What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, such as bortezomib, thalidomide, and lenalidomide, are associated with side effects including thrombosis/embolism events, peripheral neuropathy, and second primary malignancies. High-dose therapy and autologous hematopoietic stem cell transplantation (HSPC) can lead to hematologic, gastrointestinal, hepatic, hemorrhagic, infectious, metabolic, and pulmonary toxicities. Hyperbaric oxygen therapy (HBO), which is being studied for its potential to enhance oxygen delivery to tissues and improve stem cell function and engraftment, may offer a different side effect profile, but further investigation is needed to fully understand its benefits and risks.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Multiple Myeloma, including bortezomib, lenalidomide, dexamethasone, and daratumumab. These drugs are often used in combination regimens such as VRd (bortezomib, lenalidomide, dexamethasone) and DRd (daratumumab, lenalidomide, dexamethasone). Hyperbaric Oxygen Therapy (HBO) is being studied for its potential to enhance oxygen delivery to tissues, which may improve stem cell function and engraftment, potentially benefiting patients undergoing autologous hematopoietic stem cell transplantation.

What other types of research exist?

Promising alternatives to Hyperbaric Oxygen Therapy for Multiple Myeloma patients include: 1) Combined intermittent hypoxia and surface muscle electrostimulation, which has shown to increase the number of circulating CD34+ cells. 2) Pharmacological strategies to delay the reestablishment of hypoxia in the bone marrow, potentially boosting post-transplant hematopoiesis regeneration. These methods may offer enhanced efficiency in stem cell collection and engraftment.

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Hyperbaric Oxygen Therapy for Multiple Myeloma

Phase 2

Waitlist Available

Led By Omar Aljitawi, MD

Research Sponsored by Omar Aljitawi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 100 days

Awards & highlights

No Placebo-Only Group

Summary

This trial involves patients with Multiple Myeloma who are receiving high-dose therapy and stem cell transplants. Some participants will breathe pure oxygen in a pressurized room before their transplant to see if it helps them recover faster. The study will compare blood recovery times between those who receive the oxygen treatment and those who do not.

Who is the study for?

This trial is for adults aged 18-75 with Multiple Myeloma who've had a partial response or better to initial therapy, or relapsed after stem cell transplant but were in remission for at least a year. They must have good heart, liver, and lung function and agree to use contraception if of childbearing potential. Excluded are those pregnant, breastfeeding, with severe lung disease requiring oxygen, ear/sinus infections, claustrophobia, seizures history.

What is being tested?

The study tests whether one session of Hyperbaric Oxygen Therapy before autologous hematopoietic stem cell infusion can speed up blood count recovery compared to no such therapy. Participants at Wilmot Cancer Institute will be randomly assigned to either receive the therapy or not.

What are the potential side effects?

Potential side effects from Hyperbaric Oxygen Therapy may include ear pressure changes leading to discomfort or pain, sinus problems, temporary vision changes and rarely more serious events like oxygen toxicity which could cause seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 100 days

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time From Transplant to Neutrophil Count Recovery

Side effects data

From 2018 Phase 2 trial • 20 Patients • NCT02363959

10%

Repeat bronchoscopy due to bleeding during biopsy

100%

80%

60%

40%

20%

Study treatment Arm

Hyperbaric Oxygen, Airway Biopsy

No Hyperbaric Oxygen, Airway Biopsy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Hyperbaric Oxygen TherapyExperimental Treatment1 Intervention

Subjects on the experimental arm will receive 90 minutes of hyperbaric oxygen therapy approximately six hours prior to hematopoietic stem cell infusion.

Group II: No Hyperbaric Oxygen TherapyActive Control1 Intervention

Subjects on the reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell infusion.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hyperbaric Oxygen Therapy

2016

Completed Phase 4

~800

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Multiple Myeloma (MM) treatments primarily include chemotherapy, which targets rapidly dividing cancer cells; immunomodulatory drugs like lenalidomide, which enhance the immune system's ability to fight cancer; proteasome inhibitors such as bortezomib, which disrupt protein degradation in cancer cells leading to cell death; and monoclonal antibodies like daratumumab, which target specific proteins on myeloma cells to mark them for immune destruction. Autologous hematopoietic stem cell transplantation (HCT) is also a key treatment, aiming to replace diseased bone marrow with healthy stem cells. Hyperbaric Oxygen Therapy (HBO) is being studied for its potential to enhance oxygen delivery to tissues, potentially improving stem cell function and engraftment, which could be particularly beneficial in the context of HCT by promoting faster and more effective recovery of blood counts.

Three courses of high dose therapy. Feasibility in the treatment of multiple myeloma--a "France autogreffe" study.