Clinical trial · Observational
A Study to Compare the Effects of Elranatamab (PF 06863135) Versus Standard of Care (SOC) in Patients With Multiple Myeloma (MM) in Germany and US
Comparative Effectiveness of Elranatamab (PF 06863135) in Clinical Study C1071003 Versus Standard of Care (SOC) in a Real-World (RW) External Control Arm of Patients With Triple-Class Refractory (TCR) Multiple Myeloma (MM) From TherapyMonitor MM Germany
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to understand how well elranatamab (PF-06863135) may be used for relapsed refractory multiple myeloma (RRMM). MM is a type of cancer that begins in plasma cells (white blood cells that produce antibodies). 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. SOC are treatments that are accepted by medical experts as a proper treatment for a certain type of disease and that are widely used by doctors in real world. For people receiving elranatamab, the study doctors will use data from the other clinical trial (MagnetisMM-3). The study doctors will also use data from multiplemany real-world sources (TherapyMonitor MM Germany and Flatiron Health), for SOC in clinical practice. This study does not seek any participants for enrollment. The study doctors will compare the experiences of people receiving elranatamab to people receiving SOC therapies. This way, it will help the study doctors to know how well elranatamab can be used for RRMM treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Elranatamab | Drug | Elranatamab | ALIAS |
| Standard of Care | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Elranatamab
- description
- Patient cohort treated with elranatamab, coming form clinical trial Magnetis MM-3 trial
- interventionNames
- Drug: Elranatamab
- label
- Standard-of-care
- description
- Patients treated with the standard-of-care therapies according to G-BA's definition will come from real-world data sources
- interventionNames
- Drug: Standard of Care
Primary outcomes (2)
- measure
- Overall Survival (OS): C1071003 Cohort A Versus TM-MM Database Using Inverse Probability of Treatment Weights (IPTW) Analysis
- timeFrame
- C1071003: First dose to death due to any cause or censoring whichever occurred first (maximum [max] follow-up of 2.09 years [Y]); TM-MM Database: SOC to death due to any cause or censoring whichever occurred first (max follow-up of 4.22Y)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 according to G-BA's definition of standard of care 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 1st treatment following TCR eligibility not according to G-BA's definition of standard of care
References
Publications (0)
Data not yet available