التفاصيل البيبلوغرافية
| العنوان: |
Combination of bendamustine, lenalidomide, and dexamethasone (BLD) in patients with relapsed or refractory multiple myeloma is feasible and highly effective: results of phase 1/2 open-label, dose escalation study. |
| المؤلفون: |
Lentzsch, Suzanne1 sl3440@columbia.edu, O'Sullivan, Amy1, Kennedy, Ryan C.1, Abbas, Mohammad1, Dai, Lijun1, Pregja, Silvana Lalo2, Burt, Steve2, Boyiadzis, Michael1, Roodman, G. David1, Mapara, Markus Y.1, Agha, Mounzer3, Waas, John3, Shuai, Yongli4, Normolle, Daniel5, Zonder, Jeffrey A.2 |
| المصدر: |
Blood. 5/17/2012, Vol. 119 Issue 20, p4608-4613. 6p. |
| مصطلحات موضوعية: |
*DEXAMETHASONE, *DISEASE relapse, *MULTIPLE myeloma treatment, *DRUG dosage, *FOLLOW-up studies (Medicine), *THROMBOCYTOPENIA, *NEUTROPENIA, *HYPERGLYCEMIA |
| مستخلص: |
This multicenter phase 1/2 trial investigated the combination of bendamustine, lenalidomide, and dexamethasone in repeating 4-week cycles as treatment for relapsed refractory multiple myeloma (MM). Phase 1 established maximum tolerated dose (MTD). Phase 2 assessed overall response rate at the MTD. Secondary endpoints included progression-free survival (PFS) and overall survival (OS). A total of 29 évaluable patients were enrolled. Median age was 63 years (range 38-80 years). Median number of prior therapies was 3 (range, 1-6). MTD was bendamustine 75 mg/m2 (days 1 and 2), lenalidomide 10 mg (days 1 -21 ), and dexamethasone 40 mg (weekly) of a 28-day cycle. Partial response rate was 52%, with very good partial response achieved in 24%, and minimal response in an additional 24% of patients. Median follow-up was 13 months; median OS has not been reached. One-year OS is 93% (95% confidence interval [CI], 59%-99%). Median PFS is 6.1 months (95% CI, 3.7-9.4 months) with one-year PFS of 20% (95% CI, 6%-41%). Grade 3/4 adverse events included neutropenia, thrombocytopenia, anemia, hyperglycemia, and fatigue. This first phase 1/2 trial testing bendamustine, lenalidomide, and dexamethasone as treatment of relapsed refractory MM was feasible and highly active. [ABSTRACT FROM AUTHOR] |
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