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NCT07927023
A Study to Learn About a Medicine (Called Elranatamab) in People With Relapsed Refractory Multiple Myeloma
Conditions: Multiple Myeloma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 1
Sponsor: Pfizer
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, we will use data from the phase 3 clinical trial (MagnetisMM-5). We will also use data from a real-world database, representing the SOC in clinical practice. This study does not seek any participants for enrollment. We will compare the experiences of people receiving elranatamab to people receiving SOC therapies. This way, it will help us to know how well elranatamab can be used for RRMM treatment.
Eligibility Criteria
To maximize comparability, the eligibility criteria for the participants from MagnetisMM-5 trial will be applied to patients from the RWD source, as feasible.
Inclusion Criteria:
* Male or Female aged 18 years and older at index date
* Diagnosis of MM
* Measurable disease according to IMWG criteria
* Prior anti-MM therapy (1-3 prior lines of therapy)
* ECOG performance status ≤2
Exclusion Criteria:
* Acute plasma cell leukemia
* Amyloidosis
* Smoldering MM
* Stem cell transplant within 12 weeks of index or active graft versus host disease (GVHD)
* Ongoing Grade 2 or higher peripheral sensory or motor neuropathy.
* Active systemic infection or SARS-CoV-2 viral infection
* Active malignancy within 3 years before index, except for basal cell or squamous cell skin cancer or carcinoma in situ
* Other surgical, medical, or psychiatric conditions including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study
* Previous treatment with a BCMA-directed therapy or a CD3-redirecting therapy.
* Anti-CD38-directed therapy within 6 months preceding the first dose of treatment in this study
* Refractory to prior anti-CD38-directed therapy (disease progression while on or within 60 days of the last dose of any anti-CD38-directed therapy or failure to achieve at least MR).
* Previous pomalidomide therapy
* Administration with an investigational drug within 30 days prior to index
* For women of childbearing potential: Pregnancy test positive at screening
Source: ClinicalTrials.gov (NCT07927023). StuddyBuddy aggregates publicly available trial information.