Asad Bashey

Northside Hospital, St. Petersburg, Florida, United States

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Publications (75)362.88 Total impact

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    ABSTRACT: Outcomes of 475 consecutive patients receiving first allogeneic transplants for hematologic malignancy performed using T-replete HLA-haploidentical donors and post-transplant cyclophosphamide (HIDT, n=116) were compared to contemporaneous patients transplanted from 10 of 10 HLA allele matched unrelated donors (MUDT, n=178) or HLA-identical sibling donors ( MRDT, n=181). Uniform supportive care measures and assessments were used. Median follow-up was 45 months. HIDT patients were more likely to be black than MUDT patients (44% vs. 2%, p< 0.001). At two years following transplant, estimates of overall survival were 57%, 59%,72% For HIDT, MUDT and MRDT respectively (p=NS HIDT vs MUDT and 0.02 HIDT vs MRDT) and disease free survival were 54%, 50%, 56% (p=NS for both comparisons) . Cumulative incidences (CI) of non-relapse mortality were 17%, 16%, 14% and relapse were 29%, 34% and 30% (p=NS for all). CI of acute GVHD grade 2-4 were 41%, 48%, 28% (p=NS HIDT vs. MUDT, p=0.005 HIDT vs. MRDT). At two years, CI of moderate/severe chronic GVHD were 31%, 47% and 44% (p=0.004 HIDT vs MUDT, p=0.032 HIDT vs MRDT,) and 19% of HIDT, 42% of MUDT and 35% of MRDT remained on systemic immunosuppressive treatment (p=0.007 HIDT vs MUDT). Moderate/severe chronic GVHD remained significantly lower for HIDT than MUDT in patients receiving PBSC grafts (two year CI 25% vs. 48% p=0.002). On a multivariate analysis incorporating disease-risk-index (DRI) and other significant covariates, survival (HR 1.31, p=0.15), disease-free survival (HR=0.96, p=0.79) were not significantly different between HIDT and MUDT but chronic GVHD was lower in HIDT (moderate-severe HR 0.59, p=0.007). ). HIDT produce similar long-term survival with lower rates of chronic GVHD than optimally matched MUDT. HIDT should be considered a standard-of-care option for patients who lack a matched sibling donor.
    Biology of blood and marrow transplantation: journal of the American Society for Blood and Marrow Transplantation 09/2015; DOI:10.1016/j.bbmt.2015.09.002 · 3.40 Impact Factor
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    ABSTRACT: Comparison of long-term outcomes in patients with refractory/relapsed grade 1-2 follicular lymphoma (FL) after allogeneic (allo-HCT) vs. autologous hematopoietic cell transplantation (auto-HCT) in the rituximab-era. Adult patients with relapsed/refractory grade 1-2 FL undergoing 1(st) reduced-intensity allo-HCT or 1(st) autograft during 2000-2012 were evaluated. A total of 518 rituximab-treated patients were included. Allo-HCT patients were younger; more heavily pretreated, and more patients had advanced stage and chemoresistant disease. The 5-year adjusted probabilities, comparing auto- vs. allo-HCT groups for non-relapse mortality (NRM) were 5% vs. 26% (p<0.0001); relapse/progression: 54% vs. 20% (p<0.0001); progression-free survival (PFS): 41% vs. 58% (p<0.001) and overall survival (OS): 74% vs. 66% (p=0.05). Auto-HCT was associated with a higher risk of relapse/progression beyond 5 months post-HCT (RR=4.4; p<0.0001), and worse PFS (RR=2.9; p<0.0001) beyond 11 months post HCT. In the first 24 months post HCT, auto-HCT was associated with improved OS (RR=0.41; p<0.0001), but beyond 24 months with inferior OS (RR=2.2; p=0.006). A landmark analysis of patients alive and progression-free at 2-years post-HCT confirmed these observations, showing no difference in further NRM between both groups, but significantly higher risk of relapse/progression (RR=7.3; p<0.0001) and inferior PFS (RR=3.2; p<0.0001) and OS (RR=2.1; p=0.04) following auto-HCT. The 10-year cumulative incidence of second hematological malignancies following allo- and auto-HCT was 0% and 7%, respectively. Auto- and RIC-allo-HCT as 1(st) transplantation approach can provide durable disease control in grade 1-2 FL patients. Continued disease relapse-risk following auto-HCT translates into improved PFS and OS following allo-HCT, in long-term survivors. Copyright © 2015 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.
    Biology of blood and marrow transplantation: journal of the American Society for Blood and Marrow Transplantation 08/2015; DOI:10.1016/j.bbmt.2015.07.028 · 3.40 Impact Factor
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    ABSTRACT: We studied adults with acute myeloid leukemia (AML) after haploidentical (n=192) and 8/8 HLA-matched unrelated donor (n=1982), transplantation. Data were obtained from the Center for International Blood and Marrow Transplant Research. Haploidentical recipients received calcineurin inhibitor (CNI), mycophenolate and post-transplant cyclophosphamide for graft-versus-host disease (GVHD) prophylaxis; 104 patients received myeloablative and 88, reduced intensity conditioning regimens. Matched unrelated donor transplant recipients received CNI with mycophenolate or methotrexate for GVHD prophylaxis; 1245 patients received myeloablative and 737, reduced intensity conditioning regimens. In the myeloablative setting, day-30 neutrophil recovery was lower after haploidentical compared to matched unrelated donor transplants (90% versus 97%, p=0.02). Corresponding rates after reduced intensity conditioning transplants were 93% and 96%, (p=0.25). In the myeloablative setting, 3-month acute grade 2-4 (16% versus 33%, p<0.0001) and 3-year chronic GVHD (30% versus 53%, p<0.0001) were lower after haploidentical compared to matched unrelated donor transplants. Similar differences were observed after reduced intensity conditioning transplants, 19% versus 28%, (p=0.05) and 34% versus 52%, (p=0.002). Among patients receiving myeloablative regimens, 3-year probabilities of overall survival were 45% (95% CI 36-54) and 50% (95% CI 47-53) after haploidentical and matched unrelated donor transplants (p=0.38). Corresponding rates after reduced intensity conditioning transplants were 46% (95% CI 35-56) and 44% (95% CI 0.40-47) (p=0.71). Although statistical power is limited, these data suggests that survival for patients with AML after haploidentical transplantation with posttransplant cyclophosphamide is comparable with matched unrelated donor transplantation. Copyright © 2015 American Society of Hematology.
    Blood 06/2015; 126(8). DOI:10.1182/blood-2015-04-639831 · 10.45 Impact Factor
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    ABSTRACT: Chronic graft-versus-host disease (cGVHD) is a significant determinant of overall outcome and quality of life in survivors of allogeneic hematopoietic cell transplantation. Standard initial therapy of cGVHD based on prolonged use of corticosteroids and a calcineurin inhibitor and has not changed for over three decades, despite limited efficacy and long-term toxicity. Rituximab is an attractive agent for the upfront treatment of cGVHD due to its favorable toxicity profile, efficacy in steroid-refractory cGVHD, and ability to serve as a steroid sparing agent in autoimmune diseases. We hypothesized that a corticosteroid-free regimen incorporating rituximab would result in improved outcomes when used for initial treatment of cGVHD. Twenty-five patients (median age 56 years [range 29 - 77]) with extensive cGVHD were enrolled on a prospective phase II trial. Enrollment was limited to patients with first onset extensive cGVHD requiring systemic immunosuppression and without residual or concurrent acute GVHD. Chronic GVHD was classified as de novo, interrupted, and progressive in 12, 11, and 2 patients respectively. Chronic GVHD severity (NIH grade) was mild, moderate, and severe in 3, 14, and 8 patients respectively. All patients received Rituximab 375mg/m2 x 4 weekly doses, then one dose q3months x 4 doses, in addition to mycophenolate mofetil and either tacrolimus [18] or sirolimus [7]. No other systemic immunosuppression was permitted, and only a short-course of steroids (≤4 weeks) was allowed at physician discretion; otherwise patients would be deemed a treatment failure and were treated off study. Twenty-two of 25 patients (88%) responded to treatment. Of the 22 responding patients, median time to maximum response was 161 days (range 35 - 300 days) with maximum response being complete in 21/22 patients and partial in 1 patient. Excluding the three patients taken off study for treatment failure, corticosteroids were used sparingly with only 2 patients receiving any steroids for a median of 15 days (range 13-18 days). Immunosuppression was discontinued in 17 of 22 evaluable patients (77%) with median time to discontinuation of 300 days (range 138 - 488 days). Following immunosuppression discontinuation, cGVHD did recur in 7 patients after a median of 166 days (range 21-393 days), requiring reinstitution of systemic immunosuppression (estimated cGVHD recurrence rate of 37%). With a median f/u of 27 months, estimated 2-year overall survival is 82%. This regimen utilizing rituximab in the initial therapy of cGVHD is effective and avoids the use of corticosteroids in the majority of patients. In permitting early discontinuation of immunosuppression while obviating the need for prolonged exposure to systemic corticosteroids, it may result in reduced treatment-related morbidity and mortality associated with cGVHD and its treatment. Copyright © 2015 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.
    Biology of blood and marrow transplantation: journal of the American Society for Blood and Marrow Transplantation 05/2015; 21(9). DOI:10.1016/j.bbmt.2015.04.023 · 3.40 Impact Factor
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    ABSTRACT: Inadequate T-cell chimerism following reduced-intensity conditioning transplantation may contribute to graft rejection and disease relapse. Anti-thymocyte globulin (ATG) enhances early donor T-cell chimerism, but may also deplete donor T cells, increasing risks of infection and relapse. We prospectively tested administration of rabbit ATG (rATG) ⩾14 days before the infusion of the graft, followed by in vivo decay of active rATG levels, to selectively deplete host T cells. Twenty-three patients received rATG total dose 4.5 mg/kg on days -16 and -15, fludarabine 30 mg/m(2) per day on day -7 through -3, IV busulfan 130 mg/m(2) per day on days -4 and -3 and cyclophosphamide 1500 mg/m(2) on day -2. rATG levels were therapeutic in all patients on day -14, but were sub-therapeutic (<1 μg/mL) by day 0 in 82% of patients. Median donor T-cell chimerisms on days 30 and 180 were 100% (75-100%) and 100% (90-100%), respectively. Non-relapse mortality and relapse/progression at 48 months were 17 and 30%. Cumulative incidences of acute GvHD grades II-IV and III-IV were 39 and 9%. Median follow-up is 64 months (46-79 months). Survival and disease-free survival at 48 months were 70 and 52%. These data suggest that selective depletion of host T cells using this regimen is a feasible and effective strategy.Bone Marrow Transplantation advance online publication, 23 March 2015; doi:10.1038/bmt.2015.41.
    Bone marrow transplantation 03/2015; 50(6). DOI:10.1038/bmt.2015.41 · 3.57 Impact Factor
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    ABSTRACT: We enrolled a total of 30 patients on a prospective phase II trial utilizing a TBI-based myeloablative preparative regimen (fludarabine 25 mg/m2/d x 3 d and TBI 150 cGy bid on d -4 to -1 [total dose 1200cGy]) followed by infusion of unmanipulated peripheral blood stem cells from a haploidentical family donor (Haplo). Post-grafting immunosuppression consisted of Cy 50mg/kg/day on days 3 and 4, MMF through d 35, and tacrolimus through d 180. Median patient age was 46.5 years (range 24-60). Transplant diagnosis included AML [16], ALL [6], CML [5], MDS [1] and NHL [2]. Using the Dana Farber/CIBMTR Disease Risk Index (DRI), patients were classified as low [4], intermediate [12], high [11], and very high [3] risk. All patients engrafted with a median time to neutrophil and platelet recovery of 16 and 25 days, respectively. All evaluable patients achieved sustained complete donor T cell and myeloid chimerism by Day +30. Acute GVHD, grades II-IV and III-IV, was seen in 43% and 23% respectively. The cumulative incidence of chronic GVHD was 56% (severe in 10%). After a median follow-up of 24 months, the estimated 2-year overall survival (OS), disease-free survival (DFS), non-relapse mortality (NRM), and relapse rate was 78%, 73%, 3%, and 24%. Two-year DFS and relapse rate in patients with low/intermediate risk disease was 100% and 0% respectively, compared with 39% and 53% for patients with high/very high risk disease. When compared with a contemporaneously treated cohort of patients at our institution receiving myeloablative MUD transplantation (AML [17], ALL [15], CML [7], MDS [7], NHL [1], CLL [1]), outcomes were statistically similar with 2-yr OS and DFS being 78% and 73% respectively after haplo transplant vs. 71% and 64% respectively after MUD transplant. In patients with DRI low/intermediate risk disease, 2-yr DFS was superior following haplo compared with MUD transplants (100% vs. 74%, p=0.032), whereas there was no difference in DFS in patients with high/very high risk disease (39% vs. 37% for haplo and MUD respectively, p=0.821). Grade II-IV acute GVHD was seen less often following haplo compared with MUD transplant (43% vs. 63%, p=0.049), as was moderate-to-severe chronic GVHD (22% vs 58%, p=0.003). Myeloablative haplo transplantation using this regimen is a valid option for patients with advanced hematologic malignancies who lack timely access to a conventional donor. Outcomes appear at least equivalent to those seen in contemporaneous patients transplanted from MUD. Copyright © 2015 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.
    Biology of blood and marrow transplantation: journal of the American Society for Blood and Marrow Transplantation 03/2015; 21(7). DOI:10.1016/j.bbmt.2015.03.003 · 3.40 Impact Factor
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    ABSTRACT: Anthracyclines have activity against acute promyelocytic leukemia (APL) but can cause cardiac toxicity and secondary malignancy. The all-trans retinoic acid (ATRA)-arsenic trioxide (ATO) combination is an effective noncytotoxic approach for APL. However, its efficacy against high-risk APL (white blood cell count > 10,000/μL) has not been documented. Also, it requires ≥ 8 months to complete therapy. We report a retrospective analysis of 63 patients with APL given one cycle of ATO-based consolidation chemotherapy. The 5-year overall survival, event-free survival, and leukemia-free survival was 93% (95% confidence interval [CI], 82%-97%), 89% (95% CI, 77%-95%), and 92% (95% CI, 80%-97%), respectively. These data have confirmed that an abbreviated ATO-based chemotherapy regimen is an effective consolidation therapy for APL, including high-risk APL, and can be completed within 4 months. Copyright © 2014 Elsevier Inc. All rights reserved.
    Clinical Lymphoma, Myeloma and Leukemia 11/2014; 15(5). DOI:10.1016/j.clml.2014.11.001 · 2.02 Impact Factor
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    ABSTRACT: Calcineurin inhibitors (CNI) form the foundation of current GVHD prophylaxis regimens. We hypothesized that a CNI-free regimen consisting of post-transplant cyclophosphamide (PTCy) and brief-course sirolimus would reduce chronic GVHD and non-relapse mortality (NRM) following reduced intensity allogeneic peripheral blood stem cell transplant (PBSCT). Twenty-six patients, median age 61 years, received an unmanipulated PBSCT from an 8/8 locus matched donor; MRD=17, MUD=9. GVHD prophylaxis consisted of PTCy and brief-course sirolimus. Donor engraftment occurred in all patients. The cumulative incidence (CI) of grade II-IV acute GVHD, grade III-IV acute GVHD, and chronic GVHD was 46%, 15%, and 31% respectively. One year NRM was 4%. Median time to immunosuppression discontinuation was day +138. With a median follow-up of 20 months, the estimated 2-year overall survival, disease-free survival, and relapse incidence was 71%, 64%, and 32% respectively. In patients with lymphoid malignancies (CLL, NHL, HD), 2-yr DFS and relapse was 100% and 0%, respectively. Good immune reconstitution was evidenced by low CMV reactivation rates, occurring in only 4 of 19 at-risk patients (21%). GVHD prophylaxis with PTCy and sirolimus achieves consistent donor engraftment, low rates of chronic GVHD and NRM, and excellent outcomes in recipients of HLA-identical related and unrelated donor allogeneic PBSCT.
    Biology of Blood and Marrow Transplantation 11/2014; 20(11). DOI:10.1016/j.bbmt.2014.07.020 · 3.40 Impact Factor
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    A Bashey · S R Solomon ·
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    ABSTRACT: Availability of an HLA-identical sibling (MRD) or suitably matched unrelated donor (MUD) has historically been a limiting factor in the application of allogeneic hematopoietic transplantation. Although almost all patients have an HLA-haploidentical family donor, prior attempts at transplantation from such donors using T-cell replete grafts and conventional immunosuppression were associated with unacceptable rates of GVHD, and when stringent ex vivo T-cell depletion was used to control GVHD, rates of graft rejection and post-transplant infections were prohibitive. The recent approach to HLA-haploidentical donor transplantation developed in Baltimore that uses T-cell replete grafts and post-transplant CY (Haplo-post-HCT-CY) to control post-transplant allo-reactivity appears to have overcome many of the obstacles historically associated with haploidentical donor transplantation. In particular, TRM rates of <10% are usual and rapid reconstitution of immunity leads to a low rate of post-transplant infections and no post-tranplant lymphoproliferative disorders (PTLD), consistent with the hypothesis that post-transplant CY selectively depletes proliferating alloreactive T cells responsible for GVHD and graft rejection while preserving resting memory T cells essential for post-transplant immunologic recovery. In parallel trials using similar non-myeloablative conditioning regimens, Haplo-post-HCT-CY produced similar overall survival to double umbilical cord blood transplantation(DUCBT) in adult patients (62% vs 54%), with low rates of TRM (7% vs 24%), severe acute GVHD (0% vs 21%) and chronic GVHD (13% vs 25%). Furthermore, recent non-randomized comparisons adjusted for risk factors show that Haplo-post-HCT-CY achieve at least equivalent outcomes to conventional MRD and MUD transplants. Although most experience has been obtained using BM, emerging data suggest that a G-CSF mobilized PBSC graft can also safely be used for Haplo-post-HCT-CY. Haplo-post-HCT-CY also avoids the graft acquisition costs of DUCBT and MUDs and the cost of cell selection associated with T-depleted grafts. Although randomized comparisons will be forthcoming, Haplo-post-HCT-CY can already be considered a valid standard-of-care in patients who lack conventional donors thus extending the availability of allogeneic transplants to almost all patients. This donor source may also challenge the routine preference for a MUD in patients lacking an MRD.Bone Marrow Transplantation advance online publication, 19 May 2014; doi:10.1038/bmt.2014.62.
    Bone Marrow Transplantation 05/2014; 49(8). DOI:10.1038/bmt.2014.62 · 3.57 Impact Factor
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    ABSTRACT: Although pretransplant alemtuzumab can reduce GVHD following allogeneic transplantation, it may also increase the risk of mixed donor T-cell chimerism and infections. We hypothesized that the early use of DLI without withdrawal of immunosuppressive drugs in patients with mixed T-cell chimerism would lower the risk of relapse without significantly increasing the risk of GVHD post DLI. Thirty-six patients (median age 59 years) were treated in this phase II trial using reduced-intensity conditioning including s.c. alemtuzumab (total dose 43 mg) and a PBSC graft from a matched unrelated donor (UD). DLI without withdrawal of immunosuppressive drugs was administered to all 25 patients with <50% donor T-cell chimerism on day +60. The cumulative risks of acute and chronic GVHD were 42% and 59%, respectively. Estimated probabilities of non-relapse mortality (NRM) at day 100 and 1 year were 3% and 14%, respectively. With a median follow up 2.4 years, estimated survivals at day 100, 1 and 2 years were 97%, 71% and 57%, respectively. In multivariate analysis, the occurrence of acute GVHD was associated with an increased risk of mortality, whereas the occurrence of chronic GVHD had a protective effect, associated with decreased relapse and improved disease-free survival. Low-dose alemtuzumab and preemptive DLI provides favorable transplant outcomes including low NRM in an older patient population with high-risk malignancies undergoing UD transplantation.
    Bone marrow transplantation 05/2014; 49(5):616-21. DOI:10.1038/bmt.2014.2 · 3.57 Impact Factor
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    Asad Bashey ·

    Biology of blood and marrow transplantation: journal of the American Society for Blood and Marrow Transplantation 03/2014; 20(5). DOI:10.1016/j.bbmt.2014.03.009 · 3.40 Impact Factor

  • Biology of Blood and Marrow Transplantation 02/2014; 20(2):S197-S198. DOI:10.1016/j.bbmt.2013.12.327 · 3.40 Impact Factor

  • Biology of Blood and Marrow Transplantation 02/2014; 20(2):S238-S239. DOI:10.1016/j.bbmt.2013.12.399 · 3.40 Impact Factor
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    ABSTRACT: PURPOSET-cell-replete grafts from haploidentical donors using post-transplantation cyclophosphamide may represent a solution for patients who require allogeneic hematopoietic cell transplantation (alloHCT) but lack a conventional donor. We compared outcomes of alloHCT using haploidentical donors with those of transplantation using conventional HLA-matched sibling donors (MRDs) and HLA-matched unrelated donors (MUDs). PATIENTS AND METHODS Outcomes of 271 consecutive patients undergoing T-cell-replete first alloHCT for hematologic malignancies performed contemporaneously at a single center (53 using haploidentical donors; 117, MRDs; 101, MUDs) were compared. Overall and disease-free survival (DFS) were adjusted for effects of significant patient-, disease-, and transplantation-related covariates using a stratified Cox model.ResultsPatient characteristics were similar between the three donor groups. For patients undergoing MRD, MUD, and haploidentical transplantation, 24-month cumulative incidences of nonrelapse mortality were 13%, 16%, and 7% and of relapse were 34%, 34%, and 33%, respectively (P not significant [NS]). Cumulative incidences of grades 3 to 4 acute graft-versus-host disease (GVHD) at 6 months were 8%, 11%, and 11%, respectively (P NS); extensive chronic GVHD occurred in 54%, 54%, and 38% of patients, respectively (P < .05 for those undergoing haploidentical donor v MRD or MUD transplantation). Adjusted 24-month probabilities of survival were 76%, 67%, and 64% and of DFS were 53%, 52%, and 60%, respectively; these were not significantly different among the three donor groups. CONCLUSION Haploidentical transplantation performed using T-cell-replete grafts and post-transplantation cyclophosphamide achieves outcomes equivalent to those of contemporaneous transplantation performed using MRDs and MUDs. Such transplantation represents a valid alternative for patients who lack a conventional donor.
    Journal of Clinical Oncology 02/2013; 31(10). DOI:10.1200/JCO.2012.44.3523 · 18.43 Impact Factor
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    Biology of Blood and Marrow Transplantation 02/2013; 19(2):S307-S308. DOI:10.1016/j.bbmt.2012.11.453 · 3.40 Impact Factor
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    ABSTRACT: Haploidentical hematopoietic stem cell transplant (HSCT) provides an opportunity for nearly all patients to benefit from HSCT. We conducted a trial of haploidentical T cell replete allografting using a busulfan-based myeloablative preparative regimen, peripheral blood stem cells (PBSCs) as the graft source, and posttransplantation cyclophosphamide (Cy). Eligibility was limited to patients at high risk of relapse after nonmyeloablative haploidentical bone marrow transplant (BMT). Twenty patients were enrolled in the study (11 with relapsed/refractory disease and 9 who underwent transplantation while in remission and considered standard risk). Donor engraftment occurred in all 20 patients with full donor T cell and myeloid chimerism by day +30. The cumulative incidence of grades II-IV and III-IV acute graft-versus-host disease (aGVHD) was 30% and 10%, respectively. The cumulative incidence of chronic GVHD (cGVHD) was 35%. Nonrelapse mortality (NRM) at 100 days and 1 year was 10% for all patients and 0% for standard-risk patients. With a median follow-up of 20 months, the estimated 1-year overall survival (OS) and disease-free survival (DFS) was 69% and 50%, respectively, for all patients, and 88% and 67% for standard-risk patients. Myeloablative haploidentical HSCT is associated with excellent rates of engraftment, GVHD, NRM, and DFS, and is a valid option in patients with high-risk malignancies who lack timely access to a conventional donor.
    Biology of blood and marrow transplantation: journal of the American Society for Blood and Marrow Transplantation 07/2012; 18(12). DOI:10.1016/j.bbmt.2012.06.019 · 3.40 Impact Factor
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    ABSTRACT: Data are lacking on whether lenalidomide maintenance therapy prolongs the time to disease progression after autologous hematopoietic stem-cell transplantation in patients with multiple myeloma. Between April 2005 and July 2009, we randomly assigned 460 patients who were younger than 71 years of age and had stable disease or a marginal, partial, or complete response 100 days after undergoing stem-cell transplantation to lenalidomide or placebo, which was administered until disease progression. The starting dose of lenalidomide was 10 mg per day (range, 5 to 15). The study-drug assignments were unblinded in 2009, when a planned interim analysis showed a significantly longer time to disease progression in the lenalidomide group. At unblinding, 20% of patients who received lenalidomide and 44% of patients who received placebo had progressive disease or had died (P<0.001); of the remaining 128 patients who received placebo and who did not have progressive disease, 86 crossed over to lenalidomide. At a median follow-up of 34 months, 86 of 231 patients who received lenalidomide (37%) and 132 of 229 patients who received placebo (58%) had disease progression or had died. The median time to progression was 46 months in the lenalidomide group and 27 months in the placebo group (P<0.001). A total of 35 patients who received lenalidomide (15%) and 53 patients who received placebo (23%) died (P=0.03). More grade 3 or 4 hematologic adverse events and grade 3 nonhematologic adverse events occurred in patients who received lenalidomide (P<0.001 for both comparisons). Second primary cancers occurred in 18 patients who received lenalidomide (8%) and 6 patients who received placebo (3%). Lenalidomide maintenance therapy, initiated at day 100 after hematopoietic stem-cell transplantation, was associated with more toxicity and second cancers but a significantly longer time to disease progression and significantly improved overall survival among patients with myeloma. (Funded by the National Cancer Institute; number, NCT00114101.).
    New England Journal of Medicine 05/2012; 366(19):1770-81. DOI:10.1056/NEJMoa1114083 · 55.87 Impact Factor
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    Biology of Blood and Marrow Transplantation 02/2012; 18(2):S241. DOI:10.1016/j.bbmt.2011.12.110 · 3.40 Impact Factor

  • Biology of Blood and Marrow Transplantation 02/2012; 18(2):S379-S380. DOI:10.1016/j.bbmt.2011.12.473 · 3.40 Impact Factor
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    Biology of Blood and Marrow Transplantation 02/2012; 18(2):S319. DOI:10.1016/j.bbmt.2011.12.294 · 3.40 Impact Factor

Publication Stats

2k Citations
362.88 Total Impact Points


  • 2009-2015
    • Northside Hospital
      St. Petersburg, Florida, United States
  • 2008-2015
    • Northside Hospital
      Atlanta, Georgia, United States
  • 2000-2012
    • Indiana Blood and Marrow Transplantation
      Indianapolis, Indiana, United States
    • Medical College of Wisconsin
      • Center for International Blood & Marrow Transplant Research
      Milwaukee, Wisconsin, United States
  • 1998-2011
    • University of California, San Diego
      • • Department of Medicine
      • • Moores Cancer Center/Oncology
      • • Department of Pathology
      San Diego, California, United States
  • 2005
    • Stanford University
      Palo Alto, California, United States
    • University of Texas Health Science Center at San Antonio
      San Antonio, Texas, United States
  • 2003
    • University of Chicago
      • Section of Hematology/Oncology
      Chicago, Illinois, United States