scholarly journals High-dose BCNU/Melphalan conditioning regimen before autologous stem cell transplantation in newly diagnosed multiple myeloma

2017 ◽  
Vol 53 (1) ◽  
pp. 34-38 ◽  
Author(s):  
D Sivaraj ◽  
W Bacon ◽  
G D Long ◽  
D A Rizzieri ◽  
M E Horwitz ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Autologous Stem Cell Transplantation ◽  
Conditioning Regimen ◽  
High Dose ◽  
Newly Diagnosed

Sequential VAD (Vincristine, Adriamycin, Dexamethasone) and VTD (VELCADE®, Thalidomide, Dexamethasone) Induction Followed by High-Dose Therapy with Autologous Stem Cell Transplantation and Maintenance Treatment with VELCADE for Newly Diagnosed Multiple Myeloma: Interim Results of Phase II Trial.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 952-952 ◽  
Author(s):  
Sung-Soo Yoon ◽  
Hye Jin Kim ◽  
Dong Soon Lee ◽  
Hyeon Seok Eom ◽  
Jun Ho Jang ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Autologous Stem Cell Transplantation ◽  
Maintenance Treatment ◽  
Response Rate ◽  
High Dose ◽  
Hematologic Toxicity ◽  
Newly Diagnosed

Abstract Introduction Effective reduction of myeloma before autologous stem cell transplantation (ASCT) prolongs survival in multiple myeloma patients. Recently, incorporation of novel agents resulted in improved response rate and reduced side effect in newly diagnosed multiple myeloma. Method: Patients are planned to receive 2 cycles of VAD (vincristine 0.4mg D1-4, adriamycin 9mg/m2 D1-4, dexamethasone 40mg D1-4, 9–12 every 3 weeks), and VTD (bortezomib 1.3mg/m2 D1, 4, 8, 11, thalidomide 100mg daily, dexamethasone 40mg D1-4, 9–12 every 3 weeks). High dose melphalan (200mg/m2) is used as a conditioning regimen for ASCT. Bortezomib (1.3mg/m2) as a maintenance treatment is administered weekly x 4 times every 6 weeks for 4 cycles after ASCT. Response was assessed by EBMT criteria, with additional category of nCR. Adverse events were graded by the NCI-CTCAE, Version 3.0. Result: At this interim analysis, 60 patients have been entered into the ongoing trial, and efficacy could be assessed in 53 patients. After 2 cycles of VAD, response rate was 70%. After VTD, two patients showed further improvement with additional CR, and an overall response was 97% with 14% CR. Especially, patients with poor prognostic cytogenetics (n=6) all responded after VTD. So far, autologous stem cells were successfully collected in all 28 patients with a median CD34+ count of 7.8 x 106/kg (range, 2.17–44.7 x 106/kg). In 24 patients who underwent autologous stem cell transplantation, five patients gained additional CR. There was no progression in patients completed bortezomib maintenance (n=9, CR 77%). The median follow-up duration was 6 months, median time to response was 1.4 months, and median overall survival was not reached. Grade 3,4 hematologic toxicity was more frequently observed after VAD than VTD (anemia 15.8%, 4.6%, neutropenia 7.9%, 3.5%), and incidence of grade 2,3 peripheral neuropathy was low (VAD 3.5%, VTD 7%). Conclusion: Sequential VAD and VTD induction therapy in newly diagnosed multiple myeloma was highly effective, even in patients with poor prognostic cytogenetics, and did not prejudice stem cell collection. VTD could have contributed to increased RR and minimized side effects. An updated results will be presented at the ASH meeting. *Protocol Number: KMM51-NCT00378755.

High Dose Therapy with Autologous Stem Cell Transplantation Vs Standard Dose Chemotherapy In Multiple Myeloma: A Meta-Analysis

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 3559-3559
Author(s):  
Florian Faußner ◽  
Markus Pfirrmann ◽  
Wolfram Dempke
Keyword(s):  
Multiple Myeloma ◽  
Clinical Trials ◽  
Stem Cell ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Autologous Stem Cell Transplantation ◽  
Additional Data ◽  
Standard Dose ◽  
High Dose ◽  
Newly Diagnosed

Abstract Abstract 3559 Introduction. Myeloablative high dose chemotherapy (HDT) followed by single autologous stem cell transplantation is currently the standard treatment for patients younger than 65 years in newly diagnosed multiple myeloma (MM). Several randomized controlled trials (RCTs) comparing HDT with standard dose therapy (SDT) have shown some benefit in overall survival (OS) and progression free survival (PFS), whereas other RCTs did not confirm this finding. Koreth et al. (2007) performed a metaanalysis summarizing the existing data of the RCTs including 2,411 patients. These authors found a significant superiority for HDT in PFS but not in OS. Since a number of new studies have been published recently, we attempted to re-analyze the current data in terms of the endpoints OS and PFS. Methods. We searched PubMed, Embase, abstracts of former ASH meetings and ClinicalTrials.gov as well as bibliographies of included trials and recent reviews from september 2009 until may, 20th 2010. Amongst the 3,484 results in this search we identified 10 RCTs comparing HDT with SDT on an intent-to-treat-basis. Treatment characeristics and outcomes of OS and PFS were calculated using R. Furthermore, we tested for statistical heterogenity, publication bias and performed subgroup analyses. Results. 9 RCTs including 2,600 patients were fully analyzed. Patients undergoing HDT with stem cell transplantation did have significant PFS benefit (Hazard Ratio 0.73; 95% conficence intervall 0.56–0.95; P=0.02) but not OS benefit (HR 0.90; 95% CI 0.74–1.10; P=0.32) compared to patients undergoing SDT. Additional data from ongoing clinical trials are expected, thus updated results at the meeting including 10 RCTs with about 3,400 patients will be presented. Conclusion. Although there is only a trend to OS benefit with HDT, it is currently still the first line treatment. Additional data from ongoing clinical trials and new studies using novel agents like thalidomide, lenalidomide and bortezomib are egerly warrented to finally evaluate the role of HDT in the treatment management of patients with newly diagnosed MM. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Regulatory T-cell depletion in the setting of autologous stem cell transplantation for multiple myeloma: pilot study

2020 ◽  
Vol 8 (1) ◽  
pp. e000286 ◽  
Author(s):  
Benjamin A Derman ◽  
Yuanyuan Zha ◽  
Todd M Zimmerman ◽  
Rebecca Malloy ◽  
Andrzej Jakubowiak ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Autologous Stem Cell Transplantation ◽  
Ex Vivo ◽  
Conditioning Regimen ◽  
High Dose ◽  
Treg Depletion ◽  
Post Transplant

BackgroundProgression after high-dose melphalan with autologous stem cell transplantation (ASCT) in multiple myeloma (MM) may be due in part to immune dysfunction. Regulatory T (Treg) cells reconstitute rapidly after ASCT and inhibit immune responses against myeloma cells.MethodsWe performed a randomized study to evaluate two methods of Treg depletion in patients with MM undergoing ASCT. No Treg depletion was performed in the control ASCT arm. An anti-CD25 monoclonal antibody (basiliximab 20 mg IV) was administered on day +1 post-ASCT in the in vivo Treg depletion (IVTRD) arm. Tregs were depleted from autologous stem cell (ASC) grafts with anti-CD25 microbeads and the CliniMACS device in the ex vivo Treg depletion (EVTRD) arm.ResultsFifteen patients were enrolled, five in each arm. The conditioning regimen was melphalan 200 mg/m2. Primary objectives included assessments of efficiency of IVTRD/EVTRD, kinetics of Treg depletion and recovery following ASCT, and safety. EVTRD removed 90% of CD4+CD25+cells from ASC grafts. IVTRD and EVTRD led to reductions in Treg frequency between days +7 and +90 post-transplant compared with the control (p=0.007 and p<0.001, respectively).ConclusionsIVTRD and EVTRD are feasible and significantly reduce and delay Treg recovery post-ASCT for MM, and serve as a platform for using post-transplant immunotherapies to improve post-ASCT outcomes.Trial registration numberNCT01526096.

scholarly journals Bortezomib plus dexamethasone induction followed by autologous stem cell transplantation in multiple myeloma: A study from India

2016 ◽  
Vol 7 (4) ◽  
pp. 44-48
Author(s):  
Jeevan Kumar ◽  
Sachin Minhas ◽  
Kamini Khillan ◽  
Manorama Bhargava ◽  
Shyam Aggarwal
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
Partial Response ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Autologous Stem Cell Transplantation ◽  
Response Rates ◽  
Novel Agents ◽  
High Dose ◽  
Newly Diagnosed

Background: The use of novel agents for induction prior to autologous stem cell transplantation (ASCT) has considerably improved the complete response (CR) rate in multiple myeloma (MM) patients. There are very few studies from the developing countries on the use of novel agents followed by ASCT.Aims and Objectives: The current study was aimed for retrospective evaluation of the efficacy and response rates of induction with bortezomib (Velcade) plus dexamethasone (VD regimen) followed by ASCT in Indian patients.Materials and Methods: Ten patients with newly diagnosed, symptomatic MM who had received four cycles of VD induction before stem cell collection were evaluated. High dose melphalan was given for conditioning followed by stem cell transfusion. Thalidomide or lenalidomide was used as post-transplantation maintenance treatment.Results: Post VD induction, the overall response rate (ORR) was 90% including 20% CR, 40% very good partial response (VGPR), and 30% partial response (PR). Post ASCT, the ORR was 100%, including 80% CR and 20% VGPR. The 5-year overall survival and progression free survival rates were 65.6% and 57.1%, respectively.Conclusions: The VD induction regimen was effective and well tolerated in this retrospective analysis of Indian patients with newly diagnosed MM. It significantly improved the post-induction and post-transplant response rates without affecting stem cell collection.Asian Journal of Medical Sciences Vol.7(4) 2016 44-48 

High-dose lenalidomide and melphalan as conditioning for autologous stem cell transplantation in relapsed or refractory multiple myeloma.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 8021-8021
Author(s):  
Adriana C. Rossi ◽  
Jorge Monge ◽  
Ruben Niesvizky ◽  
Jing Mei Hsu ◽  
Tsiporah Shore ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
High Risk ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Autologous Stem Cell Transplantation ◽  
Phase 1 ◽  
Conditioning Regimen ◽  
High Dose ◽  
Refractory Multiple Myeloma

8021 Background: Autologous stem cell transplantation (ASCT) remains a standard of care of eligible patients with multiple myeloma, despite the many novel therapies introduced over the past decade. High dose melphalan (HDM) is the only approved regimen to date. Lenalidomide (LEN) is an oral immunomodulatory drug which has become the backbone of myeloma therapy from induction through salvage and maintenance. Early studies noted a dose response relationship, and found myelosuppression to be the dose limiting toxicity. We previously reported on our phase 1 study of high dose lenalidomide (HDLEN) with HDM in conditioning for ASCT, where no DLT was noted up to 350mg PO daily of LEN. Here we report the phase 2 data of patients undergoing ASCT with combination conditioning regimen. Methods: 50 patients with relapsed/refractory multiple myeloma (RRMM) underwent ASCT using HDLEN+HDM conditioning. HDLEN was dosed at 350mg PO daily from day -5 to day -1 and HDM was dosed 100mg/m2 on days -2 and -1. TPatients were heavily pre-treated: 32% had prior HDM-ASCT, 96% had received prior lenalidomide, and 42% prior pomalidomide; 40% prior anti-CD38 mAB. Of note, 68% entered the study with progressive disease at time of enrollment. Results: Overall response rate was 96%, with 80% being ≥VGPR. Median progression free survival (PFS) was noted at 14.3 months, while overall survival (OS) was 68.2 months. PFS was similar when patients were stratified by prior ASCT, depth of response at enrollment, or presence of high risk FISH. Toxicities were mostly hematologic (100% neutropenia and thrombocytopenia, 90% anemia), GI (88% diarrhea, 72% nausea, 42% vomiting) and metabolic (30-96% derangement in electrolytes), and similar to historical controls receiving HDM alone. Second malignancies were noted in 2 patients. Conclusions: HDLEN/HDM is a well tolerated and effective conditioning regimen for ASCT in patients with RRMM. This regimen merits further investigation as ASCT is likely to remain an integral part of the treatment of RRMM patients, yet few advancements have been made to this modality. HDLEN may be particularly useful in patients with high risk disease and those progressing after multiple lines of therapy. HDLEN added little toxicity to HDM and SPMs were not more frequent than expected per SEER database for patients in this age range. Clinical trial information: NCT01054196. [Table: see text]

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