Repeated HBO Therapy in Myeloma Patients Undergoing High-Dose Therapy and Auto-HCT

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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