Role Of Double Stem Cell Transplantation For Newly Diagnosed Multiple Myeloma In The Era Of Novel Agents

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 2171-2171
Author(s):  
Shotaro Hagiwara ◽  
Risen Hirai ◽  
Miki Nakamura ◽  
Akira Tanimura ◽  
Masataka Takeshita ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
Stem Cell Transplantation ◽  
Induction Therapy ◽  
Partial Remission ◽  
Progression Free Survival ◽  
Novel Agents ◽  
Newly Diagnosed ◽  
Free Survival

Abstract Background Autologous stem cell transplantation (ASCT) has been a part of the standard therapy for newly diagnosed multiple myeloma and several studies showed double ASCT improved the outcome in comparison with single ASCT, especially the patients who failed to achieve very good partial remission (VGPR). Recently, the introduction of novel agents significantly improved the response rate of the treatment for the multiple myeloma. Although ASCT is still crucial for newly diagnosed myeloma patients, the role of the double ASCT is unclear in the era of novel agents. We performed a single institution-based retrospective study. Methods We reviewed the medical records of patients who treated with ASCT for multiple myeloma between January 2001 and April 2013 in National Center for Global Health and Medicine, Tokyo, Japan. The regimen of the remission induction therapy, number of stem cell transplantations, survival after the first ASCT, progression free survival, the response after the induction therapy and the first ASCT were analyzed. Results Since 2001, we performed ASCT for 167 patients. Ninety-three patients were treated with double ASCT, and 2 patients were treated with tandem ASCT–allogeneic SCT. In 127 patients were treated with vincristine, adriamycin, and dexamethasone (VAD) as an induction therapy, and 40 patients were treated with bortezomib and dexamethasone (BD). Very-good-partial-remission (VGPR) or complete remission (CR) was obtained in 25.2%, 34.6% of the patients treated with VAD, and in 45.7%, 54.3% with BD regimen before and after the transplantation respectively. Overall survival (OS) and progression free survival (PFS) did not differ significantly between VAD and BD induction, the estimated 2 year-OS was 89.8% vs. 79.5%, and the 2 year-PFS was 43.2% vs. 63.5% respectively. Double transplantation improved PFS and OS in VAD induction than single transplantation (p=0.000, p=0.002). In BD induction, patients who failed to achieve VGPR or better after the first ASCT, double transplantation improved OS (p=0.010) but not PFS. In both VAD induction and BD, there was no significant survival benefit in double transplantation in patients who achieved VGPR or better. Conclusion The achievement of VGPR or better after the ASCT resulted in significantly better PFS. The role of double transplantation is still crucial for patients with inadequate response after the first ASCT even in the era of novel agents. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Impact of Different Mobilization Methods on Graft Composition and Outcome after Autologous Stem Cell Transplantation: Implications for Upfront Use of Plerixafor

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 1125-1125
Author(s):  
LaQuisa Hill ◽  
Oluchi C. Ukaegbu ◽  
Bipin N. Savani ◽  
Salyka Sengsayadeth ◽  
Stacey Goodman ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Overall Survival ◽  
Stem Cell ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Partial Remission ◽  
Progression Free Survival ◽  
Free Survival ◽  
Disease Response ◽  
Graft Composition

Abstract Early lymphocyte recovery (ELC) is associated with improved outcomes of hematologic malignancies after autologous hematopoietic stem cell transplantation (auto-SCT). ELC, its composition and impact on outcome depends on many variables; however there is limited data on ELC after different mobilization strategies (G-CSF [G] vs. G + high dose cyclophosphamide [GC] vs. G + plerixafor [GP]). Results from a recent study showed that GP based mobilization can affect the number and subsets of immune competent cells contained in the graft. We studied whether these differences are associated with immune reconstitution (ELC), engraftment, or long-term outcomes. We retrospectively identified patients undergoing auto-SCT at the Nashville VA Transplant Center between January 2000 and December 2010 in our CIBMTR database. Disease response was determined by standard CIBMTR response criteria. At our center, GP mobilization is reserved for patients who failed prior mobilization, to rescue G or GC mobilization, or as upfront usage in heavily pre-treated patients. Our patient cohort primarily included patients with multiple myeloma (MM) and lymphoma (LY). We had evaluable data on 333 patients (MM=196; LY=127; others=10). Comparative analysis of different mobilization methods are summarized in Table 1. Median number of regimens pre-SCT for MM was 2 (range 1-5) and for lymphoma 2 (range1-7). Among LY patients, 60 (47.3%) patients were in complete remission (CR), 58 (45.7%) in partial remission (PR) and 9 (7%) had stable disease (SD). Among MM patients, 69 (35.2%) were in CR or very good partial remission (VGPR) pre-transplant, 105 (53.5%) were in PR, and 14 (7.1%) had SD. There was no significant difference between disease response status among different mobilization methods for either the MM or LY patients. A higher absolute WBC count was seen in grafts after GP mobilization compared to G or GC (p=0.01), despite a majority of patients having received GP mobilization after failed G or GC mobilization, or as a rescue regimen (n=20 [89%]). Similarly, absolute lymphocyte counts were higher in grafts mobilized after GP compared to G or GC (p=0.01). All patients engrafted and there was no difference in time to WBC or platelet engraftment between mobilization methods. Although the GP cohort was more heavily treated than the other cohorts (>2 regimens for GP 82%, vs. G 72% vs. GC 58% [p=0.02]), progression-free survival (PFS) and overall survival (OS) of G vs. GC vs. GP at 2-years was not significantly different between MM and LY cohorts (Table 1). In summary, grafts mobilized with GP exhibited major differences in graft composition in conjunction with favorable post- transplant outcomes compared with grafts mobilized with G or GC. GP mobilization accelerated lymphocyte engraftment in this heavily treated group compared to G or GC. For patients proceeding to transplant heavily pre-treated, GP is a better mobilization method to ensure a robust graft is collected while avoiding the need for multiple stem cell collections and providing similar outcomes as patients less heavily treated and mobilized by G or GC. A prospective randomized controlled trial would elucidate whether progression free survival and overall survival might be improved by utilizing GP mobilization as a first-line therapy rather than as a rescue method. Table 1. Graft composition and outcomes of different stem cell mobilization methods Variable G (n=97) GC (n=213) GP (n=23) P value Numbers of regimens pre-SCT, median 2.2 (95% CI, 2.0-2.4) 1.9 (1.8-2.0) 2.3 (1.9-2.7) 0.02 WBC in graft, median (range) 184.8 (12-777.7) 138.6 (11-542) 286.1 (186-400.3) 0.01 Absolute lymphocyte in graft (x103), median (range) 128.1 (13-321.1) 73.9 (3.4-433.6) 161.2 (47.4-302.0) 0.01 ANC >500 (days), median (range) 16 (11-25) 15 (7-86) 18 (13-24) 0.16 Platelets >20 (days), median (range) 13 (9-22) 12 (7-18) 12 (10-21) 0.07 OS (2 year) Lymphoma 74.5 77.9 72.7 0.054 Multiple myeloma 89.6 74.4 72 0.76 PFS (2 year) Lymphoma 58.2 57.6 46.1 0.1 Multiple myeloma 66.3 49 60 0.21 Disclosures No relevant conflicts of interest to declare.

scholarly journals Durable Remission and Survival in Relapsed/Refractory Multiple Myeloma after Allogeneic Hematopoietic Stem Cell Transplantation

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 5884-5884 ◽  
Author(s):  
A. Megan Cornelison ◽  
Rima M Saliba ◽  
Sairah Ahmed ◽  
Yago Nieto ◽  
Qaiser Bashir ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Overall Survival ◽  
Stem Cell ◽  
Hematopoietic Stem Cell Transplantation ◽  
Stem Cell Transplantation ◽  
Progression Free Survival ◽  
Hematopoietic Stem ◽  
Free Survival ◽  
Durable Remission

Abstract Background: The role of allogeneic hematopoietic stem cell transplantation (allo-HSCT) in the setting of refractory multiple myeloma (MM) is still controversial. Although potentially curative in a subset of pts, concerns regarding treatment related mortality (TRM) and graft vs. host disease (GVHD) preclude its universal use. In this study, we evaluated the role of allo-HSCT for pts with relapsed MM. Methods: 110 consecutive pts with relapsed MM underwent allo-HSCT at our institution between 2000 and 2014. The primary objective was to assess progression-free (PFS) and overall survival (OS). Results: Median age at allo-HSCT was 54 (range, 32-71) years and median time from diagnosis to allo-HSCT was 35.7 (range, 8.6 to 228.8) months. Fifty-two (47%) and 49 (45%) pts had standard-risk (SR) and high-risk (HR) cytogenetics at the time of allo-HSCT, respectively. Pts received a median of 5 (range, 1-9) prior chemotherapy regimens and 99 (90%) pts had at least 1 (range, 0-3) prior auto-HSCTs. One hundred one (92%) pts received either a proteasome inhibitor (PI) or an immunomodulatory drug (IMiD) prior to allo-HSCT, with 65 (59%) receiving both. Sixty eight (62%) received allo-HSCT from matched related, 34 (31%) from matched unrelated, 5 (4%) from cord blood, and 3 (3%) from mismatched donors. Preparative regimen was fludarabine/melphalan-based in 88 (80%) and fludarabine/busulfan-based in 16 (15%) pts. Median time to neutrophil and platelet engraftment was 12 (range, 8-30) and 13 (range, 0-81) days, respectively. Ten pts died of non-relapse causes within 100 days (100-day TRM: 9%) and 21 (19%) within 1 year. Grade 1-4 acute GVHD was seen in 50 (45%) and cGVHD in 35 (32%) pts, respectively. Eighteen (16%) achieved a CR, 26 (23%) a VGPR and 38 (34%) achieved a PR, with an overall response rate of 73%. With a median follow up of 41.9 months (range, 6.4 to 172.9) in surviving pts, 1- and 2-year PFS were 23% and 15%, respectively (Fig 1). One and 2-year OS were 50% and 32%, respectively (Fig 2). HR cytogenetics at allo-HSCT were associated with a significantly shorter 2-year PFS (6% for HR vs. 23% for SR; p=0.007) and OS (p=0.01). A response <PR after allo-HSCT was also associated with significantly shorter 2-year PFS (p<0.001) and OS (p<0.001). Conclusions: Allo-HSCT is associated with durable remission and survival in approximately 15% of heavily pretreated pts with relapsed/refractory MM. Novel, more effective approaches are needed for patients with HR cytogenetic abnormalities. Figure 1 Progression-Free Survival Figure 1. Progression-Free Survival Figure 2 Overall Survival Figure 2. Overall Survival Disclosures No relevant conflicts of interest to declare.

The Clinical Impact of Thalidomide Maintenance on Progression Free Survival and Postrelapse Survival after Autologous Stem Cell Transplantation in Patients with Newly Diagnosed Multiple myeloma

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 3975-3975
Author(s):  
Ho Sup Lee ◽  
Yang Soo Kim ◽  
Chang-Ki Min ◽  
Je-Jung Lee ◽  
Kihyun Kim ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
Stem Cell Transplantation ◽  
Maintenance Therapy ◽  
Cell Transplantation ◽  
Induction Chemotherapy ◽  
Progression Free Survival ◽  
Salvage Chemotherapy ◽  
Novel Agents ◽  
Free Survival

Abstract Background: There have been many advances in treatments for multiple myeloma (MM). Recently, novel agents such as thalidomide, bortezomib, and lenalidomide have been developed for myeloma treatment. thalidomide was the first novel agent introduced that improved the overall response rate (ORR) and prolonged survival in transplant eligible or ineligible patients with multiple myeloma. It was first confirmed that thalidomide was active in patients with relapsed and/or refractory MM; since then, thalidomide has become an important part of MM treatment, as initial therapy for previously untreated patients, as maintenance therapy following definitive treatment, and as salvage therapy. Until now, the efficacy of thalidomide maintenance has been controversy in some studies. The purpose of this study was estimate necessity of thalidomide maintenance for improving survival in transplantation eligible patients with MM in real clinical fields. Methods: Data from patients at thirteen university hospitals in South Korea between December 2005 and May 2013 were collected retrospectively. All included patients were treated with induction chemotherapy followed by autologous stem cell transplantation (ASCT) and then with or without maintenance. The included patients were treated with thalidomide based regimens (TD;128 (50.6%), CTD; 96 (37.9%), TAD; 11 (4.3%)), mostly or other conventional regimens such as vincristine, doxorubicin and dexamethasone (VAD; 10 (4.0%), and others; 8 (3.2%)) as induction chemotherapy. And then patients received ASCT. However, patients were excluded underwent tandem ASCT or Allogeneic stem cell transplantation. The number of patients treated with thalidomide maintenance for more than six months after ASCT were 74 (29.2%) without maintenance were 179 (70.8%). The differences of survival were estimated in two groups which were defined to include patients treated with or without thalidomide maintenance. Patients who suffer from progression or relapse after ASCT were received salvage chemotherapy such as bortezomib based or other novel agents based regimen. The progression free survival (PFS) was defined duration from the date of starting induction chemotherapy to the date of disease progression, relapse, or death from any causes after ASCT. The definition of overall survival (OS) was calculated from the date of diagnosis to the date of death from any causes or final follow-up date. The postrelapse survival (PRS) was defined duration from the date of relapse after ASCT to the date of disease progression, relapse, or death from any causes. Results: The median age of the 253 patients was 57 years (range, 33-75 years) and the male to female ratio was 1.07:1.0. The response rates before ASCT were following: CR or stringent CR (sCR) in 93 (36.7%), VGPR in 63 (24.9%), PR in 86 (34.0%), and < PR in 7 (2.8%). The reason for the higher ORR in this study compared to other studies was that it included patients who were treated with thalidomide induction chemotherapy and who underwent ASCT. Most of these patients achieved more than PR or PR because the South Korean national health insurance only allowed ASCT in such patients. The differences of 3-year PFS of patients with or without maintenance were 66.1% vs 43.0%, p=0.003. The 3-year OS were 91.7% vs 84.5%, p=0.091. And the differences of PRS were not shown in two groups (11.63 vs 10.00 months, p=0.790). Conclusion: Patients treated with thalidomide maintenance after ASCT were presented higher PFS but not shown higher OS. However, long term use of thalidomide as maintenance therapy was not interfere with efficacy of salvage chemotherapy in patients suffered from progression or relapse after ASCT. So, we suggest that thalidomide maintenance might be useful for improving survival by lowering relapse or progression rates and not interfere with efficacy of salvage chemotherapy in real clinical field. In the future, further prospective studies will be needed to confirm the role of thalidomide maintenance therapy for prolonged survival in patients with MM who are treated with novel agents such as thalidomide, bortezomib, or lenalidomide. Disclosures No relevant conflicts of interest to declare.

Autologous Stem Cell Transplant: A Cost Effective and Efficacious Treatment for Newly Diagnosed Multiple Myeloma

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 2358-2358 ◽  
Author(s):  
Seema Niphadkar ◽  
Indumathy Varadarajan ◽  
Tiffany Pompa ◽  
Kevin Y Hou ◽  
Kathleen Degen ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
Maintenance Therapy ◽  
Progression Free Survival ◽  
Cost Effective ◽  
Novel Agents ◽  
Newly Diagnosed ◽  
Free Survival ◽  
Optimal Duration ◽  
The Cost

Abstract Background: Induction chemotherapy followed by autologous stem cell transplantation (ASCT) is considered a standard of care for appropriate patients with newly diagnosed multiple myeloma (MM), but with the rapid expansion of available treatments, the role of ASCT has been questioned. Numerous studies have shown an improvement in complete response (CR) and progression free survival (PFS) with ASCT but our study is a cost comparison between novel agents and ASCT. We aimed to compare the cost effectiveness of ASCT versus non-transplant regimens in relation to PFS. Methods: We queried the Healthcare Cost and Utilization Project's Nationwide Inpatient Sample (NIS) between 2008 and 2013 using the ICD-9 code 203.00 for MM and V42.81 for ASCT in the primary and secondary diagnosis fields. The analysis included patients who were 18 years or older. We monitored the trends in ASCT with regards to cost of a transplant admission and length of stay (LOS). Cost of hospitalization was adjusted for inflation in reference to the year 2011 and cost to charge ratio. Literature regarding common treatment regimens, response rates, duration of treatment, and PFS was reviewed. The assumption was made that transplant eligible patients that did not undergo transplant would be treated as though they were transplant ineligible. Gay et al 2015 showed a 43.4-month (mo) median PFS with 4 cycles of Rd followed by ASCT and lenalidomide maintenance until progression or toxicity. The cost of novel regimens was estimated using the one month commercial cost described by Roy et al and wholesale acquisition costs for new agents not described by the study which were adjusted using adjunct cost described by the study. A standard weight of 70 kg was used for agents requiring dose calculations. The cost of novel agents for an equivalent duration of 43.4 mo was estimated. Results: A total of 44778 (weighted n=9039) hospitalizations for MM (Male 55.9%, Caucasian 57.9%, peak incidence 65-79 yrs) occurred from 2008-2013. The average length of stay during ASCT admission was 11.4 +/- 0.4 days with a cost of $109,856 +/-5749.83. There has been a 16.89% decrease in LOS and 1.99% increase in the cost of ASCT (p<0.05). Gay et al showed a 43.4 mo PFS with 4 cycles Rd ($46,216) followed by ASCT ($109,856) and lenalidomide maintenance (~35.4 mo $564,453 adjusted for cost of office visits and lab work) for a total of $720,525 Conclusion: Rd + ASCT + R maintenance is efficacious for the treatment of newly diagnosed MM. The cost associated with the induction and transplant represents only 22% of the total cost, whereas lenalidomide maintenance makes up 78%. Considering secondary risks and the cost involved with lenolidomide maintenance, further investigation is warranted regarding the optimal duration of maintenance therapy and resultant progression free survival. It also raises the need for alternative options for maintenance therapy. Bortezomib and ixazomib are both more cost effective options and studies are in progress to assess their efficacy in PFS in the maintenance setting. Studies using novel agents for induction prior to ASCT are ongoing and have yet to reach an optimal duration of therapy. Table 1 shows that most of the novel agents used in combination regimens are more expensive that ASCT. Although most patients would not remain on one of these regimens for 43.4 mo, they would presumably progress through multiple lines of therapy during the 43.4 mo of PFS that ASCT provides. In an era of cost consciousness, ASCT should continue to be an integral component of MM treatment. Disclosures No relevant conflicts of interest to declare.

Newly Diagnosed Multiple Myeloma Patients with 1q21 Amplification Treated by Autologous Stem Cell Transplantation Have Shorter Progression-Free Survival Interval.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 4758-4758
Author(s):  
Pavel Nemec ◽  
Henrieta Greslikova ◽  
Petr Kuglik ◽  
Hana Filkova ◽  
Romana Zaoralova ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Autologous Stem Cell Transplantation ◽  
Progression Free Survival ◽  
Chromosome Band ◽  
Newly Diagnosed ◽  
Free Survival ◽  
End Point

Abstract Amplification of chromosome band 1q21 as well as increased expression of CKS1B gene in this area is a frequently mentioned prognostic factor for patients with multiple myeloma (MM). Total 39 newly diagnosed multiple myeloma patients (median age: 56 years) enrolled in Faculty Hospital Brno, Brno, Czech Republic, were examined for 1q21 amplification status. All patients received 4 cycles of vincristine, adriamycin and dexamethasone (VAD) as induction and one course melphalan 200mg/m2 followed by autologous stem cell transplantation (ASCT). The median follow-up from treatment start was 16.1 (range: 2.2–44.0) months. All the “end-point” intervals and treatment responses were assigned by IMWG criteria. Plasma cells were identified by cytoplasmic light-chain immunofluorescence followed by fluorescence in situ hybridisation (cIg-FISH). Amplification of 1q21 (Amp(1q21)) was assigned utilizing labelled BAC clone (RP11-205M9) DNA probe. Cut-off level for Amp(1q21) was established to 10% of total amount of cells with additional signals detected. Amp(1q21) was found in 41% (16/39) patients. Clinical parameters valid for patients with Amp(1q21) versus patients lacking Amp(1q21) were as follows: overall response rate (ORR) achieved 87.5% (14/16) vs. 91.3% (21/23) patients (p=0.404); overall survival (OS) median was 22.4 months vs. not yet reached (p=0.022); time to progression (TTP) median was 16.1 months vs. not yet reached (p=0.010); progression-free survival (PFS) median was 15.6 months vs. 25.2 months (p=0.023) and duration of response (DOR) median was 15.9 months vs. not yet reached (p=0.048). There were found statistical significant difference in all named “end-point” intervals (OS, TTP, PFS and DOR) between patients with/without Amp(1q21) but not in ORR. In conclusion, patients with Amp(1q21) treated by ASCT have significant shorter PFS median (15.6 months) when compared with patients lacking Amp(1q21) with PFS median 25.2 months (p=0.023). This findings is in accordance with previously published work (Chang et al., 2006).

A Randomized Clinical Trial of Lenalidomide and Dexamethasone with and without Autologous Stem Cell Transplant in Patients with Newly Diagnosed Multiple Myeloma: Interim Study Results,

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 4142-4142 ◽  
Author(s):  
Lijun Dai ◽  
Amy O'Sullivan ◽  
Ryan Kennedy ◽  
Mohammad Abbas ◽  
Yongli Shuai ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Multiple Myeloma ◽  
Overall Survival ◽  
Stem Cell ◽  
Low Dose ◽  
Progression Free Survival ◽  
Newly Diagnosed ◽  
Free Survival

Abstract Abstract 4142 Introduction: High dose chemotherapy combined with autologous stem cell transplantation (ASCT) as opposed to conventional chemotherapy improved progression free survival (PFS) and overall survival (OS) in multiple myeloma (MM) and is currently the standard of care for newly diagnosed MM patients less than 65 years old. Over the last decade, novel agents such as lenalidomide or bortezomib have dramatically improved MM outcomes with similar response rates as ASCT and the role of upfront ASCT has become more controversial. Therefore the goal of this randomized clinical trial is to determine the role of upfront ASCT in newly diagnosed myeloma patients receiving novel agent lenalidomide and low-dose dexamethasone induction. Methods: Patients aged ≥18 years with newly confirmed, measurable MM in stage 2 and 3 (Salmon Durie) and meeting CRAB criteria were enrolled. Patients were randomized to transplant (Arm A) or to non-transplant (Arm B). Patients in Arm A received 4 cycles of lenalidomide (25mg days 1 – 21) plus low-dose dexamethasone (40mg days 1,8,15,22) followed by ASCT conditioned with 200 mg/m2 melphalan (LD+ASCT); Arm B patients received 8 cycles of lenalidomide plus low-dose dexamethasone (LD alone). Both arms received stem cell collection after 4 cycles of therapy if patients achieved at least a partial remission (PR). Patients with stable disease (SD) or progressive disease (PD) went off study. The primary objective was to compare best response. The secondary endpoints included duration of response (DOR), progression free survival (PFS), overall survival (OS) and evaluation of secondary malignancies in both arms. Results: From February 2008 to May 2011, 44 patients with newly diagnosed MM were randomized. The patient characteristics were as follow: median age of the patients was 61.7 years (range 48∼75), 45.5% female and 55.5% male patients, ISS stage I 31%, II 51% and III 18%. 40 patients were eligible for evaluation and 20 patients were randomized to Arm A or Arm B, respectively. The data were analyzed according to latest IMWG response criteria (Blood. 2011 May 5;117(18):4691–5). In an intention to treat analysis, patients in Arm A (LD + ASCT), achieved a 100% Overall Response Rate (ORR) with 40% PR (n=8) and 60% Very Good Partial Response (VGPR) (n=12). In Arm B (LD only) the ORR was 75% (n=15), including 15% CR (n=3), 35% VGPR (n=7), 25% PR (n=5), 20% SD (n=4) and 5% PD (n=1). The ORR was significantly superior in the LD+ASCT group compared to LD alone (p=0.047). After a median follow-up of 25.3 months, 17 patients have PD (8 in LD+ASCT and 9 in LD alone), 6 have died (1 in LD+ASCT and 5 in LD alone). DOR, PFS and OS were not significantly different in both groups. OS showed a trend to be superior in patients treated with LD+ASCT (p=0.08). (Table 1). One patient in the LD+ASCT arm developed MDS 13 months after start of therapy. Conclusion: Our interim analysis of an ongoing clinical study suggests that treatment of newly diagnosed MM patients with lenalidomide plus low-dose dexamethasone induction followed by upfront ASCT resulted in significantly improved ORR. There was no difference in terms of DOR or PFS with a trend of superior OS in the LD+ASCT group. The study requires careful interpretation based on the low patient number and relatively short follow up, but supports the continued role of upfront consolidative ASCT in newly diagnosed MM patients. The incidence of secondary malignancy was low with the development of 1 MDS. Updated data on response and overall survival will be available at the time of presentation. Disclosures: Roodman: Amgen: Consultancy; Millennium Pharmaceuticals: Consultancy. Raptis:Millennium: Speakers Bureau; Celgene Corp: Speakers Bureau; Eisai: Speakers Bureau. Lentzsch:Celgene Corp: Consultancy, Research Funding; Onyx: Consultancy; Genzyme: Consultancy; prIME Oncology: Honoraria; Imedex: Honoraria; Clinical Care Options: Honoraria.

Prospective, Randomized Study of Single Compared With Double Autologous Stem-Cell Transplantation for Multiple Myeloma: Bologna 96 Clinical Study

2007 ◽  
Vol 25 (17) ◽  
pp. 2434-2441 ◽  
Author(s):  
Michele Cavo ◽  
Patrizia Tosi ◽  
Elena Zamagni ◽  
Claudia Cellini ◽  
Paola Tacchetti ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Autologous Stem Cell Transplantation ◽  
Randomized Study ◽  
Prospective Randomized Study ◽  
Newly Diagnosed ◽  
Free Survival ◽  
To Receive

Purpose We performed a prospective, randomized study of single (arm A) versus double (arm B) autologous stem-cell transplantation (ASCT) for younger patients with newly diagnosed multiple myeloma (MM). Patients and Methods A total of 321 patients were enrolled onto the study and were randomly assigned to receive either a single course of high-dose melphalan at 200 mg/m2 (arm A) or melphalan at 200 mg/m2 followed, after 3 to 6 months, by melphalan at 120 mg/m2 and busulfan at 12 mg/kilogram (arm B). Results As compared with assignment to the single-transplantation group (n = 163 patients), random assignment to receive double ASCT (n = 158 patients) significantly increased the probability to attain at least a near complete response (nCR; 33% v 47%, respectively; P = .008), prolonged relapse-free survival (RFS) duration of 18 months (median, 24 v 42 months, respectively; P < .001), and significantly extended event-free survival (EFS; median, 23 v 35 months, respectively; P = .001). Administration of a second transplantation and of novel agents for treating sequential relapses in up to 50% of patients randomly assigned to receive a single ASCT likely contributed to prolong the survival duration of the whole group, whose 7-year rate (46%) was similar to that of the double-transplantation group (43%; P = .90). Transplantation-related mortality was 3% in arm A and 4% in arm B (P = .70). Conclusion In comparison with a single ASCT as up-front therapy for newly diagnosed MM, double ASCT effected superior CR or nCR rate, RFS, and EFS, but failed to significantly prolong overall survival. Benefits offered by double ASCT were particularly evident among patients who failed at least nCR after one autotransplantation.

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