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

Myeloma Clinical Trial

Official title:

HBO Effects on Blood Count Recovery and Post-transplant Outcomes Following High-dose Therapy and Autologous HSPC Transplantation for Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03398200
• Other study ID #: 70180
• Secondary ID: UBMT17083
• Status: Completed
• Phase: Phase 2
• Start date: May 10, 2018
• Est. completion date: March 28, 2023

Study information

• Verified date: March 2024
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: March 28, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Myeloma
• Neoplasms, Plasma Cell

Intervention

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).

Other:
• No Hyperbaric Oxygen Therapy
The reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell transplant.

Locations

Country	Name	City	State
United States	The University of Kansas Cancer Center	Fairway	Kansas
United States	University of Kentucky Markey Cancer Center	Lexington	Kentucky
United States	Wilmot Cancer Institute, University of Rochester Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Omar Aljitawi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time From Transplant to Platelet Recovery		100 days
Secondary	Time From Transplant to Absolute Lymphocyte Recovery		100 days
Secondary	Number of Days of Granulocyte Colony-stimulating Factor		100 days
Secondary	Number of Units of Packed Red Blood Cells Received		100 days
Secondary	Length of Hospital Stay		100 days
Secondary	Sustained Freedom From Myeloma		100 days and 1 year