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

NCT06479954 | Active Not Recruiting

• 1 other identifier: C1071010
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Relapsed and Refractory Multiple Myeloma (RRMM)

Keywords

RRMM

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Proportion of patients with objective response rate (ORR)

  up to 52 weeks

• Incidence of other adverse drug reactions (ADRs)

  up to 52 weeks

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients who have received at least one dose of elranatamab.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

Tokyo, Japan

Location

Related Links

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

MeSH Terms

Conditions

Recurrence; Multiple Myeloma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: June 28, 2024
• Study Start: July 30, 2024
• Primary Completion (Estimated): February 25, 2027
• Study Completion (Estimated): February 25, 2027
• Last Updated: October 2, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)