A Single-arm, Open-label, Phase 2 Clinical Trial Evaluating Disease Response Following Treatment With Intravenous BHQ880, a Fully Human, Anti-Dickkopf1 (DKK1) Neutralizing Antibody in Previously Untreated Patients With High-risk, Smoldering Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 11
- 主要终点
- Overall response rate (Complete Response + Partial Response + Minimal Response) of patients achieving an objective response (defined according to the IMWG uniform response criteria by the Frequency of response of serum or urine M-protein to BHQ880A
研究概览
简要总结
This study will assess the antimyeloma effects of BHQ880A in patients with smoldering multiple myeloma with high risk of progression to active multiple myeloma. BHQ880 will be administered every 28 days in previously untreated patients. Disease assessments will be performed monthly and effects on bone metabolism will be assessed by measurement of serum and urine bone biomarkers, changes in BMD , and QCT with FEA. Additionally, the PK profile of BHQ880 as a single agent and following multiple doses will be obtained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of SMM with high-risk for progression to multiple myeloma
- •BMPC ≥ 10% and serum M-protein level ≥ 3 g/dL, OR
- •BMPC ≥ 10%, serum M-protein level < 3 g/dL, and an abnormal free light chain ratio of < 0.125 or > 8.0
- •No previous or current anti-myeloma therapies
- •Patients ≥ 18 years of age
- •Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 1
排除标准
- •Previous treatment with IV bisphosphonates (i.e., pamidronate or zoledronic acid
- •Another primary malignant disease that requires systemic treatment
- •Concomitant Paget's disease of bone, uncorrected hyperparathyroidism, or uncontrolled thyroid disease
- •Clinically significant uncontrolled heart disease (e.g., unstable angina, congestive heart failure, uncontrolled hypertension, ventricular or atrial arrhythmias)
- •Treatment with an investigational product within 28 days before the first dose of study treatment
- •Pregnant or nursing (lactating) women
- •Women of child-bearing potential, UNLESS they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
BHQ880
干预措施: BHQ880 (Drug)
结局指标
主要结局
Overall response rate (Complete Response + Partial Response + Minimal Response) of patients achieving an objective response (defined according to the IMWG uniform response criteria by the Frequency of response of serum or urine M-protein to BHQ880A
时间窗: at 6 month
次要结局
- Safety and tolerability of BHQ880 in patients with smoldering multiple myeloma by assessing AEs, SAEs, clinical laboratory values(From start of study until disease progression)
- Characterize the PK profile of BHQ880 as a single agent administered monthly by assessing BHQ880 levels in plasma(Throughout the study until disease progression)
- Evaluate the effect of BHQ880 on bone metabolism by assessing serum and urine bone biomarkers(Throughout the study until disease progression)
- Evaluate the effect of BHQ880 on bone mineral density by DXA scan and QCT(6 months and 12 months)