title: Relationship of response and survival in patients with relapsed and refractory multiple myeloma treated with pomalidomide plus low-dose dexamethasone in the MM-003 trial randomized phase III trial (NIMBUS).
abstract: Relapsed/refractory multiple myeloma (RRMM) patients have poor overall survival (OS). Pomalidomide plus low-dose dexamethasone (POM + LoDEX) significantly extends OS in RRMM vs. high-dose dexamethasone. Survival of patients with stable disease (SD) was compared to patients with progressive disease (PD) or ≥ partial response (≥PR) at cycles (C) 3, 5, and 7. Among 302 patients randomized to POM + LoDEX, at C3 19.2% achieved ≥ PR, 38.4% SD, and 14.6% PD. Patients with SD at C3 (17.4%) and C5 (13.6%) showed improved responses at C7. Median OS from randomization by response at C3 was 22.4 months for ≥ PR (n = 58, HR 0.66; 95% CI 0.40-1.08, p = 0.0976 vs. SD), 16.2 months for SD (n = 116), and 6.3 months for PD (n = 44, HR 3.43; 95% CI 2.23-5.27, p < 0.0001 vs. SD). Similar patterns were observed for C5 and C7. Results show that POM + LoDEX should be a standard treatment after lenalidomide and bortezomib, including in SD patients.
authors.affiliation: a Hematology Department , University Hospital Hôtel-Dieu , Nantes , France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Moreau
authors.affiliation: b University of Tübingen , Tübingen , Germany.
authors.forename: Katja C
authors.initials: KC
authors.lastname: Weisel
authors.affiliation: c Vancouver General Hospital , Vancouver , BC , Canada.
authors.forename: Kevin W
authors.initials: KW
authors.lastname: Song
authors.affiliation: d Celgene Corporation , Summit , NJ , USA.
authors.forename: Craig J
authors.initials: CJ
authors.lastname: Gibson
authors.affiliation: e BresMed Health Solutions , Sheffield , UK.
authors.forename: Owain
authors.initials: O
authors.lastname: Saunders
authors.affiliation: d Celgene Corporation , Summit , NJ , USA.
authors.forename: Lars Axel
authors.initials: LA
authors.lastname: Sternas
authors.affiliation: d Celgene Corporation , Summit , NJ , USA.
authors.forename: Kevin
authors.initials: K
authors.lastname: Hong
authors.affiliation: d Celgene Corporation , Summit , NJ , USA.
authors.forename: Mohamed H
authors.initials: MH
authors.lastname: Zaki
authors.affiliation: f Alexandra Hospital , Athens , Greece.
authors.forename: Meletios A
authors.initials: MA
authors.lastname: Dimopoulos
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003907:Dexamethasone / Q000008:administration & dosage; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology; D012008:Recurrence; D019233:Retreatment; D016019:Survival Analysis; D013792:Thalidomide / Q000008:administration & dosage / Q000031:analogs & derivatives; D016896:Treatment Outcome
chemical_list: D013792:Thalidomide; D003907:Dexamethasone; C467566:pomalidomide
keywords: MM-003; multiple myeloma; pomalidomide