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- Title
P-175: Outcomes of autologous-allogeneic vs autologous tandem approach followed by thalidomide maintenance for transplant-eligible patients with newly diagnosed multiple myeloma: a prospective phase II-study.
- Authors
Gagelmann, Nico; Hegenbart, Ute; Stelljes, Matthias; Kaufmann, Martin; Müller, Lutz; Ganser, Arnold; Schmid, Christoph; Kobbe, Guido; Wagner, Eva; Bornhäuser, Martin; Kiehl, Michael; Wulf, Gerald; Bethge, Wolfgang; Burchert, Andreas; Wolf, Dominik; Heinicke, Thomas; Heinzelmann, Marion; Wolschke, Christine; Völp, Andreas; Schönland, Stefan
- Abstract
The aim of this phase 2 study (NCT00777998) was to compare autologous-allogeneic tandem stem cell transplantation (auto-allo) and tandem autologous transplantation (auto-auto), both followed by maintenance therapy in transplant-eligible patients with newly diagnosed multiple myeloma (NDMM). Between 2008 and 2014 a total of 210 MM patients ≤60 years of age were included from 23 German Centers within an open-label, parallel-group, multicenter clinical trial to investigate whether auto-allo versus auto-auto followed by a 2-year maintenance therapy with thalidomide (100mg/daily), respectively, has benefit on outcome. Patients received autologous peripheral blood stem cell transplantation followed by allogeneic transplant when a matched related or unrelated donor would be available; otherwise, or if they declined allogeneic transplant, they received two autologous transplants. The primary endpoints were 4-year progression-free survival (PFS) and overall survival (OS). 178 patients underwent second transplant, of whom auto-allo received 132 and auto-auto 46 patients. The median age was 51 years (range 26-61), respectively. 32 patients in the auto-allo group and 8 patients in the auto-auto group did not receive thalidomide maintenance. The 4-year PFS was 47%(95% CI, 38-55%) for auto-allo and 35% (95% CI, 21-49%) for auto-auto, with median survival times of 40 and of 30 months (P=0.26). The 4-year OS was 66% (95% CI, 57-73%) for auto-allo and 66% (95% CI, 50-78%) for auto-auto (P=0.91). 53 (40%) patients in the auto-allo group and 28 (61%) in the auto-auto group showed progression or relapse of MM. Estimated cumulative incidence of relapse/progression was 40% (95% CI, 33-50%) for auto-allo and 63% (95% CI, 50-79%) for auto-auto (P=0.01). The estimated cumulative incidence of 4-year non-relapse mortality was 13% (95% CI, 8-20%) for auto-allo and 2% (0.3-2) for auto-auto (p=0.04). With long-term follow-up of patients, 8-year PFS was 43% (95% CI, 34-52%) for auto-allo versus 21% (95% CI, 7-35%) for auto-auto (P=0.10). Furthermore, 8-year OS was 55% (95% CI, 45-65%) for auto-allo and 50% (95% CI, 32-68%) for auto-auto (P=0.87). Median OS was not reached in both groups. Multivariate analysis on PFS at last follow-up (median, 8 years) showed a hazard ratio of 0.67 (95% CI, 0.44-1.02; P=0.06) for auto-allo (with auto-auto as reference). Other factors for improved outcome were absence of del(17p) or t(4;14), CR after induction and thalidomide maintenance. Subgroup analysis for patients with present high-risk cytogenetic features including del(17p) or t(4;14) showed a hazard ratio of 0.55 (95% CI, 0.22-1.39; P=0.21) for auto-allo (with auto-auto as reference). This prospective phase 2 study of auto-allo transplant versus auto-auto showed reduced rates of MM recurrence or progression. At long-term follow-up, auto-allo appeared to improve PFS, while OS was comparable.
- Publication
Clinical Lymphoma, Myeloma & Leukemia, 2021, Vol 21, pS132
- ISSN
2152-2650
- Publication type
Article
- DOI
10.1016/S2152-2650(21)02302-8