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Evaluating the effectiveness of multiple myeloma therapies in real-world settings

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

Observational Bristol-Myers Squibb · NCT01838512

This study is trying to see how well different approved treatments for multiple myeloma work in real life for patients who are starting treatment or have already been treated before.

Quick facts

Study typeObservational
Enrollment2555 (estimated)
Ages18 Years and up
SexAll
SponsorBristol-Myers Squibb Industry-sponsored
Drugs / interventionsCAR T
Locations198 sites (Birmingham, Alabama and 197 other locations)
Trial IDNCT01838512 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the clinical effectiveness of all approved therapies for multiple myeloma in both newly diagnosed and relapsed/refractory settings. It will collect real-world data from patients who have received at least one prior line of therapy or are starting frontline therapy. The study will document treatment strategies and outcomes to better understand how these therapies perform in everyday clinical practice. Participants will be monitored for their response to treatment and disease progression.

Who should consider this trial

Good fit: Ideal candidates include patients with newly diagnosed multiple myeloma or those with relapsed/refractory multiple myeloma who have received prior therapy.

Not a fit: Patients who have not been diagnosed with multiple myeloma or those who are not receiving any treatment for the condition may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness of multiple myeloma therapies, leading to improved treatment strategies for patients.

How similar studies have performed: Other observational studies have shown success in evaluating treatment effectiveness in real-world settings, suggesting this approach is promising.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Birmingham, Alabama and 197 other locations

+148 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Multiple Myeloma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.