NCT02884102Active, not recruitingNot Applicable
Clinical-grade Molecular Profiling of Patients With Multiple Myeloma and Related Plasma Cell Malignancies
Multiple Myeloma Research Foundation20 sites in 2 countries1,000 target enrollmentStarted: June 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 1,000
- Locations
- 20
- Primary Endpoint
- actionable mutations report
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
actionable mutations report
Time Frame: 10-14 days
Secondary Outcomes
- Disease Recurrence(Time to Progression)
- Survival Rates(Overall survival)
Investigators
Study Sites (20)
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