Bibliographic Details
| Title: |
Oral ixazomib-dexamethasone vs oral pomalidomide-dexamethasone for lenalidomide-refractory, proteasome inhibitor-exposed multiple myeloma: a randomized Phase 2 trial. |
| Authors: |
Dimopoulos, Meletios A., Schjesvold, Fredrik, Doronin, Vadim, Vinogradova, Olga, Quach, Hang, Leleu, Xavier, Montes, Yolanda Gonzalez, Ramasamy, Karthik, Pompa, Alessandra, Levin, Mark-David, Lee, Cindy, Mellqvist, Ulf Henrik, Fenk, Roland, Demarquette, Hélène, Sati, Hamdi, Vorog, Alexander, Labotka, Richard, Du, Jichang, Darif, Mohamed, Kumar, Shaji |
| Source: |
Blood Cancer Journal; Jan2022, Vol. 12 Issue 1, p1-10, 10p |
| Subject Terms: |
BORTEZOMIB, MULTIPLE myeloma, PROGRESSION-free survival, LENALIDOMIDE, QUALITY of life |
| Abstract: |
Multiple myeloma (MM) patients typically receive several lines of combination therapy and first-line treatment commonly includes lenalidomide. As patients age, they become less tolerant to treatment, requiring convenient/tolerable/lenalidomide-free options. Carfilzomib and/or bortezomib-exposed/intolerant, lenalidomide-refractory MM patients with ≥2 prior lines of therapy were randomized 3:2 to ixazomib-dexamethasone (ixa-dex) (n = 73) or pomalidomide-dexamethasone (pom-dex) (n = 49) until progression/toxicity. Median progression-free survival (mPFS) was 7.1 vs 4.8 months with ixa-dex vs pom-dex (HR 0.847, 95% CI 0.535–1.341, P = 0.477; median follow-up: 15.3 vs 17.3 months); there was no statistically significant difference between arms. In patients with 2 and ≥3 prior lines of therapy, respectively, mPFS was 11.0 vs 5.7 months (HR 1.083, 95% CI 0.547–2.144) and 5.7 vs 3.7 months (HR 0.686, 95% CI 0.368–1.279). Among ixa-dex vs pom-dex patients, 69% vs 81% had Grade ≥3 treatment-emergent adverse events (TEAEs), 51% vs 53% had serious TEAEs, 39% vs 36% had TEAEs leading to drug discontinuation, 44% vs 32% had TEAEs leading to dose reduction, and 13% vs 13% died on study. Quality of life was similar between arms and maintained during treatment. Ixa-dex represents an important lenalidomide-free, oral option for this heavily pretreated, lenalidomide-refractory, proteasome inhibitor-exposed population. Trial registration: ClinicalTrials.gov number, NCT03170882. [ABSTRACT FROM AUTHOR] |
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| Database: |
Complementary Index |
