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

Study Overview
=================
Brief 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 2 clinical trial (MagnetisMM-3). We will also use data from two real-world databases, 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.

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)

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: Elranatamab
* Drug: Standard of care


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Elranatamab<br>Patients treated with elranatamab from the MagnetisMM-3 trial | Drug: Elranatamab<br>* BCMA-CD3 bispecific antibody<br>|
| Standard of care<br>Patients treated with standard-of-care therapies from real-world data sources | Drug: Standard of care<br>* Standard of care<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate | Objective response rate (International Myeloma Working Group [IMWG] response criteria) | assessed over at least the first 9 months from index therapy start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to response | Time to response (IMWG response criteria) | assessed over at least the first 9 months from index therapy start | 
| Duration of response | Duration of response (IMWG response criteria) | assessed over at least the first 9 months from index therapy start | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myeloma, Multiple Myeloma, relapsed Multiple Myeloma, refractory Multiple Myeloma, PF-06863135, BCMA, bispecific, bispecific antibody, BCMA-CD3 bispecific, Elranatamab, MagnetisMM-3