跳至主要内容
临床试验/CTRI/2025/01/079685
CTRI/2025/01/079685招募中不适用

Moving Beyond G-CSF mobilization - Learning from a 15-year Experience of Different Stem Cell Mobilization Regimens in Plasma cell Neoplasms

ACTREC, Tata Memorial Centre1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2025年2月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
250
试验地点
1
主要终点
To determine proportion of patients with CD34+ dose more than or equal to 5x106/kg in first apheresis in various groups

研究概览

简要总结

Multiple myeloma is a blood cancer wherein abnormal proteins are produced from cancer cells and cause organ damage. After initial cancer control with chemotherapy, high dose chemotherapy and transplant is a common part of treatment in young patients. This helps in better control of cancer, as myeloma is considered incurable. For the process of transplant, stem cells are collected from blood, similar to the procedure of a regular blood donation in blood bank. Stem cells are parent cells in bone marrow which make all blood cells (red blood cells, white blood cells and platelets). Stem cells normally reside within the bone marrow. For ease of collection from the patient, we need to push them out from the bone marrow into blood. For collecting stem cells, multiple protocols are used. Common protocols have use of injections called “growth factors” which stimulate our stem cells to come out from bone marrow in blood, from where they can be collected easily. Other protocols use chemotherapy injections which creates a transient stress on the bone marrow. After few days, the bone marrow recovers from this stress, and in this process, a considerable number of stem cells are released into blood. Both the above procedures have the same common end-point of moving stem cells out from the bone marrow into blood, which enables their easy collection. There is no data from India which has compared the efficacy of chemotherapy-based protocols to growth-factor based protocols for stem cell collection from India. We wish to study this from our institute in patients with multiple myeloma. The above knowledge will help us understand appropriate benefits and drawbacks of these protocols in our setting, and thereby help future patients.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Diagnosis of plasma cell neoplasm multiple myeloma, AL amyloidosis, plasma cell leukemia or POEMS syndrome -Patients who underwent peripheral blood stem cell collection -Duration 1st September 2007 to 31st August 2024.

排除标准

  • Plasma cell neoplasms who did not undergo peripheral stem cell collection -Those for whom stem cell mobilization was initiated but not completed and not undergone a stem cell harvest.

结局指标

主要结局

To determine proportion of patients with CD34+ dose more than or equal to 5x106/kg in first apheresis in various groups

时间窗: 1 year

次要结局

  • -To determine total median CD34+ dose (x106/kg) of all harvests, in four groups(-Median CD34+ (x106/kg) in first apheresis, in four groups)

研究者

发起方
ACTREC, Tata Memorial Centre
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr Sumeet Mirgh

ACTREC TMC

研究点 (1)

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