Relapsed/Refractory Multiple Myeloma
Conditions
Keywords
Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
Brief summary
This retrospective observational study will use data from the OneOncology United States database to evaluate clinical outcomes in adults with relapsed/refractory multiple myeloma who received pomalidomide-containing or non-pomalidomide-containing treatment as second-line or third-line therapy after prior exposure to lenalidomide and a proteasome inhibitor.
Interventions
DRUGPomalidomide-containing regimens
Exposure to pomalidomide-containing index regimens, including daratumumab, pomalidomide, and dexamethasone (DPd) and carfilzomib, pomalidomide, and dexamethasone (KPd), administered in routine clinical practice.
DRUGNon-pomalidomide-containing regimens
Exposure to non-pomalidomide-containing index regimens, including daratumumab, lenalidomide, and dexamethasone (DRd), daratumumab, bortezomib, and dexamethasone (DVd), and daratumumab, carfilzomib, and dexamethasone (DKd), administered in routine clinical practice.
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a diagnosis of multiple myeloma (ICD-9: 203.00; ICD-10: C90.0x, C90) * Are ≥18 years of age at the index date * Have received a lenalidomide-containing regimen and received a proteasome inhibitor; exposures do not need to occur within the same line of therapy * Have received ≥1 subsequent lines of therapy after lenalidomide and proteasome inhibitor exposure * Have received one of the following treatment regimens as the subsequent line (index line) after lenalidomide and proteasome inhibitor exposure: * Pomalidomide-containing regimens: * Daratumumab, pomalidomide, and dexamethasone (DPd) * Carfilzomib, pomalidomide, and dexamethasone (KPd) * Non-pomalidomide-containing regimens: * Daratumumab, lenalidomide, and dexamethasone (DRd; lenalidomide-refractory participants only) * Daratumumab, bortezomib, and dexamethasone (DVd) * Daratumumab, carfilzomib, and dexamethasone (DKd)
Exclusion criteria
* Have \<6 months of follow-up from the index date; participants who died will be included even with \<6 months follow-up, but participants who died within 1 month after the index date will be excluded * Have \<6 months pre-index enrollment * Have other primary cancer diagnoses within 1 year pre-index * Excluded ICD-10 diagnosis codes: C00.xx-C76.xx, C7A, C80.xx-C88.xx, C91.xx-C96.xx, D00.xx-D09.xx, D37.xx-D47.1x, D47.3x-D49.xx * Excluded ICD-9 diagnosis codes: 149.x through 239.x * ICD codes 209.4, 209.5, 209.6, 209.7, D47.Z1, D47.Z2, and D3A will not be excluded * Received chimeric antigen receptor T-cell therapy or bispecific antibody therapy before index date or as the index line * Have ever enrolled in a clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) among participants who initiated pomalidomide-containing index regimens | Up to 6 years | — |
| Overall Survival (OS) among participants who initiated pomalidomide-containing index regimens | Up to 6 years | — |
| Overall Response Rate (ORR) among participants who initiated pomalidomide-containing index regimens | Up to 6 years | — |
| Time to Next Treatment (TTNT) among participants who initiated pomalidomide-containing index regimens | Up to 6 years | TTNT is defined as the time from initiation of the pomalidomide-containing index regimen to initiation of the next subsequent line of therapy. |
Countries
United States
Contacts
STUDY_DIRECTORBristol Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed