Non Interventional Study to Investigate the Safety and Effectiveness in Patients With Relapsed and Refractory Multiple Myeloma Treated With Elranatamab Under the Actual Use.

ELREXFIO SPECIAL INVESTIGATION- INVESTIGATION ON LONG-TERM TREATMENT -

To investigate the safety and efficacy in patients with relapsed and refractory multiple myeloma treated with elranatamab under the actual use.

Study Overview

• Status: Active, not recruiting
• Conditions: Relapsed and Refractory Multiple Myeloma (RRMM)

Detailed Description

The objective of this study is to assess the safety and efficacy in patients with relapsed and refractory multiple myeloma (RRMM) treated with elranatamab under the actual use.

• Primary objective: Confirm whether the onset status (the number of patients, incidence, grade, seriousness, timing of onset, duration, treatment and outcome) of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) is comparable to that in the clinical studies and whether adverse reactions were appropriately treated.
• Secondary objective: Confirm the onset status of any adverse reaction (including unknown adverse reaction) to long-term treatment with elranatamab and the overall response (ORR) as efficacy assessment and evaluate them in terms of benefit-risk.

Conditions for approval; Because of the extremely limited number of patients treated in Japanese clinical studies, a drug use investigation in all patients should be conducted to understand the background information of patients on elranatamab, early collect data on the safety and efficacy of elranatamab, and take measures necessary for the proper use of elranatamab until the data of a certain number of patients are accumulated.

• Study Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Pfizer

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

All of the patients who satisfy all of the registration criteria in all the institutions to which elranatamab is delivered based on the conditions for approval are subject to this study.

registration criteria ;Patients who have received at least one dose of elranatamab.

Description

Inclusion Criteria:

Patients who have received at least one dose of elranatamab.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of CRS events in adverse drug reaction	An adverse drug reaction (ADR) in cytokine release syndrome (CRS) was any untoward medical occurrence attributed to Elrexfo in a participant who received this drug. A serious ADR (SADR) was an ADR resulting in any of the following out comes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Elrefxio was assessed by the physician.	up to 52 weeks
Incidence of ICANS events in adverse drug reaction	An adverse drug reaction (ADR) in immune effector cell-associated neurotoxicity syndrome (ICANS) was any untoward medical occurrence attributed to Elrexfo in a participant who received this drug. A serious ADR (SADR) was an ADR resulting in any of the following out comes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Elrefxio was assessed by the physician.	up to 52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with objective response rate (ORR)	Defined as stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR)	up to 52 weeks
Incidence of other adverse drug reactions (ADRs)	An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Elrexfo in a participant who received this drug. A serious ADR (SADR) was an ADR resulting in any of the following out comes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Elrefxio was assessed by the physician.	up to 52 weeks

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 (Actual): July 30, 2024
• Primary Completion (Estimated): February 25, 2027
• Study Completion (Estimated): February 25, 2027

Study Registration Dates

• First Submitted: June 24, 2024
• First Submitted That Met QC Criteria: June 24, 2024
• First Posted (Actual): June 28, 2024

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: October 1, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: RRMM
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Neoplasms; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Recurrence; Multiple Myeloma
• Other Study ID Numbers: C1071010

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.