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Pilot Study of Hyperbaric Oxygen Therapy in Addition to Standard Growth Factor Support for Hematopoietic Progenitor/Stem Cell Mobilization

18 Years
Open (Enrolling)
Multiple Myeloma

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Trial Information

Pilot Study of Hyperbaric Oxygen Therapy in Addition to Standard Growth Factor Support for Hematopoietic Progenitor/Stem Cell Mobilization

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.

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

- Any other condition that the PI determines may jeopardize the safety of the subject
during the course of the study

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of stem cells collected

Outcome Time Frame:

10 days

Safety Issue:


Principal Investigator

Sarah Waheed, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arkansas


United States: Institutional Review Board

Study ID:

UARK 2010-43



Start Date:

February 2012

Completion Date:

October 2013

Related Keywords:

  • Multiple Myeloma
  • Hyperbaric oxygen
  • mobilize
  • stem cells
  • growth factor
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



University of Arkansas for Medical Science Little Rock, Arkansas  72205