NCT02462525终止1 期
A Multicenter, Phase 1/1b, Open-Label, Dose-Escalation Study of ABBV-838, an Antibody Drug Conjugate, in Subjects With Relapsed and Refractory Multiple Myeloma
AbbVie19 个研究点 分布在 4 个国家目标入组 74 人开始时间: 2015年5月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 74
- 试验地点
- 19
- 主要终点
- Maximum tolerated dose of ABBV-838
研究概览
简要总结
This is a Phase 1/1b, open-label, dose-escalation study designed to evaluate the safety, pharmacokinetics, and to determine the recommended Phase 2 dose of ABBV-838 in subjects with relapsed and refractory multiple myeloma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eastern Cooperative Oncology Group Performance Status of 0 to 2
- •Not eligible for stem cell/bone marrow transplant or have refused stem cell/bone marrow transplant or have relapsed after autologous or allogeneic stem cell/bone marrow transplant
- •Eligible for and agree to BM aspirate prior to treatment start
- •Measurable disease M component in serum (≥ 0.5 g/dL) and/or urine (≥ 0.2 g excreted in a 24 hour collection sample)
- •Must have received at least 3 prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or those who are double refractory to a PI and an immunomodulatory agent and have demonstrated disease progression (DP) on or within 60 days of completion of the last therapy; participants previously treated with an alkylating agent, in addition to an IMiD or proteasome inhibitor, are allowed to enroll in the trial
- •Participants must have adequate liver, kidney, and bone morrow function
- •Participants with a history of chronic heart failure must have cardiac ECHO indicating left ventricular ejection fraction (LVEF) ≥ 45% within 21 days prior to first dose of study drug
- •Participants in the combination therapy arms must be eligible to receive pomalidomide/dexamethasone, bortezomib/dexamethasone or lenalidomide/dexamethasone or other approved agents per current prescribing information for MM.
- •Participants who will receive combination therapy with Pomalidomide/Dexamethasone must have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy
排除标准
- •Received anti-cancer therapy including chemotherapy, immunotherapy, radiation, biologic, any investigational therapy or herbal therapy within a period of 21 days prior to the first dose of ABBV-838, and have unresolved toxicities ≥ grade 2
- •Concurrent metastatic solid tumors
- •Non-Measurable M Protein (serum or urine) and measurable sFLC (< 100 mg/mL)
- •Major surgery within 21 days prior to the first dose of ABBV-838
- •Clinically significant uncontrolled condition(s) including but not limited to the following:
- •Grade ≥ 3 peripheral neuropathy or grade 2 peripheral neuropathy with pain Uncontrolled hypercalcemia Active uncontrolled infection Symptomatic congestive heart failure Unstable angina pectoris or cardiac arrhythmia Psychiatric illness/social situation that would limit compliance with the study
- •Major immunologic reaction to any IgG containing agent or auristatin based agent
- •Participants who are taking strong CYP3A4 inhibitors
- •Positive for HIV (Human Immunodeficiency Virus) or with active hepatitis B and/or C
- •Corneal pathology that would limit evaluation of loss in visual acuity associated with corneal deposits.
- •Prior exposure to pomalidomide for subjects enrolling in the pomalidomide/dexamethasone combination arm.
研究组 & 干预措施
ABBV-838 dose escalation
Experimental
Varying doses of ABBV-838
干预措施: ABBV-838 (Drug)
ABBV-838 plus pomalidomide/dexamethasone
Experimental
ABBV-838 to be evaluated with pomalidomide/dexamethasone.
干预措施: ABBV-838 (Drug)
ABBV-838 plus pomalidomide/dexamethasone
Experimental
ABBV-838 to be evaluated with pomalidomide/dexamethasone.
干预措施: Pomalidomide (Drug)
ABBV-838 plus pomalidomide/dexamethasone
Experimental
ABBV-838 to be evaluated with pomalidomide/dexamethasone.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Maximum tolerated dose of ABBV-838
时间窗: Up to 2 years from first dose of study
The highest dose level at which less than 2 of 6 subjects or less than 33% of (if cohort is expanded beyond 6) subjects experience a dose limiting toxicity.
Maximum plasma concentration (Cmax) of ABBV-838
时间窗: Cycle 1 Day 1 (C1D1) and C3D1 pre- and post-dose; C1D4, C1D8, C1D15, C2D1, C2D15, C3D4, C3D8, C3D15, C4D1, and all subsequent ABBV-838 pre-dose dosing cycles
The maximum plasma concentration (Cmax: measured in ng/ml) is the highest concentration that a drug achieves in the blood after the first dose, but before administration of a second dose.
次要结局
- Preliminary activity of ABBV-838 monotherapy(At screening, Cycle 1 Day 15 (C1D15), C3D15, C4D1, and for subjects who have been on ABBV-838 for ≥ 6 cycles, radiologic tumor assessments may be performed every 3 cycles per Investigator discretion up to approximately 3 years)
研究者
研究点 (19)
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