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

NCT ID: NCT04862676

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-22
• Study Completion Date: 2025-06-30

Brief 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.

Detailed 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.

Conditions

Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Arm:single

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

Group Type: EXPERIMENTAL

Hyperbaric oxygen

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Omar Aljitawi

Associate Professor of Hematology/Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Omar Aljitawi, MMBS

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

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

Rochester, New York, United States

Countries

United States

Other Identifiers

R37CA225791

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UMMY19160

Identifier Type: -

Identifier Source: org_study_id