Clinical trial NCT03398200: Effects of Hyperbaric Oxygen (HBO) on Blood Count Recovery After Autologous Hematopoietic Stem Cell (HSPC) Transplant for Multiple Myeloma
Official title: HBO Effects on Blood Count Recovery and Post-transplant Outcomes Following High-dose Therapy and Autologous HSPC Transplantation for Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myeloma
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2018-01-12
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Time From Transplant to Neutrophil Count Recovery
timeFrame: 100 days
Secondary outcomes:
measure: Time From Transplant to Absolute Lymphocyte Recovery
timeFrame: 100 days
measure: Number of Days of Granulocyte Colony-stimulating Factor
timeFrame: 100 days
measure: Number of Units of Packed Red Blood Cells Received
timeFrame: 100 days
measure: Length of Hospital Stay
timeFrame: 100 days
measure: Percentage of Participants With Progressive Free Survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Fairway
country: United States
facility: The University of Kansas Cancer Center
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky Markey Cancer Center
state: Kentucky
city: Rochester
country: United States
facility: Wilmot Cancer Institute, University of Rochester Medical Center
state: New York
Study officials:
affiliation: Wilmot Cancer Institute
name: Omar Aljitawi, MD
role: PRINCIPAL_INVESTIGATOR
References: