Multiple MyelomaNCT03657251
MMRF CureCloud Research Initiative
An observational study of Multiple Myeloma, run by Multiple Myeloma Research Foundation at 4 sites in United States.
Trial summary
The MMRF CureCloud Research Initiative, a Direct-to-Patient Research effort aimed at enrolling 5,000 individuals from whom comprehensive molecular and immune analyses will be generated from blood specimens and the resulting data aggregated with the correlating clinical information. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- liquid biopsy
- How many people
- 1,105 participants
- Where
- 4 sitesUnited States
- Study dates
- 14 Jul 2020to 31 Dec 2023
- How long will I take part?
- 5 Years
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This protocol is designed to collect peripheral blood samples with annotated clinical data from patients with active Multiple Myeloma
Who may be able to join
- Patients diagnosed with active Multiple Myeloma
- Patients have signed an online consent form
Who cannot join
- Patients who live outside the United States
- Patients with a diagnosis other than Multiple Myeloma or a known or suspected precursor to Multiple Myeloma
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Multiple Myeloma Research Foundation
Norwalk, Connecticut, 06851
Washington University Medical Campus
St Louis, Missouri, 63110
About this study
Official title: The MMRF CureCloud Multiple Myeloma Research Initiative
The MMRF CureCloud Research Initiative, a Direct-to-Patient Research effort aimed at enrolling 5,000 individuals from whom comprehensive molecular and immune analyses will be generated from blood specimens and the resulting data aggregated with the correlating clinical information. Blood will be collected from all participants after electronic online consenting via a mailed blood kit designed for a mobile phlebotomy appointment. Through the consenting process, participants will also be authorizing collection of their electronic medical records information.
Read the detailed description
More than ever, there is an urgent need for a deeper understanding of the clinical, molecular and immune parameters involved in multiple myeloma disease initiation, progression and response to treatment. Such rich information, collected at the population level, is crucial to generate the evidence needed to ultimately make Precision Medicine a reality for all multiple myeloma patients. To this end the Multiple Myeloma Research Foundation (MMRF) is launching the MMRF CureCloud Research Initiative, a Direct-to-Patient Research effort aimed at enrolling 5,000 individuals from whom comprehensive molecular and immune analyses will be generated from blood specimens and the resulting data aggregated with the correlating clinical information. Blood will be collected from all participants after electronic online consenting via a mailed blood kit designed for a mobile phlebotomy appointment. Through the consenting process, participants will also allow the MMRF to collect their electronic medical records information. An important deliverable of the MMRF CureCloud Research Initiative is a curated dataset of integrated genomic, immune and correlating clinical data that will be made available to support scientific investigations through the MMRF CureCloud, a cloud-based platform with tools and capabilities for the seamless aggregation, integration and analysis of large collections of myeloma datasets.
- Conditions
- Multiple Myeloma
- Being tested
- liquid biopsy
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liquid biopsyGenetic
Participants will be asked to provide up to a maximum total 40 mL of blood for all of the required sample collection. Peripheral blood will be collected from patients who consent to the protocol. These samples will be obtained at a time scheduled by the participant with the phlebotomy service provider, and will be collected at the participant's home. Patient peripheral blood samples can be obtained at diagnosis or at any time in follow up.
| Study group | Role | What they receive |
|---|---|---|
| CureCloud Direct to Patient | Not described Receives: Genetic: liquid biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection and Analyses of Clinical Information and Peripheral Blood Samples
Patients that have been diagnosed with active Multiple Myeloma will be asked to share their clinical information and blood samples to help scientists and researchers understand these conditions better. The study will use submitted blood samples to perform comprehensive research that will include, among others, genomic and immune characterization, as well as collect past and present medical records to combine and compare with the blood sample analysis.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start14 Jul 2020
- Primary completion29 Dec 2023
- Study completion31 Dec 2023
Why it stopped: The MMRF has learned of the limitations of using a blood sample to collect genomic data, compared to a bone marrow aspirate. We decided that our resources are best served in other areas at this time.
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.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,105 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Multiple Myeloma Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hearn J Cho, MD, PhD, Principal investigator, Multiple Myeloma Research FoundationGeorge Mulligan, PhD, Principal investigator, Multiple Myeloma Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03657251
- Sponsor's protocol ID
- MMRF-18-001
- Status last verified
- Jan 2024
- First submitted
- 28 Aug 2018
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Some data collected may be deposited into databases such as dbGAP and GDC. All identifiable information will be removed prior to submission so that the data cannot be linked to the participant in any way. The database of Genotypes and Phenotypes (dbGaP) and the he Genomic Data Commons (GDC) are databases developed by the National Cancer Institute (NCI) to archive and distribute the results of studies that have investigated the interaction of genotype and phenotype. Data submitted from this study to dbGAP and GDC will only be available through controlled access and restricted to cancer research studies. Any researcher requesting access to the data must formally apply and present a research study rationale for why they need access to the data. The data may also be submitted to other future database systems which will have similar access controls as dbGAP and GDC.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The MMRF CureCloud Multiple Myeloma Research Initiative
- ClinicalTrials.gov ID
- NCT03657251
- Acronym / sponsor ID
- MMRF-18-001
- Conditions
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The MMRF has learned of the limitations of using a blood sample to collect genomic data, compared to a bone marrow aspirate. We decided that our resources are best served in other areas at this time.
- Enrolment
- 1,105 participants (actual)
- Lead sponsor
- Multiple Myeloma Research FoundationUniversity, hospital or other
- Study start
- 14 Jul 2020 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 5 Sep 2018 (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 MMRF CureCloud Research Initiative, a Direct-to-Patient Research effort aimed at enrolling 5,000 individuals from whom comprehensive molecular and immune analyses will be generated from blood specimens and the resulting data aggregated with the correlating clinical information. Blood will be collected from all participants after electronic online consenting via a mailed blood kit designed for a mobile phlebotomy appointment. Through the consenting process, participants will also be authorizing collection of their electronic medical records information.
Detailed description
More than ever, there is an urgent need for a deeper understanding of the clinical, molecular and immune parameters involved in multiple myeloma disease initiation, progression and response to treatment. Such rich information, collected at the population level, is crucial to generate the evidence needed to ultimately make Precision Medicine a reality for all multiple myeloma patients. To this end the Multiple Myeloma Research Foundation (MMRF) is launching the MMRF CureCloud Research Initiative, a Direct-to-Patient Research effort aimed at enrolling 5,000 individuals from whom comprehensive molecular and immune analyses will be generated from blood specimens and the resulting data aggregated with the correlating clinical information. Blood will be collected from all participants after electronic online consenting via a mailed blood kit designed for a mobile phlebotomy appointment. Through the consenting process, participants will also allow the MMRF to collect their electronic medical records information. An important deliverable of the MMRF CureCloud Research Initiative is a curated dataset of integrated genomic, immune and correlating clinical data that will be made available to support scientific investigations through the MMRF CureCloud, a cloud-based platform with tools and capabilities for the seamless aggregation, integration and analysis of large collections of myeloma datasets.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CureCloud Direct to Patient | – | Genetic: liquid biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This protocol is designed to collect peripheral blood samples with annotated clinical data from patients with active Multiple Myeloma
Key inclusion criteria (2 listed)
- Patients diagnosed with active Multiple Myeloma
- Patients have signed an online consent form
Key exclusion criteria (2 listed)
- Patients who live outside the United States
- Patients with a diagnosis other than Multiple Myeloma or a known or suspected precursor to Multiple Myeloma
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 |
|---|---|---|
| liquid biopsyParticipants will be asked to provide up to a maximum total 40 mL of blood for all of the required sample collection. Peripheral blood will be collected from patients who consent to the protocol. These samples will be obtained at a time scheduled by the participant with the phlebotomy service provider, and will be collected at the participant's home. Patient peripheral blood samples can be obtained at diagnosis or at any time in follow up. | Genetic | CureCloud Direct to Patient |
Primary outcome
Collection and Analyses of Clinical Information and Peripheral Blood Samples
Time frame: 5 years
Patients that have been diagnosed with active Multiple Myeloma will be asked to share their clinical information and blood samples to help scientists and researchers understand these conditions better. The study will use submitted blood samples to perform comprehensive research that will include, among others, genomic and immune characterization, as well as collect past and present medical records to combine and compare with the blood sample analysis.
Results and safety
The study was stopped early (reason given: The MMRF has learned of the limitations of using a blood sample to collect genomic data, compared to a bone marrow aspirate. We decided that our resources are best served in other areas at this time.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: Undecided. Some data collected may be deposited into databases such as dbGAP and GDC. All identifiable information will be removed prior to submission so that the data cannot be linked to the participant in any way. The database of Genotypes and Phenotypes (dbGaP) and the he Genomic Data Commons (GDC) are databases developed by the National Cancer Institute (NCI) to archive and distribute the results of studies that have investigated the interaction of genotype and phenotype. Data submitted from this study to dbGAP and GDC will only be available through controlled access and restricted to cancer research studies. Any researcher requesting access to the data must formally apply and present a research study rationale for why they need access to the data. The data may also be submitted to other future database systems which will have similar access controls as dbGAP and GDC.
Related trials for Multiple Myeloma
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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.
Hearn J Cho, MD, PhD principal investigator
Multiple Myeloma Research Foundation
George Mulligan, PhD principal investigator
Multiple Myeloma Research Foundation
4 sites 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 Multiple Myeloma Research Foundation at 4 sites in United States.
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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
The study was stopped early (reason given: The MMRF has learned of the limitations of using a blood sample to collect genomic data, compared to a bone marrow aspirate. We decided that our resources are best served in other areas at this time.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection and Analyses of Clinical Information and Peripheral Blood Samples (time frame: 5 years). 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 5 Jan 2024.