MMRF Molecular Profiling Protocol

Sponsor

Multiple Myeloma Research Foundation (Other)

Overall Status

Recruiting

CT.gov ID

NCT02884102

Collaborator

(none)

1,000

Enrollment

Locations

Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma Plasma Malignancy	Genetic: genetic sequencing

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jun 1, 2015

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Outcome Measures

Primary Outcome Measures

actionable mutations report [10-14 days]

Secondary Outcome Measures

Survival Rates [Overall survival]
Disease Recurrence [Time to Progression]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic - Scottsdale	Scottsdale	Arizona	United States	85259
2	City of Hope	Duarte	California	United States	91010
3	UCSF Medical Center	San Francisco	California	United States	94143
4	Mayo Clinic - Jacksonville	Jacksonville	Florida	United States	32224
5	Emory University	Atlanta	Georgia	United States	30322
6	University of Chicago	Chicago	Illinois	United States
7	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
8	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02215
9	University of Michigan	Ann Arbor	Michigan	United States	48109
10	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	United States	48201
11	Mayo Clinic - Rochester	Rochester	Minnesota	United States	55905
12	Washington University	Saint Louis	Missouri	United States	63110
13	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
14	Mount Sinai Medical Center	New York	New York	United States	10029
15	Levine Cancer Institute	Charlotte	North Carolina	United States	28204
16	Ohio State University	Columbus	Ohio	United States	43210
17	Sarah Cannon Research Institute	Nashville	Tennessee	United States	37203
18	Baylor Research Institute	Dallas	Texas	United States	75246
19	Virginia Cancer Specialists	Fairfax	Virginia	United States
20	Princess Margaret Cancer Centre	Toronto	Ontario	Canada	M5G 2C1