Refractory Multiple Myeloma (RRMM)
Conditions
Brief summary
The purpose of this study is to evaluate: * What is the real-world effectiveness of elranatamab in patients with relapsed and/or refractory multiple myeloma (RRMM) in Taiwan? * What are the baseline and clinical characteristics of RRMM patients who have received eltanatamab in Taiwan? * What are the treatment patterns of RRMM patients receiving elranatamab in the real-world setting in Taiwan?
Detailed description
This study is seeking participants who: * have relapsed or refractory multiple myeloma (RRMM), * have received at least four prior lines of therapy (including a PI, an IMiD, and an anti-CD38 antibody), * are 18 years or older. 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.
Interventions
DRUGNon intervention
Non intervention
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients age ≥ 18 years at the initiation of elranatamab 2. Patients who have received at least one dose of elranatamab in consistent with the approved label in Taiwan. 3. Evidence of a personally signed and dated informed consent document (ICD) indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. The ICD waiver is acceptable for patient who was ceased before recruitment.
Exclusion criteria
Patients who participated in any prior clinical trials using elranatamab.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| rwTTR (real-world time to response) | At 1 month, 3 months, 6 months, 9 months, 12 months, and 18 months following initiation of elranatamab treatment (index date.) | Time from index date to the first documented real-world response. |
| rwORR (real-world overall response rate) | At 1 month, 3 months, 6 months, 9 months, 12 months, and 18 months following initiation of elranatamab treatment (index date.) | Proportion of patients achieving real-world overall response at predefined assessment time points. |
| rwDOR (real-world duration of response） | From first response until 18 months | Time from the first documented real-world response to real-world disease progression, death, or end of study. |
| rwPFS (real-world progression-free survival) | From initiation of elranatamab treatment (index date) until 18 months | Time from index date to the first documented real-world disease progression or death. |
| rwOS (real world overall survival) | From initiation of elranatamab treatment (index date) until 18 months | Time from index date to death from any cause. |
| rwTTNT (real world time to next treatment) | From initiation of elranatamab treatment (index date) until 18 months | Time from index date to initiation of the next line of anti-myeloma therapy or end of study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Demographic: Age | At baseline | Age (measured in years) |
| Demographic: Sex | From MM diagnosis until index date, and from index date until 18 months | sex/gender (male/female) |
| Anthropometric Measures | At baseline | Height (in cm), weight (in kg), BMI (kg/m²), |
| ECOG Performance Status | At baseline | Number and proportion of patients in each ECOG PS category (0-5) |
| Myeloma-related Clinical Characteristics | At baseline | 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. |
| Laboratory Characteristics | At baseline | Baseline laboratory result of creatinine clearance (CrCl) categories (stages 1-5 or \<30/≥30 mL/min) |
| Prior Treatment History | At baseline | Number and proportion of patients with prior ASCT, prior anti-MM therapies |
| Time from Diagnosis and Line of Elranatamab Treatment | From the index date (initiation of elranatamab treatment) up to 18 months | Time from MM diagnosis to elranatamab initiation. |
| Elranatamab Discontinuation and Treatment Modifications | From the index date (initiation of elranatamab treatment) up to 18 months | 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. |
| Subsequent Treatments After Progression | From the index date (initiation of elranatamab treatment) up to 18 months | Number and proportion of patients receiving subsequent treatments following first progression or discontinuation of elranatamab. |
Countries
Taiwan
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed