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

Bristol-Myers Squibb51 sites in 6 countries2,555 target enrollmentJune 13, 2012

ConditionsMultiple Myeloma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Multiple Myeloma
Sponsor: Bristol-Myers Squibb
Enrollment: 2555
Locations: 51
Primary Endpoint: Overall Survival (OS) for participants with newly-diagnosed multiple myeloma (NDMM)
Status: Active, not recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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-world clinical practice.

Registry

clinicaltrials.gov

Start Date

June 13, 2012

End Date

March 31, 2030

Last Updated

5 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility 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:
•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:
•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

Outcomes

Primary Outcomes

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

Time Frame: Up to 8 years

Progression-Free Survival (PFS) for participants with NDMM

Time Frame: Up to 8 years

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

Time Frame: Up to 5 years

Progression-Free Survival (PFS) for participants with RRMM

Time Frame: Up to 5 years

Secondary Outcomes

Healthcare resource utilization (HCRU) for participants with NDMM(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)
Incidence of Adverse Events (AEs) for participants with RRMM(Up to 5 years)
Incidence of Adverse Events (AEs) for participants with NDMM(Up to 8 years)
Treatment patterns of approved MM therapies as measured by the Response Rate for participants with RRMM(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(From study index date until the enrollment date, assessed up to 8 years)
Healthcare resource utilization (HCRU) for participants with RRMM(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)
Patient reported outcomes as measured by EQ-5D summary index for participants with NDMM(From start of initial therapy to questionnaire completion, assessed up to 8 years)
Patient reported outcomes as measured by EQ-5D summary index for participants with RRMM(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(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(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(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(From start of initial therapy to questionnaire completion, assessed up to 5 years)