CompletedNot Applicable

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

United States514 participantsStarted 2023-06-01

Plain-language 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.

Who can participate

Age range18 Weeks

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Progression Free Survival (PFS): Study C1071003 Cohort A Versus RWD COTA Cohort- Using Unweighted Analysis

Timeframe: C1071003:First dose to confirmed PD/ death due to any cause or censoring whichever occurred first (maximum of 15 months);COTA:Initiation of first line post TCR MM to PD/ death due to any cause or censoring whichever occurred first (maximum of 64.3 months)

PFS: C1071003 Cohort A Versus COTA Cohort- Using Inverse Probability of Treatment Weights (IPTW)

PFS: Study C1071003 Cohort A Versus Flatiron Cohort - Using Unweighted Analysis

Timeframe: C1071003:First dose to confirmed PD/death due to any cause or censoring whichever occurred first(maximum of 15 months);Flatiron:Initiation of first line post TCR MM to PD/death due to any cause or censoring,whichever occurred first(maximum of 66.9 months)

PFS: Study C1071003 Cohort A Versus Flatiron Cohort - Using IPTW Analysis

Trial details

NCT IDNCT05932290

SponsorPfizer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-07-12

Results submitted2024-07-08

View on ClinicalTrials.gov More Multiple Myeloma trials