A Phase 2a, Multi-Center, Randomized, Multiple-Dose Study to Evaluate the Safety, Tolerability and Efficacy of ACE-011 (hActRIIA-IgG1) in Patients With Osteolytic Lesions of Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
Multi-center, randomized, multiple-dose study to evaluate the safety, tolerability and efficacy of ACE-011 in patients with osteolytic lesions of multiple myeloma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient at least 18 years of age with stage II or III multiple myeloma
- •One or more lytic bone lesions
- •If currently receiving bisphosphonate therapy, have been on a stable dose for ≥ 2 months before dosing day 1 or must not have received bisphosphonates within 2 months of dosing day 1
- •If patient has undergone previous autologous or allogenic hematopoietic stem cell transplantation (HSCT), they must be stable (in the opinion of the investigator) and be a minimum of 6 months since HSCT
- •Has planned HSCT for the duration of the study
- •Has moles or lesions that are currently undiagnosed, but are suspect for malignancy
- •Has an underlying condition that may result in abnormal bone metabolism other than cancer related bone lesions, such as a history of hyperparathyroidism, hypoparathyroidism, hypocalcemia, rheumatoid arthritis, myeloproliferative disorder, gout, Paget's disease of the bone, or osteomalacia; patients with a diagnosis of osteoporosis prior to multiple myeloma diagnosis are eligible to participate.
排除标准
- •Known underlying condition that may result in abnormal bone metabolism other than cancer related bone lesions
- •History of polyneuropathy ≥ grade 3
- •Patients with plasma cell leukemia
- •Planned stem cell transplant (HSCT) or radiation for the duration of the study
- •Skeletal related event within 2 weeks of study enrollment
- •Has received erythropoiesis-stimulating agents (ESAs) within the last 21 days or is planned to receive ESAs during the course of the study
- •Has received anti-myeloma therapy within the last 21 days
- •Is scheduled to receive local radiation to bone during the course of the study
- •Has taken estrogen, androgen, anabolic steroids, calcitonin or other bone-active drugs within 4 months of study enrollment
- •Woman of childbearing potential (not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months)
研究组 & 干预措施
Placebo
Subcutaneous injection on days 1, 29, 57 and 85.
干预措施: Placebo (Biological)
ACE-011 0.1 mg/kg
Subcutaneous injection of ACE-011 0.1 mg/kg every 28 days totaling four doses (days 1, 29, 57 and 85).
干预措施: ACE-011 (Biological)
ACE-011 0.3 mg/kg
Subcutaneous injection of ACE-011 0.3 mg/kg every 28 days totaling four doses (days 1, 29, 57 and 85).
干预措施: ACE-011 (Biological)
ACE-011 0.5 mg/kg
Subcutaneous injection of ACE-011 0.5 mg/kg every 28 days totaling four doses (days 1, 29, 57 and 85).
干预措施: ACE-011 (Biological)
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
时间窗: From first dose to termination visit on Day 169
A treatment emergent adverse event (TEAE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causality assessment. A TEAE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Any worsening (i.e., any clinical significant adverse change in frequency and/or intensity) of a preexisting condition, which was temporally associated with the use of the sponsor's medicinal (investigational) product, was also a TEAE. The number of participants with at least one TEAE are reported.
Number of Participants With Serious Adverse Events (SAEs)
时间窗: From first dose up to termination visit on Day 169
A Serious Adverse Event (SAE) was defined as any untoward medical occurrence that at any dose (including overdose) that was fatal, was life threatening, required or prolonged inpatient hospitalization, resulted in permanent or significant disability/incapacity, or was a congenital anomaly/birth defect. The number of participants with at least one serious adverse event are reported.
Change From Baseline in Hemoglobin
时间窗: Day 1 (baseline), Day 8, Day 29, Day 36, Day 57, Day 85, Day 113, Day 169
Summary of the change from baseline in hemoglobin (g/dL) by the pre-specified timepoints. Baseline was defined as the last measurement prior to dosing. Data were summarized for all treated participants who had at least 1 postdosing measurement.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Related to Study Drug
时间窗: From first dose to termination visit on Day 169
A treatment emergent adverse event (TEAE) related to study drug was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, that was determined to be related to the study drug. A TEAE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product. Any worsening (i.e., any clinical significant adverse change in frequency and/or intensity) of a preexisting condition, which was temporally associated with the use of the sponsor's medicinal (investigational) product, was also a TEAE. The number of participants with at least one TEAE are reported. Treatment emergent adverse events were assessed by the investigator as possibly, probably, or definitely related to the study drug.
Number of Participants With Electrocardiogram Abnormalities
时间窗: Pre-dose, Day 1, Day 92, and Day 169
The number of participants with at least one clinically significant postbaseline electrocardiogram abnormality. The abnormalities included left ventricular hypertrophy, atrial fibrillation, sinus bradycardia, sinus tachycardia, and myocardial ischemia. Data is reported as the cumulative number of participants with abnormalities over the scheduled collection timepoints.
Number of Participants With Hypertension or Increased Blood Pressure
时间窗: From baseline up to Day 92
The number of participants who experienced hypertension or an increase in blood pressure from baseline up to Day 92. Abnormal blood pressure was defined as: * Systolic blood pressure ≤ 90 or ≥ 180 mmHg * Systolic blood pressure change (increase or decrease) ≥ 20 mmHg * Diastolic blood pressure ≤ 60 or ≥ 100 mmHg * Diastolic blood pressure change (increase or decrease) ≥ 15 mmHg
次要结局
- Number of Participants With Skeletal-related Events (SRE)(From first dose up to 2 weeks post first dose)
- Percent Change From Baseline in Bone Pain Visual Analog Scale (VAS)(From baseline (Day 1) to Day 29, Day 57, Day 85, Day 113, Day 141, Day 169)