title: A phase II trial of small-dose bortezomib, lenalidomide and dexamethasone (sVRD) as consolidation/maintenance therapy in patients with multiple myeloma.
abstract: OBJECTIVE
  Consolidation/maintenance therapy induces deep remission in patients with multiple myeloma (MM); however, the most suitable regimen has been under investigation. The combination therapy with bortezomib, lenalidomide and dexamethasone (VRD) is a powerful regimen for relapsed/refractory as well as newly diagnosed MM as an induction therapy. However, severe adverse events (AEs) may become a problem when VRD is introduced without dose reduction as a consolidation/maintenance therapy.
  
  
  METHODS
  In this single-arm phase II study, we evaluated the efficacy of small-dose VRD regimen (sVRD) in the consolidation/maintenance setting. Sixteen patients who had partial response (PR) or better after any induction therapy were enrolled. Patients received at least six 28-day cycles of subcutaneous bortezomib (1.3 mg/m2on days 1 and 15), lenalidomide (10 mg on days 1-21) and dexamethasone (40 mg on days 1, 8, 15 and 22).
  
  
  RESULTS
  The overall response rate and the complete response (CR) rate were 100 and 43.8 %, respectively. In particular, one patient with CR and two patients with very good PR at enrollment achieved stringent CR during 6 courses of sVRD. With a median follow-up time of 29.4 months, the median progression-free survival (PFS) and overall survival (OS) were not reached, while the PFS and OS rates at 2.5 years were 66.6 and 77.3 %, respectively. Univariate analysis demonstrated that disease progression as a reason for discontinuation of sVRD had a negative impact on OS. There were no grade 3 or 4 hematologic or nonhematologic AEs.
  
  
  CONCLUSIONS
  Our sVRD regimen as a consolidation/maintenance therapy was highly effective and well tolerable.
authors.affiliation: Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South-1 West-16, Chuo-ku, Sapporo, Japan.
authors.forename: Soushi
authors.initials: S
authors.lastname: Ibata
authors.affiliation: Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South-1 West-16, Chuo-ku, Sapporo, Japan. tsutomus@sapmed.ac.jp.
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Sato
authors.affiliation: Gastroenterology and Hematology/Clinical Oncology, Internal Medicine, Steel Memorial Muroran Hospital, Muroran, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Kuroda
authors.affiliation: Department of Hematology, Kiyota Hospital, Sapporo, Japan.
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Nagamachi
authors.affiliation: Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South-1 West-16, Chuo-ku, Sapporo, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Iyama
authors.affiliation: Department of Hematology and Oncology, Oji General Hospital, Tomakomai, Japan.
authors.forename: Akihito
authors.initials: A
authors.lastname: Fujimi
authors.affiliation: Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South-1 West-16, Chuo-ku, Sapporo, Japan.
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Kamihara
authors.affiliation: Department of Hematology and Oncology, Asahikawa Red Cross Hospital, Asahikawa, Japan.
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Konuma
authors.affiliation: Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South-1 West-16, Chuo-ku, Sapporo, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Yoshida
authors.affiliation: Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South-1 West-16, Chuo-ku, Sapporo, Japan.
authors.forename: Ayumi
authors.initials: A
authors.lastname: Tatekoshi
authors.affiliation: Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South-1 West-16, Chuo-ku, Sapporo, Japan.
authors.forename: Akari
authors.initials: A
authors.lastname: Hashimoto
authors.affiliation: Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South-1 West-16, Chuo-ku, Sapporo, Japan.
authors.forename: Hiroto
authors.initials: H
authors.lastname: Horiguchi
authors.affiliation: Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South-1 West-16, Chuo-ku, Sapporo, Japan.
authors.forename: Kaoru
authors.initials: K
authors.lastname: Ono
authors.affiliation: Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South-1 West-16, Chuo-ku, Sapporo, Japan.
authors.forename: Kazuyuki
authors.initials: K
authors.lastname: Murase
authors.affiliation: Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South-1 West-16, Chuo-ku, Sapporo, Japan.
authors.forename: Kohichi
authors.initials: K
authors.lastname: Takada
authors.affiliation: Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South-1 West-16, Chuo-ku, Sapporo, Japan.
authors.forename: Koji
authors.initials: K
authors.lastname: Miyanishi
authors.affiliation: Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South-1 West-16, Chuo-ku, Sapporo, Japan.
authors.forename: Masayoshi
authors.initials: M
authors.lastname: Kobune
authors.affiliation: Division of Internal Medicine, Higashi Sapporo Hospital, Sapporo, Japan.
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Hirayama
authors.affiliation: Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South-1 West-16, Chuo-ku, Sapporo, Japan.
authors.forename: Junji
authors.initials: J
authors.lastname: Kato
mesh_terms: D000368:Aged; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage; D000970:Antineoplastic Agents / Q000008:administration & dosage; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000069286:Bortezomib / Q000008:administration & dosage; D003907:Dexamethasone / Q000008:administration & dosage; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D000077269:Lenalidomide; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000556:secondary; D016609:Neoplasms, Second Primary / Q000453:epidemiology; D013792:Thalidomide / Q000008:administration & dosage / Q000031:analogs & derivatives; D016896:Treatment Outcome
chemical_list: D020533:Angiogenesis Inhibitors; D000970:Antineoplastic Agents; D018931:Antineoplastic Agents, Hormonal; D013792:Thalidomide; D000069286:Bortezomib; D003907:Dexamethasone; D000077269:Lenalidomide
keywords: Bortezomib; Consolidation/maintenance; Dexamethasone; Lenalidomide; Multiple myeloma; VRD