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Prospective Research Assessme...

Prospective Research Assessment in Multiple Myeloma: An Observational Evaluation (PREAMBLE)

Last Updated: 2025-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

2555 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-13

Study Completion Date

2030-03-31

Brief Summary

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The purpose of this study is to assess the clinical effectiveness of all approved multiple myeloma (MM) therapies in the newly-diagnosed (NDMM) and the relapsed/refractory MM (RRMM) settings in real-world clinical practice.

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Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1

Participants with relapsed/refractory multiple myeloma (RRMM) followed up for up to 5 years

No interventions assigned to this group

Cohort 2

Participants with newly-diagnosed multiple myeloma (NDMM) followed up for up to 8 years

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

For RRMM participants who have received at least one prior line of therapy (LoT) for MM:

* Have documented progression from a prior LoT
* Participants who have initiated treatment with one of the following therapies within 90 days before consent for this study OR in the case where treatment has not yet been initiated, documentation that the treatment strategy was determined before consent for this study must be provided, and treatment must be initiated within 30 days after consent:
* IMiDs
* PIs
* Combination of IMiD + PI
* Newer agents with novel MOAs alone or in combination (eg, mAbs, HDACIs, Akt inhibitors, SINE, or CAR T-cell therapies)

For NDMM participants receiving frontline therapy:

* Eligible to receive frontline therapy for MM (no prior MM treatment)
* Participants who have initiated treatment for MM with one of the following therapies within 90 days before consent for this study OR in the case where treatment has not yet been initiated, documentation that the treatment strategy was determined before consent for this study must be provided, and treatment must be initiated within 30 days after consent:
* IMiDs
* PIs
* Combination of IMiD + PI
* Newer agents with novel MOAs alone or in combination (eg, mAbs, HDACIs, Akt inhibitors, SINE, or CAR T-cell therapies)

Exclusion Criteria

* Participants who are currently participating in a clinical trial for MM
* Participants who are currently receiving treatment for primary cancer other than MM
* Participants who are not willing or able to provide informed consent
* Participants who are incarcerated
* Participants under compulsory detention for treatment of a physical (eg, infectious) or psychiatric illness

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Birmingham, Alabama, United States

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Local Institute

Goodyear, Arizona, United States

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Local Institution - 0023

Anaheim, California, United States

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Anaheim, California, United States

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Local Institution - 0045

Burbank, California, United States

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Corona, California, United States

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Local Institution - 0048

Downey, California, United States

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Local Institution - 0052

Fountain Valley, California, United States

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Los Angeles, California, United States

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Santa Rosa, California, United States

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Local Institution - 0051

Santa Rosa, California, United States

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Brooksville, Florida, United States

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Local Institution - 0044

Fort Lauderdale, Florida, United States

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Jacksonville, Florida, United States

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Valdosta, Georgia, United States

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Local Institution - 0047

Valdosta, Georgia, United States

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Skokie, Illinois, United States

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Local Institution - 0041

Springfield, Illinois, United States

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Local Institution - 0058

Anderson, Indiana, United States

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Local Institution - 0011

Indianapolis, Indiana, United States

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Indianapolis, Indiana, United States

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Sioux City, Iowa, United States

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Louisville, Kentucky, United States

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Local Institution - 0042

Louisville, Kentucky, United States

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Lafayette, Louisiana, United States

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Shreveport, Louisiana, United States

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Minneapolis, Minnesota, United States

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Local Institution - 0030

Woodbury, Minnesota, United States

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Southaven, Mississippi, United States

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Kansas City, Missouri, United States

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Local Institution - 0050

Kansas City, Missouri, United States

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Local Institution - 0037

Missoula, Missouri, United States

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Saint Joseph, Missouri, United States

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Local Institution - 0020

Springfield, Missouri, United States

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Springfield, Missouri, United States

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St Louis, Missouri, United States

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Missoula, Montana, United States

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Missoula, Montana, United States

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Omaha, Nebraska, United States

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