Prospective Research Assessment in Multiple Myeloma: An Observational Evaluation (PREAMBLE)
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- Full Title:
- Prospective Research Assessment in Multiple Myeloma: An Observational Evaluation (PREAMBLE)
- Myeloma stage or condition:
- Multiple Myeloma
- Study phase:
- Summary/Purpose:
- 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
- Treatments:
- Study Arms:
- : Cohort 1
Participants with relapsed/refractory multiple myeloma (RRMM) followed up for up to 5 years - : Cohort 2
Participants with newly-diagnosed multiple myeloma (NDMM) followed up for up to 8 years
- Study Type:
- Observational
- Study Design:
- Observational Model: Cohort
- Time Perspective: Prospective
- Recruitment status:
- Recruiting
- Eligibility criteria:
-
ore 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)
- 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
- Locations / Centres:
-
Local Institution - 0065, Toronto, Ontario – Withdrawn
Local Institute, Toronto, Ontario – Recruiting
Local Institution - 0066, Toronto, Ontario – Completed
Local Institute, Weston, Ontario – Recruiting
- Contacts:
- Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone: 855-907-3286
Email: [email protected]
- Publications:
- ???
- First posted:
- 2013-04-24
- Actual start date:
- June 13, 2012
- Last updated:
- 2023-02-16
- Estimated enrollment:
- 2555
- Estimated completion date:
- 2028-09-28
- Estimated primary completion date:
- 2028-09-28
- Condition:
- Multiple Myeloma
- Gender:
- All
- Ages:
- 18 Years-N/A
- Accepts healthy volunteers:
- No
- Listed location countries:
- Canada
- France
- Germany
- Italy
- United Kingdom
- United States
- NCT number:
- NCT01838512
- Other study ID numbers:
- CA204-008
- Has Data monitoring committee:
- No
- U.S. FDA-regulated product:
- Not available
- IPD Sharing Statement :
- ???
- Responsible party:
-
Sponsor
- Study sponsor:
- lead_sponsor
Bristol-Myers Squibb
Industry
- Collaborators:
- ???
- Investigators:
- Bristol-Myers Squibb Bristol-Myers Squibb
- Protocol Registration and Results System:
- ???
- Verification date:
- 2023-02-01