EVALUATION OF CHOLECALCIFEROL (VitD3) MAINTENANCE SUPPLEMENTATION IN PATIENTS WITH MULTIPLE MYELOMA (MM) UNDERGOING TRANSPLANTATION AND IN COMBINATION WITH LENALIDOMIDE MAINTENANCE
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To describe the lymphocyte subset analysis for the two treatment arms at 120 days post autologous stem cell transplant [120 days]
研究概览
简要总结
The goal of this clinical trial is to evaluate post-transplant immune reconstitution and lymphocyte recovery as well as the 3-year progression-free survival of patients with multiple myeloma in two treatment arms. One arm will receive lenalidomide and an intensified regimen of maintenance VitD, and the other arm will receive lenalidomide and a therapeutic regimen of VitD. This clinical trial will also evaluate the overall response rate and survival for both treatment arms.
详细描述
Management of multiple myeloma (MM) has changed significantly over the past 10 years. The use of three drug induction therapy followed by autologous stem cell transplantation (ASCT) has become standard of care for transplant eligible patients with MM since randomized trials showed improved progression-free survival (PFS) and overall survival (OS) with three drugs, albeit in the non-transplant setting.
Evidence suggests Vitamin D deficiency is correlated with poorer outcomes in this population; however, it is unknown if intensified Vitamin D supplementation improves outcomes. This clinical trial aims to address this question and will postulate the impact of Vitamin D on immunoregulatory functions and the hematopoietic niche microenvironment.
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
- 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
- •Diagnosis of multiple myeloma without amyloidosis.
- •Willing and able to take medication to prevent blood clots (example: aspirin, low molecular weight heparin, etc.) and comply with lenalidomide REMS program requirements.
- •18 years or older.
- •Eligible for autologous stem cell transplantation or have completed ASCT within 120 days prior to starting the study.
- •Be able to take and swallow oral medication (capsules) whole with no impairment of gastrointestinal function.
排除标准
- •Prior transplant (solid organ or stem cell)
- •Known allergy to study drug (cholecalciferol)
- •Other prior cancer diagnosis
研究组 & 干预措施
Maintenance Vitamin D
In this arm, patients will receive maintenance Vitamin D3 prior to autologous transplantation (ASCT). Within 120 days after ASCT the following will be assessed: vitamin D level, Overall Response Rate (ORR) and Measurable Residual Disease (MRD). Then patients will receive lenalidomide and continuation of maintenance Vitamin D.
干预措施: Lenalidomide (Drug)
Maintenance Vitamin D
In this arm, patients will receive maintenance Vitamin D3 prior to autologous transplantation (ASCT). Within 120 days after ASCT the following will be assessed: vitamin D level, Overall Response Rate (ORR) and Measurable Residual Disease (MRD). Then patients will receive lenalidomide and continuation of maintenance Vitamin D.
干预措施: Maintenance Vitamin D (Drug)
No Maintenance Vitamin D
In this arm, patients will receive no maintenance vitamin D prior to ASCT. Within 120 days after ASCT the following will be assessed: vitamin D level, ORR, and MRD. Then patients will receive the standard lenalidomide dose along with no maintenance vitamin D.
干预措施: Lenalidomide (Drug)
No Maintenance Vitamin D
In this arm, patients will receive no maintenance vitamin D prior to ASCT. Within 120 days after ASCT the following will be assessed: vitamin D level, ORR, and MRD. Then patients will receive the standard lenalidomide dose along with no maintenance vitamin D.
干预措施: No maintenance Vitamin D (Drug)
结局指标
主要结局
To describe the lymphocyte subset analysis for the two treatment arms at 120 days post autologous stem cell transplant [120 days]
时间窗: 120 days
Evaluate absolute lymphocyte count and the difference in subset analysis (absolute CD4 count, absolute CD8 count) 120 days after ASCT
次要结局
- 3 year progression free survival(3 years)
- Overall Response Rate post 120 days of ASCT(120 Days)
- Overall Response Rate after transplantation(Two Years)
- 3 Year Overall Survival after transplantation(Three Years)
- Minimal Residual Disease status(Randomization; 120 days after transplantation; two years after transplantation.)
- Vitamin D levels(Before autologous stem cell transplant; 120 days after transplantation; three years post-transplantation)
- Adverse Event Reporting(Three years)
- Neutrophil and Platelet Engraftment and Transfusion Independence(After transplantation, an average of 30 days)
研究者
Amany Keruakous, MD, MS.
Assistant Professor of Medicine
Augusta University