MyelomaEarly Phase 1NCT04862676
Repeated HBO Therapy in Myeloma Patients Undergoing High-Dose Therapy and Auto-HCT
A Early Phase 1 study testing Hyperbaric oxygen in people with Myeloma, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Myeloma
- What is being tested?
- Hyperbaric oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2022to 30 Jun 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, 14642-0001
About this study
Official title: A Pilot Study to Determine the Safety and Efficacy of Repeated Hyperbaric Oxygen Therapy in Multiple Myeloma Patients Undergoing High-Dose Therapy and Autologous Stem/Progenitor Transplantation
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.
Read the 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
- Being tested
- Hyperbaric oxygen
- Medical subject headings
- Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygenDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm:single | Experimental | Repeated treatments with hyperbaric oxygen on Days 0, +1 and +2 of high-dose therapy melphalan and autologous transplants. Receives: Drug: Hyperbaric oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 100 days
Secondary outcomes (1)
Time to neutrophil recovery
Based on the patient having achieved three consecutive days of Absolute Neutrophil Count (ANC) ≥ 500/microliter
Measured: 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start22 Apr 2022
- Primary completion4 Apr 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelomaStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Omar Aljitawi, University of Rochester
- Investigators
- Omar Aljitawi, MMBS, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862676
- Sponsor's protocol ID
- UMMY19160
- Other IDs
- R37CA225791
- Status last verified
- Sep 2025
- First submitted
- 6 Nov 2020
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual data collected during the trial will be shared after deidentification, including dictionaries.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Determine the Safety and Efficacy of Repeated Hyperbaric Oxygen Therapy in Multiple Myeloma Patients Undergoing High-Dose Therapy and Autologous Stem/Progenitor Transplantation
- ClinicalTrials.gov ID
- NCT04862676
- Acronym / sponsor ID
- UMMY19160
- Conditions
- Myeloma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 4 Apr 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm:single | Experimental | Drug: Hyperbaric oxygenRepeated treatments with hyperbaric oxygen on Days 0, +1 and +2 of high-dose therapy melphalan and autologous transplants. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric oxygenThe 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. | Drug | Experimental Arm:single |
Primary outcome
Number of participants with a treatment-limiting toxicity
Time frame: 24 hours
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.
Number of participants with an AE or SAE attributed to HBO therapy.
Time frame: 100 days
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.
1 secondary outcome
Time to neutrophil recovery
Time frame: 100 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: Yes. All individual data collected during the trial will be shared after deidentification, including dictionaries.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omar Aljitawi, MMBS principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Hyperbaric oxygen in people with Myeloma, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with a treatment-limiting toxicity (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.