MMRF Molecular Profiling Protocol
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02884102 |
|
Recruitment Status :
Recruiting
First Posted : August 30, 2016
Last Update Posted : March 19, 2019
|
Sponsor:
Multiple Myeloma Research Foundation
Information provided by (Responsible Party):
Multiple Myeloma Research Foundation
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 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 Genetics related topics:
Multiple myeloma
MedlinePlus related topics:
Multiple Myeloma
Primary Outcome Measures :
- actionable mutations report [ Time Frame: 10-14 days ]
Secondary Outcome Measures :
- Survival Rates [ Time Frame: Overall survival ]
- Disease Recurrence [ Time Frame: Time to Progression ]
Biospecimen Retention: Samples With DNA
bone marrow and peripheral blood samples will be obtained
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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:
- 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.
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
| Contact: Jennifer Yesil, M.S. | 203.652.0237 | yesilj@themmrf.org |
Locations
Show 20 study locations
Sponsors and Collaborators
Multiple Myeloma Research Foundation
Investigators
| Principal Investigator: | Leif Bergsagel, M.D. | Mayo Clinic |
| Responsible Party: | Multiple Myeloma Research Foundation |
| ClinicalTrials.gov Identifier: | NCT02884102 |
| 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:
|
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 |