Prospective Research Assessment in Multiple Myeloma: An Observational Evaluation (PREAMBLE)
Recruiting
- Conditions
- Multiple Myeloma
- Registration Number
- NCT01838512
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2555
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Survival (OS) for participants with newly-diagnosed multiple myeloma (NDMM) Up to 8 years Progression-Free Survival (PFS) for participants with NDMM Up to 8 years Overall Survival (OS) for participants with relapsed/refractory multiple myeloma (RRMM) Up to 5 years Progression-Free Survival (PFS) for participants with RRMM Up to 5 years
- Secondary Outcome Measures
Name Time Method 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-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 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
Trial Locations
- Locations (118)
Local Institution
🇬🇧Liverpool, United Kingdom
Local Institution - 0021
🇺🇸Birmingham, Alabama, United States
Local Institution - 0013
🇺🇸Muscle Shoals, Alabama, United States
Local Institute
🇬🇧Swansea, United Kingdom
Local Institution - 0023
🇺🇸Anaheim, California, United States
Local Institution - 0045
🇺🇸Burbank, California, United States
Local Institution - 0048
🇺🇸Downey, California, United States
Local Institution - 0052
🇺🇸Fountain Valley, California, United States
Local Institution - 0051
🇺🇸Santa Rosa, California, United States
Local Institution - 0057
🇺🇸Washington, District of Columbia, United States
Scroll for more (108 remaining)Local Institution🇬🇧Liverpool, United Kingdom