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Primary Objective:
1. To describe the distribution of treatment regimens and objective response rate (ORR) in a Benchmark Cohort of real-world patients with relapsed/refractory multiple myeloma (RRMM) who initiate treatment after meeting the following criteria: (1) have either (a) at least three prior lines (3L) and are triple-class exposed (TCE), or (b) are triple-class refractory (TCR), and (2) meet similar inclusion/exclusion criteria to patients in phase 2 cohort 2 of the R5458-ONC-1826 (NCT03761108) trial.
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Real-world (RW) patients with RRMM who have either at least three prior lines of therapy (LOT) and are triple-class exposed (3L+/TCE), or are triple-class refractory (TCR), meet similar inclusion/exclusion criteria used to establish phase 2 cohort 2 of the R5458-ONC-1826 trial, and are initiating currently available therapies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional | Other | No study treatment will be administered on this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients exposed to each type of regimen by line of therapy (LOT) | Distribution of treatment regimens | Up to 6 years |
| Proportion of patients with objective response rate (ORR) | Defined as stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) | Up to 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of response (DOR) | Defined as time from the date of the first documented response (best overall response of sCR, CR, VGPR, PR) until the first date of progressive disease (PD) by International Myeloma Working Group (IMWG) or death due to any cause, whichever occurs first. | Up to 6 years |
| Progression-free survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other protocol-defined Inclusion/Exclusion criteria apply
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Patients with RRMM who have either at least three prior lines of therapy (LOT) and are triple-class exposed (3L+/TCE), or are triple-class refractory (TCR).
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regeneron Research Facility | Tarrytown | New York | 10591 | United States |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054219 | Neoplasms, Plasma Cell |
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Defined as time from the start of study treatment until the first date of PD by IMWG, or death due to any cause, whichever occurs first. |
| Up to 6 years |
| Overall survival (OS) | OS is measured from the start of study treatment until death due to any cause. | Up to 6 years |
| Time to next treatment (TTNT) | Defined as time from the start of study treatment until the initiation of the subsequent LOT. | Up to 6 years |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| 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 |