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

December 1, 2025 updated by: Bristol-Myers Squibb
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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

2555

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Local Institute
      • Toronto, Ontario, Canada, M5G 2M9
        • Local Institution - 0066
      • Weston, Ontario, Canada, M9N 1N8
        • Local Institute
  • France
      • Blois, France
        • Local Institute
      • Chalon-sur-Saône, France
        • Local Institute
      • La Roche-sur-Yon, France, 85925
        • Local Institution - 0100
      • La Roche-sur-Yon, France
        • Local Institute
      • Limoges, France
        • Local Institute
      • Meaux, France
        • Local Institute
      • Nantes, France
        • Local Institute
      • Rennes, France, 35033
        • Local Institute
  • Germany
      • Aschaffenburg, Germany, 63739
        • Local Institute
      • Berlin, Germany, 10407
        • Local Institute
      • Dresden, Germany, 01099
        • Local Institute
      • Hamm, Germany, 59071
        • Local Institution - 0070
      • Magdeburg, Germany, 39104
        • Local Institute
      • Magdeburg, Germany, 39104
        • Local Institution - 0067
      • München, Germany
        • Local Institute
      • Rostock, Germany
        • Local Institute
      • Wiesbaden, Germany, 65191
        • Local Institution - 0085
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Germany, 69120
        • Local Institute
    • North Rhine-Westphalia
      • Hamm, North Rhine-Westphalia, Germany, 59071
        • Local Institute
  • Italy
      • Ancona, Italy, 042002
        • Local Institute
      • Ancona, Italy, 60126
        • Local Institute
      • Cagliari, Italy, 09121
        • Local Institution - 0119
      • Cagliari, Italy, B354
        • Local Institute
      • Florence, Italy, 50134
        • Local Institution - 0111
      • Florence, Italy, 50139
        • Local Institute
      • Lecce, Italy, 73100
        • Local Institute
      • Messina, Italy, 98122
        • Local Institution - 0120
      • Milan, Italy, 20121
        • Local Institute
      • Milan, Italy, 20133
        • Local Institution - 0116
      • Napoli, Italy, 80136
        • Local Institute
      • Napoli, Italy, 80139
        • Local Institution - 0114
      • Pesaro, Italy, 61122
        • Local Institution - 0115
      • Pescara, Italy, 65124
        • Local Institution - 0121
      • Roma, Italy, 00189
        • Local Institution
      • Roma, Italy, 00161
        • Local Institute
      • Terni, Italy, 05100
        • Local Institution - 0107
      • Terni, Italy, 5100
        • Local Institute
      • Torino, Italy, 10126
        • Local Institute
      • Torino, Italy, 10126
        • Local Institution - 0112
      • Vicenza, Italy, 36100
        • Local Institute
      • Vicenza, Italy, 36100
        • Local Institution - 0117
    • Pesaro E Urbino
      • Pesaro, Pesaro E Urbino, Italy, 61122
        • Local Institute
  • United Kingdom
      • Leeds, United Kingdom, LS9 7TF
        • Local Institute
      • Liverpool, United Kingdom, L7 8XP
        • Local Institution
      • Nottingham, United Kingdom, NG5 1PB
        • Local Institute
      • Nottingham, United Kingdom, NG5 1PB
        • Local Institution - 0095
      • Stafford, United Kingdom, ST16 3SA
        • Local Institute
      • Swansea, United Kingdom, SA2 8QA
        • Local Institute
    • Cornwall
      • Truro, Cornwall, United Kingdom, TR1 3LJ
        • Local Institute
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35213
        • Local Institution
    • Arizona
      • Goodyear, Arizona, United States, 85338
        • Local Institute
    • California
      • Anaheim, California, United States, 92801
        • Local Institution
      • Anaheim, California, United States, 92801
        • Local Institution - 0023
      • Burbank, California, United States, 91505
        • Local Institution - 0045
      • Corona, California, United States, 92880
        • Local Institution
      • Downey, California, United States, 90241
        • Local Institution - 0048
      • Fountain Valley, California, United States, 92708
        • Local Institution - 0052
      • Los Angeles, California, United States, 90013
        • Local Institute
      • Santa Rosa, California, United States, 95403
        • Local Institute
      • Santa Rosa, California, United States, 95403
        • Local Institution - 0051
    • Florida
      • Brooksville, Florida, United States, 34613
        • Local Institution
      • Fort Lauderdale, Florida, United States, 33308
        • Local Institution - 0044
      • Jacksonville, Florida, United States, 32256
        • Local Institution
    • Georgia
      • Valdosta, Georgia, United States, 31602
        • Local Institute
      • Valdosta, Georgia, United States, 31602
        • Local Institution - 0047
    • Illinois
      • Skokie, Illinois, United States, 60077
        • Local Institution
      • Springfield, Illinois, United States, 62794-9677
        • Local Institution - 0041
    • Indiana
      • Anderson, Indiana, United States, 46016
        • Local Institution - 0058
      • Indianapolis, Indiana, United States, 46237
        • Local Institution - 0011
      • Indianapolis, Indiana, United States, 46237
        • Local Institution
    • Iowa
      • Sioux City, Iowa, United States, 51101
        • Local Institute
    • Kentucky
      • Louisville, Kentucky, United States, 40201
        • Local Institute
      • Louisville, Kentucky, United States, 40202
        • Local Institution - 0042
    • Louisiana
      • Lafayette, Louisiana, United States, 70503
        • Local Institution
      • Shreveport, Louisiana, United States, 71103
        • Local Institution
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Local Institution
      • Woodbury, Minnesota, United States, 55125
        • Local Institution - 0030
    • Mississippi
      • Southaven, Mississippi, United States, 38671
        • Local Institute
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Local Institute
      • Kansas City, Missouri, United States, 64132
        • Local Institution - 0050
      • Missoula, Missouri, United States, 59802
        • Local Institution - 0037
      • Saint Joseph, Missouri, United States, 64501
        • Local Institute
      • Springfield, Missouri, United States, 65804
        • Local Institution - 0020
      • Springfield, Missouri, United States, 65804
        • Local Institution
      • St Louis, Missouri, United States, 63110
        • Local Institution
    • Montana
      • Missoula, Montana, United States, 59802
        • Local Institute
      • Missoula, Montana, United States, 59807
        • Local Institute
    • Nebraska
      • Omaha, Nebraska, United States, 68124
        • Local Institute
      • Omaha, Nebraska, United States, 68124
        • Local Institution - 0024
    • New Jersey
      • No City Provided, New Jersey, United States, 00000
        • Local Institution - France
      • No City Provided, New Jersey, United States, 00000
        • Local Institution - Germany
      • No City Provided, New Jersey, United States, 00000
        • Local Institution - Italy
      • No City Provided, New Jersey, United States, 00000
        • Local Institution - Canada
      • No City Provided, New Jersey, United States, 00000
        • Local Institution - United Kingdom
      • No City Provided, New Jersey, United States, 00000
        • Local Institution - USA
    • New York
      • Stony Brook, New York, United States, 11794
        • Local Institution - 0049
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • Local Institute
      • Cary, North Carolina, United States, 27518
        • Local Institution - 0033
      • Gastonia, North Carolina, United States, 28054
        • Local Institution - 0010
      • Gastonia, North Carolina, United States, 28054
        • Local Institution
    • Ohio
      • Canton, Ohio, United States, 44718
        • Local Institute
      • Canton, Ohio, United States, 44718
        • Local Institution - 0022
      • Cleveland, Ohio, United States, 44109-1900
        • Local Institute
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Local Institute
    • Oregon
      • Portland, Oregon, United States, 97200
        • Local Institute
    • Pennsylvania
      • Pottstown, Pennsylvania, United States, 19464
        • Local Institute
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Local Institute
      • Charleston, South Carolina, United States, 29414
        • Local Institution - 0016
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Local Institute
      • Memphis, Tennessee, United States, 38120
        • Local Institution
    • Texas
      • Amarillo, Texas, United States, 79106
        • Local Institute
      • Corpus Christi, Texas, United States, 78350
        • Local Institute
      • Dallas, Texas, United States, 75229
        • Local Institute
      • Dallas, Texas, United States, 75231
        • Local Institute
      • Dallas, Texas, United States, 75231
        • Local Institution - 0025
      • Dallas, Texas, United States, 75390
        • Local Institute
      • Dallas, Texas, United States, 75390
        • Local Institution - 0014
      • Garland, Texas, United States, 75042
        • Local Institution - 0032
      • San Antonio, Texas, United States, 78217
        • Local Institute
      • San Antonio, Texas, United States, 78217
        • Local Institution - 0027
      • Sherman, Texas, United States, 75090
        • Local Institute
    • Washington
      • Seattle, Washington, United States, 98101
        • Local Institute
      • Spokane, Washington, United States, 99202
        • Local Institute
      • Spokane, Washington, United States, 99202
        • Local Institution - 0026
      • Yakima, Washington, United States, 98901
        • Local Institute
      • Yakima, Washington, United States, 98902
        • Local Institute
      • Yakima, Washington, United States, 98902
        • Local Institution - 0031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of two cohorts: Participants with relapsed/refractory (RR) multiple myeloma (MM) and those with newly-diagnosed (ND) multiple myeloma (MM).

Description

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Cohort 1
Participants with relapsed/refractory multiple myeloma (RRMM) followed up for up to 5 years
Cohort 2
Participants with newly-diagnosed multiple myeloma (NDMM) followed up for up to 8 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS) for participants with relapsed/refractory multiple myeloma (RRMM)
Time Frame: Up to 5 years
Up to 5 years
Overall Survival (OS) for participants with newly-diagnosed multiple myeloma (NDMM)
Time Frame: Up to 8 years
Up to 8 years
Progression-Free Survival (PFS) for participants with RRMM
Time Frame: Up to 5 years
Up to 5 years
Progression-Free Survival (PFS) for participants with NDMM
Time Frame: Up to 8 years
Up to 8 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Treatment patterns of approved MM therapies as measured by the Response Rate for participants with RRMM
Time Frame: From study index date until the enrollment date, assessed up to 5 years
From study index date until the enrollment date, assessed up to 5 years
Treatment patterns of approved MM therapies as measured by the Response Rate for participants with NDMM
Time Frame: From study index date until the enrollment date, assessed up to 8 years
From study index date until the enrollment date, assessed up to 8 years
Healthcare resource utilization (HCRU) for participants with RRMM
Time Frame: Up to 5 years
Up to 5 years
Healthcare resource utilization (HCRU) for participants with NDMM
Time Frame: Up to 8 years
Up to 8 years
Healthcare resource utilization (HCRU) for participants with RRMM
Time Frame: From the day of enrollment until death, withdrawal of consent, enrollment into a clinical trial for MM, loss to follow-up, or end of study, whichever comes first; assessed up to 60 months
From the day of enrollment until death, withdrawal of consent, enrollment into a clinical trial for MM, loss to follow-up, or end of study, whichever comes first; assessed up to 60 months
Healthcare resource utilization (HCRU) for participants with NDMM
Time Frame: From the day of enrollment until death, withdrawal of consent, enrollment into a clinical trial for MM, loss to follow-up, or end of study, whichever comes first; assessed up to 96 months
From the day of enrollment until death, withdrawal of consent, enrollment into a clinical trial for MM, loss to follow-up, or end of study, whichever comes first; assessed up to 96 months
Patient reported outcomes as measured by EQ-5D summary index for participants with RRMM
Time Frame: From start of initial therapy to questionnaire completion, assessed up to 5 years
From start of initial therapy to questionnaire completion, assessed up to 5 years
Patient reported outcomes as measured by EQ-5D summary index for participants with NDMM
Time Frame: From start of initial therapy to questionnaire completion, assessed up to 8 years
From start of initial therapy to questionnaire completion, assessed up to 8 years
Patient reported outcomes as measured by EORTC-QLQ-C30 for participants with RRMM
Time Frame: From start of initial therapy to questionnaire completion, assessed up to 5 years
From start of initial therapy to questionnaire completion, assessed up to 5 years
Patient reported outcomes as measured by EORTC-QLQ-C30 for participants with NDMM
Time Frame: From start of initial therapy to questionnaire completion, assessed up to 8 years
From start of initial therapy to questionnaire completion, assessed up to 8 years
Patient reported outcomes as measured by EORTC-QLQ-MY20 for participants with RRMM
Time Frame: From start of initial therapy to questionnaire completion, assessed up to 5 years
From start of initial therapy to questionnaire completion, assessed up to 5 years
Patient reported outcomes as measured by EORTC-QLQ-MY20 for participants with NDMM
Time Frame: From start of initial therapy to questionnaire completion, assessed up to 8 years
From start of initial therapy to questionnaire completion, assessed up to 8 years
Incidence of Adverse Events (AEs) for participants with RRMM
Time Frame: Up to 5 years
Up to 5 years
Incidence of Adverse Events (AEs) for participants with NDMM
Time Frame: Up to 8 years
Up to 8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2012

Primary Completion (Estimated)

March 31, 2030

Study Completion (Estimated)

March 31, 2030

Study Registration Dates

First Submitted

April 19, 2013

First Submitted That Met QC Criteria

April 23, 2013

First Posted (Estimated)

April 24, 2013

Study Record Updates

Last Update Posted (Estimated)

December 2, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA204-008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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