title: Pomalidomide plus low-dose dexamethasone in myeloma refractory to both bortezomib and lenalidomide: comparison of 2 dosing strategies in dual-refractory disease.
abstract: Pomalidomide at doses of 2 or 4 mg/d has demonstrated excellent activity in patients with multiple myeloma (MM). We opened 2 sequential phase 2 trials using the pomalidomide with weekly dexamethasone (Pom/dex) regimen at differing doses to study the efficacy of this regimen in patients who have failed both lenalidomide and bortezomib. Pomalidomide was given orally 2 or 4 mg daily with dexamethasone 40 mg weekly. Thirty-five patients were enrolled in each cohort. Confirmed responses in the 2-mg cohort consisted of very good partial response (VGPR) in 5 (14%), partial response (PR) in 4 (11%), minor response (MR) in 8 (23%) for an overall response rate of 49%. In the 4-mg cohort, confirmed responses consisted of complete response (CR) in 1 (3%), VGPR in 3 (9%), PR in 6 (17%), MR in 5 (14%) for an overall response rate of 43%. Overall survival at 6 months is 78% and 67% in the 2- and 4-mg cohort, respectively. Myelosuppression was the most common toxicity. This nonrandomized data suggests no advantage for 4 mg over the 2 mg daily. Pomalidomide overcomes resistance in myeloma refractory to both lenalidomide and bortezomib. This trial is registered at http://ClinicalTrials.gov, number NCT00558896.
authors.affiliation: Mayo Clinic College of Medicine, Rochester, MN, USA. lacy.martha@mayo.edu
authors.forename: Martha Q
authors.initials: MQ
authors.lastname: Lacy
authors.forename: Jacob B
authors.initials: JB
authors.lastname: Allred
authors.forename: Morie A
authors.initials: MA
authors.lastname: Gertz
authors.forename: Suzanne R
authors.initials: SR
authors.lastname: Hayman
authors.forename: Kristen Detweiler
authors.initials: KD
authors.lastname: Short
authors.forename: Francis
authors.initials: F
authors.lastname: Buadi
authors.forename: Angela
authors.initials: A
authors.lastname: Dispenzieri
authors.forename: Shaji
authors.initials: S
authors.lastname: Kumar
authors.forename: Philip R
authors.initials: PR
authors.lastname: Greipp
authors.forename: John A
authors.initials: JA
authors.lastname: Lust
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Russell
authors.forename: David
authors.initials: D
authors.lastname: Dingli
authors.forename: Steven
authors.initials: S
authors.lastname: Zeldenrust
authors.forename: Rafael
authors.initials: R
authors.lastname: Fonseca
authors.forename: P Leif
authors.initials: PL
authors.lastname: Bergsagel
authors.forename: Vivek
authors.initials: V
authors.lastname: Roy
authors.forename: A Keith
authors.initials: AK
authors.lastname: Stewart
authors.forename: Kristina
authors.initials: K
authors.lastname: Laumann
authors.forename: Sumithra J
authors.initials: SJ
authors.lastname: Mandrekar
authors.forename: Craig
authors.initials: C
authors.lastname: Reeder
authors.forename: S Vincent
authors.initials: SV
authors.lastname: Rajkumar
authors.forename: Joseph R
authors.initials: JR
authors.lastname: Mikhael
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D001897:Boronic Acids / Q000627:therapeutic use*; D000069286:Bortezomib; D003907:Dexamethasone / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D019008:Drug Resistance, Neoplasm / Q000187:drug effects; D005260:Female; D006801:Humans; D000077269:Lenalidomide; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000401:mortality; D011719:Pyrazines / Q000627:therapeutic use*; D016019:Survival Analysis; D013792:Thalidomide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D017211:Treatment Failure; D016896:Treatment Outcome
chemical_list: D001897:Boronic Acids; D011719:Pyrazines; D013792:Thalidomide; D000069286:Bortezomib; D003907:Dexamethasone; C467566:pomalidomide; D000077269:Lenalidomide