A Double-blind, Placebo-controlled, Randomized Phase 2 Study of BHQ880, an Anti-Dickkopf1 (DKK1) Monoclonal Antibody (mAb), in Patients With Untreated Multiple Myeloma and Renal Insufficiency
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 3
- 主要终点
- effect of BHQ880 compared with placebo on time to first Skeletal Related Event (SRE) in patients with untreated multiple myeloma and renal insufficiency in combination with bortezomib and dexamethasone
研究概览
简要总结
The study will evaluate the effects of BHQ880 in patients with previously untreated multiple myeloma and renal insufficiency who are not considered candidates for bisphosphonate therapy. The primary objective of the study will be to evaluate the effect of BHQ880 in combination with bortezomib and dexamethasone, compared to placebo administered with the combination on the time to first Skeletal Related Event (SRE) on study.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of multiple myeloma
- •Life expectancy of more than 6 months in the absence of intervention
- •Must not have received previous or be receiving current antimyeloma therapies
- •Renal insufficiency
- •Recovered from the effects of any prior surgery or radiotherapy
排除标准
- •Prior IV bisphosphonate therapy at any time or oral bisphosphonate therapy within 4 months of study entry
- •Paget's disease of bone or uncorrected hyperparathyroidism
- •Impaired cardiac function
- •Known HIV, known active hepatitis B, or known or suspected hepatitis C infection
- •Pregnant or nursing (lactating) women,
- •Women of child-bearing potential, UNLESS agreeable to using 2 birth control methods
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
BHQ880 + bortezomib and dexamethasone
干预措施: BHQ880 (Drug)
BHQ880 + bortezomib and dexamethasone
干预措施: bortezomib (Drug)
BHQ880 + bortezomib and dexamethasone
干预措施: dexamethasone (Drug)
BHQ880 Placebo + bortezomib and dexamethasone
干预措施: BHQ880 Placebo (Drug)
BHQ880 Placebo + bortezomib and dexamethasone
干预措施: bortezomib (Drug)
BHQ880 Placebo + bortezomib and dexamethasone
干预措施: dexamethasone (Drug)
结局指标
主要结局
effect of BHQ880 compared with placebo on time to first Skeletal Related Event (SRE) in patients with untreated multiple myeloma and renal insufficiency in combination with bortezomib and dexamethasone
时间窗: 18-month median time to first SRE assumed for the placebo arm
Time to first SRE from randomization
次要结局
- safety and tolerability of BHQ880 in combination with bortezomib and dexamethasone(From screening through month 17)
- Characterize the PharmacoKinetics (PK) profiles of BHQ880 and bortezomib(At screening and weeks 1, 2, 4, 7, 10, 11, 13, 16, 25 and 34)
- Evaluate the effect of BHQ880 on bone metabolism(At screening and at months 3, 6, 12, and 18)
- Determine the antimyeloma effect of BHQ880 compared to placebo when used in combination with bortezomib and dexamethasone.(From the first dose of study medication through month 17)