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

University of Rochester

Status and phase

Active, not recruiting

Early Phase 1

Conditions

Myeloma

Treatments

Drug: Hyperbaric oxygen

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04862676

R37CA225791 (U.S. NIH Grant/Contract)

UMMY19160

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

15 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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