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Looking for participantsPhase3

A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments

Sponsor: Pfizer

NCT ID: NCT05020236

View on ClinicalTrials.gov ↗

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.

Multiple Myeloma

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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
Inclusion Criteria: * 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 Criteria: * Smoldering multiple myeloma. * Plasma cell leukemia. * Amyloidosis. * POEMS Syndrome. * Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease. * Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection. * 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.

Where Is This Study? (6 UK sites)

Royal Bournemouth Hospital

Bournemouth BH7 7DW, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Research Development & Support

clinicalresearch@bournemouth.ac.uk01202 961200

Churchill Hospital, Oxford University Hospitals NHS Foundation Trust

Oxford OX3 7LE, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Shahista Hussain

ouhtma@ouh.nhs.uk---

University Hospital of Wales

Cardiff CF14 4XW, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Elen de Lacy

PHW.Research@wales.nhs.uk02920 104468

Bristol Haematology and Oncology Centre

Bristol BS2 8ED, United Kingdom

ACTIVE_NOT_RECRUITING

Kent and Canterbury Hospital

Canterbury CT1 3NG, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Caroline Cowley, Research & Innovation/Clinical Trials Unit Manager

ekhuft.researchandinnovation@nhs.net01227 783169

The Christie NHS Foundation Trust

Manchester M20 4BX, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Research and Innovation Office

the-christie.ri@nhs.net---

How to Get in Touch

Pfizer CT.gov Call Center

Sponsor contact

CONTACT

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-08