Multiple MyelomaNCT02884102
MMRF Molecular Profiling Protocol
An observational study of Multiple Myeloma and Plasma Malignancy, run by Multiple Myeloma Research Foundation at 20 sites in 2 countries.
Trial summary
This protocol is now being used as screening for the MyDRUG study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Plasma Malignancy
- What is being tested?
- genetic sequencing
- How many people
- 1,000 participants
- Where
- 20 sitesin 2 countries
- Study dates
- Jun 2015to Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
United States19 sites
University of Michigan
Ann Arbor, Michigan, 48109
Emory University
Atlanta, Georgia, 30322
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Levine Cancer Institute
Charlotte, North Carolina, 28204
University of Chicago
Chicago, Illinois
Ohio State University
Columbus, Ohio, 43210
Baylor Research Institute
Dallas, Texas, 75246
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
City of Hope
Duarte, California, 91010
Virginia Cancer Specialists
Fairfax, Virginia
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Mount Sinai Medical Center
New York, New York, 10029
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
UCSF Medical Center
San Francisco, California, 94143
Mayo Clinic - Scottsdale
Scottsdale, Arizona, 85259
Washington University
St Louis, Missouri, 63110
About this study
Official title: Clinical-grade Molecular Profiling of Patients With Multiple Myeloma and Related Plasma Cell Malignancies
This protocol is now being used as screening for the MyDRUG study
Read the 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.
- Conditions
- Multiple Myeloma, Plasma Malignancy
- Being tested
- genetic sequencing
- Keywords
- genetic sequencing, relapsed
- Medical subject headings
- Multiple Myeloma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genetic sequencingGenetic
What is being measured
The primary outcome is the main question the study is designed to answer.
actionable mutations report
Measured: 10-14 days
Secondary outcomes (2)
Survival Rates
Measured: Overall survival
Disease Recurrence
Measured: Time to Progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startJun 2015
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Multiple Myeloma Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leif Bergsagel, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02884102
- Sponsor's protocol ID
- MMRF-002
- Status last verified
- Feb 2023
- First submitted
- 25 Aug 2016
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical-grade Molecular Profiling of Patients With Multiple Myeloma and Related Plasma Cell Malignancies
- ClinicalTrials.gov ID
- NCT02884102
- Acronym / sponsor ID
- MMRF-002
- Conditions
- Multiple Myeloma, Plasma Malignancy
- Keywords
- genetic sequencing, relapsed
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Multiple Myeloma Research FoundationUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 30 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| genetic sequencing | Genetic | – |
Primary outcome
actionable mutations report
Time frame: 10-14 days
2 secondary outcomes
Survival Rates
Time frame: Overall survival
Disease Recurrence
Time frame: Time to Progression
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leif Bergsagel, M.D. principal investigator
Mayo Clinic
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma and Plasma Malignancy, run by Multiple Myeloma Research Foundation at 20 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
actionable mutations report (time frame: 10-14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.