title: 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.
abstract: 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.
authors.affiliation: Department of Haematology and Oncology, University of Leipzig, Leipzig, Germany. Wolfram.Poenisch@medizin.uni-leipzig.de
authors.forename: Wolfram
authors.initials: W
authors.lastname: Pönisch
authors.forename: Simone
authors.initials: S
authors.lastname: Heyn
authors.forename: Juliane
authors.initials: J
authors.lastname: Beck
authors.forename: Ina
authors.initials: I
authors.lastname: Wagner
authors.forename: Martin
authors.initials: M
authors.lastname: Mohren
authors.forename: Franz A
authors.initials: FA
authors.lastname: Hoffmann
authors.forename: Thoralf
authors.initials: T
authors.lastname: Lange
authors.forename: Marion
authors.initials: M
authors.lastname: Schmalfeld
authors.forename: Thomas
authors.initials: T
authors.lastname: Zehrfeld
authors.forename: Andreas
authors.initials: A
authors.lastname: Schwarzer
authors.forename: Cornelia
authors.initials: C
authors.lastname: Winkelmann
authors.forename: Thomas
authors.initials: T
authors.lastname: Edelmann
authors.forename: Ramona
authors.initials: R
authors.lastname: Röhrborn
authors.forename: Karin
authors.initials: K
authors.lastname: Hebenstreit
authors.forename: Haifa K
authors.initials: HK
authors.lastname: Al-Ali
authors.forename: Nadja
authors.initials: N
authors.lastname: Jäkel
authors.forename: Dietger
authors.initials: D
authors.lastname: Niederwieser
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use*; D000069461:Bendamustine Hydrochloride; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D000077269:Lenalidomide; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy*; D009588:Nitrogen Mustard Compounds / Q000008:administration & dosage / Q000009:adverse effects; D011239:Prednisolone / Q000008:administration & dosage / Q000009:adverse effects; D012008:Recurrence; D013792:Thalidomide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives
chemical_list: D009588:Nitrogen Mustard Compounds; D013792:Thalidomide; D000069461:Bendamustine Hydrochloride; D011239:Prednisolone; D000077269:Lenalidomide
keywords: bendamustine; lenalidomide; phase 1 study; prednisolone; relapsed/refractory multiple myeloma