title: Pomalidomide (CC4047) plus low dose dexamethasone (Pom/dex) is active and well tolerated in lenalidomide refractory multiple myeloma (MM).
abstract: Patients with multiple myeloma progressing on current therapies have limited treatment options. Pomalidomide (CC4047), an immunomodulatory drug, has significant activity in relapsed myeloma and previous studies suggest activity in lenalidomide refractory disease. To better define its efficacy in this group, we treated a cohort of lenalidomide refractory patients. Pomalidomide was given orally (2 mg) daily, continuously in 28-day cycles along with dexamethasone (40 mg) given weekly. Responses were assessed by the International Myeloma Working Group Criteria. Thirty-four patients were enrolled. The best response was very good partial response in 3 (9%), partial response (PR) in 8 (23%), best responses (MR) in 5 (15%), stable disease in 12 (35%) and progressive disease in 6 (18%), for an overall response rate of 47%. Of the 14 patients that were considered high risk, 8 (57%) had responses including 4 PR and 4 MR. The median time to response was 2 months and response duration was 9.1 months, respectively. The median overall survival was 13.9 months. Toxicity was primarily hematologic, with grade 3 or 4 toxicity seen in 18 patients (53%) consisting of anemia (12%), thrombocytopenia (9%) and neutropenia (26%). The combination of pomalidomide and dexamethasone (Pom/dex) is highly active and well tolerated in patients with lenalidomide-refractory myeloma.
authors.affiliation: Division of Hematology, Mayo Clinic College of Medicine, Rochester, MN 55905, USA. lacy.martha@mayo.edu
authors.forename: M Q
authors.initials: MQ
authors.lastname: Lacy
authors.forename: S R
authors.initials: SR
authors.lastname: Hayman
authors.forename: M A
authors.initials: MA
authors.lastname: Gertz
authors.forename: K D
authors.initials: KD
authors.lastname: Short
authors.forename: A
authors.initials: A
authors.lastname: Dispenzieri
authors.forename: S
authors.initials: S
authors.lastname: Kumar
authors.forename: P R
authors.initials: PR
authors.lastname: Greipp
authors.forename: J A
authors.initials: JA
authors.lastname: Lust
authors.forename: S J
authors.initials: SJ
authors.lastname: Russell
authors.forename: D
authors.initials: D
authors.lastname: Dingli
authors.forename: S
authors.initials: S
authors.lastname: Zeldenrust
authors.forename: R
authors.initials: R
authors.lastname: Fonseca
authors.forename: P L
authors.initials: PL
authors.lastname: Bergsagel
authors.forename: V
authors.initials: V
authors.lastname: Roy
authors.forename: J R
authors.initials: JR
authors.lastname: Mikhael
authors.forename: A K
authors.initials: AK
authors.lastname: Stewart
authors.forename: K
authors.initials: K
authors.lastname: Laumann
authors.forename: J B
authors.initials: JB
authors.lastname: Allred
authors.forename: S J
authors.initials: SJ
authors.lastname: Mandrekar
authors.forename: S V
authors.initials: SV
authors.lastname: Rajkumar
authors.forename: F
authors.initials: F
authors.lastname: Buadi
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003907:Dexamethasone / Q000008:administration & dosage*; D018450:Disease Progression; D004361:Drug Tolerance; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000401:mortality; D018570:Risk Assessment; D015996:Survival Rate; D013792:Thalidomide / Q000008:administration & dosage / Q000031:analogs & derivatives
chemical_list: D000970:Antineoplastic Agents; D013792:Thalidomide; D003907:Dexamethasone; C467566:pomalidomide
references.citation: Br J Haematol. 2008 Jan;140(1):36-45
references.pmid: 17995965
references.citation: Leukemia. 2009 Jan;23(1):3-9
references.pmid: 18971951
references.citation: J Exp Med. 1998 Jun 1;187(11):1885-92
references.pmid: 9607928
references.citation: J Biol Chem. 2001 Jun 22;276(25):22382-7
references.pmid: 11297551
references.citation: J Immunol. 1999 Jul 1;163(1):380-6
references.pmid: 10384139
references.citation: Br J Haematol. 2003 Jan;120(1):10-7
references.pmid: 12492571
references.citation: Blood. 2002 Jun 15;99(12):4525-30
references.pmid: 12036884
references.citation: Proc Natl Acad Sci U S A. 1996 Jul 23;93(15):7552-6
references.pmid: 8755512
references.citation: Proc Natl Acad Sci U S A. 1994 Apr 26;91(9):4082-5
references.pmid: 7513432
references.citation: J Clin Oncol. 2004 Aug 15;22(16):3269-76
references.pmid: 15249589
references.citation: Br J Haematol. 2008 Apr;141(1):41-51
references.pmid: 18324965
references.citation: Blood. 2001 Jul 1;98(1):210-6
references.pmid: 11418482
references.citation: Mayo Clin Proc. 2009 Dec;84(12):1095-110
references.pmid: 19955246
references.citation: Leukemia. 2006 Sep;20(9):1467-73
references.pmid: 16855634
references.citation: Semin Oncol. 2005 Aug;32(4 Suppl 5):S24-30
references.pmid: 16085014