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Can pressurized oxygen boost stem cell transplants for myeloma?

NCT ID NCT04862676

Disease control Sponsor: University of Rochester Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This early-phase study tested whether repeated hyperbaric oxygen therapy is safe for multiple myeloma patients who are about to receive high-dose chemotherapy and a stem cell transplant. Twenty-nine participants were exposed to 100% oxygen at 2.5 times normal atmospheric pressure for 90-minute sessions. The main goal was to check for serious side effects within 24 hours and longer-term effects up to 100 days after transplant.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
hyperbaric oxygen
What this could lead to
If it works, this could point toward a way to make stem cell transplants safer and more effective for multiple myeloma patients.
What could go wrong
This is a very early, small pilot study with only 29 participants. It only looked at safety, not whether hyperbaric oxygen actually helps treat the cancer. There are also risks like seizures or lung injury from the high-pressure oxygen.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

29 people

The number who actually took part.

Started

Apr 2022

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma plasma cell neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myeloma

Contacts and locations

Locations

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

    Rochester, New York, 14642-0001, United States

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