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J Hematol Oncol. 2017 Jul 6;10(1):137. doi: 10.1186/s13045-017-0501-4.

Randomized, double-blind, placebo-controlled phase III study of ixazomib plus lenalidomide-dexamethasone in patients with relapsed/refractory multiple myeloma: China Continuation study.

Author information

1
Department of Hematology, Chang Zheng Hospital, The Second Military Medical University, Shanghai, 200003, China. houjian167@sohu.com.
2
First Hospital Affiliated Zhe Jiang Medical University, Hangzhou, China.
3
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Science & Peking Union Medical College, Tianjin, China.
4
The First Affiliated Hospital of Soochow University, Jiangsu, China.
5
The Third Affiliated Hospital of Beijing Medical University, Beijing, China.
6
Peking Union Medical College Hospital, Beijing, China.
7
Peking University People's Hospital, Beijing, China.
8
Guangdong General Hospital/Guangdong Academy of Medical Sciences, Guangzhou, China.
9
Xijing Hospital, The Fourth Military Medical University, Xi'an, China.
10
Ruijin Hospital, Shanghai Jiao Tong University, Shanghai, China.
11
The Third Hospital Xiang Ya Medical University, Changsha, China.
12
Millennium Pharmaceuticals, Inc. (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.), Cambridge, MA, USA.
13
Dana-Farber Cancer Institute, Boston, MA, USA.
14
University Hospital Hôtel-Dieu, Nantes, France.

Abstract

BACKGROUND:

The China Continuation study was a separate regional expansion of the global, double-blind, placebo-controlled, randomized phase III TOURMALINE-MM1 study of ixazomib plus lenalidomide-dexamethasone (Rd) in patients with relapsed/refractory multiple myeloma (RRMM) following one to three prior therapies.

METHODS:

Patients were randomized (1:1) to receive ixazomib 4.0 mg or placebo on days 1, 8, and 15, plus lenalidomide 25 mg on days 1-21 and dexamethasone 40 mg on days 1, 8, 15, and 22, in 28-day cycles. Randomization was stratified according to number of prior therapies, disease stage, and prior proteasome inhibitor exposure. The primary endpoint was progression-free survival (PFS). In total, 115 Chinese patients were randomized (57 ixazomib-Rd, 58 placebo-Rd).

RESULTS:

At the preplanned final analysis for PFS, after median PFS follow-up of 7.4 and 6.9 months, respectively, PFS was improved with ixazomib-Rd versus placebo-Rd (median 6.7 vs 4.0 months; HR 0.598; p = 0.035). At the preplanned final analysis of overall survival (OS), after median follow-up of 20.2 and 19.1 months, respectively, OS was improved with ixazomib-Rd versus placebo-Rd (median 25.8 vs 15.8 months; HR 0.419; p = 0.001). On the ixazomib-Rd and placebo-Rd arms, respectively, 38 (67%) and 43 (74%) patients reported grade ≥3 adverse events (AEs), 19 (33%) and 18 (31%) reported serious AEs, and 4 (7%) and 5 (9%) died on-study. The most frequent grade 3/4 AEs were thrombocytopenia (18%/7% vs 14%/5%), neutropenia (19%/5% vs 19%/2%), and anemia (12%/0 vs 26%/2%).

CONCLUSIONS:

This study demonstrated that PFS and OS were significantly improved with ixazomib-Rd versus placebo-Rd, with limited additional toxicity, in patients with RRMM.

TRIAL REGISTRATION:

ClinicalTrials.gov, NCT01564537.

KEYWORDS:

China; Ixazomib; Multiple myeloma; Oral; Overall survival; Progression-free survival; Proteasome inhibitor; Relapsed/refractory

PMID:
28683766
PMCID:
PMC5500972
DOI:
10.1186/s13045-017-0501-4
[Indexed for MEDLINE]
Free PMC Article

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