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MMRF CureCloud Research Initiative

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ClinicalTrials.gov Identifier: NCT03657251
Recruitment Status : Recruiting
First Posted : September 5, 2018
Last Update Posted : July 27, 2020
Sponsor:
Information provided by (Responsible Party):
Multiple Myeloma Research Foundation

Study Description
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Brief 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. 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 linkage to their electronic medical records information.

Condition or disease Intervention/treatment
Multiple Myeloma Smoldering Multiple Myeloma Genetic: liquid biopsy

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 be authorizing linkage to 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. Finally, in order to fulfill the vision of the MMRF CureCloud Research Initiative to make Precision Medicine a reality for all myeloma patients, thoughtful strategies truly making participants active participants in the research will be employed.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: The MMRF CureCloud Multiple Myeloma Research Initiative
Estimated Study Start Date : July 14, 2020
Estimated Primary Completion Date : July 31, 2025
Estimated Study Completion Date : July 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Groups and Cohorts
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Group/Cohort Intervention/treatment
CureCloud Direct to Patient Genetic: liquid biopsy
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.


Outcome Measures
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Primary Outcome Measures :
  1. Collection and Analyses of Clinical Information and Peripheral Blood Samples [ Time Frame: 5 years ]
    Patients that have been diagnosed with Multiple Myeloma, or one of its precursor conditions 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.


Biospecimen Retention:   Samples With DNA
Blood will be collected from all participants after electronic online consenting via a mailed blood kit designed for a mobile phlebotomy appointment.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This protocol is designed to collect peripheral blood samples with annotated clinical data from patients with Multiple Myeloma or a pre-myeloma condition such as SMM.
Criteria

Inclusion Criteria:

  1. Patients diagnosed with Multiple Myeloma or a known or suspected precursor condition to Multiple Myeloma.
  2. Patients have signed an online consent form

Exclusion Criteria:

  1. Patients who live outside the United States
  2. Patients with a diagnosis other than Multiple Myeloma or a known or suspected precursor to Multiple Myeloma
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03657251


Contacts
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Contact: Jennifer Yesil, M.S. 203-652-0237 yesilj@themmrf.org

Locations
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United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Irene Ghobrial, MD         
Sponsors and Collaborators
Multiple Myeloma Research Foundation
Investigators
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Principal Investigator: Daniel Auclair, PhD Multiple Myeloma Research Foundation
More Information
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Additional Information:

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Responsible Party: Multiple Myeloma Research Foundation
ClinicalTrials.gov Identifier: NCT03657251    
Other Study ID Numbers: MMRF-18-001
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Smoldering Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
 Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Precancerous Conditions
Hypergammaglobulinemia