Clinical trial NCT03657251: MMRF CureCloud Research Initiative
Official title: The MMRF CureCloud Multiple Myeloma Research Initiative
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Multiple Myeloma
Lead sponsor: Multiple Myeloma Research Foundation
Sponsor class: OTHER
First posted: 2018-09-05
Enrollment: 1105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Collection and Analyses of Clinical Information and Peripheral Blood Samples
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Norwalk
country: United States
facility: Multiple Myeloma Research Foundation
state: Connecticut
city: Saint Louis
country: United States
facility: Washington University Medical Campus
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: Multiple Myeloma Research Foundation
name: Hearn J Cho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Multiple Myeloma Research Foundation
name: George Mulligan, PhD
role: PRINCIPAL_INVESTIGATOR
References: