A Real World Study of Elranatamab in Patients With RR Multiple Myeloma in Taiwan

N/ANot Yet RecruitingNCT07391761

Pfizer30 enrolled

Overview

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 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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Refractory Multiple Myeloma (RRMM)

Interventions

Non interventionDRUG

Non intervention

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Taichung Veterans General Hospital

Taichung, Taiwan

Outcomes

Primary Outcomes

rwTTR (real-world time to response)

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.)

rwORR (real-world overall response rate)

Proportion of patients achieving real-world overall response at predefined assessment time points.

Time frame: 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.

Time frame: 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.

Time frame: From initiation of elranatamab treatment (index date) until 18 months

rwOS (real world overall survival)

Time from index date to death from any cause.

Time frame: 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.

Time frame: From initiation of elranatamab treatment (index date) until 18 months

Secondary Outcomes

Demographic: Age

Age (measured in years)

Central Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Data from ClinicalTrials.gov

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