Clinical trial NCT06007989: Assessing the Relationship Between Hypoxia and the Immune Environment in Myeloma Patients (CHIME)
Official title: Assessing the Relationship Between Hypoxia and the Immune Environment in Myeloma Patients (CHIME)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Myeloma
Keywords: multiplex
immunohistochemistry
hypoxia
single-cell RNA sequencing
pimonidazole
myeloma
microenvironment
metabolomics
Lead sponsor: The Christie NHS Foundation Trust
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient with newly diagnosed or previously treated myeloma

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.


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

Primary outcomes:
measure: Qualitative assessment of the utility of a set of investigational tools for investigating the bone marrow microenvironment in myeloma patients
timeFrame: Assessment is at the time of diagnosis.
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
state: Greater Manchester
Study officials:
affiliation: University of Manchester, The Christie NHS Foundation Trust
name: Emma Searle, MBChB, MA, MRCP, FRCPath, PhD
role: PRINCIPAL_INVESTIGATOR
References: