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Can we predict myeloma before it starts? new study aims to find out

NCT ID NCT03689595

Knowledge-focused Sponsor: Dana-Farber Cancer Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

The PROMISE study is enrolling 30,000 people at high risk for multiple myeloma, including African Americans and those with a family history of blood cancers. Participants provide blood samples so researchers can track changes over time and identify who progresses to myeloma. The goal is to better understand risk factors and potentially catch the disease earlier.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help identify who is most likely to develop multiple myeloma, enabling earlier monitoring or intervention.
What could go wrong
This is an observational study, not a treatment trial. It may not directly lead to new therapies, and results may take years to emerge.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 30,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2018

Expected to finish

Oct 2033

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

All special populations who fall within the eligible high-risk age range, ≥ 30 years of age are included.

Ages

30 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria for Cohort 1: * 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 Inclusion Criteria for Cohort 2A: 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 * 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 Inclusion Criteria for Cohort 2B: 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 Exclusion Criteria for Cohort 1: * 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 Exclusion Criteria for Cohort 2A and 2B: * 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.

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Conditions

The condition(s) this trial relates to.

monoclonal gammopathy of uncertain significance plasma cell myeloma smoldering plasma cell myeloma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple myeloma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.