EUCTR2010-022029-13-DE进行中（未招募）不适用
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 - NA
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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
- •Other protocol-defined inclusion criteria may apply
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
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 exclusion criteria may apply
研究者
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