scholarly journals Reporting of adverse event data in hematopoietic stem cell transplantation clinical trials involving investigational new drugs or devices: A report from the William Guy Forbeck Foundation 2001 focus meeting on clinical trials in hematopoietic stem cell transplantation

2002 ◽  
Vol 8 (6) ◽  
pp. 295-302
Author(s):  
Paul J Martin ◽  
Joseph H Antin ◽  
Daniel J Weisdorf ◽  
Virginia Paton ◽  
Mary M Horowitz
Keyword(s):  
Clinical Trials ◽  
Stem Cell ◽  
Hematopoietic Stem Cell Transplantation ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Hematopoietic Stem Cell ◽  
New Drugs ◽  
Event Data ◽  
Hematopoietic Stem ◽  
Adverse Event Data

A Randomized Trial of Two 2-Dose Influenza Vaccination Strategies for Patients Following Autologous Hematopoietic Stem Cell Transplantation

2020 ◽  
Author(s):  
Benjamin W Teh ◽  
Vivian K Y Leung ◽  
Francesca L Mordant ◽  
Sheena G Sullivan ◽  
Trish Joyce ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Stem Cell ◽  
Hematopoietic Stem Cell Transplantation ◽  
Stem Cell Transplantation ◽  
Influenza Vaccination ◽  
Cell Transplantation ◽  
Hematopoietic Stem Cell ◽  
Influenza B ◽  
High Dose ◽  
Hematopoietic Stem

Abstract Background Seroprotection and seroconversion rates are not well understood for 2-dose inactivated influenza vaccination (IIV) schedules in autologous hematopoietic stem cell transplantation (autoHCT) patients. Methods A randomized, single-blind, controlled trial of IIV in autoHCT patients in their first year post-transplant was conducted. Patients were randomized 1:1 to high-dose (HD) IIV followed by standard dose (SD) vaccine (HD-SD arm) or 2 SD vaccines (SD-SD arm) 4 weeks apart. Hemagglutination inhibition (HI) assay for IIV strains was performed at baseline, 1, 2, and 6 months post–first dose. Evaluable primary outcomes were seroprotection (HI titer ≥40) and seroconversion (4-fold titer increase) rates and secondary outcomes were geometric mean titers (GMTs), GMT ratios (GMRs), adverse events, influenza-like illness (ILI), and laboratory-confirmed influenza (LCI) rates and factors associated with seroconversion. Results Sixty-eight patients were enrolled (34/arm) with median age of 61.5 years, majority male (68%) with myeloma (68%). Median time from autoHCT to vaccination was 2.3 months. For HD-SD and SD-SD arms, percentages of patients achieving seroprotection were 75.8% and 79.4% for H1N1, 84.9% and 88.2% for H3N2 (all P > .05), and 78.8% and 97.1% for influenza-B/Yamagata (P = .03), respectively. Seroconversion rates, GMTs and GMRs, and number of ILI or LCIs were not significantly different between arms. Adverse event rates were similar. Receipt of concurrent cancer therapy was independently associated with higher odds of seroconversion (OR, 4.3; 95% CI, 1.2–14.9; P = .02). Conclusions High seroprotection and seroconversion rates against all influenza strains can be achieved with vaccination as early as 2 months post-autoHCT with either 2-dose vaccine schedules. Clinical Trials Registration Australian New Zealand Clinical Trials Registry: ACTRN12619000617167.

Bortezomib Therapy for Multiple Myeloma in Relapse after Reduced Intensity Conditioning Allogeneic Hematopoietic Stem Cell Transplantation (RICT).

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 5399-5399
Author(s):  
Sophie Ducastelle ◽  
Daniela Revesz ◽  
Jacques Troncy ◽  
Samira Mahmoudi ◽  
Xavier Thomas ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
Hematopoietic Stem Cell Transplantation ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Hematopoietic Stem Cell ◽  
Median Time ◽  
New Drugs ◽  
Hematological Toxicity ◽  
Hematopoietic Stem

Abstract Multiple myeloma (MM) remains incurable and specially of poor prognosis in case of refractory or relapsed disease. However, recent therapeutic advances including the use of new drugs are promising. Although, Bortezomib, new proteasome inhibitor, has proven its efficacy in patients with refractory or relapsed MM, it has not been sufficiently evaluated in the setting of allogeneic hematopoietic stem cell transplantation. Here, we report four cases of MM patients, very heavily pre-treated and all previously transplanted, who received bortezomib associated to dexamethasone for relapse after allogeneic RICT (median time from diagnosis: 68 months, median time from RICT: 41 months). We studied the feasibility, efficacy and safety of bortezomib: two patients achieved a complete remission, one patient a very good partial response, and one had no response. The tolerance was excellent with only one patient who developed a reversible grade 3 hematological toxicity. No GVHD recrudescence was observed. All patients relapsed after completion of bortezomib treatment. This questions about the potential benefit of maintenance therapy with bortezomib. Given the feasibility and the high efficacy of bortezomib combined with dexamethasone in relapsed MM after RICT, our results argue in favour of an immune-modulatory activity of bortezomib. New strategies combining RICT and bortezomib are warranted to increase and maintain an adequate response. Combination RICT and bortezomib regimen are anticipated to further extend survival in relapsed MM.

scholarly journals What is the role of Autologous Hematopoietic Stem Cell Transplantation (AHSCT) in the scenario of new drugs for Multiple Myeloma (MM)

JBMTCT ◽  
2020 ◽  
Vol 1 (1) ◽  
pp. 27-29
Author(s):  
Abrahão Elias Hallack Neto ◽  
Angelo Maiolino
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
Hematopoietic Stem Cell Transplantation ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Hematopoietic Stem Cell ◽  
New Drugs ◽  
High Dose ◽  
Hematopoietic Stem ◽  
Immunomodulatory Action

Patients with multiple myeloma (MM) in clinical con­ditions to be referred to autologous hematopoietic stem cell transplantation (AHSCT) generally start therapy with an induction chemotherapy followed by high-dose alkylating and AHSCT. The ideal regimen and the number of pre-AHSCT induction is still a controversial subject, however, opting for at least three to four cycles of chemotherapy including a drug with immunomodulatory action, a protea­some inhibitor, with a corticosteroid, are advised as the first line before AHSCT.

scholarly journals Intensive immunosuppression followed by autologous hematopoietic stem cell transplantation for the treatment of multiple sclerosis

2020 ◽  
Vol 13 ◽  
pp. 175628642092946
Author(s):  
Jan Lycke ◽  
Stig Lenhoff
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trials ◽  
Stem Cell ◽  
Hematopoietic Stem Cell Transplantation ◽  
Stem Cell Transplantation ◽  
Disease Activity ◽  
Cell Transplantation ◽  
Hematopoietic Stem Cell ◽  
Randomized Clinical Trials ◽  
Hematopoietic Stem

Autologous hematopoietic stem cell transplantation (AHSCT) to treat multiple sclerosis (MS) has mostly been used in devastating cases as the last option to stop further neurological deterioration. However, evidence from several retrospective clinical trials indicates that young, less disabled patients with highly inflammatory active MS are the most likely to benefit from AHSCT, and after moving from high-intensity to nonmyeloablative procedures the tolerability of AHSCT has increased and its associated risk and mortality have declined considerably. Recent meta-analyses and randomized clinical trials show that AHSCT is more effective than currently approved disease-modifying therapies (DMTs), with suppression of disease activity in 70–90% of patients and long-term cessation of disease activity in two-thirds of treated patients. The rationale for AHSCT is to eliminate autoimmunity and achieve immune resetting by intense immunosuppression followed by infusion of autologous hematopoietic stem cells. Similar effects on the immune system have been suggested for cladribine and alemtuzumab treatment and, together with AHSCT, they constitute the induction or immune-reconstitution therapies for MS. Although, further randomized controlled trials of AHSCT for MS are needed, it has become clear that improved patient selection and lower intensity conditioning regimens have reduced AHSCT associated risks and mortality and strengthened the position of AHSCT among other DMTs. Do we have enough experience and scientific support for AHSCT in MS to move from an exclusive treatment for aggressive, treatment-resistant MS and acquire broader indications, similar to other effective DMTs?

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