PMID- 23782711
OWN - NLM
STAT- MEDLINE
DCOM- 20150419
LR  - 20211021
IS  - 1756-8722 (Electronic)
IS  - 1756-8722 (Linking)
VI  - 6
DP  - 2013 Jun 19
TI  - A multicenter, open-label, phase 2 study of lenalidomide plus low-dose 
      dexamethasone in Chinese patients with relapsed/refractory multiple myeloma: the 
      MM-021 trial.
PG  - 41
LID - 10.1186/1756-8722-6-41 [doi]
AB  - BACKGROUND: There is an unmet need for treatment options in Chinese patients with 
      relapsed or refractory multiple myeloma (RRMM). Lenalidomide plus low-dose 
      dexamethasone is effective and generally well tolerated in Caucasian RRMM 
      patients, but no previous study has evaluated this regimen in Chinese RRMM 
      patients. METHODS: MM-021 is a phase 2, multicenter, single-arm open-label 
      registration trial conducted to assess the efficacy, safety, and pharmacokinetics 
      of lenalidomide plus low-dose dexamethasone in Chinese patients with RRMM. 
      Patients with >/=1 prior antimyeloma therapy received lenalidomide plus low-dose 
      dexamethasone until disease progression or discontinuation. Follow-up of 
      surviving patients continued for >/=1 year after enrollment. The lenalidomide dose 
      was 25 mg/day, and was adjusted according to baseline renal function. Most 
      patients had advanced disease (85.6% had Durie-Salmon stage III) and were heavily 
      pretreated (56.7% had received >/=4 prior regimens; 69.5% prior thalidomide and 
      63.1% prior bortezomib); 5.3% had immunoglobulin D (IgD) disease. RESULTS: The 
      safety population comprised 199 eligible patients. In the efficacy population 
      (n = 187), the disease control rate (at least stable disease) was 94.7%, and the 
      overall response rate (at least partial response) was 47.6%. High response rates 
      were also achieved in patients who had renal impairment and in those with IgD 
      disease. After a median study follow-up of 15.2 months, the median response 
      duration was 8.8 months (range, 0.4-18.8 months) and median progression-free 
      survival was 8.3 months (95% CI 6.5-9.8). The most common grade 3-4 adverse 
      events (AEs) were anemia (26.1%), neutropenia (25.1%), thrombocytopenia (14.6%), 
      pneumonia (13.1%), leukopenia (9.5%), and decreased neutrophil count (8.5%). AEs 
      led to lenalidomide dose reduction and/or interruption in 40.2% of patients, and 
      treatment discontinuation in about 9% of patients. The pharmacokinetic profile of 
      lenalidomide was similar to that reported in Caucasian and Japanese patients. 
      CONCLUSIONS: Lenalidomide plus low-dose dexamethasone was associated with a high 
      response rate and acceptable safety profile in heavily pretreated Chinese 
      patients with RRMM, including those with renal impairment and IgD subtype. These 
      findings highlight the clinical potential of this regimen in Chinese RRMM 
      patients who have exhausted current treatment options. TRIAL REGISTRATION: China 
      State Food and Drug Administration (SFDA) registration (CTA reference numbers: 
      209 L10808; 209 L10809; 209 L10810; and 209 L10811) and ClinicalTrials.gov 
      identifier: NCT01593410.
FAU - Hou, Jian
AU  - Hou J
FAU - Du, Xin
AU  - Du X
FAU - Jin, Jie
AU  - Jin J
FAU - Cai, Zhen
AU  - Cai Z
FAU - Chen, Fangping
AU  - Chen F
FAU - Zhou, Dao-bin
AU  - Zhou DB
FAU - Yu, Li
AU  - Yu L
FAU - Ke, Xiaoyan
AU  - Ke X
FAU - Li, Xiao
AU  - Li X
FAU - Wu, Depei
AU  - Wu D
FAU - Meng, Fanyi
AU  - Meng F
FAU - Ai, Huisheng
AU  - Ai H
FAU - Zhang, Jingshan
AU  - Zhang J
FAU - Wortman-Vayn, Honeylet
AU  - Wortman-Vayn H
FAU - Chen, Nianhang
AU  - Chen N
FAU - Mei, Jay
AU  - Mei J
FAU - Wang, Jianmin
AU  - Wang J
LA  - eng
SI  - ClinicalTrials.gov/NCT01593410
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20130619
PL  - England
TA  - J Hematol Oncol
JT  - Journal of hematology & oncology
JID - 101468937
RN  - 4Z8R6ORS6L (Thalidomide)
RN  - 7S5I7G3JQL (Dexamethasone)
RN  - F0P408N6V4 (Lenalidomide)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Combined Chemotherapy Protocols/pharmacokinetics/*therapeutic use
MH  - China
MH  - Dexamethasone/administration & dosage
MH  - Disease Progression
MH  - Disease-Free Survival
MH  - Female
MH  - Humans
MH  - Lenalidomide
MH  - Male
MH  - Middle Aged
MH  - Multiple Myeloma/*drug therapy/metabolism/pathology
MH  - Neoplasm Recurrence, Local/pathology
MH  - Thalidomide/administration & dosage/analogs & derivatives/pharmacokinetics
MH  - Treatment Outcome
PMC - PMC3699390
EDAT- 2013/06/21 06:00
MHDA- 2015/04/22 06:00
PMCR- 2013/06/19
CRDT- 2013/06/21 06:00
PHST- 2013/04/23 00:00 [received]
PHST- 2013/06/13 00:00 [accepted]
PHST- 2013/06/21 06:00 [entrez]
PHST- 2013/06/21 06:00 [pubmed]
PHST- 2015/04/22 06:00 [medline]
PHST- 2013/06/19 00:00 [pmc-release]
AID - 1756-8722-6-41 [pii]
AID - 10.1186/1756-8722-6-41 [doi]
PST - epublish
SO  - J Hematol Oncol. 2013 Jun 19;6:41. doi: 10.1186/1756-8722-6-41.