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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04862676
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Early Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Rochester
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Omar Aljitawi, MMBS
Principal Investigator Affiliation University of Rochester
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Myeloma
Additional Details

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.

Arms & Interventions

Arms

Experimental: Experimental Arm:single

Repeated treatments with hyperbaric oxygen on Days 0, +1 and +2 of high-dose therapy melphalan and autologous transplants.

Interventions

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.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Lisa Metzger

Lisa_Metzger@urmc.rochester.edu

(585) 276-7078

For additional contact information, you can also visit the trial on clinicaltrials.gov.