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

NCT03398200 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 70180UBMT17083
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 3

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.

Conditions

Myeloma

Outcome Measures

Primary Outcomes (1)

• 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.

  100 days

Secondary Outcomes (5)

• Time From Transplant to Absolute Lymphocyte Recovery

  100 days

• Number of Days of Granulocyte Colony-stimulating Factor

  100 days

• Number of Units of Packed Red Blood Cells Received

  100 days

• Length of Hospital Stay

  100 days

• Percentage of Participants With Progressive Free Survival

  1 year

Study Arms (2)

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.

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.

Other: No Hyperbaric Oxygen Therapy

Interventions

Hyperbaric Oxygen Therapy BIOLOGICAL

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).

Hyperbaric Oxygen Therapy

No Hyperbaric Oxygen Therapy OTHER

The reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell transplant.

No Hyperbaric Oxygen Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Omar Aljitawi: lead

Study Sites (3)

The University of Kansas Cancer Center

Fairway, Kansas, 66205, United States

Location

University of Kentucky Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

Wilmot Cancer Institute, University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Neoplasms, Plasma Cell

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Results Point of Contact

• Title: Omar Aljitawi, MD
• Organization: University of Rochester

Omar_Aljitawi@URMC.Rochester.edu

(585) 275-4099

Study Officials

• Omar Aljitawi, MD

  Wilmot Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Hematology/Oncology

Study Record Dates

• First Submitted: January 5, 2018
• First Posted: January 12, 2018
• Study Start: May 10, 2018
• Primary Completion: September 30, 2022
• Study Completion: March 28, 2023
• Last Updated: February 7, 2025
• Results First Posted: November 8, 2023

Record last verified: 2025-01

Locations

US (3)