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OpenTrials
Completed

NCT Number: NCT06592222

A Study to Learn About the Effectiveness of the Medicine Called Elranatamab in People With Relapsed Refractory Multiple Myeloma as Compared With Standard of Care Therapies

This study is to understand how well elranatamab (PF-06863135) may be used for relapsed refractory multiple myeloma (RRMM). Sometimes MM might improve at first, but then gets resistant to the treatment and starts growing again (known as relapsed refractory). This study medicine will be compared with standard-of-care (SOC) therapies used in real-world clinical practice. For people receiving elranatamab, the investigators will use data from the phase 2 clinical trial (MagnetisMM-3). The investigators will also use data from a real-world data source, representing the SOC in clinical practice. This study does not seek any participants for enrollment. The investigators will compare the experiences of people receiving elranatamab to people receiving SOC therapies. This way, it will help the investigators to know how well elranatamab can be used for RRMM treatment.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer

New York, 10001, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 18 years and older at index date
  • Diagnosis of MM
  • Measurable disease according to IMWG criteria
  • ECOG performance status ≤2
  • Refractory to at least 1 proteasome inhibitor, 1 immunomodulatory drug, and 1 anti-CD38 treatment (ie, triple-class refractory [TCR])
  • At least 1 treatment following their TCR eligibility

Exclusion criteria

  • Acute plasma cell leukemia
  • Amyloidosis
  • Smoldering MM
  • Stem cell transplant within 12 weeks of index or active graft versus host disease (GVHD)
  • Active malignancy within 3 years before index, except for basal cell or squamous cell skin cancer or carcinoma in situ
  • Administration with an investigational drug within 30 days prior to index

Treatment and study plan

Elranatamab

Drug

BCMA-CD3 bispecific antibody

Standard of care

Drug

Standard of care

Primary outcomes

  1. Progression-free survival

    Time frame: From the index therapy start until progression or death due to any cause, whichever occurs first, assessed up to 6 years

Secondary outcomes

  1. Overall surival

    Time frame: From the index therapy start until death due to any cause assessed up to 6 years

  2. Duration of response

    Time frame: From the first documentation of objective response until progression or death due to any cause, whichever occurs first, assessed up to 6 years

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Comparative Effectiveness of Elranatamab in Clinical Study C1071003 Versus Physician's Choice of Treatment (PCT) in Real-World (RW) External Control Arms in Patients With Triple-Class Refractory (TCR) Multiple Myeloma (MM)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
May 20, 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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