Repeated HBO Therapy in Myeloma Patients Undergoing High-Dose Therapy and Auto-HCT

Myeloma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04862676
• Other study ID #: UMMY19160
• Secondary ID: R37CA225791
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 22, 2022
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: University of Rochester
• Contact: Omar Aljitawi
• Phone: (585) 275-5863
• Email: Omar_Aljitawi[@]urmc.rochester.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Hyperbaric oxygen
The treatment consists of exposure to hyperbaric oxygen at 2.5 atmospheric absolutes (ATA) for a total of 90 minutes after compression to 2.5 atmosphere absolutes (ATA) in a monoplace hyperbaric chamber breathing 100% oxygen. The subjects will be in the chamber for a total of 120 minutes as approximately 10-15 minutes are spent during the compression and decompression phases and subjects have 5-10 minute room air breaks every 30 minutes of hyperbaric oxygen treatment.

Locations

Country	Name	City	State
United States	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with a treatment-limiting toxicity	Treatment-limiting toxicities (defined as the occurrence of any of the following complications within 24 hours of HBO: Seizure disorder, pneumothorax, death, any irreversible grade Ill or any grade IV toxicity that is determined by the treating physician to be at least likely related to HBO therapy) will be assessed 24-hours post-hyperbaric oxygen therapy.	24 hours
Primary	Number of participants with an AE or SAE attributed to HBO therapy.	Possible long-term effects of hyperbaric oxygen therapy treatment prior to autologous peripheral blood stem cell transplant will be assessed at day +100 post-transplant. AEs and SAEs will be graded using CTCAE version 5.	100 days
Secondary	Time to neutrophil recovery	Based on the patient having achieved three consecutive days of Absolute Neutrophil Count (ANC) = 500/microliter	100 days