A Randomized, Comparative, Double-blind Trial of Pentaisomaltose and Dimethyl Sulphoxide for Cryoprotection of Hematopoietic Stem Cells in Subjects With Multiple Myeloma or Malignant Lymphoma With a Need for Autologous Transplantation
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- Incidence of subjects with AEs of special interest (limited)
研究概览
简要总结
A randomized, comparative, double-blind trial of pentaisomaltose and dimethyl sulphoxide for cryoprotection of hematopoietic stem cells in subjects with multiple myeloma or malignant lymphoma with a need for autologous transplantation
详细描述
The trial is a randomized, comparative, double-blind trial comparing the efficacy and safety of pentaisomaltose (PentaHibe®, Pharmacosmos A/S, Holbæk; termed PIM in the following) and dimethyl sulphoxide (DMSO), when used for preservation of harvested hematopoietic stem cells. Approximately 150 subjects with a diagnosis of multiple myeloma or malignant lymphoma (a minimum of 30 % of each diagnosis and an equal distribution in each preservation group) and undergoing autologous stem cell transplantation (ASCT) will be included.
The subjects will be randomized 1:1 to receive ASCT preserved in the following cryo-protective agent (CPA):
- A: PIM 16 %
- B: DMSO 10 %
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The subject, trial personnel, and Pharmacosmos personnel will be blinded to the CPA. Blinding will be obtained by shielding the blinded trial personnel from seeing the preparation of the CPA and having unblinded personnel not involved in any trial assessments (efficacy or safety) responsible for randomization, preparation, and accountability of the CPA. The CPA will not be labelled in a way that would reveal the content of the CPA for the blinded personnel or the subject. CPA accountability will be monitored by an unblinded CRA.
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
- •Men or women ≥ 18 years
- •Multiple myeloma or malignant lymphoma diagnosis in which ASCT is indicated according to the standard procedures at the hospital
- •Willing to be hospitalized for minimum 24 hours after the ASCT
- •Willingness to participate and signing the ICF
排除标准
- •Multiple myeloma or lymphoma invasion of the central nervous system
- •Previous treatment with ASCT
- •Severe infection
- •Unsuitable for apheresis
- •Unable to provide ≥3 bags with a cell concentration ≥2.0×106 CD34+ cells/kg bodyweight per bag during apheresis
- •Pregnant or nursing women. To avoid pregnancy, women of childbearing potential have to use adequate contraception (e.g., intrauterine devices, hormonal contraceptives, or double barrier method) during the whole trial period and up to 1 year after the last ASCT
- •Men, even if surgically sterilized, (i.e., status post vasectomy), who do not agree to practice effective barrier contraception during the entire trial period and through 6 months after the last ASCT, or agrees to completely abstain from heterosexual intercourse
- •Any other medical condition which, in the opinion of the Investigator, will put the subject's disease management at risk or may result in the subject being unable to comply with the trial requirements
结局指标
主要结局
Incidence of subjects with AEs of special interest (limited)
时间窗: 24 hours after ASCT
Incidence of subjects with AEs of special interest (limited) occurring within 24 hours after ASCT: headache, nausea, vomiting, bradycardia, or unpleasant odor
Engraftment of hematopoietic stem cells
时间窗: 19 days
Incidence of subjects with engraftment of hematopoietic stem cells, defined as 2 consecutive measurements with a neutrophil concentration \>0.5×109/L within the first 19 days after ASCT
次要结局
- Incidence of subjects with AEs of special interest (limited)(19 days)
- Time to engraftment of neutrophil cells(19 days)