safe and feasible in both conventional and high-dose settings. Bortezomib, a proteasome inhibitor, is an active agent in newly diagnosed or relapsed multiple myeloma in conventional therapy setting. We conducted a randomized phase II trial to determine the safety and efficacy of a combination of ATO, AA and melphalan with or without bortezomib as preparative regimen in patients with myeloma. Methods: Sixty patients were enrolled and 58 patient received ASCT between October 2006 and September 2007. One patient developed respiratory failure and another developed extensive pulmonary embolism after enrollment and did not proceed to ASCT. All 58 evaluable patients received melphalan 100 mg/m2 IV on days -4 and -3, AA 1000 mg/day IV on days -9 to -3 and ATO 0.25 mg/kg IV on days -9 to -3. Patients were randomized to 3 arms; no bortezomib (arm 1), bortezomib 1 mg/m2 on days -9, -6 and -3 (arm 2), and bortezomib 1.5 mg/m2 on days -9, -6 and -3 (arm 3). Patients were also asked to fill out a standardized Quality of Life (QOL) questionnaire at enrollment and at 6 months post-ASCT. Results: Median age of patients in arms 1, 2 and 3 were 61, 59 and 64 years, respectively (p=0.08). Median interval between diagnosis and ASCT were 12.2, 9.6 and 8.8 months, respectively (p=0.3). Cytogenetic abnormalities were detected in 2, 5 and 8 patients in arms 1, 2 and 3, respectively (p=0.08). With a median follow up of 11.4 months (range 5 to 20) post ASCT in surviving patients, cumulative non-relapse mortality was1.7%. Grade 3–4 toxicity was seen in 6 patients in arm 1 (mucositis 3, dyspnea 1, acute renal failure 1, pleural effusion 1), 6 patients in arm 2 (mucositis 3, diarrhea 1, pneumonia 1 and hydronephrosis 1) and 6 patients in arm 3 (pulmonary edema 2, mucositis 1, intestinal obstruction 1, low back pain 1, elevated transaminases 1) (p=0.9). The most common adverse events were nausea, diarrhea and pedal edema. Grade 1–2 weight gain due to fluid retention was seen in 84, 70 and 95% of patients in arms 1, 2 and 3, respectively (p= 0.1). Median time to neutrophil engraftment (ANC 〉500/dl) was 10 days in each arm. Complete response rates in arms 1, 2 and 3 were 26, 10 and 16%, respectively (0=0.4). Kaplan-Meiers estimates of progression-free survival (PFS) and overall survival (OS) are shown in Figures 1 and 2. Median PFS and OS have not been reached. There was no significant difference in CR, PFS or OS between the 3 arms (p = 0.4, 0.62 and 0.4, respectively). Relapsed disease at ASCT (p=0.003), 〉12 months interval between diagnosis and ASCT (p=0.05), and cytogenetic abnormalities at diagnosis (p=0.005) predicted a shorter PFS. On a subset analysis, there was no significant difference in PFS or OS between the 3 arms in patients undergoing ASCT in first remission. Fifty-patients submitted their responses to the QOL questionnaire. More patients at 6-month post ASCT reported better overall health (56% vs.12%, p=0.0001). In contrast, more patients at study enrollment reported moderate to severe pain (44% vs. 27%, p=0.09) and debilitating emotional problems (42% vs. 23%, p=0.07). Conclusions: Adding bortezomib to ATO, AA and high dose melphalan is safe and well tolerated as preparative regimen for ASCT in patients with multiple myeloma. Patients with chromosomal abnormalities were predominantly treated in the bortezomib arms without an adverse impact on PFS or OS. Overall QOL indicators showed improvement at 6-month post ASCT. Longer follow up is needed to assess the efficacy of this combination. FIGURE 1 FIGURE 1. FIGURE 2 FIGURE 2.

Description: BACKGROUND: Developing prognostic factors for allo SCT is important in deciding transplant approaches for older patients with AML/MDS. BNP levels and CRP levels have been shown to predict outcomes in patients with amyloidosis or cardiovascular diseases. We hypothesized that in patients with AML/MDS pretransplant levels of BNP and CRP would be associated with transplant outcomes. PATIENT & METHODS: All patients with AML/MDS undergoing allogeneic SCT from January 1 2006 until December 31 2006 had pre SCT levels of BNP and CRP drawn and included for analysis. Pretransplants levels of BNP and CRP were analyzed in quartiles and correlated with NCI toxicities, 1 year non relapse mortality (NRM) and overall survival (OS). RESULTS: Patient characteristics are summarized in table 1 and outcomes according to remission status are summarized in table 2. In brief, a total of 106 patients were identified, median age was 50 years, median time to allo SCT was 9 months, 50% of patients were in CR at the time of SCT. Patients IN CR were younger, had lower comorbidity scores, lower median pre SCT CRP and BNP levels and had a higher likelihood of receiving an ablative regimen than patients NOT IN CR. In patients IN CR low levels of CRP prior to SCT predicted for better 1 yr survival and lower NRM. In patients NOT IN CR, higher CRP and BNP levels were associated with a trend towards an increased risk of toxicity. Higher CRP levels were also associated with a trend towards worse OS and NRM rates. CONCLUSIONS: Pre SCT CRP and BNP levels are associated with allogeneic transplant outcomes in patients with AML/MDS and further study with larger patient numbers is warranted. The relationship of CRP levels and NRM suggests a potential role for IL6 in transplant associated toxicities. Patient Characteristics Variable CR @ SCT No CR @ SCT p CRP nl range (4 15% 40% 0.02 % RIC 36% 55% .05 CRP median 0.31 1.1 median 12% 0.5 37% 3.0 (0.09) 52% ne (0.007) CRP≤ 1st qtl 8% 100% 0% CRP 〉 1st qtl 10% 0.6 38% ne (0.03) 41% ne (0.09) BNP≤ 1st qtl 7% 61% 21% BNP 〉 1st qtl 10% 0.6 36% 0.8 (0.7) 47% 0.5 (0.4) NOT IN CR PRE SCT CRP≤ median 8% 39% 10% CRP 〉 median 25% 0.1 50% 1.1 (0.8) 14% 1.6 (0.6) CRP≤ 1st qtl 7% 71% 0% CRP 〉 1st qtl 19% 0.3 39% 0.5 (0.2) 16% ne (0.1) BNP≤ 1st qtl 0% 58% 8% BNP 〉 1st qtl 20% 0.07 45% 0.9 (0.9) 12% 0.8 (0.8)

Description: Abstract 1186 Poster Board I-208 Background: Almost all patients with multiple myeloma (MM) who receive autologous hematopoietic stem cell transplantation (auto HCT) eventually relapse. The treatment options for these patients include novel agents or second (salvage) auto or allogeneic (allo) HCT. Use of reduced intensity conditioning (RIC) has significantly reduced the transplant-related mortality (TRM) with allo HCT. We evaluated the outcomes of patients who received salvage auto or allo HCT for relapsed MM. Methods: Sixty-two patients (24 females and 38 males), with a median age of 55 years (range: 37-73) received a salvage auto HCT between January 1992 and December 2008, whereas 44 patients (19 females and 25 males), with a median age of 51 years (range 32-65) received salvage allo HCT (12 unrelated and 32 related donor) between October 1988 and December 2006. Among 12 patients with unrelated allo HCT, ten were matched at 10/10 HLA loci, while two patients were mismatched at 1 or 2 loci, respectively. Among 32 patients with related donor allo HCT, 29 matched at 10/10 loci, while 3 patients had one or two antigen mismatches. In the allo HCT group eight patients received myeloablative regimens (MA), while thirty six patients received RIC regimens. MA regimens were fludarabine + melphalan 180 mg/m2 in 4 patients, busulfan + cyclophosphamide in 2 patients, busulfan + melphalan in one patient and TBI-based in another patient. RIC regimens were fludarabine + melphalan ≤140 mg/m2 in 34 patients and cyclophosphamide + fludarabine in 2 patients. Results: Median follow-up for both auto and allo HCT patients was 24 months. Median prior treatment regimens in auto and allo HCT patients were 4 (2-16) and 5 (2-10), respectively. Overall response rates in evaluable patients in auto HCT and allo HCT were 63% and 75%, respectively. Cumulative incidence of grade II-IV acute GVHD was 27% and limited or extensive chronic GVHD was 43% in allo HCT group. One-hundred day TRM in auto HCT and allo HCT groups was 3% and 9%, respectively. Most common causes of nonrelapse mortality were infections (12%) in auto, and acute or chronic GVHD (24%) in allo HCT group. Median progression free survival (PFS) and overall survival (OS) for auto HCT were 15.5 and 43.3 months, and for allo HCT were 6.9 and 14 months, respectively. Patients receiving MA regimens had significantly shorter PFS and OS than patients receiving RIC regimens. Conclusions: Both second auto and allo HCT are feasible for salvage therapy in patients with advanced MM, who had relapsed after an auto HCT. Disease progression remains the major cause of treatment failure. RIC regimens have improved the outcome of allo HCT. Disclosures: No relevant conflicts of interest to declare.

Description: Background: Several trials have shown that autologous stem cell transplantation is superior to conventional therapy in terms of complete response (CR) rate, event-free survival (EFS) and overall survival (OS). This treatment, however, is generally limited to patients younger than 65 due to concerns about excessive toxicity and treatment-related mortality (TRM) in older patients. Previous reports have shown that age alone should not exclude patients from high-dose therapy, as long as they fulfill other eligibility criteria. In this report we analyzed the safety and efficacy of high-dose chemotherapy (HDT) and autologous transplant in patients with MM who were ≥ 70 years at the time of autotransplant. Methods: Twenty-six patients (16 males, 10 females) with a median age of 72 (range 70–79) underwent HDT and an autograft between July 1999 and October 2005. The preparative regimen was melphalan 200 mg/m2 in 19 patients (73%), melphalan 180 mg/m2 in 6 and melphalan140 mg/m2 in 1 patient. Of the 26 patients, 12 were receiving first remission consolidation, 7 had primary refractory disease and 7 had relapsed disease. Clonal cytogenetic abnormalities were present in 5 patients (19%). Results: Twenty-two of the 26 patients were alive after a median follow up of 15 months (range 2–63). Responses (complete + partial response) were seen in 20 patients (77%), five (19%) of which were complete responses. Median EFS and OS were 19 and 31.6 months, respectively. 100-day TRM was 0%. Median times to absolute neutrophil count of ≥0.5 × 109/l and platelets ≥20 × 109/l were 10 and 10 days, respectively. Three-year EFS and OS were 37% and 49%, respectively. A low serum albumin (

Description: Background: Arsenic trioxide (ATO) has been shown to be synergistic with melphalan both in vitro and in vivo. We conducted a randomized phase II trial to determine the safety and efficacy of a combination of ATO, melphalan, and ascorbic acid (AA) as a preparative regimen in patients undergoing autologous hematopoietic progenitor cell transplantation for multiple myeloma (MM). We also assessed the impact of ATO levels on melphalan pharmacokinetics, engraftment, and toxicity. Methods: Forty-eight patients with secretory myeloma (23 females, 25 males; median age, 54; range 35–70) were treated between 4/04 and 8/05. All patients received melphalan 100 mg/m2 IV on days -4 and -3 and AA 1000 mg/day IV on days -9 to -3. Patients were randomized to 3 arms: no ATO (arm 1), ATO 0.15 mg/kg IV on days -9 to -3 (arm 2), and ATO 0.25 mg/kg IV on days -9 to -3 (arm 3). Twelve patients had received a prior autograft, with a median 4.5 x 106/kg (range 2.3–10.9) CD34+ cells infused. Results: Patients in all 3 arms were evenly matched. Twenty-nine patients (60%) were transplanted for consolidation of first remission and 19 patients (40%) for relapsed disease. With a median follow-up of 26 months (range 10–37) post-autograft, no dose-limiting toxicity, or nonrelapse mortality was reported. Toxicity was limited to grade 1 or 2 nausea, vomiting, and diarrhea and was comparable in all 3 arms. Melphalan pharmacokinetics was not altered by ATO pretreatment. Median time to neutrophil engraftment (absolute neutrophil count 〉500/dL) was 9 days, with no engraftment failures or delays in either the control or ATO arms. The complete response (CR) rate for all patients was 25% (12/48), and the partial response rate was 60% (29/48) for an overall response rate (ORR = CR + PR) of 85%. Progression-free survival (PFS) and overall survival (OS) after 24 months of follow-up were 59% and 91%, respectively. Median PFS was 29 months; median OS has not been reached. There was no significant difference in CR, ORR, PFS, or OS among the 3 arms (P =.9, .9, .5, and .6, respectively). PFS and OS were comparable among patients with chromosomal abnormalities or relapsed disease at transplant and patients undergoing a second autotransplant for salvage. Conclusions: Addition of ATO + AA to high-dose melphalan is safe and well tolerated as a preparative regimen for autotransplants in patients with MM, including high-risk patients. There was no adverse impact of ATO on engraftment. Longer follow-up is necessary to assess the efficacy of this combination on PFS and OS.

Description: Background: Thalidomide/Dexamethasone (TD) has become one of the most commonly used induction therapies for patients with symptomatic multiple myeloma (MM) eligible for high dose therapy (HDT) intensification with autologous stem cell transplant (ASCT). Bortezomib (Velcade) has been added to the combination of TD (VTD) in an effort to reduce MM tumor burden further prior to HDT.The impact of this addition on HDT outcomes has not been fully explored. Purpose: To determine the impact of the addition of bortezomib to TD induction therapy in patients with MM undergoing HDT and ASCT consolidation. Patients and Methods: Patients were eligible for this analysis if they had undergone HDT with ASCT for first remission consolidation or primary refractory disease within 12 months of diagnosis between 9/03 and 12/05 and had received either TD or VTD as induction therapy. Patients receiving VTD after TD were excluded. Patients receiving more than 1 chemo regimen other than TD or VTD were excluded. Chemomobilization was NOT considered an exclusion criteria. Results A total of 78 patients qualified for the analysis (27 VTD; 51 TD). Patient and treatment characteristics are summarized in table 1. In brief, the patients receiving VTD had a higher rate of cytogenetic abnormalities and received less cycles of chemotherapy prior to SCT. Although pre-SCT response rates were similar between patients receiving VTD or TD (95% vs 92%) there was a trend for a higher CR rate in the VTD group (15% vs 6%). Post transplants response rates assessed between 3–6 months demonstrated that 28% and 38% of VTD patients achieved near CR and CR respectively while 19% and 23% had these responses post TD induction. There was no difference in 2 year OS and PFS among patients receiving VTD or TD (91% vs 81% and 35% and 56% respectively). Conclusion: Both VTD and TD as induction treatment are associated with high response rates prior to SCT as well as 6 months post SCT. In this retrospective analysis no survival benefit was seen for induction therapy with VTD over TD, despite higher near CR and CR rates. However randomized trials need to be performed addressing type of induction as well as duration of induction therapy prior to high dose therapy consolidation. Patient and Treatment Characteristics Variables VTD TD N 27 51 Median Age 54 (34–71) 56 (34–71) %ISS〉 1 76% 65% % CG Abnormal 37% 19% p=.009 B2M @ Dx 2.99 3.19 Cycles Prior to SCT 2 4 p=.00009 % Mel 200 74% 69% Post SCT Maintenance 15/27 23/51

Description: BACKGROUND: High circulating levels of cardiac troponins, T and I (cTnT and cTnI) and brain-type natriuretic peptide (BNP) are associated with shorter overall survival and increased transplant-related mortality (TRM) in patients with amyloidosis undergoing high-dose chemotherapy and autologous stem cell transplantation (auto SCT). Their role as prognostic markers in myeloma is not clearly defined. We evaluated the utility of BNP, cTnT and cTnI as prognostic markers in patients undergoing auto SCT for myeloma. METHODS: We retrospectively analyzed patients who received high-dose chemotherapy followed by auto SCT at MD Anderson Cancer Center between January 1 and December 31, 2006. Pre auto SCT levels of BNP, cTnT and cTnI were available in all patients. The upper limit of BNP was 100 ng/L, cTnT 0.01 ng/ml and cTnI 0.03 ng/ml. RESULTS: A total of 105 patients (68 male and 37 female) with a median age of 57 (31–73) received auto SCT during the study period. Seventy-seven patients received high-dose melphalan 200 mg/m2 as preparative regimen, while 28 patients received a combination of melphalan 140 mg/m2 + busulfan 130 mg/m2 × 4 days. Median follow up of surviving patients was 21 months (1–30). Twenty-four (23%) patients had a high BNP level (〉100 ng/L) prior to transplantation, 7 patients had a high cTnT level (〉0.01ng/ml) and 12 patients had a high cTnI level (〉0.03 ng/ml). In 101 evaluable patients, responses (complete 22 + partial 53) were seen in 75 (74%) patients. Overall survival (OS) and progression-free survival (PFS) at 24 months was 86 and 58%, respectively. There was no significant difference in 24-month OS in the high BNP group (p=0.7). Eight patients died of non-relapse causes, with only one death in patients with high BNP (p=0.67). Grade 3–4 cardiac adverse events were reported in 2 patients only, one of whom had elevated BNP (p=0.54). An increase in either BNP, cTnT or cTNI was seen in 30 patients. These patients did not have a significant increase in TRM (p=0.68) or cardiac toxicity, or a decrease in OS. CONCLUSION: High pretransplant levels of BNP, cTnT or cTnI levels, either individually or together, did not adversely impact cardiac events, TRM or OS.