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NCT Number: NCT06479954

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Relapsed and Refractory Multiple Myeloma (RRMM) Blood Protein Disorders Cardiovascular Diseases Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Vascular Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer

Tokyo, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients who have received at least one dose of elranatamab.

Treatment and study plan

Primary outcomes

  1. Incidence of CRS events in adverse drug reaction

    Time frame: up to 52 weeks

    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.

  2. Incidence of ICANS events in adverse drug reaction

    Time frame: up to 52 weeks

    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.

Secondary outcomes

  1. Proportion of patients with objective response rate (ORR)

    Time frame: up to 52 weeks

    Defined as stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR)

  2. Incidence of other adverse drug reactions (ADRs)

    Time frame: up to 52 weeks

    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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

ELREXFIO SPECIAL INVESTIGATION- INVESTIGATION ON LONG-TERM TREATMENT -

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 28, 2024
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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