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Hyperbaric Oxygen Therapy for Multiple Myeloma

Phase < 1
Recruiting
Led By Omar Aljitawi, MMBS
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects should have New York Heart Association Functional Classification of: Class 1 or Class II.
Subjects with Multiple myeloma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 100 days
Awards & highlights

Study Summary

This trial is for subjects with multiple myeloma who are eligible for high-dose therapy and autologous stem cell transplantation.

Who is the study for?
This trial is for adults with multiple myeloma who are fit enough for high-dose therapy and autologous stem cell transplantation. They must have good organ function and be able to perform daily activities without significant assistance. Pregnant or breastfeeding individuals, those with severe lung conditions, recent chest surgery or radiation, active infections, tobacco use before transplant, history of pneumothorax, ear/sinus issues or seizures cannot participate.Check my eligibility
What is being tested?
The study is testing the effects of repeated Hyperbaric Oxygen (HBO) Therapy in patients with multiple myeloma undergoing high-dose chemotherapy followed by their own stem cell transplant. The goal is to see if HBO can improve outcomes during this intense treatment process.See study design
What are the potential side effects?
Potential side effects from HBO therapy may include ear pressure changes leading to discomfort or pain, temporary vision changes, fatigue after treatments, oxygen toxicity which could cause lung problems or seizures although rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My heart condition allows me to perform daily activities with no or slight limitations.
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I have been diagnosed with multiple myeloma.
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I am 18 years old or older.
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I can care for myself but may not be able to do active work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~100 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 100 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with a treatment-limiting toxicity
Therapeutic procedure
Secondary outcome measures
Time to neutrophil recovery

Trial Design

1Treatment groups
Experimental Treatment
Group I: Experimental Arm:singleExperimental Treatment1 Intervention
Repeated treatments with hyperbaric oxygen on Days 0, +1 and +2 of high-dose therapy melphalan and autologous transplants.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hyperbaric oxygen
2013
Completed Phase 4
~280

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,663 Previous Clinical Trials
40,925,890 Total Patients Enrolled
579 Trials studying Multiple Myeloma
189,116 Patients Enrolled for Multiple Myeloma
University of RochesterLead Sponsor
838 Previous Clinical Trials
518,552 Total Patients Enrolled
11 Trials studying Multiple Myeloma
311 Patients Enrolled for Multiple Myeloma
Omar Aljitawi, MMBSPrincipal InvestigatorUniversity of Rochester

Media Library

Hyperbaric oxygen Clinical Trial Eligibility Overview. Trial Name: NCT04862676 — Phase < 1
Multiple Myeloma Research Study Groups: Experimental Arm:single
Multiple Myeloma Clinical Trial 2023: Hyperbaric oxygen Highlights & Side Effects. Trial Name: NCT04862676 — Phase < 1
Hyperbaric oxygen 2023 Treatment Timeline for Medical Study. Trial Name: NCT04862676 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To which persons is entry into this trial open?

"To be eligible for this trial, potential participants must have a diagnosis of multiple myeloma and fall in the age range between 18 to 75 years old. There is room within the study for an estimated 15 patients."

Answered by AI

Is there currently an ongoing enrollment process for this research project?

"Correct. According to the clinicaltrials.gov database, this medical trial is still recruiting participants and was first published on April 22nd 2022 with a recent update being recorded on May 5th 2022. The study requires 15 patients from 1 site to complete their research project."

Answered by AI

How many participants are engaged in this investigation?

"Affirmative. Clinicaltrials.gov shows that this medical study, which was first announced on April 22nd 2022, is currently recruiting participants. The research team are looking for 15 patients to be recruited at the single site location."

Answered by AI

Is this research accessible to individuals aged 55 and above?

"This study is accepting participants that are aged between 18 and 75."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Repeated HBO Therapy in Myeloma Patients Undergoing High-Dose Therapy and Auto-HCT
Omar Aljitawi 2022. "Repeated HBO Therapy in Myeloma Patients Undergoing High-Dose Therapy and Auto-HCT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04862676.
~0 spots leftby May 2024
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