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

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 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

Trial Eligibility

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

Study Info

Interventions

Locations Recruiting

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