Clinical trial · Interventional
Repeated HBO Therapy in Myeloma Patients Undergoing High-Dose Therapy and Auto-HCT
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
NCT04862676CI-TRIAL-00094898completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myeloma | Multiple Myeloma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hyperbaric oxygen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental Arm:single
- description
- Repeated treatments with hyperbaric oxygen on Days 0, +1 and +2 of high-dose therapy melphalan and autologous transplants.
- interventionNames
- Drug: Hyperbaric oxygen
Primary outcomes (2)
- measure
- Number of participants with a treatment-limiting toxicity
- timeFrame
- 24 hours
- description
- 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.
- measure
- Number of participants with an AE or SAE attributed to HBO therapy.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.