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

Running, not enrolling

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID: NCT01838512
Run by: Bristol-Myers Squibb
People needed: 2555
Starts: 2012-06-13
Expected to finish: 2030-03-31
Last updated by the study team: 2025-12-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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 it is running

Local Institute — Goodyear, Arizona, United States
Local Institution - 0023 — Anaheim, California, United States
Local Institution — Anaheim, California, United States
Local Institution - 0045 — Burbank, California, United States
Local Institution — Corona, California, United States
Local Institution - 0048 — Downey, California, United States
Local Institution - 0052 — Fountain Valley, California, United States
Local Institute — Los Angeles, California, United States
Local Institute — Santa Rosa, California, United States
Local Institution - 0051 — Santa Rosa, California, United States
Local Institution — Brooksville, Florida, United States
Local Institution - 0044 — Fort Lauderdale, Florida, United States
Local Institution — Jacksonville, Florida, United States
Local Institute — Valdosta, Georgia, United States
Local Institution - 0047 — Valdosta, Georgia, United States
Local Institution — Skokie, Illinois, United States
Local Institution - 0041 — Springfield, Illinois, United States
Local Institution - 0058 — Anderson, Indiana, United States
Local Institution - 0011 — Indianapolis, Indiana, United States
Local Institution — Indianapolis, Indiana, United States
Local Institute — Sioux City, Iowa, United States
Local Institute — Louisville, Kentucky, United States
Local Institution - 0042 — Louisville, Kentucky, United States
Local Institution — Lafayette, Louisiana, United States
Local Institution — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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