Multiple MyelomaNCT03689595
Predicting Progression of Developing Myeloma in a High-Risk Screened Population (PROMISE)
An observational study of Multiple Myeloma, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
The PROMISE Study aims to establish a prospective cohort of individuals with precursor conditions to multiple myeloma, such as monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM). Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Samples of blood (2-4 tablespoons) from 4 tubes will be collected -Analysis will be performed on the blood to test for multiple myeloma precursor conditions.
- How many people
- 30,000 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2018to 31 Oct 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All special populations who fall within the eligible high-risk age range, ≥ 30 years of age are included.
Who may be able to join
- Age ≥ 30 years
- AA race (self-identified) and/or first-degree relative of a patient with a plasma cell dyscrasia such as MGUS, SMM, MM, and Waldenström's Macroglobulinemia, or another blood cancer.
- OR
- Those over 18 are also eligible if they have 2 or more family members with a blood cancer
- Screened positive by mass spectrometry in the Ghobrial Lab for SMM or MGUS as part of the Mass General Brigham Biobank arm AND fits one of the following two groups of criteria:
- Age ≥ 30 years
Show all 10Show fewer
- AA race (self-identified) and/or first-degree relative of a patient with a plasma cell dyscrasia such as MGUS, SMM, MM, and Waldenström's Macroglobulinemia, or another blood cancer.
- OR • Those over 18 are also eligible if they have 2 or more family members with a blood cancer
- Screened positive by mass spectrometry in the Ghobrial Lab for SMM or MGUS as part of the Mass General Brigham Biobank arm AND fits the criteria listed below:
- Age ≥ 18 years
Who cannot join
- Persons diagnosed with cancer at any site (including hematologic cancers) with symptomatic disease requiring active therapy.
- Persons with an already diagnosed plasma cell dyscrasia such as MGUS, SMM, MM, and Waldenström's Macroglobulinemia
- Persons under the age of 18 years old
- First-degree relatives would not need to be identified by the participant.
- This study includes all special populations who fall within the eligible high-risk age range, ≥ 30 years of age, including adults unable to consent, pregnant women, and prisoners. These populations will not be excluded as this is a non-therapeutic study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
The PROMISE Study aims to establish a prospective cohort of individuals with precursor conditions to multiple myeloma, such as monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM). We will study these patients as a means to identify risk factors for progression to symptomatic multiple myeloma.
Read the detailed description
The goal of the PROMISE research study is to determine clinical/genomic alterations present in individuals with MGUS and SMM, who are diagnosed through screening of a high-risk population. We also seek to determine clinical/genomic/epigenetic and immune environmental predictors of progression to multiple myeloma in patients with MGUS and SMM.
- Conditions
- Multiple Myeloma
- Being tested
- Samples of blood (2-4 tablespoons) from 4 tubes will be collected -Analysis will be performed on the blood to test for multiple myeloma precursor conditions.
- Keywords
- Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Samples of blood (2-4 tablespoons) from 4 tubes will be collected -Analysis will be performed on the blood to test for multiple myeloma precursor conditions.Other
Collection of blood sample from participants
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Healthy individuals who meet this protocols high-risk criteria for developing MM in their lifetime.
* Samples of blood (2-4 tablespoons) from 4 tubes will be collected
* Analysis will be performed on the blood to test for multiple myeloma precursor conditions. Receives: Other: Samples of blood (2-4 tablespoons) from 4 tubes will be collected -Analysis will be performed on the blood to test for multiple myeloma precursor conditions. | |
| Cohort 2 | People who have screened positive by mass spectrometry in the Ghobrial Lab for SMM or MGUS as part of the Mass General Brigham Biobank.
* Samples of blood (2-4 tablespoons) from 4 tubes will be collected
* Analysis will be performed on the blood to test for multiple myeloma precursor conditions. Receives: Other: Samples of blood (2-4 tablespoons) from 4 tubes will be collected -Analysis will be performed on the blood to test for multiple myeloma precursor conditions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression (TTP) from MGUS/SMM to overt multiple myeloma.
Progression to symptomatic multiple myeloma
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start31 Oct 2018
- Primary completion31 Oct 2033 (estimated)
- Study completion31 Oct 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irene Ghobrial, MD, Dana-Farber Cancer Institute
- Investigators
- Irene Ghobrial, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689595
- Sponsor's protocol ID
- 18-370
- Status last verified
- Jul 2026
- First submitted
- 20 Sep 2018
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bertamini L, Alberge JB, Lee DJ, El-Khoury H, Kim S, Fleming G, Murphy C, Colchie J, Davis MI, Perry J, Lightbody ED, Allam S, Goqwana LN, Philip V, Smyth N, Sakrikar D, Perkins M, Harding S, Troske D, Getz G, Karlson EW, Munshi N, Anderson KC, Trippa L, Marinac CR, Chen WC, Joffe M, Ghobrial IM. Serum free light chains in a racially diverse population including African Americans and populations from South Africa. Blood. 2025 Feb 20;145(8):840-849. doi: 10.1182/blood.2024026078.
PubMed 39571144Lee DJ, El-Khoury H, Tramontano AC, Alberge JB, Perry J, Davis MI, Horowitz E, Redd R, Sakrikar D, Barnidge D, Perkins MC, Harding S, Mucci L, Rebbeck TR, Ghobrial IM, Marinac CR. Mass spectrometry-detected MGUS is associated with obesity and other novel modifiable risk factors in a high-risk population. Blood Adv. 2024 Apr 9;8(7):1737-1746. doi: 10.1182/bloodadvances.2023010843.
PubMed 38212245El-Khoury H, Lee DJ, Alberge JB, Redd R, Cea-Curry CJ, Perry J, Barr H, Murphy C, Sakrikar D, Barnidge D, Bustoros M, Leblebjian H, Cowan A, Davis MI, Amstutz J, Boehner CJ, Lightbody ED, Sklavenitis-Pistofidis R, Perkins MC, Harding S, Mo CC, Kapoor P, Mikhael J, Borrello IM, Fonseca R, Weiss ST, Karlson E, Trippa L, Rebbeck TR, Getz G, Marinac CR, Ghobrial IM. Prevalence of monoclonal gammopathies and clinical outcomes in a high-risk US population screened by mass spectrometry: a multicentre cohort study. Lancet Haematol. 2022 May;9(5):e340-e349. doi: 10.1016/S2352-3026(22)00069-2. Epub 2022 Mar 25.
PubMed 35344689
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Progression of Developing Myeloma in a High-Risk Screened Population (PROMISE)
- ClinicalTrials.gov ID
- NCT03689595
- Acronym / sponsor ID
- 18-370
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 31 Oct 2018 (actual)
- Primary completion
- 31 Oct 2033 (estimated)
- Study completion
- 31 Oct 2033 (estimated)
- First posted
- 28 Sep 2018 (actual)
- 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.
The PROMISE Study aims to establish a prospective cohort of individuals with precursor conditions to multiple myeloma, such as monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM). We will study these patients as a means to identify risk factors for progression to symptomatic multiple myeloma.
Detailed description
The goal of the PROMISE research study is to determine clinical/genomic alterations present in individuals with MGUS and SMM, who are diagnosed through screening of a high-risk population. We also seek to determine clinical/genomic/epigenetic and immune environmental predictors of progression to multiple myeloma in patients with MGUS and SMM.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Other: Samples of blood (2-4 tablespoons) from 4 tubes will be collected -Analysis will be performed on the blood to test for multiple myeloma precursor conditions.Healthy individuals who meet this protocols high-risk criteria for developing MM in their lifetime. * Samples of blood (2-4 tablespoons) from 4 tubes will be collected * Analysis will be performed on the blood to test for multiple myeloma precursor conditions. |
| Cohort 2 | – | Other: Samples of blood (2-4 tablespoons) from 4 tubes will be collected -Analysis will be performed on the blood to test for multiple myeloma precursor conditions.People who have screened positive by mass spectrometry in the Ghobrial Lab for SMM or MGUS as part of the Mass General Brigham Biobank. * Samples of blood (2-4 tablespoons) from 4 tubes will be collected * Analysis will be performed on the blood to test for multiple myeloma precursor conditions. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All special populations who fall within the eligible high-risk age range, ≥ 30 years of age are included.
Key inclusion criteria (10 listed)
- Age ≥ 30 years
- AA race (self-identified) and/or first-degree relative of a patient with a plasma cell dyscrasia such as MGUS, SMM, MM, and Waldenström's Macroglobulinemia, or another blood cancer.
- OR
- Those over 18 are also eligible if they have 2 or more family members with a blood cancer
- Screened positive by mass spectrometry in the Ghobrial Lab for SMM or MGUS as part of the Mass General Brigham Biobank arm AND fits one of the following two groups of criteria:
Key exclusion criteria (5 listed)
- Persons diagnosed with cancer at any site (including hematologic cancers) with symptomatic disease requiring active therapy.
- Persons with an already diagnosed plasma cell dyscrasia such as MGUS, SMM, MM, and Waldenström's Macroglobulinemia
- Persons under the age of 18 years old
- First-degree relatives would not need to be identified by the participant.
- This study includes all special populations who fall within the eligible high-risk age range, ≥ 30 years of age, including adults unable to consent, pregnant women, and prisoners. These populations will not be excluded as this is a non-therapeutic study.
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 |
|---|---|---|
| Samples of blood (2-4 tablespoons) from 4 tubes will be collected -Analysis will be performed on the blood to test for multiple myeloma precursor conditions.Collection of blood sample from participants | Other | Cohort 1, Cohort 2 |
Primary outcome
Time to progression (TTP) from MGUS/SMM to overt multiple myeloma.
Time frame: 15 years
Progression to symptomatic multiple myeloma
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Derived from this study: PubMed 39571144Bertamini L, Alberge JB, Lee DJ, El-Khoury H, Kim S, Fleming G, Murphy C, Colchie J, Davis MI, Perry J, Lightbody ED, Allam S, Goqwana LN, Philip V, Smyth N, Sakrikar D, Perkins M, Harding S, Troske D, Getz G, Karlson EW, Munshi N, Anderson KC, Trippa L, Marinac CR, Chen WC, Joffe M, Ghobrial IM. Serum free light chains in a racially diverse population including African Americans and populations from South Africa. Blood. 2025 Feb 20;145(8):840-849. doi: 10.1182/blood.2024026078.
- Derived from this study: PubMed 38212245Lee DJ, El-Khoury H, Tramontano AC, Alberge JB, Perry J, Davis MI, Horowitz E, Redd R, Sakrikar D, Barnidge D, Perkins MC, Harding S, Mucci L, Rebbeck TR, Ghobrial IM, Marinac CR. Mass spectrometry-detected MGUS is associated with obesity and other novel modifiable risk factors in a high-risk population. Blood Adv. 2024 Apr 9;8(7):1737-1746. doi: 10.1182/bloodadvances.2023010843.
- Derived from this study: PubMed 35344689El-Khoury H, Lee DJ, Alberge JB, Redd R, Cea-Curry CJ, Perry J, Barr H, Murphy C, Sakrikar D, Barnidge D, Bustoros M, Leblebjian H, Cowan A, Davis MI, Amstutz J, Boehner CJ, Lightbody ED, Sklavenitis-Pistofidis R, Perkins MC, Harding S, Mo CC, Kapoor P, Mikhael J, Borrello IM, Fonseca R, Weiss ST, Karlson E, Trippa L, Rebbeck TR, Getz G, Marinac CR, Ghobrial IM. Prevalence of monoclonal gammopathies and clinical outcomes in a high-risk US population screened by mass spectrometry: a multicentre cohort study. Lancet Haematol. 2022 May;9(5):e340-e349. doi: 10.1016/S2352-3026(22)00069-2. Epub 2022 Mar 25.
- Individual participant dataSharing planned: No
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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.
Irene Ghobrial, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Dana-Farber Cancer Institute at 1 site in United States.
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 10 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Time to progression (TTP) from MGUS/SMM to overt multiple myeloma. (time frame: 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03689595, which also lists 3 linked publications.
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 31 Jul 2026.