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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pomalidomide-containing regimens | Participants who initiated daratumumab, pomalidomide, and dexamethasone (DPd) or carfilzomib, pomalidomide, and dexamethasone (KPd) index regimens in the 2L or 3L setting after prior exposure to lenalidomide and a proteasome inhibitor. |
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| Non-pomalidomide-containing regimens | Participants who initiated daratumumab, lenalidomide, and dexamethasone (DRd), or daratumumab, bortezomib, and dexamethasone (DVd), or daratumumab, carfilzomib, and dexamethasone (DKd) index regimens in the 2L or 3L setting after prior exposure to lenalidomide and a proteasome inhibitor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pomalidomide-containing regimens | Drug | Exposure to pomalidomide-containing index regimens, including daratumumab, pomalidomide, and dexamethasone (DPd) and carfilzomib, pomalidomide, and dexamethasone (KPd), administered in routine clinical practice. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | TTNT is defined as the time from initiation of the pomalidomide-containing index regimen to initiation of the next subsequent line of therapy. | Up to 6 years |
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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:
Daratumumab, pomalidomide, and dexamethasone (DPd)
Carfilzomib, pomalidomide, and dexamethasone (KPd)
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
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
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Adults with relapsed/refractory multiple myeloma treated in the OneOncology United States database who previously received both a lenalidomide-containing regimen and a proteasome inhibitor and subsequently initiated specified pomalidomide-containing or non-pomalidomide-containing regimens in the second-line or third-line setting.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OneOncology Network | Nashville | Tennessee | 37219 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| Non-pomalidomide-containing regimens | Drug | 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. |
|
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |