An International, Multicenter, Non-interventional Post-Authorization Safety Study to Evaluate the Effectiveness and Safety of Elranatamab in Patients with Relapsed/Refractory Multiple Myeloma (RRMM) treated in Real-World Settings (MagnetisMM-16)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/106402
• EU PAS number:
  EUPAS106401
• Study ID:
  106402
• Official title and acronym:
  An International, Multicenter, Non-interventional Post-Authorization Safety Study to Evaluate the Effectiveness and Safety of Elranatamab in Patients with Relapsed/Refractory Multiple Myeloma (RRMM) treated in Real-World Settings (MagnetisMM-16)
• DARWIN EU® study:
  No
• Study countries:
  Brazil

  Germany

  Italy

  Spain

  United Kingdom
• Study description:
  This prospective, international, longitudinal cohort study will evaluate the effectiveness and safety of elranatamab in routine clinical practice in patients 18 years and older. Approximately 198 patients will be recruited from primary care centers, hematology/oncology clinics, and academic centers in the Germany, the United Kingdom, Brazil, Spain and Italy. Each patient’s treatment will be consistent with routine practice, at the discretion of the treating physician and according to the local Health Authority approved product label. After Health Authority approval, multiple myeloma patients receiving at least one dose of elranatamab who satisfy the inclusion and exclusion criteria may be enrolled. Patients will be followed prospectively for up to 3 years after enrollment in the study or until withdrawal, physician discretion, loss to follow-up, death, or study termination, whichever occurs the earliest.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Pfizer

IQVIA

United Kingdom

iOMEDICO

Germany

Study timelines

Date when funding contract was signed

Planned: 04/04/2023

Actual: 27/07/2023

Study start date

Planned: 01/11/2023

Actual: 09/07/2024

Data analysis start date

Planned: 30/08/2029

Date of final study report

Planned: 24/11/2029

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

C1071016_Protocol_Elranatamab NIS_V1.0_31Aug2023_FINAL_redacted.pdf

Updated protocol

C1071016_Protocol_Elranatamab NIS_V2.0_04Jun2024_FINAL_Signed_Redacted.pdf

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable