Effects of Hyperbaric Oxygen (HBO) on Blood Count Recovery After Autologous Hematopoietic Stem Cell (HSPC) Transplant for Multiple Myeloma
Condition: Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Hyperbaric Oxygen Therapy; No Hyperbaric Oxygen Therapy
Intervention description: 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).; The reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell transplant.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 99.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

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