MyelomaPhase 2NCT03398200
Effects of Hyperbaric Oxygen (HBO) on Blood Count Recovery After Autologous Hematopoietic Stem Cell (HSPC) Transplant for Multiple Myeloma
A Phase 2 study testing Hyperbaric Oxygen Therapy and No Hyperbaric Oxygen Therapy in people with Myeloma, run by Omar Aljitawi at 3 sites in United States.
Trial summary
Patients with Multiple Myeloma who are considered for high-dose therapy and autologous transplantation at the bone marrow transplant clinic at the Wilmot Cancer Institute (WCI) will be be approached to participate in this trial. 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 Therapy and No Hyperbaric Oxygen Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 May 2018to 28 Mar 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Voluntary written informed consent.
- Multiple myeloma diagnosis applying the latest criteria by International Working Group. Patients should have received myeloma-directed induction therapy with appropriate response (partial response or better) in newly diagnosed myeloma patients. Multiple myeloma patients who relapse following induction therapy or following prior autologous hematopoietic stem cell transplant are also eligible as far as remission following their first autologous hematopoietic stem cell transplant lasted 12 months or more.
- Patients who are considered for high-dose therapy and autologous transplantation at the bone marrow transplant clinic at Wilmot Cancer Institute will be screened for eligibility to enroll in this study and if eligible will be approached to participate. Eligible patients will have the chance to tour the hyperbaric oxygen facility prior to signing the consent form.
- Subjects must be ≥ 18 years old and ≤ 75 years old.
- Karnofsky performance status (KPS) of ≥ 70%.
- Adequate hepatic, cardiac and pulmonary function to be eligible for transplant. Minimum criteria include:
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- - Alanine aminotransferase (ALT), aspartate aminotransferase (AST): < 4x institutional upper limit of normal (IULN)
- - Total bilirubin: ≤ 2.0 mg/dL
- - Ejection fraction (EF) measured by two-dimensional echocardiography (2D-ECHO) or multigated acquisition (MUGA) scan of ≥ 45%
- - Forced expiratory volume at one second (FEV1), forced vital capacity (FVC), and diffusing capacity of lung for carbon monoxide (DLCO) ≥ 50% of predicted value (corrected to serum hemoglobin)
- - Electrocardiogram (EKG) with no clinically significant arrhythmia.
- Patients should have New York Heart Association (NYHA) Functional Classification, class I or II (No or mild limitation during ordinary activity).
- Patients should be evaluated for fitness for hyperbaric oxygen therapy by a hyperbaric oxygen trained medical professional who is not part of the study team prior to starting preparative regimen.
- Women of child-bearing potential should have a negative urine pregnancy test within 4 weeks of starting preparative regimen.
- Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days following completion of therapy. Should a woman or partner become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician and the investigator immediately.
- A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- - Has not undergone a hysterectomy or bilateral oophorectomy; or
- - Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
Who cannot join
- Pregnant or breastfeeding
- Severe chronic obstructive pulmonary disease requiring oxygen supplementation
- History of spontaneous pneumothorax
- Active ear/sinus infection
- History of sinus or ear surgery, excluding myringotomy or ear tubes
- Claustrophobia
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- History of seizures
- Evidence of pneumothorax or significant pulmonary fibrosis on chest imaging
- Prior chest surgery or irradiation
- Patients who had intrathecal chemotherapy within 2 weeks of starting preparative regimen or cranial irradiation within 4 weeks of starting preparative regimen
- Active infection (viral, fungal, and/or bacterial)
- Positive screening for Hepatitis A, B, or C indicating an ongoing infection
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The University of Kansas Cancer Center
Fairway, Kansas, 66205
University of Kentucky Markey Cancer Center
Lexington, Kentucky, 40536
Wilmot Cancer Institute, University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: HBO Effects on Blood Count Recovery and Post-transplant Outcomes Following High-dose Therapy and Autologous HSPC Transplantation for Multiple Myeloma
Patients with Multiple Myeloma who are considered for high-dose therapy and autologous transplantation at the bone marrow transplant clinic at the Wilmot Cancer Institute (WCI) will be be approached to participate in this trial. Eligible patients who choose to participate will be randomized so that half receive one hyperbaric oxygen therapy session prior to hematopoetic stem cell infusion and half will not. All subjects will have their blood counts monitored closely and time to count recovery will be compared between the two groups.
- Conditions
- Myeloma
- Being tested
- Hyperbaric Oxygen Therapy, No Hyperbaric Oxygen Therapy
- 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 Oxygen TherapyBiological
The intervention consists of exposure to hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours, in a single see-through hyperbaric chamber, breathing 100% oxygen for 90 minutes while subjects are resting in supine position. During the 2 hours, there will be compression and decompression phases for 15 minutes each in which subjects will be breathing compressed environmental air (21% oxygen).
No Hyperbaric Oxygen TherapyOther
The reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell transplant.
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric Oxygen Therapy | Experimental | Subjects on the experimental arm will receive 90 minutes of hyperbaric oxygen therapy approximately six hours prior to hematopoietic stem cell infusion. Receives: Biological: Hyperbaric Oxygen Therapy |
| No Hyperbaric Oxygen Therapy | Active comparator | Subjects on the reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell infusion. Receives: Other: No Hyperbaric Oxygen Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time From Transplant to Neutrophil Count Recovery
Time from transplant to neutrophil recovery was measured as the first day of absolute neutrophil count >=0.5 thou/ul after nadir.
Measured: 100 days
Secondary outcomes (5)
Time From Transplant to Absolute Lymphocyte Recovery
Measured: 100 days
Number of Days of Granulocyte Colony-stimulating Factor
Measured: 100 days
Number of Units of Packed Red Blood Cells Received
Measured: 100 days
Length of Hospital Stay
Measured: 100 days
Percentage of Participants With Progressive Free Survival
A progressive response is defined as follows:
Increase of > 25% from lowest response value in any one or more of the following:
Serum M-component and/or (the absolute increase must be > 0.5 g/dL)6 Urine M-component and/or (the absolute increase must be > 200 mg/24 h) Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be > 10 mg/dL Bone marrow plasma cell percentage; the absolute percentage must be > 10%7 Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas Development of hypercalcaemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder
Anyone who did not have a progressive response was considered as progression free survival.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start10 May 2018
- Primary completion30 Sep 2022
- Study completion28 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MyelomaStudies of the same condition, open and under way.
- 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Omar Aljitawi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Omar Aljitawi, University of Rochester
- Investigators
- Omar Aljitawi, MD, Principal investigator, Wilmot Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398200
- Sponsor's protocol ID
- 70180
- Other IDs
- UBMT17083
- Status last verified
- Jan 2025
- First submitted
- 5 Jan 2018
- Last updated
- 7 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HBO Effects on Blood Count Recovery and Post-transplant Outcomes Following High-dose Therapy and Autologous HSPC Transplantation for Multiple Myeloma
- ClinicalTrials.gov ID
- NCT03398200
- Acronym / sponsor ID
- 70180
- Conditions
- Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Omar AljitawiUniversity, hospital or other
- Study start
- 10 May 2018 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 28 Mar 2023 (actual)
- First posted
- 12 Jan 2018 (actual)
- Results
- Posted 8 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with Multiple Myeloma who are considered for high-dose therapy and autologous transplantation at the bone marrow transplant clinic at the Wilmot Cancer Institute (WCI) will be be approached to participate in this trial. Eligible patients who choose to participate will be randomized so that half receive one hyperbaric oxygen therapy session prior to hematopoetic stem cell infusion and half will not. All subjects will have their blood counts monitored closely and time to count recovery will be compared between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric Oxygen Therapy | Experimental | Biological: Hyperbaric Oxygen TherapySubjects on the experimental arm will receive 90 minutes of hyperbaric oxygen therapy approximately six hours prior to hematopoietic stem cell infusion. |
| No Hyperbaric Oxygen Therapy | Active comparator | Other: No Hyperbaric Oxygen TherapySubjects on the reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell infusion. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Voluntary written informed consent.
- Multiple myeloma diagnosis applying the latest criteria by International Working Group. Patients should have received myeloma-directed induction therapy with appropriate response (partial response or better) in newly diagnosed myeloma patients. Multiple myeloma patients who relapse following induction therapy or following prior autologous hematopoietic stem cell transplant are also eligible as far as remission following their first autologous hematopoietic stem cell transplant lasted 12 months or more.
- Patients who are considered for high-dose therapy and autologous transplantation at the bone marrow transplant clinic at Wilmot Cancer Institute will be screened for eligibility to enroll in this study and if eligible will be approached to participate. Eligible patients will have the chance to tour the hyperbaric oxygen facility prior to signing the consent form.
- Subjects must be ≥ 18 years old and ≤ 75 years old.
- Karnofsky performance status (KPS) of ≥ 70%.
Key exclusion criteria (12 listed)
- Pregnant or breastfeeding
- Severe chronic obstructive pulmonary disease requiring oxygen supplementation
- History of spontaneous pneumothorax
- Active ear/sinus infection
- History of sinus or ear surgery, excluding myringotomy or ear tubes
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 Oxygen TherapyThe intervention consists of exposure to hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours, in a single see-through hyperbaric chamber, breathing 100% oxygen for 90 minutes while subjects are resting in supine position. During the 2 hours, there will be compression and decompression phases for 15 minutes each in which subjects will be breathing compressed environmental air (21% oxygen). | Biological | Hyperbaric Oxygen Therapy |
| No Hyperbaric Oxygen TherapyThe reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell transplant. | Other | No Hyperbaric Oxygen Therapy |
Primary outcome
Time From Transplant to Neutrophil Count Recovery
Time frame: 100 days
Time from transplant to neutrophil recovery was measured as the first day of absolute neutrophil count >=0.5 thou/ul after nadir.
5 secondary outcomes
Time From Transplant to Absolute Lymphocyte Recovery
Time frame: 100 days
Number of Days of Granulocyte Colony-stimulating Factor
Time frame: 100 days
Number of Units of Packed Red Blood Cells Received
Time frame: 100 days
Length of Hospital Stay
Time frame: 100 days
Percentage of Participants With Progressive Free Survival
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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, MD principal investigator
Wilmot Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hyperbaric Oxygen Therapy and No Hyperbaric Oxygen Therapy in people with Myeloma, run by Omar Aljitawi at 3 sites 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 18 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 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time From Transplant to Neutrophil Count Recovery (time frame: 100 days). 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 7 Feb 2025.