Multiple Myeloma
Conditions
Keywords
Hyperbaric oxygen, mobilize, stem cells, growth factor
Brief summary
The purpose of this study is to evaluate the safety and efficacy of hyperbaric oxygen therapy (HBOT) as a therapeutic option in mobilizing stem cells for autologous stem cell transplant.
Detailed description
Subjects will receive HBOT daily for 10 days in conjunction with standard growth factor treatment regimens for stem cell mobilization. The role of HBOT in stem cell mobilization as well as its role on oxidative stress will be evaluated.
Interventions
DRUGHyperbaric Oxygen Therapy
Treatment Monday through Friday in a monoplace hyoerbaric chamber 100% oxygen at 2.0 atmospheres (14.7 PSI or the equivalent of being under 33 feet of sea water) for 90 minutes at pressure. Treatment lasts 2 hours as time is allowed for gradual pressurization and depressurization. Each subject will be treated for two weeks for a total of 10 HBOT treatments
Sponsors
University of Arkansas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who are being considered for autologous stem cell transplant as part of their routine care who have failed at least one prior attempt at stem cell mobilization with any of currently available standard regimens using growth factors. * Patients in who the use of Mozobil® is medically justified but is not possible because of insurance or financial reasons * Patients scheduled to begin standard growth factor treatment with Neupogen® as part of routine care. * Patients who have had a bone marrow evaluation performed within one month prior to enrollment as part of routine clinical care or under IRB# 02815. * Patients who have had a chest x-ray or CT Chest within 60 days prior to enrollment. * ECOG performance status ≤ 3 performed within 60 days prior to enrollment which will be determined by history. * Patients who are at least 18 years of age at the time of registration. * Patient must have signed an IRB-approved informed consent and understand the investigational nature of the study.
Exclusion criteria
* Clinically significant hepatic dysfunction as noted by direct bilirubin or AST \>3 times the upper normal limit or clinically significant concurrent hepatitis within 60 days prior to enrollment. * History of New York Heart Association (NYHA) Class III or Class IV heart failure * Recent (\< 6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrhythmias from medical history. * Untreated pneumothorax from medical history. * Uncontrolled seizure disorder from medical history * Uncontrolled insulin dependent diabetes (verified by routine labs in medical record) * History of severe claustrophobia * Severe COPD (FEV1 \< 50% of predicted on pulmonary function test) performed within 60 days prior to enrollment * Untreated ear barotraumas from medical history * Pregnancy or currently breastfeeding (females of childbearing potential must agree to use adequate contraception during the study). A urine pregnancy test will be performed prior to initiating HBOT. * Patients currently receiving Bleomycin, Cisplatin, Disulfiram, Doxorubicin, and Sulfamylon. * Any other condition that the PI determines may jeopardize the safety of the subject during the course of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Stem Cells Collected | one week post-treatment | Total stem cells collected from all participants at one week post-study treatment |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hyperbaric Oxygen Therapy Treatment Monday through Friday in a monoplace hyperbaric chamber 100% oxygen at 2.0 atmospheres for 90 minutes at pressure. Treatment lasts about 2 hours as time is allowed for gradual pressurization and depressurization. Treated for two weeks a total of 10 HBOT treatments. | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Toxicity not study related | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Hyperbaric Oxygen Therapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age, Continuous | 68.25 years STANDARD_DEVIATION 50.185 |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 8 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Number of Stem Cells Collected
Total stem cells collected from all participants at one week post-study treatment
Time frame: one week post-treatment
Population: Four of eight enrolled subjects completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hyperbaric Oxygen Therapy | Number of Stem Cells Collected | 8910000 stem cells |