Phase I / II Study Of Carfilzomib (CFZ) Intensification Early After Autologous Transplantation (AHCT) For Plasma Cell Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
Background:
- Plasma cell myeloma is a type of cancer that affects the plasma cells in the bone marrow. It can be difficult to treat with chemotherapy. One possible treatment combines chemotherapy with a stem cell transplant. To make this treatment more effective, researchers want to give another drug along with the transplant. This drug, carfilzomib, is often used to help treat plasma cell myeloma. However, it is not usually given along with the transplant. Researchers want to see if it is safe and effective to combine the stem cell transplant with carfilzomib, and if it improves the results of the transplant.
Objectives:
- To test the safety and effectiveness of carfilzomib given with stem cell transplant for plasma cell myeloma.
Eligibility:
- Individuals between 18 and 75 years of age who are having a stem cell transplant to treat plasma cell myeloma.
Design:
- Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Imaging studies and a bone marrow biopsy will also be performed.
- Participants will have their own stem cells collected for the transplant. The transplant will be performed according to the standard of care.
- All participants will receive carfilzomib on the first 2 days after transplant. The study doctors will determine the number of additional doses that they may have.
- Treatment will be monitored with frequent blood tests and imaging studies.
详细描述
Background:
- Despite very significant progress in therapy for plasma cell myeloma (PCM) in the last decade, the disease remains mostly incurable.
- High-dose chemotherapy followed by autologous hematopoietic cell transplantation (AHCT) continues to be a critical component of early treatment for PCM, but it is clear that the disease is not eradicated by the present high-dose therapy strategy, while intensifying the preparative regimen has, to this day, resulted in either no improvement in disease control or increased toxicity.
- Carfilzomib (CFZ) is a newer proteasome inhibitor with increased activity and a safer toxicity profile than bortezomib in PCM. The favorable toxicity profile makes it a likely candidate for increasing anti-PCM drug exposure in the early post-AHCT period.
Objectives:
Primary Objectives
-Evaluate feasibility and toxicity of an increasing number of doses of CFZ administered in the early period post-AHCT for PCM
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort 1- CFZ 20 mg/m^2 (Day 1,2)
Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)
•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:
Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2
Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9
Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70.
干预措施: Carfilzomib (Drug)
Cohort 1- CFZ 20 mg/m^2 (Day 1,2)
Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)
•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:
Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2
Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9
Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70.
干预措施: Melphalan (Drug)
Cohort 1- CFZ 20 mg/m^2 (Day 1,2)
Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)
•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:
Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2
Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9
Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70.
干预措施: Filgrastim (Drug)
Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)
Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)
•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:
Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2
Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9
Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70.
干预措施: Carfilzomib (Drug)
Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)
Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)
•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:
Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2
Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9
Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70.
干预措施: Melphalan (Drug)
Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)
Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)
•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:
Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2
Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9
Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70.
干预措施: Filgrastim (Drug)
Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)
Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)
•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:
Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2
Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9
Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70.
干预措施: Carfilzomib (Drug)
Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)
Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)
•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:
Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2
Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9
Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70.
干预措施: Melphalan (Drug)
Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)
Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)
•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:
Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2
Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9
Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70.
干预措施: Filgrastim (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: 8 months and 15 days
Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Engraftment Failure Transplant Related Mortality
时间窗: up to day 100
Engraftment failure is defined as the failure to achieve neutrophil engraftment by day 21; defined from day 0, day of autologous hematopoietic cell transplantation (AHCT), as the first of three consecutive days on which the patient's absolute neutrophil count is greater than 0.5x10(9)/l following the nadir. Transplant related mortality is defined as any subject who dies in the first 100 days post-AHCT of any non-relapse related cause.
次要结局
- Evaluate the Immune Reconstitution Post-Pre-autologous Hematopoietic Cell Transplantation (AHCT) Following Carfilzomib (CFZ) Therapy(Post-AHCT following CFZ therapy)
- Evaluate the Effects of the Addition of Carfilzomib (CFZ) in the Early Post-Pre-autologous Hematopoietic Cell Transplantation (AHCT) Period on the Response Rate at Day 100 Post-AHCT(Day 100 post-AHCT)
研究者
Daniel Fowler, M.D.
Principal Investigator
National Institutes of Health Clinical Center (CC)