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

NCT06007989 | Unknown

• 1 other identifier: CFTsp212
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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. 1.If myeloma cells 'live' in areas of low oxygen in the bone marrow
2. 2.What are the immune and bone marrow cells which are neighbours of myeloma cells?
3. 3.Are there genetic changes in low oxygen myeloma cells
4. 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.

Conditions

Myeloma

Keywords

multiplex; immunohistochemistry; hypoxia; single-cell RNA sequencing; pimonidazole; myeloma; microenvironment; metabolomics

Outcome Measures

Primary Outcomes (1)

• Qualitative assessment of the utility of a set of investigational tools for investigating the bone marrow microenvironment in myeloma patients

  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

  Assessment is at the time of diagnosis.

Study Arms (1)

Basic science study, no intervention.

Basic science study, no intervention.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patient with newly diagnosed or previously treated myeloma

You may qualify if:

• \. 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Christie NHS Foundation Trust: lead

Study Sites (1)

The Christie NHS Foundation Trust

Manchester, Greater Manchester, M20 4BX, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms, Plasma Cell; Hypoxia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

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

  University of Manchester, The Christie NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam Jones, MBBS, MSc, MRCP

CONTACT

+44 161 276 1234; adam.jones35@nhs.net

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: August 23, 2023
• Study Start: November 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 23, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)