A Study to Learn About the Effectiveness of the Medicine Called Elranatamab in People With Relapsed Refractory Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

Comparative Effectiveness of Elranatamab (PF-06863135) in Clinical Study C1071003 Versus Standard of Care (SOC) in Real-World (RW) External Control Arms in Patients With Triple-Class Refractory (TCR) Multiple Myeloma (MM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05932290
• Other study ID #: C1071031
• Status: Completed
• Start date: June 1, 2023
• Est. completion date: July 12, 2023

Study information

• Verified date: December 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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 multiple real-world sources, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: July 12, 2023
• Est. primary completion date: July 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Elranatamab
BCMA-CD3 bispecific antibody
• Standard of care
Standard of care

Locations

Country	Name	City	State
United States	Pfizer	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	Time from the index therapy start until confirmed progression or death due to any cause, whichever occurs first	From the index therapy start until confirmed progression or death due to any cause, whichever occurs first, assessed up to 6 years
Secondary	Overall survival	Time from the index therapy start until death due to any cause	From the index therapy start until death due to any cause, whichever occurs first, assessed up to 6 years

External Links

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