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

Last updated: October 1, 2025
Sponsor: Pfizer
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Bone Diseases

Leukemia

Multiple Myeloma

Treatment

N/A

Clinical Study ID

NCT06479954
C1071010
  • Ages > 16
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patients who have received at least one dose of elranatamab.

Study Design

Total Participants: 1
Study Start date:
July 30, 2024
Estimated Completion Date:
February 25, 2027

Study 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.

Connect with a study center

  • Pfizer

    Tokyo,
    Japan

    Site Not Available

  • Pfizer

    Tokyo 1850147,
    Japan

    Site Not Available

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