MMRF Molecular Profiling Protocol

February 27, 2023 updated by: Multiple Myeloma Research Foundation

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C1
        • Princess Margaret Cancer Centre
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic - Scottsdale
    • California
      • Duarte, California, United States, 91010
        • City of Hope
      • San Francisco, California, United States, 94143
        • UCSF Medical Center
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic - Jacksonville
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Illinois
      • Chicago, Illinois, United States
        • University of Chicago
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Detroit, Michigan, United States, 48201
        • Barbara Ann Karmanos Cancer Institute
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic - Rochester
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Levine Cancer Institute
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor Research Institute
    • Virginia
      • Fairfax, Virginia, United States
        • Virginia Cancer Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
actionable mutations report
Time Frame: 10-14 days
10-14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Survival Rates
Time Frame: Overall survival
Overall survival
Disease Recurrence
Time Frame: Time to Progression
Time to Progression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Multiple Myeloma Research Foundation

Investigators

  • Principal Investigator: Leif Bergsagel, M.D., Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

August 25, 2016

First Submitted That Met QC Criteria

August 25, 2016

First Posted (Estimate)

August 30, 2016

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 27, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMRF-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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