التفاصيل البيبلوغرافية
| العنوان: |
A phase 1, open-label, dose-escalation study of pralatrexate in combination with bortezomib in patients with relapsed/refractory multiple myeloma. |
| المؤلفون: |
Dunn, Tamara J., Dinner, Shira, Price, Elizabeth, Coutré, Steven E., Gotlib, Jason, Hao, Ying, Berube, Caroline, Medeiros, Bruno C., Liedtke, Michaela |
| المصدر: |
British Journal of Haematology; Apr2016, Vol. 173 Issue 2, p253-259, 7p, 2 Charts |
| مصطلحات موضوعية: |
DRUG efficacy, DRUG dosage, BORTEZOMIB, COMBINATION drug therapy, DISEASE relapse, MULTIPLE myeloma treatment, FOLIC acid metabolism |
| مستخلص: |
Pralatrexate inhibits folic acid metabolism, and preclinical studies have shown that it is cytotoxic to multiple myeloma cells. This phase 1 study investigated the safety and efficacy of pralatrexate in combination with bortezomib in adults with relapsed or refractory multiple myeloma. A standard 3 + 3 design was used. Patients received intravenous pralatrexate at doses ranging from 10 to 30 mg/m2 and intravenous bortezomib at a dose of 1·3 mg/m2 on days 1, 8 and 15 of each 4-week cycle. Eleven patients were enrolled and completed a median of two cycles. The maximum tolerated dose was 20 mg/m2. Two patients experienced dose-limiting toxicity of mucositis. The most frequent non-haematological toxicities were fatigue (55%) and mucositis (45%). There were three serious adverse events in three patients: rash, sepsis and hypotension. One patient (9%) had a very good partial response, 1 (9%) had a partial response, 1 (9%) had minimal response and two (18%) had progressive disease. The median duration of response was 4 months, the median time to next treatment was 3·4 months and the median time to progression was 4 months. Pralatrexate, in combination with bortezomib, was generally safe and demonstrated modest activity in relapsed or refractory multiple myeloma. Clinicaltrials.gov identifier: NCT01114282. [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
Complementary Index |
