MMRF CureCloud Research Initiative

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.

Study Overview

• Status: Terminated
• Conditions: Multiple Myeloma
• Intervention / Treatment: 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 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 Type: Observational
• Enrollment (Actual): 1105

Contacts and Locations

• Study Contact: Name: Jennifer Rogers, M.S.; Phone Number: 203-652-0237; Email: rogersj@themmrf.org

Study Locations

• United States
  • Connecticut
    • Norwalk, Connecticut, United States, 06851
      • Multiple Myeloma Research Foundation
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University Medical Campus
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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 active Multiple Myeloma

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Multiple Myeloma Research Foundation
• Investigators: Principal Investigator: Hearn J Cho, MD, PhD, Multiple Myeloma Research Foundation; Principal Investigator: George Mulligan, PhD, Multiple Myeloma Research Foundation

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2020
• Primary Completion (Actual): December 29, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: August 28, 2018
• First Submitted That Met QC Criteria: August 30, 2018
• First Posted (Actual): September 5, 2018

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: MMRF-18-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No