Long-term safety follow-up of a randomized trial of darbepoetin alpha and intravenous iron following autologous hematopoietic cell transplantation.
JASPERS, Aurélie ; Baron, Frédéric ; et al
in American Journal of Hematology (in press)Detailed reference viewed: 5 (0 ULg)
Darbepoetin-alfa and intravenous iron administration after autologous hematopoietic stem cell transplantation : A prospective multicenter randomized trial
BEGUIN, Yves ; ; DE PRIJCK, Bernard et al
in American Journal of Hematology (2013), 88
We conducted a randomized study analyzing the impact of darbepoetin alfa (DA) administration with or without intravenous (i.v.) iron on erythroid recovery after autologous hematopoietic cell ... [more ▼]
We conducted a randomized study analyzing the impact of darbepoetin alfa (DA) administration with or without intravenous (i.v.) iron on erythroid recovery after autologous hematopoietic cell transplantation (HCT). Patients were randomized between no DA (Arm 1), DA 300 lg every 2 weeks starting on Day 28 after HCT (Arm 2), or DA plus i.v. iron 200 mg on Days 28, 42, and 56 (Arm 3). The proportion achieving complete hemoglobin (Hb) response within 18 weeks (primary end point) was 21% in Arm 1 (n524), 79% in Arm 2 (n525), and 100% in Arm 3 (n523; P < 0.0001). Erythropoietic response was shown to be significantly higher in Arm 3 (n546) than in Arm 2 (n550; P50.008), resulting in lower DA use, reduced drug costs, and improved quality of life scores, but the effect on transfusions was not significant. In multivariate analysis, DA administration (P< 0.0001), i.v. iron administration (P50.0010), high baseline Hb (P< 0.0001), and low baseline creatinine (P50.0458) were independently associated with faster achievement of complete Hb response. In conclusion, DA is highly effective to ensure full erythroid reconstitution after autologous HCT when started on Day 28 post-transplant. I.v. iron sucrose further improves erythroid recovery. [less ▲]Detailed reference viewed: 25 (3 ULg)
Academic clinical trials run by the transplant committee of the Belgian Hematological Society
VANDAMME, Arnaud ; ; BEGUIN, Yves
in Belgian Journal of Hematology (2012), 3(2), 62-67
The Transplantation Committee of the Belgian Hematological Society (BHS) is supported by all university centers and nonuniversity centers with significant transplant activity. The committee is involved in ... [more ▼]
The Transplantation Committee of the Belgian Hematological Society (BHS) is supported by all university centers and nonuniversity centers with significant transplant activity. The committee is involved in the development of transplant guidelines and recommendations, the transplant peer review process, contacts with regulatory authorities, the introduction of expanded access and medical need programs and the initiation of academic studies addressing important questions in the transplant field. Since 2008, 8 clinical trials have been initiated after approval by the Ethics Committees and the National Competent Authority (AFMPS/FAGG). So far, one of them has been completed and is being prepared for publication. In this paper, we briefly describe the rationale, objectives, treatment arms, major inclusion criteria and current status of these different trials. In addition and for each trial a link is provided to the BHS website to obtain more details regarding inclusion criteria, participating centers and administrative/contact information [less ▲]Detailed reference viewed: 39 (11 ULg)
Multiple Myeloma, an update on diagnosis and treatment.
Caers, Jo ; ; et al
in European Journal of Haematology (2008), 81(5), 329-343Detailed reference viewed: 11 (3 ULg)
De bijdrage van muismodellen bij studies naar multipel myeloom
; ; et al
in Nederlands Tijdschrift voor Hematologie (2007), 4(4), 193-143Detailed reference viewed: 22 (0 ULg)
The belgian experience in unrelated donor bone marrow transplantation: identification of center experience as an important prognostic factor.
Dresse, Marie-Françoise ; ; et al
in Haematologica (1999), 84(7), 637-42
BACKGROUND AND OBJECTIVE: We reviewed all unrelated donor bone marrow transplants (UDBMT) performed in Belgium up to December 1995 to identify prognostic factors for relapse, transplant-related mortality ... [more ▼]
BACKGROUND AND OBJECTIVE: We reviewed all unrelated donor bone marrow transplants (UDBMT) performed in Belgium up to December 1995 to identify prognostic factors for relapse, transplant-related mortality and survival. DESIGN AND METHODS: A total of 163 UDBMT were performed in 92 males and 71 females aged 1-55 (median 26) years. Patients were transplanted for ALL (n=35), AML (n=34), CML (n=51), other myeloid malignancies (n=14), SAA (n=21) or miscellaneous other diseases (n=8). Most patients had advanced disease; a few patients were in CR1 (n=10) or early chronic phase (CP) of CML (n=5). RESULTS: Overall survival at 5 yrs was 17% (95% confidence interval: 8-32%), but survival was significantly better for patients with non-malignant disorders (55% at 4 yrs). The relapse rate +/-SE was projected to be 40 (28-54)% at 5 yrs, 36 (20-56)% for standard-risk and 68 (43-85)% for high-risk malignancies (p=0.0029). There was no relapse in CML patients transplanted in 1st CP compared to 68% at 4 yrs with more advanced CML (p=0.0033). Grade II-IV acute graft-versus-host disease (aGVHD) occurred in 55% by day 100 and was strongly modulated by age, ranging from 41% in <20-yr-old to 80% in >40-yr-old patients (p=0. 0021). Transplant-related mortality (TRM) was projected to be 72 (52-87)% at 5 yrs including 2 very late deaths from lung fibrosis and secondary cancer. Main causes of death were original disease in 27, secondary malignancy in 2, GVHD in 28, interstitial pneumonia in 21, other infections in 19, and miscellaneous toxic causes in 21 patients. In multivariate analysis, the relapse rate was strongly dependent on the disease status (p=0.0029), TRM being significantly worse with older age (p=0.0049), and overall survival being significantly worse in more advanced disease (p=0.0006), after a second transplant (p=0.0166), in centers of smaller size (p=0.0316) and in older patients (NS). INTERPRETATION AND CONCLUSIONS: Although results have improved somewhat in recent years, UDBMT remains a procedure with a high TRM. UDBMT should be performed in patients with less advanced diseases and in centers with more experience, particularly in the treatment of adult patients. [less ▲]Detailed reference viewed: 82 (6 ULg)