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首页> 美国卫生研究院文献>other >A Phase I Dose-Escalation Trial of High-Dose Melphalan with Palifermin for Cytoprotection Followed by Autologous Stem Cell Transplantation for Patients with Multiple Myeloma with Normal Renal Function
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A Phase I Dose-Escalation Trial of High-Dose Melphalan with Palifermin for Cytoprotection Followed by Autologous Stem Cell Transplantation for Patients with Multiple Myeloma with Normal Renal Function

机译：高剂量Melphalan的I次升级试验具有颅骨保护性的paliferphin然后对多发性肾功能多发性骨髓瘤的患者进行自体干细胞移植

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Melphalan 200 mg/m2 is the standard conditioning regimen for patients with multiple myeloma (MM) with normal renal function (NRF) undergoing autologous stem cell transplant (ASCT). In an effort to escalate the dose of melphalan and to improve the efficacy, we designed a dose-escalation study of melphalan in conjunction with palifermin in patients with NRF, with the hope that a higher dose of melphalan can be administered with an acceptable degree of oral mucositis (OM). We enrolled 19 patients (18 evaluable) with NRF. Dose-escalation of melphalan administered on day –2 began at 200 mg/m2 with palifermin administered at a fixed dose of 60 mcg/kg/day. Palifermin was given as an i.v. bolus on day −5, −4, and −3, and then on day +1, +2, and +3. Subsequent dose escalations of melphalan were done at 20 mg/m2 increments up to a maximum dose of 280 mg/m2. Of 18 evaluable patients, there were no treatment-related deaths by day 100. The median age was 48.5 years (range, 33-65 years). The most common adverse events related to palifermin included rash (18 events, no ≥grade 3 events), elevation of amylase (10 events, 4 were grade 3 but asymptomatic), and lipase (5 events, 2 were grade 3 but asymptomatic), edema (11 events, no ≥grade 3). The overall incidence of OM grade 3 was 44% (8/18) with a median duration of severe mucositis of 5 days (range, 3-6 days). Eleven patients (61%) required opioid analgesics. None of the patients received total parenteral nutrition (TPN)asogastric feeding. Two of 6 patients who were given melphalan 280 mg/m2 did not develop OM. Cardiac dose-limiting toxicity (DLT) in the form of atrial fibrillation did occur in 1 of 6 patients treated with melphalan 280 mg/m2. Palifermin has permitted safe dose escalation of melphalan up to 280 mg/m2, thus reaching the cumulative dosage of melphalan administered in tandem ASCT. This higher dose of melphalan has the potential to improve the efficacy and, hopefully, outcomes of patients with MM with a single ASCT. A phase 2 trial is necessary to better delineate the antimyeloma efficacy of this regimen.
机译：Melphalan 200 mg / m 2 是肾功能正常（NRF）的多发性骨髓瘤（MM）接受自体干细胞移植（ASCT）的患者的标准调理方案。为了提高美法仑的剂量并提高疗效，我们设计了美法仑联合palifermin治疗NRF患者的剂量递增研究，希望可以以可接受的程度服用更高剂量的美法仑。口腔粘膜炎（OM）。我们招募了19名NRF患者（18名可评估）。在第2天服用美法仑的剂量递增开始于200 mg / m 2 ，而以剂量为60 mcg / kg / day的palifermin服用。 Palifermin是i.v.在第-5，-4和-3天推注，然后在第+ 1，+ 2和+3日推注。随后以20 mg / m 2 的增量逐步增加美法仑的剂量，直至最大剂量为280 mg / m 2 。在18位可评估的患者中，到第100天，没有与治疗相关的死亡。中位年龄为48.5岁（范围：33-65岁）。与palifermin相关的最常见不良事件包括皮疹（18事件，无≥3级事件），淀粉酶升高（10事件，4为3级但无症状）和脂肪酶（5事件，2为3级但无症状），水肿（11次，≥3级）。 OM 3级的总发生率为44％（8/18），中度重度粘膜炎持续时间为5天（范围3-6天）。 11名患者（61％）需要使用阿片类镇痛药。所有患者均未接受全胃肠外营养（TPN）/鼻胃喂养。接受美法仑280 mg / m 2 的6例患者中有2例未发生OM。以美法仑280 mg / m 2 治疗的6例患者中有1例发生了心房颤动形式的心脏剂量限制毒性（DLT）。 Palifermin已允许将美法仑的安全剂量逐步提高至280 mg / m 2 ，从而达到串联ASCT中所用美法仑的累积剂量。较高剂量的美法仑有可能改善单次ASCT的MM患者的疗效，并有望改善其结果。为了更好地描述该方案的抗骨髓瘤疗效，必须进行2期试验。

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