Multiple MyelomaAuto-HBONCT02087657
Pilot Study Exploring the Use of Hyperbaric Oxygen in Autologous Peripheral Blood Stem Cell Transplantation
A study testing Administration of hyperbaric oxygen in people with Multiple Myeloma and Hodgkin's Disease, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
By doing this study, researchers hope to learn the following: The safety of hyperbaric oxygen administration in the setting of the autologous transplant The effects of hyperbaric oxygen administration on neutrophil count recovery and engraftment Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Myeloma, Hodgkin's Disease, Non-Hodgkin's Lymphoma
- What is being tested?
- Administration of hyperbaric oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Aug 2017
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary written informed consent
- Subjects with Multiple Myeloma (MM), Hodgkin's Disease (HD), and non-Hodgkins lymphoma (NHL) who are eligible for high-dose chemotherapy and autologous PBSC transplant. Subjects should be enrolled within 30 days of transplant.
- Subjects must be >/= 18 yrs old and </= 70 yrs old
- Karnofsky performance status of >/= 70%
- Adequate hepatic, renal, cardiac and pulmonary function to be eligible for transplant. Minimum criteria include:
- ALT (alanine aminotransferase), AST (aspartate aminotransferase): < 4x IULN (institutional upper limit of normal)
Show all 11Show fewer
- Total bilirubin: </= 2.0 mg/dL
- Creatinine: </= 2.0 mg/dL
- EF (ejection fraction) measured by 2D-ECHO or MUGA (multiple gated acquisition) scan of >/= 45%
- FEV1 (forced expiratory volume), FVC (forced vital capacity) and DLCD(diffusing capacity of lung for carbon monoxide) >/= 50% of predicted value (corrected to serum hemoglobin)
- Women of child-bearing potential and men with partners of child-bearing potential must use adequate contraception prior to study entry and up to 30 days following treatment.
Who cannot join
- Pregnant or breast feeding
- Severe chronic obstructive pulmonary disease requiring oxygen supplementation
- History of spontaneous pneumothorax
- Active ear/sinus infection
- Claustrophobia
- HIstory of sinus or ear surgery, excluding myringotomy or ear tubes
- History of seizures
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Pilot Study Exploring the Use of Hyperbaric Oxygen in Autologous Peripheral Blood Stem Cell Transplant
By doing this study, researchers hope to learn the following:
- The safety of hyperbaric oxygen administration in the setting of the autologous transplant
- The effects of hyperbaric oxygen administration on neutrophil count recovery and engraftment
Read the detailed description
The post stem cell transplant complications of neutropenic fever and mucositis, related to the chemotherapy and/or radiation on hematopoietic tissue administered prior to peripheral blood stem cell transplant, are reversible upon neutrophil count recovery. The investigators will investigate the use of hyperbaric oxygen as an intervention to shorten neutropenia post-high-dose chemotherapy and autologous peripheral blood stem cell transplant. The idea of using hyperbaric oxygen therapy in autologous stem cell transplantation is based on the investigators pre-clinical work that supported the use of hyperbaric oxygen to improve umbilical cord blood (cluster of differentiation 34) CD34+ stem cell transplantation.
- Conditions
- Multiple Myeloma, Hodgkin's Disease, Non-Hodgkin's Lymphoma
- Being tested
- Administration of hyperbaric oxygen
- Keywords
- Peripheral Blood Stem Cell (PBSC) Transplant, Hyperbaric oxygen, Lymphoma, Myeloma
- Medical subject headings
- Multiple Myeloma, Hodgkin Disease, Lymphoma, Non-Hodgkin, Lymphoma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of hyperbaric oxygenDevice
Also called Monoplace Hyperbaric Chamber Model 3200 and 3200R
Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric Oxygen Treatment | Experimental | Administration of hyperbaric oxygen on the morning of stem cell transplant (Day 0). Receives: Device: Administration of hyperbaric oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of a treatment limiting toxicity
Treatment limiting toxicities are defined as the occurrence of any of the following complications within 24hrs of treatment: seizure disorder, pneumothorax, death, irreversible grade III or any grade IV toxicity that is determined by the treating physician to be at least likely related to HBO therapy.
Measured: Toxicity assessment occurs within 24hrs of treatment
Secondary outcomes (1)
Reduction in time to neutrophil recovery and engraftment post-cord blood transplant.
Subjects will be followed daily until neutrophil recovery, defined as three consecutive days of achieving a neutrophil count of > 500/mm3. If subjects do not exhibit neutrophil recovery by Day 40 post transplant, they will be considered primary graft failures.
Measured: Daily measurement of neutrophil counts, up to 40 days post transplant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionAug 2016
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- SWOG Cancer Research Network
- Responsible party
- Sponsor
- Investigators
- Omar Aljitawi, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087657
- Sponsor's protocol ID
- Auto-HBO
- Acronym
- Auto-HBO
- Status last verified
- Feb 2017
- First submitted
- 12 Mar 2014
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Exploring the Use of Hyperbaric Oxygen in Autologous Peripheral Blood Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT02087657
- Acronym / sponsor ID
- Auto-HBO / Auto-HBO
- Conditions
- Multiple Myeloma, Hodgkin's Disease, Non-Hodgkin's Lymphoma
- Keywords
- Peripheral Blood Stem Cell (PBSC) Transplant, Hyperbaric oxygen, Lymphoma, Myeloma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- SWOG Cancer Research Network
- Study start
- Mar 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2017 (estimated)
- First posted
- 14 Mar 2014 (estimated)
- 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.
By doing this study, researchers hope to learn the following:
- The safety of hyperbaric oxygen administration in the setting of the autologous transplant
- The effects of hyperbaric oxygen administration on neutrophil count recovery and engraftment
Detailed description
The post stem cell transplant complications of neutropenic fever and mucositis, related to the chemotherapy and/or radiation on hematopoietic tissue administered prior to peripheral blood stem cell transplant, are reversible upon neutrophil count recovery. The investigators will investigate the use of hyperbaric oxygen as an intervention to shorten neutropenia post-high-dose chemotherapy and autologous peripheral blood stem cell transplant. The idea of using hyperbaric oxygen therapy in autologous stem cell transplantation is based on the investigators pre-clinical work that supported the use of hyperbaric oxygen to improve umbilical cord blood (cluster of differentiation 34) CD34+ stem cell transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric Oxygen Treatment | Experimental | Device: Administration of hyperbaric oxygenAdministration of hyperbaric oxygen on the morning of stem cell transplant (Day 0). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Voluntary written informed consent
- Subjects with Multiple Myeloma (MM), Hodgkin's Disease (HD), and non-Hodgkins lymphoma (NHL) who are eligible for high-dose chemotherapy and autologous PBSC transplant. Subjects should be enrolled within 30 days of transplant.
- Subjects must be >/= 18 yrs old and </= 70 yrs old
- Karnofsky performance status of >/= 70%
- Adequate hepatic, renal, cardiac and pulmonary function to be eligible for transplant. Minimum criteria include:
Key exclusion criteria (7 listed)
- Pregnant or breast feeding
- Severe chronic obstructive pulmonary disease requiring oxygen supplementation
- History of spontaneous pneumothorax
- Active ear/sinus infection
- Claustrophobia
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 |
|---|---|---|
| Administration of hyperbaric oxygenAlso: Monoplace Hyperbaric Chamber Model 3200 and 3200RHyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours | Device | Hyperbaric Oxygen Treatment |
Primary outcome
Presence or absence of a treatment limiting toxicity
Time frame: Toxicity assessment occurs within 24hrs of treatment
Treatment limiting toxicities are defined as the occurrence of any of the following complications within 24hrs of treatment: seizure disorder, pneumothorax, death, irreversible grade III or any grade IV toxicity that is determined by the treating physician to be at least likely related to HBO therapy.
1 secondary outcome
Reduction in time to neutrophil recovery and engraftment post-cord blood transplant.
Time frame: Daily measurement of neutrophil counts, up to 40 days post transplant.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2017.
Related trials for Multiple Myeloma
RecruitingObservational study
Family Study of Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell
RecruitingPhase 1
ELEVATE-MM: Elotuzumab, Iberdomide and Dexamethasone Post Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma
Myeloma, Multiple Myeloma
Not yet recruiting
A Randomized Controlled Trial of a Wearable Core Body Temperature Sensor Versus Standard Temperature Monitoring for Early Detection of Cytokine Release Syndrome in Patients Undergoing CAR T-Cell Therapy in an Outpatient Setting
Myeloma
RecruitingObservational study
Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants
Graft-versus-leukemia, Graft vs Host Disease
Not yet recruiting
Monitoring for CardioToxicity Using WeArable deVices While Undergoing cancEr Treatments (MCT-WAVE)
Cardiotoxicity, Cancer
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
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Administration of hyperbaric oxygen in people with Multiple Myeloma and Hodgkin's Disease, run by University of Kansas Medical Center 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 11 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 14 Feb 2017. 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.
Are results available for this study?
Results are not available in the source record.
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?
Presence or absence of a treatment limiting toxicity (time frame: Toxicity assessment occurs within 24hrs of treatment). 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 14 Feb 2017.