Tests elranatamab alone and with daratumumab in multiple myeloma after prior treatment
Tests elranatamab, with or without daratumumab, in adults with relapsed multiple myeloma.
Plain-language title generated from the registry record
Registry title: A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments
Key facts
- Where
- Bergen, Oslo, Stavanger, and Trondheim, NorwaySee the 4 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Which of these best describes your myeloma treatment so far?
- Have you ever taken lenalidomide (also called Revlimid), a tablet medicine for myeloma?
- Has a doctor told you that your myeloma can be measured in your blood or urine tests?
- Which describes how well you can look after yourself?
Source: NCT05020236, who can take part
Where in Norway
- Haukeland UniversitetssjukehusBergen, NorwayNo longer taking part
- Oslo University Hospital HF UllevaalOslo, NorwayNo longer taking part
- Helse Stavanger HFStavanger, NorwayNo longer taking part
- St. Olavs hospital HFTrondheim, NorwayNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Pfizer
- Trial code
- NCT05020236EU 2023-509208-14-00
- Record updated
- 24 August 2026
- Original description
The purpose of this clinical trial is to (1) learn whether the BCMA-CD3 bispecific antibody elranatamab can provide more benefit to people with multiple myeloma compared to a combination therapy including daratumumab, pomalidomide, and dexamethasone, and (2) learn about the safety and activity of elranatamab in combination with the anti-CD38 monoclonal antibody daratumumab. People with multiple myeloma who have received previous treatment including lenalidomide will be enrolled in the study.Read full original descriptionShow less
AN OPEN-LABEL, 3-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) MONOTHERAPY AND ELRANATAMAB + DARATUMUMAB VERSUS DARATUMUMAB + POMALIDOMIDE + DEXAMETHASONE IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST 1 PRIOR LINE OF THERAPY INCLUDING LENALIDOMIDE AND A PROTEASOME INHIBITOR
The purpose of this clinical trial is to (1) learn whether the BCMA-CD3 bispecific antibody elranatamab can provide more benefit to people with multiple myeloma compared to a combination therapy including daratumumab, pomalidomide, and dexamethasone, and (2) learn about the safety and activity of elranatamab in combination with the anti-CD38 monoclonal antibody daratumumab. People with multiple myeloma who have received previous treatment including lenalidomide will be enrolled in the study.
Part 1 of the study will assess the safety and activity of different doses of elranatamab in combination with daratumumab.
People participating in Part 2 of the study will be randomly assigned to receive either elranatamab alone, elranatamab plus daratumumab, or daratumumab, pomalidomide, and dexamethasone. Part 2 will evaluate the safety and activity of (1) elranatamab alone compared to daratumumab, pomalidomide, and dexamethasone, and (2) elranatamab plus daratumumab.
Part 3 will assess the effect of increased measures to protect against infection in people treated with either elranatamab alone or together with daratumumab.
All people participating in the study will receive study treatment until their disease progresses, they experience unacceptable side effects, or they choose to no longer participate in the study.
Inclusion: Prior diagnosis of multiple myeloma as defined by IMWG criteria (Rajkumar et al, 2014); Measurable disease based on IMWG criteria as defined by at least 1 of the following:; Serum M-protein ≥0.5 g/dL; Urinary M-protein excretion ≥200 mg/24 hours; Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65); Prior anti-multiple myeloma therapy including treatment with lenalidomide; ECOG performance status ≤2; Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1; Not pregnant and willing to use contraception.
Exclusion: Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease; Any other active malignancy within 3 years prior to enrolment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ; Previous treatment with a BCMA-directed therapy; Live attenuated vaccine within 4 weeks of the first dose of study intervention; Administration with an investigational product (e.g. drug or vaccine) concurrent with study intervention or within 30 days preceding the first dose of study intervention used in this study; POEMS Syndrome; Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection; Smoldering multiple myeloma; Plasma cell leukemia; Amyloidosis.