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NCT03657251 Clinical Trial

MMRF CureCloud Research Initiative

Multiple Myeloma Clinical Trial

Official title:
The MMRF CureCloud Multiple Myeloma Research Initiative

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03657251
Other study ID # MMRF-18-001
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date July 14, 2020
Est. completion date December 31, 2023

Study information
Verified date January 2024
Source Multiple Myeloma Research Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 1105
Est. completion date December 31, 2023
Est. primary completion date December 29, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Patients diagnosed with active 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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States University of Texas Southwestern Medical Center Dallas Texas
United States Hackensack University Medical Center Hackensack New Jersey
United States Multiple Myeloma Research Foundation Norwalk Connecticut
United States Washington University Medical Campus Saint Louis Missouri

Sponsors (1)
Lead Sponsor Collaborator
Multiple Myeloma Research Foundation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 5 years
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