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

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ClinicalTrials.gov Identifier: NCT04862676
Recruitment Status : Not yet recruiting
First Posted : April 28, 2021
Last Update Posted : March 10, 2022
Sponsor:
Information provided by (Responsible Party):
Omar Aljitawi, University of Rochester

Study Description
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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.

Condition or disease Intervention/treatment Phase
Myeloma Drug: Hyperbaric oxygen Early Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : April 15, 2022
Estimated Primary Completion Date : May 15, 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental Arm:single
Repeated treatments with hyperbaric oxygen on Days 0, +1 and +2 of high-dose therapy melphalan and autologous transplants.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with a treatment-limiting toxicity [ Time Frame: 24 hours ]
    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.

  2. Number of participants with an AE or SAE attributed to HBO therapy. [ Time Frame: 100 days ]
    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.


Secondary Outcome Measures :
  1. Time to neutrophil recovery [ Time Frame: 100 days ]
    Based on the patient having achieved three consecutive days of Absolute Neutrophil Count (ANC) ≥ 500/microliter


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04862676


Contacts
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Contact: Lisa Metzger (585) 276-7078 Lisa_Metzger@urmc.rochester.edu
Contact: Omar Aljitawi, MBBS (585) 275-5863 Omar_Aljitawi@urmc.rochester.edu

Sponsors and Collaborators
University of Rochester
Investigators
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Principal Investigator: Omar Aljitawi, MMBS University of Rochester
More Information
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Responsible Party: Omar Aljitawi, Associate Professor of Hematology/Oncology, University of Rochester
ClinicalTrials.gov Identifier: NCT04862676    
Other Study ID Numbers: UMMY19160
First Posted: April 28, 2021    Key Record Dates
Last Update Posted: March 10, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All individual data collected during the trial will be shared after deidentification, including dictionaries.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be available immediately following publication. No end date.
Access Criteria: Anyone who wishes to access the date for any type of analyses.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases