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

Last updated: July 2, 2025
Sponsor: University of Rochester
Overall Status: Active - Not Recruiting

Phase

1

Condition

Platelet Disorders

Multiple Myeloma

Hematologic Neoplasms

Treatment

Hyperbaric oxygen

Clinical Study ID

NCT04862676
UMMY19160
R37CA225791
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 startingpreparative regimen or cranial irradiation within 4 weeks of starting preparativeregimen

  • Active and uncontrolled viral, fungal or bacterial infection

  • Use of tobacco 72 hours prior to transplant

Study Design

Total Participants: 15
Treatment Group(s): 1
Primary Treatment: Hyperbaric oxygen
Phase: 1
Study Start date:
April 22, 2022
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York 14642-0001
    United States

    Site Not Available

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