MMRF CureCloud Research Initiative

• ClinicalTrials.gov Identifier: NCT03657251
• Recruitment Status: Active, not recruiting
• First Posted: September 5, 2018
• Last Update Posted: February 28, 2023
• Sponsor: Multiple Myeloma Research Foundation
• Information provided by (Responsible Party): Multiple Myeloma Research Foundation

Tracking Information

• First Submitted Date: August 28, 2018
• First Posted Date: September 5, 2018
• Last Update Posted Date: February 28, 2023
• Actual Study Start Date: July 14, 2020
• Estimated Primary Completion Date: July 31, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 3, 2023)

Collection and Analyses of Clinical Information and Peripheral Blood Samples [ Time Frame: 5 years ]

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.

Original Primary Outcome Measures (submitted: August 30, 2018)

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.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: MMRF CureCloud Research Initiative
• Official Title: The MMRF CureCloud Multiple Myeloma Research Initiative
• 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.
• 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 [Patient Registry]
• Study Design: Observational Model: Other; Time Perspective: Prospective
• Target Follow-Up Duration: 5 Years

Biospecimen

Retention:   Samples With DNA

Description:

Blood will be collected from all participants after electronic online consenting via a mailed blood kit designed for a mobile phlebotomy appointment.

• 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
• Condition: Multiple Myeloma

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.

Study Groups/Cohorts

CureCloud Direct to Patient

Intervention: Genetic: liquid biopsy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: August 30, 2018): 5000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 31, 2026
• Estimated Primary Completion Date: July 31, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03657251
• Other Study ID Numbers: MMRF-18-001
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

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.

• Current Responsible Party: Multiple Myeloma Research Foundation
• Original Responsible Party: Same as current
• Current Study Sponsor: Multiple Myeloma Research Foundation
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Multiple Myeloma Research Foundation
• Verification Date: February 2023