NCT03398200 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2025-02-07

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Time From Transplant to Neutrophil Count Recovery

→

outcome · POSTED

Time From Transplant to Absolute Lymphocyte Recovery

→

outcome · POSTED

Number of Days of Granulocyte Colony-stimulating Factor

→

outcome · POSTED

Number of Units of Packed Red Blood Cells Received

→

outcome · POSTED

Length of Hospital Stay

→

outcome · POSTED

Percentage of Participants With Progressive Free Survival

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→

Who could take part

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
healthy Volunteers: false
maximum Age: 75 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Subjects on the experimental arm will receive 90 minutes of hyperbaric oxygen therapy approximately six hours prior to hematopoietic stem cell infusion.
intervention Names
Biological: Hyperbaric Oxygen Therapy
label
Hyperbaric Oxygen Therapy
type
EXPERIMENTAL
description
Subjects on the reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell infusion.
intervention Names
Other: No Hyperbaric Oxygen Therapy
label
No Hyperbaric Oxygen Therapy
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
Hyperbaric Oxygen Therapy
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).
name
Hyperbaric Oxygen Therapy
type
BIOLOGICAL
arm Group Labels
No Hyperbaric Oxygen Therapy
description
The reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell transplant.
name
No Hyperbaric Oxygen Therapy
type
OTHER

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 99
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Time from transplant to neutrophil recovery was measured as the first day of absolute neutrophil count \>=0.5 thou/ul after nadir.
measure
Time From Transplant to Neutrophil Count Recovery
time Frame
100 days

secondary Outcomes

measure
Time From Transplant to Absolute Lymphocyte Recovery
time Frame
100 days
measure
Number of Days of Granulocyte Colony-stimulating Factor
time Frame
100 days
measure
Number of Units of Packed Red Blood Cells Received
time Frame
100 days
measure
Length of Hospital Stay
time Frame
100 days
description
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.
measure
Percentage of Participants With Progressive Free Survival
time Frame
1 year

Full study description

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.

Source references

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-56b36ebc01fe69c54ca8
requested nct id
NCT03398200
primary nct id
NCT03398200
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Plasma+Cell+Neoplasms&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
payload sha256
a4dcfc11280c39af45abd0d4bc67f12aea1e5ab74ed521e68cbb8e67037c21a2
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-56b36ebc01fe69c54ca8
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT03398200
occurrences
context exact
NCT03398200
end
11
exact text
NCT03398200
start
0
offset unit
unicode_code_points
query cond
Plasma Cell Neoplasms
query disease state id
ds-plasma-cell-neoplasms
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
source file sha256
2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
source json pointer
/studies/546/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
0efcc06ed78e5ec5369ed9589a2672fc6dc9c4bffb3c8c85fdbf9f43de5b59c6
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Plasma+Cell+Neoplasms&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice