Multiple MyelomaNCT04659252
CORONADO (Circulating tumOur pROtein quaNtification cApillary blooD cOvid-19)
An observational study of Multiple Myeloma, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
Trial summary
The coronavirus (COVID-19) pandemic has brought severe challenges for myeloma patients. Myeloma patients are considered ultra-high risk for COVID-19 and fall into the strictest group for shielding. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- n/a - samples collected along routine care samples only
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Mar 2021to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Multiple myeloma patients attending routine phlebotomy clinic.
Who may be able to join
- A diagnosis of a B-cell dyscrasia
- Measurable disease by serum free light chain assay
- Signed informed consent
Who cannot join
- Patients <21 years of age
- Cognitive impairment
- Non-B Cell Dyscrasia patients
Trial locations and contacts
1 site in 1 country.
Haemato-oncology Research Team contact
United Kingdom1 site, 1 recruiting
- Recruiting
The Royal Marsden NHS Foundation Trust
Sutton, SM25PT
Chloe Burrows, Chloe.burrows@rmh.nhs.uk
Kevin Boyd
About this study
Official title: Circulating Tumour Protein Quantification From Capillary Blood for Patient Selfsampling and Safe Remote Monitoring of Multiple Myeloma During COVID-19
The coronavirus (COVID-19) pandemic has brought severe challenges for myeloma patients. Myeloma patients are considered ultra-high risk for COVID-19 and fall into the strictest group for shielding. When on treatment, but also during times of active surveillance, patients have to regularly and frequently leave shielding and visit the hospital for blood tests to monitor their disese. This is specifically for quantification of circulating tumour protein biomarker tests for paraprotein (PP) and/or serum free light chains (sFLCs) by specialised biochemistry units.
This research aims to evaluate the potential use of an at-home patient administered technique to sample blood. The purpose of the blood sampling technique is to monitor your disease status. We want to test if it is possible to monitor a patient's disease status using this alternative blood collection method when compared to monitoring disease status using the traditional blood collection methods (venous blood sampling).
The new VAMS method is not intended to be used interchangeably or will not replace the current method. This study is to evaluate an alternative sample type that may be used to improve the patient pathway, especially during these uncertain times.
- Conditions
- Multiple Myeloma
- Being tested
- n/a - samples collected along routine care samples only
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
n/a - samples collected along routine care samples onlyOther
This is a non-interventional study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Validated FLC
Validated FLC method for use with VAMS that conforms to ISO15189:2012 accreditation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start4 Mar 2021
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Institute of Cancer Research, United KingdomThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Marsden NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Kevin Boyd, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04659252
- Sponsor's protocol ID
- CCR5361
- Status last verified
- Mar 2021
- First submitted
- 8 Dec 2020
- Last updated
- 11 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumour Protein Quantification From Capillary Blood for Patient Selfsampling and Safe Remote Monitoring of Multiple Myeloma During COVID-19
- ClinicalTrials.gov ID
- NCT04659252
- Acronym / sponsor ID
- CCR5361
- Conditions
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Collaborators
- Royal Marsden NHS Foundation Trust
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 9 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The coronavirus (COVID-19) pandemic has brought severe challenges for myeloma patients. Myeloma patients are considered ultra-high risk for COVID-19 and fall into the strictest group for shielding. When on treatment, but also during times of active surveillance, patients have to regularly and frequently leave shielding and visit the hospital for blood tests to monitor their disese. This is specifically for quantification of circulating tumour protein biomarker tests for paraprotein (PP) and/or serum free light chains (sFLCs) by specialised biochemistry units.
This research aims to evaluate the potential use of an at-home patient administered technique to sample blood. The purpose of the blood sampling technique is to monitor your disease status. We want to test if it is possible to monitor a patient's disease status using this alternative blood collection method when compared to monitoring disease status using the traditional blood collection methods (venous blood sampling).
The new VAMS method is not intended to be used interchangeably or will not replace the current method. This study is to evaluate an alternative sample type that may be used to improve the patient pathway, especially during these uncertain times.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Multiple myeloma patients attending routine phlebotomy clinic.
Key inclusion criteria (3 listed)
- A diagnosis of a B-cell dyscrasia
- Measurable disease by serum free light chain assay
- Signed informed consent
Key exclusion criteria (3 listed)
- Patients <21 years of age
- Cognitive impairment
- Non-B Cell Dyscrasia patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| n/a - samples collected along routine care samples onlyThis is a non-interventional study. | Other | – |
Primary outcome
Validated FLC
Time frame: 6 months
Validated FLC method for use with VAMS that conforms to ISO15189:2012 accreditation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haemato-oncology Research Team contact
Kevin Boyd principal investigator
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chloe Burrows (02089156773, chloe.burrows@rmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validated FLC (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021.