Clinical trial · Observational
Prospective Research Assessment in Multiple Myeloma: An Observational Evaluation (PREAMBLE)
NCT01838512CI-TRIAL-00098220active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Cohort 1
- description
- Participants with relapsed/refractory multiple myeloma (RRMM) followed up for up to 5 years
- label
- Cohort 2
- description
- Participants with newly-diagnosed multiple myeloma (NDMM) followed up for up to 8 years
Primary outcomes (4)
- measure
- Overall Survival (OS) for participants with relapsed/refractory multiple myeloma (RRMM)
- timeFrame
- Up to 5 years
- measure
- Overall Survival (OS) for participants with newly-diagnosed multiple myeloma (NDMM)
- timeFrame
- Up to 8 years
- measure
- Progression-Free Survival (PFS) for participants with RRMM
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.