Clinical Trial Finder

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

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.

Arms

Experimental: Experimental Arm:single

Repeated treatments with hyperbaric oxygen on Days 0, +1 and +2 of high-dose therapy melphalan and autologous transplants.

Interventions

Drug: - Hyperbaric oxygen

The treatment consists of exposure to hyperbaric oxygen at 2.5 atmospheric absolutes (ATA) for a total of 90 minutes after compression to 2.5 atmosphere absolutes (ATA) in a monoplace hyperbaric chamber breathing 100% oxygen. The subjects will be in the chamber for a total of 120 minutes as approximately 10-15 minutes are spent during the compression and decompression phases and subjects have 5-10 minute room air breaks every 30 minutes of hyperbaric oxygen treatment.