A Phase II Prospective clinical trial in patients with Multiple Myeloma and Amyloidosis: Evaluating Feasibility of home Administered Subcutaneous Bortezomib Injections.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Variables to be estimated Percentage of patients with self administer bortezomib and incidence of grade 3 or more side effects
研究概览
简要总结
This is a Phase 2 study evaluating the feasibility and safety of self-administered subcutaneous bortezomib injections at home in patients diagnosed with multiple myeloma and amyloidosis.
Primary endpoint isFeasibility of self-administered Bortezomib injection at home, assessed by adherence to the self administration regimen, safety outcomes, and patient satisfaction & Proportion of participants achieving a Relative Dose Intensity(RDI) of Bortezomib surpassing the predetermined threshold of 80%.
Secondary Endpoint is Incidence and severity of adverse events such as injection site reactions, systemic reactions, and other treatment-related complications associated with self-administered subcutaneous bortezomib injections at home & Treatment adherence and persistence (Proportion of doses note self administered, Treatment interruptions, Discontinuations of self administration)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 15.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient diagnosed with Multiple Myeloma and Amyloidosis (Confirmed with : Bone marrow biopsy, blood reports?) At baseline normal hematological parameters :
- •Absolute neutrophil count (ANC) ≥ 1.5 × 10â¹/L,
- •Platelet count ≥ 100 ×10â¹/L, and
- •Hemoglobin ≥ 8 g/dL (may have been transfused) Patient willing to give consent.
排除标准
- •Pregnant or nursing woman.
- •Inability to understand the written and verbal instructions.
- •Not willing for follow-up as per the protocol.
- •Skin disease hampering subcutaneous administration Seropositivity for HIV, HBsAg or HCV.
结局指标
主要结局
Variables to be estimated Percentage of patients with self administer bortezomib and incidence of grade 3 or more side effects
时间窗: 2 years
次要结局
- To assess the safety(Grade 3 side effects) over the course of study.(2 years)
研究者
Dr Bhausaheb Bagal
Tata Memorial Centre