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Phase II clinical trial for the evaluation of bortezomib within the reduced intensity conditioning regimen ( RIC ) and post‐allogeneic transplantation for high‐risk myeloma patients
Author(s) -
CaballeroVelázquez Teresa,
LópezCorral Lucia,
Encinas Cristina,
CastillaLlorente Cristina,
Martino Rodrigo,
Rosiñol Laura,
Sampol Antonia,
Caballero Dolores,
Serrano David,
Heras Inmaculada,
San Miguel Jesús,
PérezSimón José A.
Publication year - 2013
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1111/bjh.12410
Subject(s) - multiple myeloma , medicine , bortezomib , regimen , transplantation , cfu gm , clinical trial , conditioning regimen , oncology , hematopoietic stem cell transplantation , stem cell , biology , progenitor cell , genetics
Summary The current study was designed to assess the safety and efficacy of bortezomib in combination with fludarabine and melphalan as reduced intensity conditioning before allogeneic stem cell transplantation in patients with high risk multiple myeloma. Sixteen patients were evaluable. The median number of previous line of treatment was 3; all patients had relapsed following a prior autograft and 13 had previously received bortezomib. Fifteen of them either remained stable or improved disease status at day +100 post‐transplant, including 11 patients with active disease. More specifically, nine patients (56%) and five patients (31%) reached complete remission and partial response, respectively. 25% developed grade III acute graft‐versus‐host disease. The cumulative incidence of non‐relapse mortality, relapse and overall survival were 25%, 54% and 41%, respectively, at 3 years. Regarding the non‐haematological toxicity (grade>2), two patients developed peripheral neuropathy, two patients liver toxicity and 1 pulmonary toxicity early post‐transplant. The haematological toxicity was only observed during the first three cycles mostly related to low haemoglobin and platelet levels. The current trial is the first one evaluating the safety and efficacy of bortezomib as part of a reduced intensity conditioning regimen among patients with high risk multiple myeloma.