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Active, not recruitingNCT01838512Updated Dec 2, 2025

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

An observational study in Multiple Myeloma, sponsored by Bristol-Myers Squibb. Active, not recruiting at 130 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-02.

Sponsored by Bristol-Myers Squibb · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,555
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Multiple Myeloma

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03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's planned enrollment of 2,555 is above the median of 140 across 468 observational studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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).

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

Inclusion criteria

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

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

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,555 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Overall Survival (OS) for participants with relapsed/refractory multiple myeloma (RRMM)

    Time frame: Up to 5 years

  2. Overall Survival (OS) for participants with newly-diagnosed multiple myeloma (NDMM)

    Time frame: Up to 8 years

  3. Progression-Free Survival (PFS) for participants with RRMM

    Time frame: Up to 5 years

  4. Progression-Free Survival (PFS) for participants with NDMM

    Time frame: Up to 8 years

Secondary outcomes

  1. 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

  2. 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

  3. Healthcare resource utilization (HCRU) for participants with RRMM

    Time frame: Up to 5 years

  4. Healthcare resource utilization (HCRU) for participants with NDMM

    Time frame: Up to 8 years

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. Incidence of Adverse Events (AEs) for participants with RRMM

    Time frame: Up to 5 years

  14. Incidence of Adverse Events (AEs) for participants with NDMM

    Time frame: Up to 8 years

07

Study locations

130 sites
  • Local Institution
    Birmingham, Alabama 35213, United States
  • Local Institute
    Goodyear, Arizona 85338, United States
  • Local Institution - 0023
    Anaheim, California 92801, United States
  • Local Institution
    Anaheim, California 92801, United States
  • Local Institution - 0045
    Burbank, California 91505, United States
  • Local Institution
    Corona, California 92880, United States
  • Local Institution - 0048
    Downey, California 90241, United States
  • Local Institution - 0052
    Fountain Valley, California 92708, United States
  • Local Institute
    Los Angeles, California 90013, United States
  • Local Institute
    Santa Rosa, California 95403, United States
  • Local Institution - 0051
    Santa Rosa, California 95403, United States
  • Local Institution
    Brooksville, Florida 34613, United States
  • Local Institution - 0044
    Fort Lauderdale, Florida 33308, United States
  • Local Institution
    Jacksonville, Florida 32256, United States
  • Local Institute
    Valdosta, Georgia 31602, United States
  • Local Institution - 0047
    Valdosta, Georgia 31602, United States
  • Local Institution
    Skokie, Illinois 60077, United States
  • Local Institution - 0041
    Springfield, Illinois 62794-9677, United States
  • Local Institution - 0058
    Anderson, Indiana 46016, United States
  • Local Institution - 0011
    Indianapolis, Indiana 46237, United States
  • Local Institution
    Indianapolis, Indiana 46237, United States
  • Local Institute
    Sioux City, Iowa 51101, United States
  • Local Institute
    Louisville, Kentucky 40201, United States
  • Local Institution - 0042
    Louisville, Kentucky 40202, United States
  • Local Institution
    Lafayette, Louisiana 70503, United States
  • Local Institution
    Shreveport, Louisiana 71103, United States
  • Local Institution
    Minneapolis, Minnesota 55404, United States
  • Local Institution - 0030
    Woodbury, Minnesota 55125, United States
  • Local Institute
    Southaven, Mississippi 38671, United States
  • Local Institute
    Kansas City, Missouri 64132, United States
  • Local Institution - 0050
    Kansas City, Missouri 64132, United States
  • Local Institution - 0037
    Missoula, Missouri 59802, United States
  • Local Institute
    Saint Joseph, Missouri 64501, United States
  • Local Institution - 0020
    Springfield, Missouri 65804, United States
  • Local Institution
    Springfield, Missouri 65804, United States
  • Local Institution
    St Louis, Missouri 63110, United States
  • Local Institute
    Missoula, Montana 59802, United States
  • Local Institute
    Missoula, Montana 59807, United States
  • Local Institute
    Omaha, Nebraska 68124, United States
  • Local Institution - 0024
    Omaha, Nebraska 68124, United States
  • Local Institution - Canada
    No City Provided, New Jersey 00000, United States
  • Local Institution - France
    No City Provided, New Jersey 00000, United States
  • Local Institution - Germany
    No City Provided, New Jersey 00000, United States
  • Local Institution - Italy
    No City Provided, New Jersey 00000, United States
  • Local Institution - United Kingdom
    No City Provided, New Jersey 00000, United States
  • Local Institution - USA
    No City Provided, New Jersey 00000, United States
  • Local Institution - 0049
    Stony Brook, New York 11794, United States
  • Local Institute
    Cary, North Carolina 27518, United States
  • Local Institution - 0033
    Cary, North Carolina 27518, United States
  • Local Institution - 0010
    Gastonia, North Carolina 28054, United States
  • Local Institution
    Gastonia, North Carolina 28054, United States
  • Local Institute
    Canton, Ohio 44718, United States
  • Local Institution - 0022
    Canton, Ohio 44718, United States
  • Local Institute
    Cleveland, Ohio 44109-1900, United States
  • Local Institute
    Tulsa, Oklahoma 74136, United States
  • Local Institute
    Portland, Oregon 97200, United States
  • Local Institute
    Pottstown, Pennsylvania 19464, United States
  • Local Institute
    Charleston, South Carolina 29414, United States
  • Local Institution - 0016
    Charleston, South Carolina 29414, United States
  • Local Institute
    Knoxville, Tennessee 37920, United States
  • Local Institution
    Memphis, Tennessee 38120, United States
  • Local Institute
    Amarillo, Texas 79106, United States
  • Local Institute
    Corpus Christi, Texas 78350, United States
  • Local Institute
    Dallas, Texas 75229, United States
  • Local Institute
    Dallas, Texas 75231, United States
  • Local Institution - 0025
    Dallas, Texas 75231, United States
  • Local Institute
    Dallas, Texas 75390, United States
  • Local Institution - 0014
    Dallas, Texas 75390, United States
  • Local Institution - 0032
    Garland, Texas 75042, United States
  • Local Institute
    San Antonio, Texas 78217, United States
  • Local Institution - 0027
    San Antonio, Texas 78217, United States
  • Local Institute
    Sherman, Texas 75090, United States
  • Local Institute
    Seattle, Washington 98101, United States
  • Local Institute
    Spokane, Washington 99202, United States
  • Local Institution - 0026
    Spokane, Washington 99202, United States
  • Local Institute
    Yakima, Washington 98901, United States
  • Local Institute
    Yakima, Washington 98902, United States
  • Local Institution - 0031
    Yakima, Washington 98902, United States
  • Local Institute
    Toronto, Ontario M4N 3M5, Canada
  • Local Institution - 0066
    Toronto, Ontario M5G 2M9, Canada
  • Local Institute
    Weston, Ontario M9N 1N8, Canada
  • Local Institute
    Blois, France
  • Local Institute
    Chalon-sur-Saône, France
  • Local Institution - 0100
    La Roche-sur-Yon, 85925, France
  • Local Institute
    La Roche-sur-Yon, France
  • Local Institute
    Limoges, France
  • Local Institute
    Meaux, France
  • Local Institute
    Nantes, France
  • Local Institute
    Rennes, 35033, France
  • Local Institute
    Heidelberg, Baden-Wurttemberg 69120, Germany
  • Local Institute
    Hamm, North Rhine-Westphalia 59071, Germany
  • Local Institute
    Aschaffenburg, 63739, Germany
  • Local Institute
    Berlin, 10407, Germany
  • Local Institute
    Dresden, 01099, Germany
  • Local Institution - 0070
    Hamm, 59071, Germany
  • Local Institute
    Magdeburg, 39104, Germany
  • Local Institution - 0067
    Magdeburg, 39104, Germany
  • Local Institute
    München, Germany
  • Local Institute
    Rostock, Germany
  • Local Institution - 0085
    Wiesbaden, 65191, Germany

Showing the first 100 of 130 sites across 6 countries.

08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01838512
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Apr 24, 2013
Start date
Jun 13, 2012
Primary completion
Mar 31, 2030 (estimated)
Completion
Mar 31, 2030 (estimated)
Last update
Dec 2, 2025

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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