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

NCT ID: NCT06007989

Last Updated: 2023-08-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-08-01

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.

Conditions

Myeloma

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Basic science study, no intervention.

Basic science study, no intervention.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Christie NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emma Searle, MBChB, MA, MRCP, FRCPath, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Manchester, The Christie NHS Foundation Trust

Locations

The Christie NHS Foundation Trust

Manchester, Greater Manchester, United Kingdom

Countries

United Kingdom

Central Contacts

Adam Jones, MBBS, MSc, MRCP

Role: CONTACT

adam.jones35@nhs.net

+44 161 276 1234

Facility Contacts

Clare Griffin, MA, PhD

Role: primary

clare.griffin1@nhs.net

+44 161 446 3000

Other Identifiers

CFTsp212

Identifier Type: -

Identifier Source: org_study_id