ALBERT

Description: Second autologous stem cell transplant (ASCT) is a treatment option for multiple myeloma (MM) patients (pts) who have disease progression after first ASCT. About 20% of MM pts have evidence of renal dysfunction and many more develop it subsequently. Outcomes of second ASCT in pts with renal dysfunction have not been described. We identified 18 pts at our institution who underwent a second ASCT for relapsed MM and had evidence of renal dysfunction (creatinine clearance ≤ 60ml/min/1.73m2). Pts who underwent a planned tandem transplant were excluded from this analysis. Patient characteristics are shown in Table 1. The median age of pts was 61 years (range, 49-72). The median time between first and second ASCT was 49.8 months (range, 19.2-81.9). Ten pts received one chemotherapy regimen while nine pts received two or more chemotherapy regimens between first and second ASCT. The chemotherapy regimens used between first and second transplant included IMid based (n=6), proteosome inhibitor based (n=3) and combination of both (n=9). Approximately half of the pts had progressive disease at the time of second ASCT. Median creatinine clearance at the time of second ASCT was 43.5 ml/min//1.73m2. All pts received G-CSF 5µg/Kg from day + 6 till absolute neutrophil count was ≥1500/µL, norfloxacin, acyclovir and fluconazole were used for antimicrobial prophylaxis during the hospitalization. One pt was dialysis dependent. Patients received a median dose of melphalan of 140mg/m2 (range 100-200 mg/m2). Median follow up post second ASCT was 17.1 months (range, 2.4- 100). One pt died 74 days after the transplant due to multi- organ failure. Disease status at day 100 post ASCT is shown in Table 2. Thirteen of 17 pts had a partial response or better after second ASCT. Of 17 evaluable pts at day 100, twelve had an upgrade from the disease response category achieved with the last regimen used prior to second ASCT while five pts had stable disease response. Three pts received maintenance therapy after the second ASCT with bortezomib(n=2) and lenalidomide (n=1). Figures 1 and 2 show the overall survival (OS) and relapse free survival (RFS). Median RFS was 22.2 months and median OS was 27 months. The outcomes of patients with renal dysfunction who underwent ASCT in the era of novel agents at our institution are comparable to those reported for second ASCT. The transplant related mortality was not higher than expected and the median PFS of about 2 years makes the option of second ASCT in this group of patients a valuable treatment modality. The utility of maintenance therapy after the second ASCT is not established, but may have contributed to the durable responses seen in some pts assessed herein and deserves to be investigated further. Table 1: Pt Characteristics (N=18) Patient Characteristics N (%) Median Age (range) 61 years(49-72) Median Time from First ASCT (range) 49.8 months(19.2-81.9) Gender Male 9(50%) Females 9 (50%) Race Caucasians 13 (72%) Others 5 (28%) Disease status at time of ASCT PD 9 (50%) SD 5 (28%) PR 1 (5.5 %) VGPR 2 (11%) CR 1 (5.5%) Median creatinine clearance (range) 43.5 (5-59) Subtype IgG Kappa 10 (56%) IgG Lambda 6 (33%) Kappa Light Chain 2 (11%) Cytogenetic Risk Standard 10 (56%) High Risk 4(22%) Unknown 4 (22%) Melphalan Dose median mg/m2( range) 140 (100-200) {100(2pts), 140(10pts), 180(1pt), 200(4pts)} Median CD 34 Cell dose x106/kg (range) 4.66(2.6-27.5) Median Engraftment Day (range) WBC 11 (9-16) Platelets 21 (12-61) Median Days of Hospitalization (range) 19(11-74) PD: Progressive disease, SD: Stable disease; PR: Partial response; VGPR: Very good partial response; CR: complete response; WBC White blood cells Table 2 Disease status at Day 100 post ASCT Disease status at Day 100 post ASCT N(%) CR 4 (22%) VGPR 4 (22%) PR 5 (28%) SD 3 (17%) PD 1 (5.5%) NOT AVAILABLE * 1 (5.5%) PD: Progressive disease, SD: Stable disease; PR: Partial response; VGPR: Very good partial response; CR: complete response; *Pt died at day 74 post second ASCT PD: Progressive disease, SD: Stable disease; PR: Partial response; VGPR: Very good partial response; CR: complete response; * Pt died at day 74 post second ASCT Figure 1 Figure 1. Figure 2 Figure 2. Disclosures No relevant conflicts of interest to declare.

Description: Background: Ibrutinib (ibr) for the treatment of chronic lymphocytic leukemia (CLL) has improved progression-free survival (PFS) compared to other treatments, especially in high-risk patients (pts). However, resistance occurs and is associated with mutations in the drug binding target (BTK) and its immediate downstream target (PLCg2). These ibr resistance mutations (IRmut) are detectable months prior to developing progressive disease (PD) and predict clinical relapse. Prospectively determining the time from starting ibr to development of IRmut and from IRmut detection to PD will improve our understanding of how to manage these patients. Venetoclax (ven) is highly effective after ibr and decreases IRmut. Adding ven to ibr for ibr resistance is a rational choice as this combination is safe and effective in CLL. Adding an agent rather than stopping ibr avoids disease flare associated with ibr discontinuation. This phase 2 study was designed to follow CLL pts taking ibr and at high risk for resistance (observation cohort) and to test ven in combination with ibr for those who develop PD (intervention cohort). This will determine: the incidence of IRmut and PD in this population, the ORR with ibr/ven, and the ability of this combination to eliminate IRmut. Trial Design and Methods: This multisite study will open at 4 centers initially. Eligible pts are adults with CLL taking ibr for ≥12 months and at high risk for ibr resistance defined as having ≥2 prior treatments and del(17p)(p13.1) on FISH panel and/or a complex karyotype. Pts with known IRmut or who cannot continue ibr for any reason are excluded. Enrolled pts enter the observation cohort and are followed every 3 months with a clinic visit, blood counts, and testing for IRmut. Pts who develop IRmut will also have CT scans at their visits to detect PD. Those with IRmut who develop PD by iwCLL 2018 criteria will enter the intervention cohort. Pts in the intervention cohort will start ven in addition to ibr. Ven will be ramped-up over 5 weeks to a target dose of 400mg. Pts will take combination ibr/ven for 12 cycles of 28 days in length. After 12 cycles they will undergo response assessment and those achieving a complete remission (CR) with no detectable leukemia (uMRD) in both the blood and bone marrow will stop ven and continue ibr alone. Those who do not achieve CR with uMRD will continue ibr/ven until cycle 24 and undergo a second response assessment. If in a CR with uMRD after 24 cycles they continue on ibr alone. If a CR with uMRD is not achieved after 24 cycles patients continue ibr/ven until PD, intolerance, death, or end of study which is 30 months after the last patient enters the intervention cohort (Figure). In the intervention cohort all pts will be tested for IRmut in the blood every 3 months with bone marrow testing at response assessments. The study has co-primary endpoints of ORR to combination ibr/ven after 12 cycles and the rate of IRmut negative status at that time in the intervention cohort. ORR will be tested first using a single-stage phase 2 design with a null hypothesis that the rate is ≤50% versus the alternative hypothesis that it is ≥75%. Only if the combination is effective in ORR will the rate of IRmut negative status be formally tested. Constraining overall Type I and II errors to 0.10 using this sequential testing strategy, 26 evaluable pts are required and 28 will be accrued. Secondary endpoints for the intervention cohort are the PFS and overall survival since starting the combination ibr/ven and the incidence and type of adverse events with ibr/ven. Secondary endpoints in the observation cohort are the incidence of IRmut during ibr treatment and the PFS after developing an IRmut. We estimate that 180 pt-years of follow up for the observation cohort will be needed. The yearly rate of mutation development in this population is approximately 20%, therefore this will identify 36 pts with IRmut. Of those with IRmut, approximately 80% will remain eligible to enter the intervention cohort. Accrual to the observation cohort will stop once 28 pts enter the intervention cohort. Conclusion: This multicenter phase 2 trial examines the development of IRmut and clinical resistance to ibr in a cohort of high-risk CLL pts and will determine the efficacy of adding ven to ibr in those who develop PD. We expect to determine the natural course of molecular and clinical ibr resistance in CLL and if adding ven is an effective treatment strategy. Figure Disclosures Rogers: Acerta: Consultancy; Genentech: Research Funding; Abbvie: Research Funding; Janssen: Research Funding. Bhat:Pharmacyclics: Consultancy; Janssen: Consultancy. Stephens:Karyopharm: Research Funding; Gilead: Research Funding; Acerta: Research Funding. Ye:Janssen: Research Funding; Karyopharm: Research Funding; Portola: Research Funding; MingSight: Research Funding; Sanofi: Research Funding. Byrd:Pharmacyclics LLC, an AbbVie Company: Other: Travel Expenses, Research Funding, Speakers Bureau; Janssen: Consultancy, Other: Travel Expenses, Research Funding, Speakers Bureau; Pharmacyclics LLC, an AbbVie Company: Other: Travel Expenses, Research Funding, Speakers Bureau; Acerta: Research Funding; Genentech: Research Funding; Gilead: Other: Travel Expenses, Research Funding, Speakers Bureau; Ohio State University: Patents & Royalties: OSU-2S; Novartis: Other: Travel Expenses, Speakers Bureau; Janssen: Consultancy, Other: Travel Expenses, Research Funding, Speakers Bureau; Gilead: Other: Travel Expenses, Research Funding, Speakers Bureau; Novartis: Other: Travel Expenses, Speakers Bureau; BeiGene: Research Funding; BeiGene: Research Funding; TG Therapeutics: Other: Travel Expenses, Research Funding, Speakers Bureau; Genentech: Research Funding; Ohio State University: Patents & Royalties: OSU-2S; TG Therapeutics: Other: Travel Expenses, Research Funding, Speakers Bureau; Acerta: Research Funding. Woyach:Janssen: Consultancy, Research Funding; Pharmacyclics LLC, an AbbVie Company: Consultancy, Research Funding; AbbVie: Research Funding; Karyopharm: Research Funding; Loxo: Research Funding; Morphosys: Research Funding; Verastem: Research Funding. OffLabel Disclosure: This abstract discussion the use of combination ibrutinib and venetoclax in CLL.

Description: Introduction: Proteasome inhibitors (PI) and immunomodulatory drugs have become the backbone of therapy for multiple myeloma (MM). The oral boron-containing selective and reversible proteasome inhibitor ixazomib has shown to induce deep and durable responses (Kumar RK et la, Blood 2016. 128(20):2415-2422). Triplets containing ixazomib, has shown to be more efficacious than doublet regimens in the relapse setting (Moreau P, et al. N Engl J Med 2016. 374:1621-1634).However, to date, there is not companion diagnostics capable of predicting PI response. We have recently discovered that MM patients resistant to PI lack of the ankyrin (ANK) and death domain (DD) present in the 3'-end of NFKB2. Loss of NFKB2 3'end frequently resulted from a structural rearrangements. We found that NFKB2-ANK and -DD are crucial at initiating bortezomib's apoptotic signal by facilitating caspase-8 activation (unpublished data). Based on this findings, we designed this study to examine the efficacy of NFKB2 break apart FISH to predict the response to ixazomib and dexamethasone (Id) vs. ixazomib, lenalidomide and dexamethasone (IRd) in early relapse MM patients. Methods: In this phase 2 biomarker-driven open-label trial, relapsed patients with G3 treatment related adverse events were higher in Arm A (45%) and Arm C (60%) vs Arm B (15%). The most common (≥10%) ≥ grade 3 include URI/pneumonia 16% and diarrhea 12% in Id NFKB2 FISH negative vs. neutropenia 18% and diarrhea (10%) in the IRd NFKB2 FISH positive arm. Treatment discontinuations only occurred in 3 NFKB2 FISH positive Id treated patient (13%). Conclusion: Interim analysis demonstrates a trend higher efficacy and ≥G3 toxicity of ixazomib with dexamethasone in MM patients with negative NFKB2 break-apart FISH compared to those with a positive test. Efficacy and toxicity of the triplet regimen are comparable to what is seen in the Tourmaline 1 trial. This study is registered clinicaltrials.gov# NCT02765854 Disclosures Bernal-Mizrachi: TAKEDA: Research Funding; Winship Cancer Institute: Employment, Patents & Royalties; Kodikas Therapeutic Solutions, Inc: Equity Ownership. Nooka:GSK: Honoraria, Other: advisory board participation; Adaptive technologies: Honoraria, Other: advisory board participation; GSK: Honoraria, Other: advisory board participation; Spectrum pharmaceuticals: Honoraria, Other: advisory board participation; Adaptive technologies: Honoraria, Other: advisory board participation; Janssen: Honoraria, Other: advisory board participation; Celgene: Honoraria, Other: advisory board participation; BMS: Honoraria, Other: advisory board participation; Takeda: Honoraria, Other: advisory board participation; Amgen: Honoraria, Other: advisory board participation; Adaptive technologies: Honoraria, Other: advisory board participation; Adaptive technologies: Honoraria, Other: advisory board participation; Spectrum pharmaceuticals: Honoraria, Other: advisory board participation; Spectrum pharmaceuticals: Honoraria, Other: advisory board participation; BMS: Honoraria, Other: advisory board participation. Ye:Portola Pharmaceuticals: Research Funding; MingSight: Research Funding; Janssen: Research Funding; Karyopharm: Research Funding; Sanofi: Research Funding; Onyx: Research Funding; Celgene: Research Funding; Takeda: Research Funding; AbbVie: Research Funding. Vij:Takeda: Honoraria, Research Funding; Sanofi: Honoraria; Karyopharm: Honoraria; Janssen: Honoraria; Bristol-Myers Squibb: Honoraria, Research Funding; Celgene: Honoraria, Research Funding; Genentech: Honoraria. Hofmeister:Oncopeptides: Membership on an entity's Board of Directors or advisory committees; Nektar: Honoraria, Membership on an entity's Board of Directors or advisory committees; Karyopharm: Membership on an entity's Board of Directors or advisory committees; Imbrium: Membership on an entity's Board of Directors or advisory committees; Celgene: Honoraria; Janssen: Membership on an entity's Board of Directors or advisory committees. Rushton:KSLBiomedical: Employment. Lonial:Genentech: Consultancy; Karyopharm: Consultancy; Celgene Corporation: Consultancy, Research Funding; Takeda: Consultancy, Research Funding; Amgen: Consultancy; BMS: Consultancy; Janssen: Consultancy, Research Funding; GSK: Consultancy. Kaufman:Amgen: Consultancy; Winship Cancer Institute of Emory University: Employment; AbbVie: Consultancy; Takeda: Consultancy; Celgene: Consultancy; TG Therapeutics: Consultancy; Karyopharm: Membership on an entity's Board of Directors or advisory committees; Bristol-Myers Squibb: Consultancy; Incyte: Consultancy; Pharmacyclics: Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria.

Description: Background: Despite recent advances, follicular lymphoma (FL) remains incurable for most patients. Relapsed/refractory (r/r) FL is associated with decremental treatment responses, accumulating toxicity, and poor survival among early failures of 1st line chemoimmunotherapy. Underscored by the recent approvals of idelalisib, copanlisib, and duvelisib, targeting B-cell receptor (BCR) signaling produces ORR of ~50% in r/r patients; however, new agents with a better therapeutic index over long-term administration are needed. SYK is a key regulator of BCR signaling (upstream of BTK and PI3K), and its inhibition results in clinical activity in FL. Compared with unaffected nodes, lymph nodes from FL patients have greater numbers of follicular helper T cells that express high levels of IL-4, which may support the tumor via the JAK1/3 pathway. Cerdulatinib, an oral, reversible inhibitor of SYK and JAK kinases (JAK1, JAK3, TYK2), previously reported a ~45% overall response rate (ORR) in r/r FL as a single agent. Xenograft studies suggest cerdulatinib may combine with rituximab to enhance antitumor activity. We report updated results from a phase 2a study of single-agent cerdulatinib and initial results in combination with rituximab in r/r FL. Methods: This phase 2a study confirmed the safety and efficacy of cerdulatinib 30 mg BID in r/r B- and T-cell lymphoma patients. Dose reductions were permitted to 15 mg BID. Response was assessed by Lugano criteria. Results: A planned interim analysis was performed on July 18, 2019, in which enrollment was 40 patients in the single-agent cohort and 19 patients in the rituximab combination cohort. For the single-agent cohort, median age (range) was 64 (42-81) years and median prior therapies (range) was 3 (1-9). Ninety-five percent of patients had prior anti-CD20 therapy, and 25% had prior therapy with BCR pathway inhibitors. For the combination cohort, median age (range) was 67 (47-85) years and median prior therapies (range) was 3 (1-10). Eighty-eight percent of patients had prior anti-CD20 therapy, and 32% had prior therapy with BCR pathway inhibitors. The safety profile appeared similar in both cohorts. The most common treatment-emergent grade 3+ adverse events in ≥5% of patients for both cohorts were lipase increase (27%), neutropenia (18%), diarrhea (12%), amylase increase (10%), hypertension (8%), nausea (7%), and pneumonia (5%). Grade 3+ infections occurred in 17.5% of single-agent cohort patients and 15.8% of combination cohort patients. Amylase and lipase increases generally were not associated with abdominal pain or pancreatitis. In addition, to date there has been no evidence of cumulative toxicity. The ORR was 45% as a single agent (12.5% complete response [CR], 32.5% partial response [PR], with 25% stable disease [SD] and 5% progressive disease [PD] in 40 evaluable patients) and 59% in the combination cohort (11.7% CR, 47% PR, with 27.8% SD and no PD in 17 evaluable patients). Responses typically occurred after 2 cycles, generally improved over time, and were durable in the single-agent cohort, with 10 patients on drug for 〉1 year. Enrollment in the combination cohort is ongoing. Updated safety and efficacy will be presented. Conclusion: The recommended cerdulatinib phase 2 dose of 30 mg BID was tolerable and efficacious in heavily pretreated r/r FL. The cerdulatinib + rituximab combination appears to be well tolerated, with tumor reductions in all evaluable patients. The safety profile and unique mechanism of action of cerdulatinib support further combination studies in FL. Disclosures Smith: Pharmacyclics: Research Funding; Denovo Biopharma: Research Funding; Portola Pharmaceuticals: Research Funding; Seattle Genetics: Research Funding; Acerta Pharma BV: Research Funding; AstraZeneca: Membership on an entity's Board of Directors or advisory committees, Research Funding; Incyte Corporation: Research Funding; Genentech: Research Funding; Bristol-Myers Squibb (spouse): Research Funding; Ignyta (spouse): Research Funding; Ayala (spouse): Research Funding; Merck Sharp & Dohme Corp: Consultancy, Research Funding. Munoz:AstraZeneca: Speakers Bureau; Pharmacyclics LLC an AbbVie Company: Consultancy, Research Funding, Speakers Bureau; Kite Pharma: Consultancy, Research Funding, Speakers Bureau; Gilead: Consultancy, Speakers Bureau; Fosunkite: Speakers Bureau; Kyowa: Consultancy, Honoraria, Speakers Bureau; Bayer: Consultancy, Speakers Bureau; Seattle Genetics: Consultancy, Honoraria, Research Funding; Celgene: Research Funding; Portola: Research Funding; Incyte: Research Funding. Stevens:Astellas: Consultancy. Smith:Portola Pharmaceuticals: Research Funding. Feldman:Kite Pharma: Honoraria, Other: Travel expenses, Speakers Bureau; Janssen: Honoraria, Speakers Bureau; Takeda: Honoraria, Speakers Bureau; Bayer: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Seattle Genetics: Consultancy, Honoraria, Other: Travel expenses, Speakers Bureau; Pharmacyclics: Honoraria, Other: Travel expenses, Speakers Bureau; AbbVie: Honoraria, Other: Travel expenses, Speakers Bureau; Viracta: Research Funding; Trillium: Research Funding; Roche: Research Funding; Amgen: Research Funding; Cell Medica: Research Funding; Roche: Research Funding; Corvus: Research Funding; Eisai: Research Funding; Kyowa Hakko Kirin: Research Funding; Pfizer: Research Funding; Portola Pharma: Research Funding; Celgene: Honoraria, Research Funding, Speakers Bureau. Ye:MingSight: Research Funding; Janssen: Research Funding; Karyopharm: Research Funding; Sanofi: Research Funding; Onyx: Research Funding; Celgene: Research Funding; Takeda: Research Funding; AbbVie: Research Funding; Portola Pharmaceuticals: Research Funding. de Vos:Verastem: Consultancy; Portola Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees; Bayer: Consultancy. Miller:Verastem: Consultancy, Honoraria, Research Funding, Speakers Bureau; Incyte: Consultancy, Honoraria, Research Funding, Speakers Bureau; Novartis: Honoraria, Research Funding, Speakers Bureau; Takeda: Honoraria, Research Funding, Speakers Bureau. Birrell:Portola Pharmaceuticals: Employment, Equity Ownership. Leeds:Portola Pharmaceuticals: Employment, Equity Ownership. Coffey:Portola Pharmaceuticals: Employment, Equity Ownership, Research Funding. Conley:Portola Pharmaceuticals: Employment, Equity Ownership. Michelson:Portola Pharmaceuticals: Employment, Equity Ownership. Curnutte:Portola Pharmaceuticals: Employment, Equity Ownership.

Description: Approximately 20% of Multiple Myeloma (MM) patients (pts) have renal dysfunction(RD) at the time of diagnosis and some more may develop it during the course of their disease. Autologous stem cell transplant (ASCT) is a treatment modality for this incurable malignancy and there are ongoing studies to determine the optimal timing of ASCT in this disease. There are conflicting data regarding the outcomes among different racial groups with regards to ASCT in MM. In this restrospective review we studied outcomes in pts of different races with RD undergoing ASCT for MM. Between June 2005 and December 2013, we identified 107 pts with MM with RD (creatinine clearance 〈 60 ml/min/1.73 m2) who were not on hemodialysis and underwent ASCT at our institution. Of the 107 pts, 76 were caucasian(C) pts and 31 were identified as other (O) races (25 African American, one Hispanic, two Middle-eastern, three Asian). The patient characteristics of both groups are shown in Table 1. There were no statistically significant differences in the characteristics between the 2 groups. Approximately a quarter of the pts received their melphalan dose on the inpatient unit in both groups. During the hospitalization all pts received G-CSF from Day +6 till absolute neutrophil count ≥ 1500/µl and antimicrobial prophylaxis with norfloxacin, acyclovir and fluconazole. The median follow up was 35.9 months (range, 5.1-106.3). One patient in the C group died 98 days after ASCT and had evidence of disease progression. There were no deaths in the O group during the 100 days after ASCT. Table 2 shows post ASCT disease status and details about post ASCT maintenance therapy. There were no statistically significant differences between the groups in disease status or change in disease status at day 100 post ASCT. Although more patients in the C group received maintenance therapy post ASCT, this difference was not statistically significant. Figures 1 and 2 show the relapse free survival (RFS)and overall survival (OS) of both groups. The median RFS for C and O groups were 32.3 and 20.9 months (p =0.63, log rank), respectively. The median OS of the C and O groups were 73.1 and 47.8 month (p=0.31, log rank), respectively. Our limited experience suggests that there was no effect of race in the post ASCT outcomes for MM pts with RD. ASCT was safe with acceptable transplant related mortality and good long -term outcomes for MM pts with renal dysfunction. Table 1: Patient Characteristics (N=107) Patient Characteristics Caucasians (n=76) Others (n=31) Median Age (range) 63 (36-73) 64(28-73) 0.58 Gender Male 42 (55%) 17 (55%) 0.9 Females 35 (45%) 14 (45%) Chemo regimens prior to ASCT 1 51 (67%) 21 (68%) 0.95 ≥ 2 25 (33%) 10 (32%) Agents used prior to ASCT IMid 12 (16%) 4 (13%) 0.85 PI 18 (24%) 9 (29%) Both 46 (60%) 18 (58%) Disease status at time of ASCT PD 7 (10%) 5 (16%) 0.35 SD 9 (12%) 4 (13%) PR 20 (26%) 11 (35%) VGPR 20 (26%) 8 (26%) CR 20 (26%) 3 (10%) Median creatinine clearance (range) 45.5 (15-60) 43 (21-60) 0.35 Subtype* IgG Kappa 29 (34%) 18 (58%) 0.25 IgG Lambda 18 (24%) 6 (19%) Ig A Kappa 9 (12%) 2 (6%) Ig A Lambda 5 (7%) 3 (10%) K Light Chain 6 (8%) 0 L Light Chain 5 (7%) 0 Non- Secretory 3 (4%) 2 (6%) Cytogenetic Risk Standard 65 (85%) 18 (58%) 0.67 High Risk 5 (7%) 2 (6%) Median Melphalan Dose mg/m2 (range) 140 (140-200) {140(58),160(5), 180(4),200(9)}® 140 (100-200) {100(2),140(25), 200(9)} 0.89 Administration of Melphalan Inpatient 18 (24%) 9 (29%) 0.56 Outpatient 58 (76%) 22 (71%) Median CD 34 Cell dose x106/kg (range) 3.3 (2 -10.1) 3.9 (2.3-9.5) 0.34 Median Engraftment Day (range) Neutrophil 12 (11-20) 12(10-27) 0.86 Platelets 18(11-88) 17 (11-42) 0.10 Median Days of Hospitalization (range) 15 (9-65) 16 (12-55) 0.96 * 1 pt each in the caucasian group had IgD Lambda and IgM Kappa paraprotein ® Pts received 160 and 180 mg doses as part of a study PI: proteosome inhibitors, PD: progressive disease, SD: stable disease, PR: partial response, VGPR: very good partial response, CR: Complete response Table 2: Disease status at Day 100 post ASCT Caucasian (N=76) Other (N=31) P Value Disease Status CR 26 (34%) 6 (19%) 0.5 VGPR 20 (26%) 12 (38%) PR 17 (22%) 6 (19%) SD 7 (9%) 4 (13%) PD 2 (3%) 2 (7%) Not available 4 (6%) 1 (3%) Change in Disease Status Improved 23 (30%) 13 (42%) 0.66 Unchanged 45 (59%) 15 (48%) Worsened 4 (6%) 2 (7%) Not available 4 (6%) 1 (3%) Maintenance Therapy IMid 40 (53%) 9 (29%) 0.15 PI 2 (3%) 1 (3%) None 29 (38%) 19 (61%) Not Known 5 (7%) 2 (7%) Figure 1 Figure 1. Figure 2 Figure 2. Disclosures No relevant conflicts of interest to declare.