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

Not yet recruiting

• Conditions: Myeloma

• Registration Number: NCT06007989
• Lead Sponsor: The Christie NHS Foundation Trust

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:

1. If myeloma cells 'live' in areas of low oxygen in the bone marrow

2. What are the immune and bone marrow cells which are neighbours of myeloma cells?

3. Are there genetic changes in low oxygen myeloma cells

For the pilot study, we want to know:

4. 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-16
• Study First Submitted QC: 2023-08-16
• Last Update Submitted: 2023-08-16
• Study First Posted: 2023-08-23
• Last Update Posted: 2023-08-23
• Study Start: 2023-11-01
• Primary Completion: 2024-02-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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.

  2. 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

1. Involvement in the planning and/or conduct of the study (applies to staff at the study site)
2. Evidence of any significant clinical disorder or laboratory finding that made it undesirable for the patient to participate in the study
3. 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The Christie NHS Foundation Trust; 🇬🇧 Manchester, Greater Manchester, United Kingdom