NCT02884102

Brief Summary

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

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Jun 2015

Longer than P75 for all trials

Geographic Reach
2 countries

20 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Jun 2015Jun 2026

Study Start

First participant enrolled

June 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

May 6, 2025

Status Verified

February 1, 2023

Enrollment Period

11 years

First QC Date

August 25, 2016

Last Update Submit

May 5, 2025

Conditions

Keywords

genetic sequencingrelapsed

Outcome Measures

Primary Outcomes (1)

  • actionable mutations report

    10-14 days

Secondary Outcomes (2)

  • Survival Rates

    Overall survival

  • Disease Recurrence

    Time to Progression

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • It is the enrolling study physician's discretion to decide if a patient is not fit enough to undergo a bone marrow aspirate.
  • Patients who are incarcerated are not eligible to participate.
  • Women who are pregnant
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Mayo Clinic - Scottsdale

Scottsdale, Arizona, 85259, United States

Location

City of Hope

Duarte, California, 91010, United States

Location

UCSF Medical Center

San Francisco, California, 94143, United States

Location

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

University of Chicago

Chicago, Illinois, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Baylor Research Institute

Dallas, Texas, 75246, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, United States

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2C1, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

bone marrow and peripheral blood samples will be obtained

MeSH Terms

Conditions

Multiple MyelomaRecurrence

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Leif Bergsagel, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2016

First Posted

August 30, 2016

Study Start

June 1, 2015

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

May 6, 2025

Record last verified: 2023-02

Locations