MMRF Molecular Profiling Protocol

Active, not recruiting

• Conditions: Plasma Malignancy; Multiple Myeloma

• Registration Number: NCT02884102
• Lead Sponsor: Multiple Myeloma Research Foundation

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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2016-08-25
• Study First Submitted QC: 2016-08-25
• Study First Posted: 2016-08-30
• Status Verified: 2023-02
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-06
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
actionable mutations report	10-14 days

Secondary Outcome Measures

Name	Time	Method
Survival Rates	Overall survival
Disease Recurrence	Time to Progression

Trial Locations

Locations (20)

Mayo Clinic - Scottsdale; 🇺🇸 Scottsdale, Arizona, United States

City of Hope; 🇺🇸 Duarte, California, United States

Mount Sinai Medical Center; 🇺🇸 New York, New York, United States

Mayo Clinic - Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

Levine Cancer Institute; 🇺🇸 Charlotte, North Carolina, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

Baylor Research Institute; 🇺🇸 Dallas, Texas, United States

Virginia Cancer Specialists; 🇺🇸 Fairfax, Virginia, United States

Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

UCSF Medical Center; 🇺🇸 San Francisco, California, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Mayo Clinic - Rochester; 🇺🇸 Rochester, Minnesota, United States

Sarah Cannon Research Institute; 🇺🇸 Nashville, Tennessee, United States

Barbara Ann Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States