Status:
COMPLETED
Repeated HBO Therapy in Myeloma Patients Undergoing High-Dose Therapy and Auto-HCT
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Myeloma
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
Brief Summary
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.
Detailed Description
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 wil...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
April 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04862676
Start Date
April 22 2022
End Date
June 30 2025
Last Update
September 10 2025
Active Locations (1)
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1
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642-0001