Status:
ACTIVE_NOT_RECRUITING
Prospective Research Assessment in Multiple Myeloma: An Observational Evaluation (PREAMBLE)
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Brief 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-w...
Eligibility Criteria
Inclusion
- For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
- 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
- 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
Key Trial Info
Start Date :
June 13 2012
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2030
Estimated Enrollment :
2555 Patients enrolled
Trial Details
Trial ID
NCT01838512
Start Date
June 13 2012
End Date
March 31 2030
Last Update
December 2 2025
Active Locations (130)
Enter a location and click search to find clinical trials sorted by distance.
1
Local Institution
Birmingham, Alabama, United States, 35213
2
Local Institute
Goodyear, Arizona, United States, 85338
3
Local Institution - 0023
Anaheim, California, United States, 92801
4
Local Institution
Anaheim, California, United States, 92801