Non intervention
DrugNon intervention
NCT Number: NCT07391761
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?
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Observational
Kaohsiung Chang Gung Memorial Hospital, Kachsiung, Taiwan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients who participated in any prior clinical trials using elranatamab.
Non intervention
Time frame: 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.
Time frame: 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.
Time frame: From first response until 18 months
Time from the first documented real-world response to real-world disease progression, death, or end of study.
Time frame: From initiation of elranatamab treatment (index date) until 18 months
Time from index date to the first documented real-world disease progression or death.
Time frame: From initiation of elranatamab treatment (index date) until 18 months
Time from index date to death from any cause.
Time frame: 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.
Time frame: At baseline
Age (measured in years)
Time frame: From MM diagnosis until index date, and from index date until 18 months
sex/gender (male/female)
Time frame: At baseline
Height (in cm), weight (in kg), BMI (kg/m²),
Time frame: At baseline
Number and proportion of patients in each ECOG PS category (0-5)
Time frame: 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.
Time frame: At baseline
Baseline laboratory result of creatinine clearance (CrCl) categories (stages 1-5 or <30/≥30 mL/min)
Time frame: At baseline
Number and proportion of patients with prior ASCT, prior anti-MM therapies
Time frame: From the index date (initiation of elranatamab treatment) up to 18 months
Time from MM diagnosis to elranatamab initiation.
Time frame: 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.
Time frame: 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.
Pfizer
Industry
A Multi-center Observational Study of the Effectiveness of Elranatamab in Patients With Relapsed and/or Refractory Multiple Myeloma in Taiwan
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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