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Effects of Hyperbaric Oxygen (HBO) on Blood Count Recovery After Autologous Hematopoietic Stem Cell (HSPC) Transplant for Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT03398200
Recruitment Status : Recruiting
First Posted : January 12, 2018
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
Omar Aljitawi, University of Rochester

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Myeloma Biological: Hyperbaric Oxygen Therapy Other: No Hyperbaric Oxygen Therapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: HBO Effects on Blood Count Recovery and Post-transplant Outcomes Following High-dose Therapy and Autologous HSPC Transplantation for Multiple Myeloma
Actual Study Start Date : May 10, 2018
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2021


Arm Intervention/treatment
Experimental: Hyperbaric Oxygen Therapy
Subjects on the experimental arm will receive 90 minutes of hyperbaric oxygen therapy approximately six hours prior to hematopoietic stem cell infusion.
Biological: Hyperbaric Oxygen Therapy
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).

Active Comparator: No Hyperbaric Oxygen Therapy
Subjects on the reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell infusion.
Other: No Hyperbaric Oxygen Therapy
The reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell transplant.




Primary Outcome Measures :
  1. Time from transplant to neutrophil count recovery [ Time Frame: 100 days ]

Secondary Outcome Measures :
  1. Time from transplant to platelet recovery [ Time Frame: 100 days ]
  2. Time from transplant to absolute lymphocyte recovery [ Time Frame: 100 days ]
  3. Number of days of granulocyte colony-stimulating factor [ Time Frame: 100 days ]
  4. Number of units of packed red blood cells received [ Time Frame: 100 days ]
  5. Length of hospital stay [ Time Frame: 100 days ]
  6. Sustained freedom from myeloma [ Time Frame: 100 days and 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:
  • - 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)

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03398200


Contacts
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Contact: Omar Aljitawi, MD 585-275-5823 Omar_Aljitawi@urmc.rochester.edu
Contact: Erin Cebula, MPH 585-275-3883 Erin_Cebula@urmc.rochester.edu

Locations
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United States, New York
Wilmot Cancer Institute, University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Erin Cebula, MPH    585-275-3883    Erin_Cebula@urmc.rochester.edu   
Sponsors and Collaborators
Omar Aljitawi
Investigators
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Principal Investigator: Omar Aljitawi, MD Wilmot Cancer Institute

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Responsible Party: Omar Aljitawi, Associate Professor of Hematology/Oncology, University of Rochester
ClinicalTrials.gov Identifier: NCT03398200     History of Changes
Other Study ID Numbers: 70180
UBMT17083 ( Other Identifier: Wilmot Cancer Institute Clinical Trials Office )
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases