MMRF CureCloud Research Initiative

Sponsor
Multiple Myeloma Research Foundation (Other)
Overall Status
Recruiting
CT.gov ID
NCT03657251
Collaborator
(none)
5,000
1
72.5
68.9

Study Details

Study Description

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 Phase
  • 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

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
5000 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
The MMRF CureCloud Multiple Myeloma Research Initiative
Anticipated Study Start Date :
Jul 14, 2020
Anticipated Primary Completion Date :
Jul 31, 2025
Anticipated Study Completion Date :
Jul 31, 2026

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. Collection and Analyses of Clinical Information and Peripheral Blood Samples [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Dana Farber Cancer Institute Boston Massachusetts United States 02115

Sponsors and Collaborators

  • Multiple Myeloma Research Foundation

Investigators

  • Principal Investigator: Daniel Auclair, PhD, Multiple Myeloma Research Foundation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Multiple Myeloma Research Foundation
ClinicalTrials.gov Identifier:
NCT03657251
Other Study ID Numbers:
  • MMRF-18-001
First Posted:
Sep 5, 2018
Last Update Posted:
Jul 27, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 27, 2020