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The purpose of this study is to evaluate:
This study is seeking participants who:
Participants receive elranatamab according to the approved label in Taiwan and continue treatment until disease progression or discontinuation. The study will evaluate real-world effectiveness and describe patient characteristics and treatment patterns to better understand elranatamab use in routine care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elranatamab in Patients with Relapsed and/or Refractory Multiple Myeloma | Patients with Relapsed and/or Refractory Multiple Myeloma treated with Elranatamab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non intervention | Drug | Non intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| rwTTR (real-world time to response) | Time from index date to the first documented real-world response. | At 1 month, 3 months, 6 months, 9 months, 12 months, and 18 months following initiation of elranatamab treatment (index date.) |
| rwORR (real-world overall response rate) | Proportion of patients achieving real-world overall response at predefined assessment time points. | At 1 month, 3 months, 6 months, 9 months, 12 months, and 18 months following initiation of elranatamab treatment (index date.) |
| rwDOR (real-world duration of response） | Time from the first documented real-world response to real-world disease progression, death, or end of study. | From first response until 18 months |
| rwPFS (real-world progression-free survival) | Time from index date to the first documented real-world disease progression or death. | From initiation of elranatamab treatment (index date) until 18 months |
| rwOS (real world overall survival) | Time from index date to death from any cause. | From initiation of elranatamab treatment (index date) until 18 months |
| rwTTNT (real world time to next treatment) | Time from index date to initiation of the next line of anti-myeloma therapy or end of study. | From initiation of elranatamab treatment (index date) until 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic: Age | Age (measured in years) | At baseline |
| Demographic: Sex | sex/gender (male/female) | From MM diagnosis until index date, and from index date until 18 months |
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Inclusion criteria:
Exclusion criteria:
Patients who participated in any prior clinical trials using elranatamab.
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Study population will consist of RRMM patients who have initiated elranatamab in consistent with the local health authority approved product label
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Chang Gung Memorial Hospital | Kachsiung | 833 | Taiwan | |||
| Taichung Veterans General Hospital |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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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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| Anthropometric Measures | Height (in cm), weight (in kg), BMI (kg/m²), | At baseline |
| ECOG Performance Status | Number and proportion of patients in each ECOG PS category (0-5) | At baseline |
| Myeloma-related Clinical Characteristics | Baseline disease characteristics including myeloma type (IgG, non-IgG, light-chain, non-secretory), bone marrow plasma cell %, presence of EMD, ECOG status, CRAB symptoms, ISS/R-ISS stage, MGUS, SMM, and cytogenetic risk. | At baseline |
| Laboratory Characteristics | Baseline laboratory result of creatinine clearance (CrCl) categories (stages 1-5 or <30/≥30 mL/min) | At baseline |
| Prior Treatment History | Number and proportion of patients with prior ASCT, prior anti-MM therapies | At baseline |
| Time from Diagnosis and Line of Elranatamab Treatment | Time from MM diagnosis to elranatamab initiation. | From the index date (initiation of elranatamab treatment) up to 18 months |
| Elranatamab Discontinuation and Treatment Modifications | Number and proportion of patients with treatment discontinuation (and reasons), dosing or schedule modifications (excluding step-up), and switches from QW to Q2W after 6 cycles. | From the index date (initiation of elranatamab treatment) up to 18 months |
| Subsequent Treatments After Progression | Number and proportion of patients receiving subsequent treatments following first progression or discontinuation of elranatamab. | From the index date (initiation of elranatamab treatment) up to 18 months |
| Taichung |
| 40705 |
| Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Linkou Chang Gung Memorial Hospital | Taoyuan | 333 | Taiwan |
| 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 |