Clinical trial NCT04862676: Repeated HBO Therapy in Myeloma Patients Undergoing High-Dose Therapy and Auto-HCT
Official title: A Pilot Study to Determine the Safety and Efficacy of Repeated Hyperbaric Oxygen Therapy in Multiple Myeloma Patients Undergoing High-Dose Therapy and Autologous Stem/Progenitor Transplantation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Myeloma
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-04-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Subjects with multiple myeloma (MM) who are considered eligible for high-dose therapy and autologous stem cell transplantation by the transplant team at WCI will be enrolled in the study.

Detailed description: Subjects with multiple myeloma (MM) who are considered eligible for high-dose therapy and autologous stem cell transplantation by the transplant team at WCI will be enrolled in the study. Subjects will receive HBO therapy on Days 0, +1 and +2 of the transplant. The treatment consists of exposure to hyperbaric oxygen at 2.5 atmospheric absolutes for a total of 90 minutes after compression to 2.5 atmosphere absolutes in a monoplace hyperbaric chamber (Model 3200/3200R, Sechrist Industries, Inc., USA), breathing 100% oxygen. Subjects will be in the chamber for a total of 120 minutes as approximately 10-15 minutes will be spent during the compression and decompression phases and subjects will have 5-10 minute room air breaks every 30 minutes of hyperbaric oxygen treatment. Subjects will be seen daily until neutrophil recovery is documented . After neutrophil recovery is documented, the subjects will be seen in clinic at least weekly through day +100. A final visit will be scheduled day +100. As part of routine care, subjects will be followed daily or as directed by the treating physician until neutrophil recovery, defined as three consecutive days of achieving a neutrophil count of \>500/mm3. Laboratory testing will occur per institutional guidelines. Follow-up will continue until Day +100. Donor chimerism and disease status will be determined by bone marrow biopsy on Day +30 and day +100 post-transplant.

Eligibility criteria: Inclusion Criteria:

* Subjects with Multiple myeloma
* Subjects must be 18 years old
* Karnosfsky Performance of greater than 70 percent
* Adequate hepatic, cardiac and pulmonary function
* Subjects should have New York Heart Association Functional Classification of: Class 1 or Class II.

Exclusion Criteria:

* Pregnant or breastfeeding
* Severe chronic obstructive pulmonary disease requiring oxygen supplementation
* History of spontaneous pneumothorax
* Active ear/sinus infection
* Sinus surgery within the last 5 years
* Claustrophobia
* History of recurrent seizures within 5 years of study enrollment
* Evidence of pneumothorax or significant pulmonary fibrosis on chest imaging within 60 days of transplant
* Prior chest surgery involving thoracotomy or prior direct irradiation to the lungs
* Subjects who have had intrathecal chemotherapy within 2 weeks of starting preparative regimen or cranial irradiation within 4 weeks of starting preparative regimen
* Active and uncontrolled viral, fungal or bacterial infection
* Use of tobacco 72 hours prior to transplant

Primary outcomes:
measure: Number of participants with a treatment-limiting toxicity
timeFrame: 24 hours
measure: Number of participants with an AE or SAE attributed to HBO therapy.
timeFrame: 100 days
Secondary outcomes:
measure: Time to neutrophil recovery
timeFrame: 100 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: James P. Wilmot Cancer Center at University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester
name: Omar Aljitawi, MMBS
role: PRINCIPAL_INVESTIGATOR
References: