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

Bristol-Myers Squibb (BMS)

Status: Active, not recruiting

Conditions: Multiple Myeloma

Study type: Observational

Funder types: Industry

Identifiers

NCT01838512

CA204-008

Details and patient eligibility

About

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.

Enrollment: 2,555 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more 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)

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

Trial design

2,555 participants in 2 patient groups

Cohort 1

Description:

Participants with relapsed/refractory multiple myeloma (RRMM) followed up for up to 5 years

Cohort 2

Description:

Participants with newly-diagnosed multiple myeloma (NDMM) followed up for up to 8 years