MMRF Molecular Profiling Protocol

Multiple Myeloma Clinical Trial

Official title:

Clinical-grade Molecular Profiling of Patients With Multiple Myeloma and Related Plasma Cell Malignancies

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02884102
• Other study ID #: MMRF-002
• Status: Active, not recruiting
• Start date: June 2015
• Est. completion date: June 2023

Study information

• Verified date: February 2023
• Source: Multiple Myeloma Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms
• Neoplasms, Plasma Cell
• Plasma Malignancy

Intervention

Genetic:
• genetic sequencing

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Levine Cancer Institute	Charlotte	North Carolina
United States	University of Chicago	Chicago	Illinois
United States	Ohio State University	Columbus	Ohio
United States	Baylor Research Institute	Dallas	Texas
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	City of Hope	Duarte	California
United States	Virginia Cancer Specialists	Fairfax	Virginia
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Mayo Clinic - Jacksonville	Jacksonville	Florida
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Mount Sinai Medical Center	New York	New York
United States	Mayo Clinic - Rochester	Rochester	Minnesota
United States	Washington University	Saint Louis	Missouri
United States	UCSF Medical Center	San Francisco	California
United States	Mayo Clinic - Scottsdale	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Multiple Myeloma Research Foundation

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	actionable mutations report		10-14 days
Secondary	Survival Rates		Overall survival
Secondary	Disease Recurrence		Time to Progression