MMRF Molecular Profiling Protocol

Multiple Myeloma Research Foundation

Status: Active, not recruiting

Conditions: Multiple Myeloma; Plasma Malignancy

Treatments: Genetic: genetic sequencing

Study type: Observational

Funder types: Other

Identifiers

NCT02884102

MMRF-002

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.