At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Elranatamab (drug), Daratumumab (drug), Pomalidomide (drug), Dexamethasone (drug)
- How long the study runs
- Study runs about 67 months (dates as stated)
- About the drug or intervention
- Elranatamab — drug: subcutaneous · Daratumumab — drug: Daratumumab / hyaluronidase, subcutaneous · Pomalidomide — drug: oral · Dexamethasone — drug: oral
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at a medicine called elranatamab, taken on its own or together with another medicine called daratumumab, in people with multiple myeloma (a blood cancer) who have already had other treatments, including lenalidomide. The study is funded by Pfizer.
Who can take part
- You have been diagnosed with multiple myeloma
- Your disease can be measured using standard blood and urine tests
- You have already had treatment for multiple myeloma, including a medicine called lenalidomide
- You are able to carry out day-to-day activities, at least with some help (performance status of 2 or better)
- You have recovered from side effects of earlier treatments
- You are not pregnant and are willing to use contraception
Who may not be able to
- You have smouldering multiple myeloma (an early form that often needs no treatment)
- You have plasma cell leukaemia, amyloidosis, or POEMS syndrome (related conditions)
- You have had a stem cell transplant in the last 12 weeks, or have active graft versus host disease
- You have an active infection such as hepatitis B, hepatitis C, HIV, COVID-19, or another uncontrolled infection
- You have had another cancer in the last 3 years, apart from some treated skin cancers
- You have previously had treatment that targets BCMA (a protein on myeloma cells)
- You have had a live vaccine in the last 4 weeks
- You are taking another experimental drug or vaccine now, or did so in the last 30 days
What taking part involves
- • Taking the study medicine elranatamab, either on its own or together with daratumumab
Time commitment: Not stated — ask the trial team about how many visits are needed, how long the study lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 893
- Started
- 2021-10-04
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for multiple myeloma
- • Phase3 - 893 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with multiple myeloma
Where?
- • Bournemouth - Royal Bournemouth Hospital
- • Oxford - Churchill Hospital, Oxford University Hospitals NHS Foundation Trust
- • Cardiff - University Hospital of Wales
- • Bristol - Bristol Haematology and Oncology Centre
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
- How fit you need to be: ECOG 2 or better
Treatment history
Treatments you must have had:
- ✓ to baseline severity
What the study is looking for
- ✓Prior diagnosis of multiple myeloma as defined by IMWG criteria (Rajkumar et al, 2014).
- ✓cancer that can be measured on scans 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...
Who cannot take part
- ✗Smoldering multiple myeloma.
- ✗Plasma cell leukemia.
- ✗Amyloidosis.
- ✗POEMS Syndrome.
- ✗Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease.
See the full criteria
Where Is This Study? (6 UK sites)
Royal Bournemouth Hospital
Bournemouth BH7 7DW, United Kingdom
Research Development & Support
clinicalresearch@bournemouth.ac.uk01202 961200Churchill Hospital, Oxford University Hospitals NHS Foundation Trust
Oxford OX3 7LE, United Kingdom
University Hospital of Wales
Cardiff CF14 4XW, United Kingdom
Bristol Haematology and Oncology Centre
Bristol BS2 8ED, United Kingdom
Kent and Canterbury Hospital
Canterbury CT1 3NG, United Kingdom
Caroline Cowley, Research & Innovation/Clinical Trials Unit Manager
ekhuft.researchandinnovation@nhs.net01227 783169The Christie NHS Foundation Trust
Manchester M20 4BX, United Kingdom
How to Get in Touch
Pfizer CT.gov Call Center
Sponsor contactCONTACT
