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Trial Title:
Assessing the Relationship Between Hypoxia and the Immune Environment in Myeloma Patients (CHIME)
NCT ID:
NCT06007989
Condition:
Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Hypoxia
Conditions: Keywords:
multiplex
immunohistochemistry
hypoxia
single-cell RNA sequencing
pimonidazole
myeloma
microenvironment
metabolomics
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Cross-Sectional
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.
Criteria for eligibility:
Study pop:
Adult patient with newly diagnosed or previously treated myeloma
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Christie NHS Foundation Trust
Address:
City:
Manchester
Zip:
M20 4BX
Country:
United Kingdom
Contact:
Last name:
Clare Griffin, MA, PhD
Phone:
+44 161 446 3000
Email:
clare.griffin1@nhs.net
Start date:
November 1, 2023
Completion date:
August 1, 2024
Lead sponsor:
Agency:
The Christie NHS Foundation Trust
Agency class:
Other
Source:
The Christie NHS Foundation Trust
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06007989
