Multiple Myeloma
Conditions
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.
Interventions
None listed
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) for participants with relapsed/refractory multiple myeloma (RRMM) | Up to 5 years |
| Overall Survival (OS) for participants with newly-diagnosed multiple myeloma (NDMM) | Up to 8 years |
| Progression-Free Survival (PFS) for participants with RRMM | Up to 5 years |
| Progression-Free Survival (PFS) for participants with NDMM | Up to 8 years |
Secondary
| Measure | Time frame |
|---|---|
| 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 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 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 | Up to 5 years |
| Healthcare resource utilization (HCRU) for participants with NDMM | Up to 8 years |
Countries
Canada, France, Germany, Italy, United Kingdom, United States
Outcome results
None listed