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

A Multi-center Observational Study of the Effectiveness of Elranatamab in Patients With Relapsed and/or Refractory Multiple Myeloma in Taiwan

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?

Study Overview

• Status: Not yet recruiting
• Conditions: Refractory Multiple Myeloma (RRMM)
• Intervention / Treatment: Drug: Non intervention

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.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• Taiwan
  • Kachsiung, Taiwan, 833
    • Kaohsiung Chang Gung Memorial Hospital
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taoyuan, Taiwan, 333
    • Linkou Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Study population will consist of RRMM patients who have initiated elranatamab in consistent with the local health authority approved product label

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Elranatamab in Patients with Relapsed and/or Refractory Multiple Myeloma; Patients with Relapsed and/or Refractory Multiple Myeloma treated with Elranatamab	Drug: Non intervention; Non intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: January 29, 2026
• First Posted (Actual): February 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma
• Other Study ID Numbers: C1071049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No