ABSTRACT
Objective: To evaluate the efficacy and safety of bendamustine combined with pomalidomide and dexamethasone (BPD regimen) in the treatment of relapsed multiple myeloma (MM) with extramedullary disease. Methods: This open, single-arm, multicenter prospective cohort study included 30 relapsed MM patients with extramedullary disease diagnosed in seven hospitals including Qingdao Municipal Hospital. The patients were treated with BPD regimen from February 2021 to November 2022. This study analyzed the efficacy and adverse reactions of the BPD regimen. Results: The median age of the 30 patients was 62 (47-72) years, of which 18 (60% ) had first-time recurrence. The overall response rate (ORR) of the 18 patients with first-time recurrence was 100%, of which three (16.7% ) achieved complete remission, 10 (55.5% ) achieved very good partial remission (VGPR), and five (27.8% ) achieved partial remission (PR). The ORR of 12 patients with recurrence after second-line or above treatment was 50%, including zero patients with ≥VGPR and six patients (50% ) with PR. Three cases (25% ) had stable disease, and three cases (25% ) had disease progression. The one-year progression free survival rate of all patients was 65.2% (95% CI 37.2% -83.1% ), and the 1-year overall survival rate was 90.0% (95% CI 76.2% -95.4% ). The common grade 3-4 hematology adverse reactions included two cases (6.7% ) of neutropenia and one case (3.3% ) of thrombocytopenia. The overall adverse reactions are controllable. Conclusions: The BPD regimen has good efficacy and tolerance in relapsed MM patients with extramedullary disease.
Subject(s)
Humans , Middle Aged , Aged , Multiple Myeloma/drug therapy , Bendamustine Hydrochloride/therapeutic use , Prospective Studies , Dexamethasone/therapeutic use , Antineoplastic Combined Chemotherapy Protocols/therapeutic useABSTRACT
Objective:To develop a method for the determination of palladium in bendamustine hydrochloride by GFAAS. Meth-ods:The sample was destroyed by heat, and the content of palladium was determined by GFAAS with the detection wavelength of 247. 6 nm. Results:The absorbance and the content of palladium showed a good linear relationship within the range of 20-60 ng· ml-1(r=0. 998 4). The average recovery of palladium was 102. 9%(RSD=1. 7%, n=9). Conclusion: The method is sensitive and simple, which can be used for the determination of palladium in bendamustine hydrochloride.
ABSTRACT
Objective:To evaluate the efficacy and toxicity of single-agent bendamustine in patients with indolent B-cell non-Hodgkin's lymphoma (NHL) refractory to rituximab. Methods:Between April 2010 and April 2013, 100 patients with rituximab-refrac-tory indolent B-cell NHL from 8 institutions were enrolled. Bendamustine was administered at 120 mg/m2 on days 1 and 2 every 21 days for 6-8 cycles. The primary endpoint was the overall response rate (ORR). The secondary endpoints included disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety. Results:One hundred patients with a median age of 56 (rang-ing from 28 to 74) years were recruited in this clinical study. The total number of chemotherapy was 447 cycles, and the median number was 4 cycles. Ninety-three patients could be evaluated for efficacy. Fifteen patients (16.1%) had complete remission (CR), 52 (55.9%) had partial remission (PR), 22 (23.7%) had stable disease (SD), and 4 (4.3%) had progression disease (PD). The ORR and DCR were 72%and 95.7%, respectively. After a median follow-up of 26.6 months (ranging from 2 to 48.4 months), 59 patients (63.4%) had PD.The median PFS was 8.53 (95%CI:6.518-10.542) months, and PFS rate for 1 year was (40.6±5.3)%. Forty-eight patients (48%) had 3/4 grade adverse events, including leucopenia (26%), neutropenia (24%), and anemia (11%). Conclusion:Single-agent bendamustine produced a high rate of objective responses in patients with rituximab-refractory indolent B-cell NHL and could be one of the new op-tions for second-line treatment of these patients. The most common adverse event is hematologic toxicity.
ABSTRACT
@#In the HPLC analysis of bendamustine hydrochloride, two related substances(IMP01 and IMP02)were detected. These two related substances were identified by LC-MS/MS and their structural confirmation was unambiguously carried out by synthesis followed by characterization using Q-TOF/MS and NMR. Based on the spectral data, related substances IMP01 and IMP02 were characterized as 4-(1-methyl-5-morpholino-1H-benzo［d］imidazol-2-yl)butyric acid hydrochloride and 4-{1-methyl-5-［(2-chloroethyl)(2-hydroxyethyl)amino］-1H-benzo［d］imidazol-2-yl)} butyric acid hydrochloride, respectively. Bendamustine hydrochloride and its related substances were separated under the established LC-MS condition. HPLC is a useful method for the determination of the related substances in bendamustine hydrochloride. Results obtained are valuable for its manufacturing process and quality control.
ABSTRACT
Objective:To observe the clinical efficacy and toxicities of bendamustine hydrochloride in patients with rituximab-re-fractory indolent B-cell non-Hodgkin's lymphoma (NHL). Methods:A total of 25 patients with rituximab-refractory NHL received bendamustine hydrochloride 120 mg/m2 intravenously on days 1 and 2 of the 21-day cycle. The short-term response, progression free survival, and toxicities were evaluated. Results:The total number of chemotherapy of the 25 patients was 122 cycles, and the median number was 5 cycles. All patients could be evaluated for efficacy. Among the patients, 6 had complete remission, 13 had partial remis-sion, 3 had stable disease, and 3 had progression disease. The overall response rate and clinical benefit rate were 76%and 88%, respec-tively. Until the deadline, 13 patients had progression disease. The median duration of response was 8 months, and the median progres-sion-free survival (PFS) was 9.3 months. Subgroup analysis showed that PFS is significantly related to bone marrow involvement and serum LDH level (P<0.05). The main adverse effects were myelosuppression, gastrointestinal reactions, and infection. Rash was found in 2 patients, and 1 case of gastric cancer was discovered after 5 cycles of treatment. Conclusion:Bendamustine hydrochloride was ef-fective and tolerable in patients with rituximab-refractory indolent B-cell NHL.
ABSTRACT
Bendamustine hydrochloride is used to treat chronic lymphocytic leukemia. It kills the existing cancer cells and limits the growth of new cancer cells. Three simple, rapid and sensitive spectrophotometric methods were developed for the determination of Bendamustine hydrochloride in phosphate buffer (pH 8.0) (Method A) and boric buffer (pH 9.0) (Method B). Method C is a difference spectroscopy technique in which the amplitude was chosen for the analytical calculations. Bendamustine hydrochloride obeys Beer-Lambert’s law over the concentration range 1-40 μg/ml, 0.1-40 μg/ml and 5- 40 μg/ml with regression equations y = 0.003x + 0.001(r² = 0.998) y = 0.0027x + 0.0005 (r² = 0.999), and y = 0.0034x + 0.006 (r² = 0.994) for Method A, B and C respectively. The methods were validated as per ICH guidelines and can be applied for the determination of Bendamustine hydrochloride in pharmaceutical formulations.