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

NCT04862676 | Completed Early Phase 1 DMC FDA Drug

• 2 other identifiers: UMMY19160R37CA225791
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Myeloma

Outcome Measures

Primary Outcomes (2)

• Number of participants with a treatment-limiting toxicity

  Treatment-limiting toxicities (defined as the occurrence of any of the following complications within 24 hours of HBO: Seizure disorder, pneumothorax, death, any irreversible grade Ill or any grade IV toxicity that is determined by the treating physician to be at least likely related to HBO therapy) will be assessed 24-hours post-hyperbaric oxygen therapy.

  24 hours

• Number of participants with an AE or SAE attributed to HBO therapy.

  Possible long-term effects of hyperbaric oxygen therapy treatment prior to autologous peripheral blood stem cell transplant will be assessed at day +100 post-transplant. AEs and SAEs will be graded using CTCAE version 5.

  100 days

Secondary Outcomes (1)

• Time to neutrophil recovery

  100 days

Study Arms (1)

Experimental Arm:single

EXPERIMENTAL

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

Drug: Hyperbaric oxygen

Interventions

Hyperbaric oxygen 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.

Experimental Arm:single

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

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

Rochester, New York, 14642-0001, United States

Location

MeSH Terms

Conditions

Neoplasms, Plasma Cell

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Omar Aljitawi, MMBS

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Hematology/Oncology

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: April 28, 2021
• Study Start: April 22, 2022
• Primary Completion: April 4, 2025
• Study Completion: June 30, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available immediately following publication. No end date.
• Access Criteria: Anyone who wishes to access the date for any type of analyses.

Locations

US (1)