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)

• Published in: Leukemia & lymphoma 2016-12, Vol.57 (12), p.2839-2847
• Main Authors: Moreau, Philippe, Weisel, Katja C., Song, Kevin W., Gibson, Craig J., Saunders, Owain, Sternas, Lars Axel, Hong, Kevin, Zaki, Mohamed H., Dimopoulos, Meletios A.
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Dexamethasone - administration & dosage; Drug Resistance, Neoplasm; Female; Humans; Male; Middle Aged; MM-003; multiple myeloma; Multiple Myeloma - drug therapy; Multiple Myeloma - mortality; Multiple Myeloma - pathology; pomalidomide; Recurrence; Retreatment; Survival Analysis; Thalidomide - administration & dosage; Thalidomide - analogs & derivatives; Treatment Outcome
• ISSN: 1042-8194; 1029-2403
• DOI: 10.1080/10428194.2016.1180685

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