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Lenalidomide, bendamustine and prednisolone exhibits a favourable safety and efficacy profile in relapsed or refractory multiple myeloma: final results of a phase 1 clinical trial OSHO – #077
Author(s) -
Pönisch Wolfram,
Heyn Simone,
Beck Juliane,
Wagner Ina,
Mohren Martin,
Hoffmann Franz A.,
Lange Thoralf,
Schmalfeld Marion,
Zehrfeld Thomas,
Schwarzer Andreas,
Winkelmann Cornelia,
Edelmann Thomas,
Röhrborn Ramona,
Hebenstreit Karin,
AlAli Haifa K.,
Jäkel Nadja,
Niederwieser Dietger
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.12361
Subject(s) - bendamustine , lenalidomide , multiple myeloma , medicine , refractory (planetary science) , maximum tolerated dose , prednisolone , safety profile , oncology , pharmacology , clinical trial , adverse effect , materials science , rituximab , lymphoma , composite material
Summary This phase 1 dose finding study tested a combination of lenalidomide, bendamustine and prednisolone ( RBP ) in 21 patients in five cohorts with advanced multiple relasped/refractory myeloma ( MM ) to determine the maximum tolerable dose ( MTD ) of the combination. The first cohort received a starting dose of lenalidomide 10 mg/d, days 1–21, bendamustine 60 mg/m 2 /d, days 1–2, and prednisolone 100 mg/d, days 1–4. Dose escalation was done in cohorts of three to six patients with lenalidomide dose increasing to 15, 20 and 25 mg, and after reaching 25 mg/d, bendamustine was increased to 75 mg/m 2 . A total of 21 patients were enrolled and all completed at least two cycles. Two patients developed dose‐limiting haemotoxicity: one patient on lenalidomide 25 mg/d and bendamustine 60 mg/m 2 and another patient at the highest dose level (lenalidomide 25 mg/d and bendamustine 75 mg/m 2 ). The MTD was not reached. Sixteen patients (76%) responded after at least two cycles of RBP with one stringent complete response ( CR ), one near CR , five very good partial response and nine partial response. After a median observation time of 16 months, progression‐free survival at 18 months was 48% and overall survival was 64%. In conclusion, RBP with lenalidomide 25 mg/d, days 1–21 and bendamustine 75 mg/m 2 days 1–2 is well tolerated in patients with relapsed/refractory MM .