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MMRF Molecular Profiling Protocol

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ClinicalTrials.gov Identifier: NCT02884102
Recruitment Status : Recruiting
First Posted : August 30, 2016
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Multiple Myeloma Research Foundation

Study Description
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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
Multiple Myeloma Plasma Malignancy Genetic: genetic sequencing

Study Design
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Study Type : Observational
Estimated 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 : June 2015
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. actionable mutations report [ Time Frame: 10-14 days ]

Secondary Outcome Measures :
  1. Survival Rates [ Time Frame: Overall survival ]
  2. Disease Recurrence [ Time Frame: Time to Progression ]

Biospecimen Retention:   Samples With DNA
bone marrow and peripheral blood samples will be obtained

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02884102


Contacts
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Contact: Jennifer Yesil, M.S. 203.652.0237 yesilj@themmrf.org

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Sponsors and Collaborators
Multiple Myeloma Research Foundation
Investigators
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Principal Investigator: Leif Bergsagel, M.D. Mayo Clinic
More Information
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Responsible Party: Multiple Myeloma Research Foundation
ClinicalTrials.gov Identifier: NCT02884102     History of Changes
Other Study ID Numbers: MMRF-002
First Posted: August 30, 2016    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Keywords provided by Multiple Myeloma Research Foundation:
genetic sequencing
relapsed
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases