Clinical trial NCT02884102: MMRF Molecular Profiling Protocol
Official title: Clinical-grade Molecular Profiling of Patients With Multiple Myeloma and Related Plasma Cell Malignancies
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Multiple Myeloma
Plasma Malignancy
Keywords: genetic sequencing
relapsed
Lead sponsor: Multiple Myeloma Research Foundation
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with multiple myeloma and other related disorders including, without limitation to, smoldering myeloma, monoclonal gammopathy of undetermined significance (MGUS), primary plasma cell leukemia, solitary plasmacytoma, and amyloidosis

Brief summary: This protocol is now being used as screening for the MyDRUG study

Detailed description: Here we propose an "integrative sequencing approach" utilizing a 1500 gene exome comparative analysis between multiple myeloma or related plasma cell malignancies and normal cells coupled to capture transcriptome sequencing to provide a nearly comprehensive landscape of the genetic alterations for the purpose of identifying informative and/or actionable mutations in patients with multiple myeloma and plasma cell malignancies. The approach will enable the detection of point mutations, insertions/deletions, gene fusions and rearrangements, amplifications/deletions, and outlier expressed genes among other classes of alterations.

Eligibility criteria: Inclusion Criteria:

1. Patients must have a diagnosis of multiple myeloma or related malignancy
2. Patients are undergoing standard of care bone marrow aspirates
3. Patients (male or female) from any race or ethnicity must be at least 18 years of age at the time of registration.
4. Procedure-specific signed informed consent form prior to initiation of any study-related procedures.

Exclusion Criteria:

1. It is the enrolling study physician's discretion to decide if a patient is not fit enough to undergo a bone marrow aspirate.
2. Patients who are incarcerated are not eligible to participate.
3. Women who are pregnant
4. Patients who have had another malignancy within the last five (5) years (except for basal or squamous cell carcinoma, or in situ cancer of the cervix) where there is a possibility to contaminate the bone marrow aspirate.

Primary outcomes:
measure: actionable mutations report
timeFrame: 10-14 days
Secondary outcomes:
measure: Survival Rates
timeFrame: Overall survival
measure: Disease Recurrence
timeFrame: Time to Progression
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic - Scottsdale
state: Arizona
city: Duarte
country: United States
facility: City of Hope
state: California
city: San Francisco
country: United States
facility: UCSF Medical Center
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic - Jacksonville
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic - Rochester
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Dallas
country: United States
facility: Baylor Research Institute
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: Mayo Clinic
name: Leif Bergsagel, M.D.
role: PRINCIPAL_INVESTIGATOR
References: