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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
99
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.
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, United States
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.
Time frame: 100 days
Time From Transplant to Absolute Lymphocyte Recovery
Time frame: 100 days
Number of Days of Granulocyte Colony-stimulating Factor
Time frame: 100 days
Number of Units of Packed Red Blood Cells Received
Time frame: 100 days
Length of Hospital Stay
Time frame: 100 days
Percentage of Participants With Progressive Free Survival
A progressive response is defined as follows: Increase of \> 25% from lowest response value in any one or more of the following: Serum M-component and/or (the absolute increase must be \> 0.5 g/dL)6 Urine M-component and/or (the absolute increase must be \> 200 mg/24 h) Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be \> 10 mg/dL Bone marrow plasma cell percentage; the absolute percentage must be \> 10%7 Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas Development of hypercalcaemia (corrected serum calcium \> 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder Anyone who did not have a progressive response was considered as progression free survival.
Time frame: 1 year
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