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2221 Hyperbaric Oxygen (HBO) Effects on Blood Count Recovery and Post-Transplant Outcomes Following High-Dose Therapy and Autologous HSPC Transplantation for Multiple Myeloma: A Multicenter Phase II Randomized Clinical Trial

Program: Oral and Poster Abstracts
Session: 731. Autologous Transplantation: Clinical and Epidemiological: Poster I
Hematology Disease Topics & Pathways:
Non-Biological therapies, Devices, Therapies
Saturday, December 9, 2023, 5:30 PM-7:30 PM

Leyla Shune, MD1, Ayman Qasrawi, MD2*, Gerhard Hildebrandt, MD3, Eric J Huselton, MD4*, Howard Langstein, MD5*, Dennis Allin6*, Kaitlyn Burrows7*, Andrea M Baran, MS8*, Jane L. Liesveld, MD4, Neil Blumberg, MD5, Brea Lipe, MD9, Andrew G Evans, MD, PhD10*, Derick R Peterson, PhD8* and Omar Aljitawi, MD11

1Division of Hematologic Malignancies & Cellular Therapeutics, University of Kansas Medical Center, Westwood, KS
2Department of Hematology, University of Kentucky, Lexington, KY
3The University of Missouri-Columbia, Columbia, MO
4James P. Wilmot Cancer Center, University of Rochester Medical Center, Rochester, NY
5University of Rochester, Rochester, NY
6University of Kansas, Lenexa, KS
7Wilmot Cancer Institute, The University of Rochester Medical Center, Rochester
8Department of Biostatistics and Computational Biology, University of Rochester Medical Center, Rochester, NY
9University of Rochester Medical Center, Rochester, NY
10Department of Pathology and Laboratory Medicine, University of Rochester Medical Center, Rochester, NY
11James P. Wilmot Cancer Center, University of Kansas Medical Center, Rochester, NY


By reducing systemic erythropoietin (EPO) levels, in vivo studies showed that hyperbaric oxygen (HBO) promoted homing of transplanted umbilical cord hematopoietic stem/progenitor cells (HSPC) to the bone marrow. In a pilot study, we demonstrated that HBO in autologous HSPC transplantation (auto-HSPC) was well tolerated. Time to absolute neutrophil (ANC) recovery was correlated with HBO-mediated reduction in EPO levels.


In this phase II multicenter clinical trial, patients with multiple myeloma (MM) receiving high-dose melphalan and auto-HSPC were randomized 1:1 between HBO and no HBO. HBO was given as 100% oxygen, 2.5 ATA for a total of 90 min, in a single treatment on Day 0, 6 hours before cell infusion. The study's primary objective was to evaluate the effect of HBO on blood count recovery, filgrastim use, blood transfusions, and length of hospitalization (LOH). Exploratory objectives include HBO effects on EPO and IL-15 measured at several time points (pre-conditioning, Day 0 pre-HBO, 6- and 8-hours following HBO, and Days 1-3, 7 and 15 post-transplant). In addition, we explore HBO effects on Day 15 NK cell recovery.


A total of 99 patients were enrolled, with 52 randomized to HBO. Baseline characteristics were well balanced except for cell dose, with higher odds that patients with lower cell dose were treated with HBO. There was insufficient evidence of a difference between the two groups regarding time to neutrophil recovery, filgrastim use, blood transfusions, or LOH. Patients randomized to receive HBO were 1.7 (95% CI: 1.1-2.7) times more likely to have lymphocyte recovery (ALC) to > 0.5 k/µL by any given day compared to control (Figure-1). EPO levels (only University of Rochester Medical Center patients) were lower for HBO versus placebo on Day 1 (unadjusted p = 0.02), but there was insufficient evidence of a difference at other time points (Figure-2). Regarding immune reconstitution, IL-15 levels were not significantly different between the two groups. Significant correlation was found between Day 2 IL-15 levels and ALC recovery (p=0.01). We observed higher median NK cell count at Day 15 in the HBO arm (246 vs. 183), but this did not reach statistical significance (P=0.59).


HBO resulted in lower EPO levels at Day +1 of auto-HSPC, translating to faster ALC recovery with no effect on neutrophil recovery. Longer follow-up is needed to determine if this will impact progression free survival. Higher NK cell recovery in the HBO arm compared to the non-HBO was not significant to account for the improvement in ALC recovery in the HBO arm. A pilot study (NCT04862676) is ongoing to determine if multiple HBO treatments can keep EPO levels low beyond Day +1 and impact outcomes.

Disclosures: Lipe: Janssen, GSK, BMS, ABBVIE, Sanofi: Consultancy.

*signifies non-member of ASH