Assessing the Relationship Between Hypoxia and the Immune Environment in Myeloma Patients (CHIME)

Sponsor

The Christie NHS Foundation Trust (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06007989

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study is looking at how myeloma is related to low oxygen levels (hypoxia) in the bone marrow. This is to understand the disease better. It might also guide treatment in the future.

For the study, we will run tests on a portion of the samples taken during a bone marrow biopsy. A bone marrow biopsy is taken as part of the diagnosis or follow up of myeloma. The tests in our study will look closely at the make-up of immune cells in the bone marrow, highlight areas of low oxygen, and look at genetic changes in cells from low-oxygen areas. We will ask patients to take a capsule the day before their bone marrow biopsy containing pimonidazole hydrochloride, a substance which will show up areas of low oxygen on tests.

Overall we want to know:

If myeloma cells 'live' in areas of low oxygen in the bone marrow
What are the immune and bone marrow cells which are neighbours of myeloma cells?
Are there genetic changes in low oxygen myeloma cells

For the pilot study, we want to know:

Can we use new techniques to study questions 1-3? The techniques we want to use are pimonidazole with multiplex immunohistochemistry and single cell RNA sequencing.

The information we get from the tests will help us get a better understanding of how myeloma works. Future studies may also use these results to develop new kinds of drugs for myeloma.

Condition or Disease	Intervention/Treatment	Phase
Myeloma

Study Design

Study Type:

Observational

Anticipated Enrollment :

10 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

Assessing the Relationship Between Hypoxia and the Immune Environment in Myeloma Patients (CHIME)

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Basic science study, no intervention. Basic science study, no intervention.

Outcome Measures

Primary Outcome Measures

Qualitative assessment of the utility of a set of investigational tools for investigating the bone marrow microenvironment in myeloma patients [Assessment is at the time of diagnosis.]
Specifically we aim to determine the feasibility of using pimonidazole as a marker of hypoxia in conjunction with: A) Multiplex immunohistochemistry to characterise the spatial organization of cellular inflammatory elements and myeloma cells in the bone marrow, B)Single cell RNA sequencing to characterise the expression profile of myeloma cells in hypoxic areas of marrow

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

1. Male or female patients referred to The Christie NHS Foundation Trust from another hospital with proven multiple myeloma which may be either treatment naïve or previously treated.

Aged 18 or over 3. World Health Organisation (WHO) performance status 0 to 2 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks 4. Provision of written informed consent 5. Willing to undergo a bone marrow biopsy 6. Willing to take pimonidazole hydrochloride

Exclusion Criteria:

Involvement in the planning and/or conduct of the study (applies to staff at the study site)
Evidence of any significant clinical disorder or laboratory finding that made it undesirable for the patient to participate in the study
Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements