A Pilot Study to Determine the Safety and Efficacy of Repeated Hyperbaric Oxygen Therapy in Multiple Myeloma Patients Undergoing High-Dose Therapy and Autologous Stem/Progenitor Transplantation
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Number of participants with a treatment-limiting toxicity
研究概览
简要总结
Subjects with multiple myeloma (MM) who are considered eligible for high-dose therapy and autologous stem cell transplantation by the transplant team at WCI will be enrolled in the study.
详细描述
Subjects with multiple myeloma (MM) who are considered eligible for high-dose therapy and autologous stem cell transplantation by the transplant team at WCI will be enrolled in the study. Subjects will receive HBO therapy on Days 0, +1 and +2 of the transplant. The treatment consists of exposure to hyperbaric oxygen at 2.5 atmospheric absolutes for a total of 90 minutes after compression to 2.5 atmosphere absolutes in a monoplace hyperbaric chamber (Model 3200/3200R, Sechrist Industries, Inc., USA), breathing 100% oxygen. Subjects will be in the chamber for a total of 120 minutes as approximately 10-15 minutes will be spent during the compression and decompression phases and subjects will have 5-10 minute room air breaks every 30 minutes of hyperbaric oxygen treatment. Subjects will be seen daily until neutrophil recovery is documented . After neutrophil recovery is documented, the subjects will be seen in clinic at least weekly through day +100. A final visit will be scheduled day +100. As part of routine care, subjects will be followed daily or as directed by the treating physician until neutrophil recovery, defined as three consecutive days of achieving a neutrophil count of >500/mm3. Laboratory testing will occur per institutional guidelines. Follow-up will continue until Day +100. Donor chimerism and disease status will be determined by bone marrow biopsy on Day +30 and day +100 post-transplant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Subjects with Multiple myeloma
- •Subjects must be 18 years old
- •Karnosfsky Performance of greater than 70 percent
- •Adequate hepatic, cardiac and pulmonary function
- •Subjects should have New York Heart Association Functional Classification of: Class 1 or Class II.
排除标准
- •Pregnant or breastfeeding
- •Severe chronic obstructive pulmonary disease requiring oxygen supplementation
- •History of spontaneous pneumothorax
- •Active ear/sinus infection
- •Sinus surgery within the last 5 years
- •Claustrophobia
- •History of recurrent seizures within 5 years of study enrollment
- •Evidence of pneumothorax or significant pulmonary fibrosis on chest imaging within 60 days of transplant
- •Prior chest surgery involving thoracotomy or prior direct irradiation to the lungs
- •Subjects who have had intrathecal chemotherapy within 2 weeks of starting preparative regimen or cranial irradiation within 4 weeks of starting preparative regimen
- •Active and uncontrolled viral, fungal or bacterial infection
- •Use of tobacco 72 hours prior to transplant
研究组 & 干预措施
Experimental Arm:single
Repeated treatments with hyperbaric oxygen on Days 0, +1 and +2 of high-dose therapy melphalan and autologous transplants.
干预措施: Hyperbaric oxygen (Drug)
结局指标
主要结局
Number of participants with a treatment-limiting toxicity
时间窗: 24 hours
Treatment-limiting toxicities (defined as the occurrence of any of the following complications within 24 hours of HBO: Seizure disorder, pneumothorax, death, any irreversible grade Ill or any grade IV toxicity that is determined by the treating physician to be at least likely related to HBO therapy) will be assessed 24-hours post-hyperbaric oxygen therapy.
Number of participants with an AE or SAE attributed to HBO therapy.
时间窗: 100 days
Possible long-term effects of hyperbaric oxygen therapy treatment prior to autologous peripheral blood stem cell transplant will be assessed at day +100 post-transplant. AEs and SAEs will be graded using CTCAE version 5.
次要结局
- Time to neutrophil recovery(100 days)
研究者
Omar Aljitawi
Associate Professor of Hematology/Oncology
University of Rochester