NCT03657251

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 collection of their electronic medical records information.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,105

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 5, 2018

Completed
1.9 years until next milestone

Study Start

First participant enrolled

July 14, 2020

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

3.5 years

First QC Date

August 28, 2018

Last Update Submit

January 2, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

CureCloud Direct to Patient

Genetic: liquid biopsy

Interventions

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.

CureCloud Direct to Patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This protocol is designed to collect peripheral blood samples with annotated clinical data from patients with active Multiple Myeloma

You may qualify if:

  • Patients diagnosed with active Multiple Myeloma
  • Patients have signed an online consent form

You may not qualify if:

  • Patients who live outside the United States
  • Patients with a diagnosis other than Multiple Myeloma or a known or suspected precursor to Multiple Myeloma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Multiple Myeloma Research Foundation

Norwalk, Connecticut, 06851, United States

Location

Washington University Medical Campus

St Louis, Missouri, 63110, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

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.

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Liquid Biopsy

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

BiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingInvestigative Techniques

Study Officials

  • Hearn J Cho, MD, PhD

    Multiple Myeloma Research Foundation

    PRINCIPAL INVESTIGATOR
  • George Mulligan, PhD

    Multiple Myeloma Research Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2018

First Posted

September 5, 2018

Study Start

July 14, 2020

Primary Completion

December 29, 2023

Study Completion

December 31, 2023

Last Updated

January 5, 2024

Record last verified: 2024-01

Locations