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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 100 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~100 days
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
13,719 Previous Clinical Trials
40,963,518 Total Patients Enrolled
588 Trials studying Multiple Myeloma
189,410 Patients Enrolled for Multiple Myeloma
University of RochesterLead Sponsor
845 Previous Clinical Trials
535,002 Total Patients Enrolled
11 Trials studying Multiple Myeloma
311 Patients Enrolled for Multiple Myeloma
Omar Aljitawi, MMBSPrincipal InvestigatorUniversity of Rochester
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had chest surgery or radiation to my lungs before.My liver, heart, and lungs are functioning well.My heart condition allows me to perform daily activities with no or slight limitations.You have used tobacco in the 3 days before the transplant.I haven't had chemotherapy in the spine or brain radiation in the last 2 to 4 weeks.You are afraid of being in small, enclosed spaces.I have been diagnosed with multiple myeloma.I have had sinus surgery in the last 5 years.I have had seizures in the last 5 years.I am 18 years old or older.I do not have any ongoing serious infections.I have had a collapsed lung or significant lung scarring seen on a chest scan within the last 2 months.I can care for myself but may not be able to do active work.I need oxygen therapy for my severe COPD.I currently have an ear or sinus infection.I have had a collapsed lung without injury.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental Arm:single
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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