title: Bendamustine, lenalidomide and dexamethasone (BRd) has high activity as 2nd-line therapy for relapsed and refractory multiple myeloma - a phase II trial.
abstract: The combination of lenalidomide (Revlimid®, R) and dexamethasone (d) is a standard regimen for patients with relapsed/refractory multiple myeloma (rrMM). With this regimen, only a small fraction of patients will achieve high quality responses [≥ very good partial response (VGPR)]. The combination of bendamustine (B), lenalidomide and dexamethasone (BRd) has shown high efficacy in patients with advanced rrMM. However, dose-limiting haematotoxicity restricted its use in extensively pre-treated patient populations. This prospective, multicentre Phase II study evaluated the efficacy and safety of BRd in rrMM patients with one prior line of therapy. Fifty patients were enrolled (median age 68·5 years [range 46-83]) and were treated with B 75 mg/m2days 1, 2; R 25 mg days 1-21 and d (40/20 mg) days 1, 8, 15 and 22, for 6 28-day induction cycles, followed by 12 cycles with Rd alone. Pegfilgrastim was administered according to protocol-defined criteria. The study aimed to demonstrate a complete response (CR)/VGPR rate of >40% after induction therapy. Of 45 evaluable patients, 23 (51%) achieved a CR/VGPR. Grade 4 neutropenia or thrombocytopenia occurred in 17 (34%) and 8 (16%) of patients, respectively. BRd is a safe and efficacious regimen as a second line treatment for rrMM, leading to high quality responses in a considerable proportion of patients.
authors.affiliation: Medical Oncology and Haematology, Kantonsspital Graubünden, Chur, Switzerland.
authors.forename: Ulrich J M
authors.initials: UJ
authors.lastname: Mey
authors.affiliation: Haematology/Oncology, Schwarzwald-Baar-Klinikum, Villingen-Schwenningen, Germany.
authors.forename: Wolfram
authors.initials: W
authors.lastname: Brugger
authors.affiliation: Department of Oncology, Kantonsspital Baden, Baden, Switzerland.
authors.forename: Heike
authors.initials: H
authors.lastname: Schwarb
authors.affiliation: Department of Oncology, Kantonsspital Baden, Baden, Switzerland.
authors.forename: Stefanie
authors.initials: S
authors.lastname: Pederiva
authors.affiliation: Gemeinschaftspraxis Hämatologie/Onkologie, Leipzig, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Schwarzer
authors.affiliation: Onkologie Ravensburg, Ravensburg, Germany.
authors.forename: Tobias
authors.initials: T
authors.lastname: Dechow
authors.affiliation: Haemato-Onkologische Praxis Moers, Moers, Germany.
authors.forename: Paul
authors.initials: P
authors.lastname: Jehner
authors.affiliation: Fachinternistische Gemeinschaftspraxis und Therapiezentrum, Witten, Germany.
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Rauh
authors.affiliation: Oncology/Haematology, Kantonsspital Muensterlingen, Muensterlingen, Switzerland.
authors.forename: Christian J
authors.initials: CJ
authors.lastname: Taverna
authors.affiliation: Department of Medical Oncology and Haematology, Stadtspital Triemli, Zuerich, Switzerland.
authors.forename: Mathias
authors.initials: M
authors.lastname: Schmid
authors.affiliation: Haematology, Oncology and Tumourimmunology, Helios Clinic Berlin-Buch, Berlin, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Schmidt-Hieber
authors.affiliation: Onkozentrum Dresden, Dresden, Germany.
authors.forename: Steffen
authors.initials: S
authors.lastname: Doerfel
authors.affiliation: Kantonsspital Winterthur, Winterthur, Switzerland.
authors.forename: Natalie
authors.initials: N
authors.lastname: Fischer
authors.affiliation: Department of Haematology, Kantonsspital Luzern, Luzern, Switzerland.
authors.forename: Axel
authors.initials: A
authors.lastname: Ruefer
authors.affiliation: Haemato-Onkologische Schwerpunktpraxis Troisdorf, Troisdorf, Germany.
authors.forename: Carsten
authors.initials: C
authors.lastname: Ziske
authors.affiliation: Onkologische Gemeinschaftspraxis Frankfurt, Frankfurt, Germany.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Knauf
authors.affiliation: Medical Oncology and Haematology, Kantonsspital Graubünden, Chur, Switzerland.
authors.forename: Richard
authors.initials: R
authors.lastname: Cathomas
authors.affiliation: Medical Oncology and Haematology, Kantonsspital Graubünden, Chur, Switzerland.
authors.forename: Roger
authors.initials: R
authors.lastname: von Moos
authors.affiliation: Department of Medical Oncology, Kantonsspital St. Gallen, St. Gallen, Switzerland.
authors.forename: Felicitas
authors.initials: F
authors.lastname: Hitz
authors.affiliation: Clinical Trials Unit, Kantonsspital St. Gallen, St. Gallen, Switzerland.
authors.forename: Rafael
authors.initials: R
authors.lastname: Sauter
authors.affiliation: Clinical Trials Unit, Kantonsspital St. Gallen, St. Gallen, Switzerland.
authors.forename: Elke
authors.initials: E
authors.lastname: Hiendlmeyer
authors.affiliation: Division of Haematology and Transfusion Medicine, Kantonsspital Aarau, Aarau, Switzerland.
authors.forename: Nathan
authors.initials: N
authors.lastname: Cantoni
authors.affiliation: Division of Haematology and Transfusion Medicine, Kantonsspital Aarau, Aarau, Switzerland.
authors.forename: Mario
authors.initials: M
authors.lastname: Bargetzi
authors.affiliation: Department of Medical Oncology, Kantonsspital St. Gallen, St. Gallen, Switzerland.
authors.forename: Christoph
authors.initials: C
authors.lastname: Driessen
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069461:Bendamustine Hydrochloride / Q000009:adverse effects; D003907:Dexamethasone / Q000008:administration & dosage; D006801:Humans; D000077269:Lenalidomide; D008875:Middle Aged; D009101:Multiple Myeloma / Q000150:complications / Q000188:drug therapy*; D009503:Neutropenia / Q000139:chemically induced; D012074:Remission Induction / Q000379:methods; D016879:Salvage Therapy / Q000379:methods*; D013792:Thalidomide / Q000008:administration & dosage / Q000031:analogs & derivatives; D013921:Thrombocytopenia / Q000139:chemically induced / Q000150:complications; D016896:Treatment Outcome
chemical_list: D013792:Thalidomide; D003907:Dexamethasone; D000069461:Bendamustine Hydrochloride; D000077269:Lenalidomide
keywords: bendamustine; lenalidomide; multiple myeloma; phase II; second-line