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

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

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 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.

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