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A prospective, international phase 2 study of bortezomib retreatment in patients with relapsed multiple myeloma
Author(s) -
Petrucci Maria T.,
Giraldo Pilar,
Corradini Paolo,
Teixeira Adriana,
Dimopoulos Meletios A.,
Blau Igor W.,
Drach Johannes,
Angermund Ralf,
Allietta Nathalie,
Broer Esther,
Mitchell Vivien,
Bladé Joan
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.12198
Subject(s) - bortezomib , medicine , common terminology criteria for adverse events , multiple myeloma , adverse effect , clinical endpoint , dexamethasone , surgery , clinical trial
Summary Multiple myeloma ( MM ) typically follows a relapsing course with many patients requiring multiple therapies. This single‐arm phase 2 study prospectively evaluated the efficacy and safety of bortezomib retreatment in MM patients who had relapsed after achieving at least a partial response (≥PR) to prior bortezomib‐based therapy. Patients aged ≥18 years, with measurable, secretory MM , who relapsed ≥6 months after prior bortezomib treatment were eligible. Patients received up to eight cycles of bortezomib (±dexamethasone). The primary endpoint was best confirmed response at retreatment; secondary endpoints included duration of response ( DOR ), time to progression ( TTP ), and safety. Adverse events ( AEs ) were graded by N ational C ancer I nstitute C ommon T erminology C riteria for A dverse E vents version 3.0. A total of 130 patients (median of two prior lines of therapy) were enrolled and received retreatment. At retreatment, 28% and 72% of patients received bortezomib and bortezomib‐dexamethasone, respectively. Overall response rate was 40%. In patients who achieved ≥ PR , median DOR and TTP were 6·5 and 8·4 months, respectively. Thrombocytopenia was the most common grade ≥3 AE (35%). Forty percent of patients experienced neuropathy events, which improved and resolved in a median of 1·5 and 8·9 months, respectively. In conclusion, bortezomib retreatment was effective and tolerable in relapsed MM patients, with no evidence of cumulative toxicities.