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
- Linvoseltamab (drug), Elotuzumab (drug), Pomalidomide (drug), Dexamethasone (drug)
- How long the study runs
- Study runs about 115 months (dates as stated)
- About the drug or intervention
- Linvoseltamab — drug: REGN5458 will be administered by intravenous (IV) infusion · Elotuzumab — drug: Elotuzumab will be administered by IV infusion · Pomalidomide — drug: Pomalidomide capsules will be administered by mouth (PO) · Dexamethasone — drug: Dexamethasone tablets/capsules will be administered PO and/or by IV infusion
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 410
- Started
- 2023-09-18
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for relapsed refractory multiple myeloma (rrmm)
- • Phase3 - 410 participants
- • This study is researching an experimental drug called linvoseltamab, also called REGN5458
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with relapsed refractory multiple myeloma (rrmm)
Where?
- • Cambridge - Addenbrooke's Hospital
- • Edinburgh - Western General Hospital
- • Birmingham - Queen Elizabeth Hospital Birmingham
- • London - Barts Health NHS Trust
- • +4 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This study is researching an experimental drug called linvoseltamab, also called REGN5458. Linvoseltamab has previously been studied by itself (without other cancer drugs) in participants who had advanced multiple myeloma that returned and needed to be treated again after many other therapies had failed. These participants were no longer benefiting from standard medications and had no good treatment options. In that study, some participants who were treated with linvoseltamab had improvement of their myeloma (shrinkage of their tumors), including some participants who had complete responses (that is, the treatment got rid of all evidence of myeloma in their bodies). This study is focused on participants who have multiple myeloma that has returned or needs to be treated again after one to four prior treatments and have standard cancer treatment options available to them. The aim of this study is to see how safe and effective linvoseltamab is compared to a combination of three cancer drugs: elotuzumab, pomalidomide and dexamethasone, (called EPd) in participants who have returned after having received prior treatment that included lenalidomide, a proteosome inhibitor, and (for participants in some countries) a cluster of differentiation 38 (CD38) antibody. Half of the participants in this study will get linvoseltamab, and the other half will get EPd. This study is looking at several other research questions, including: * How long participants benefit from receiving linvoseltamab compared with EPd * How many participants treated with linvoseltamab or EPd have improvement of their multiple myeloma and by how much * What side effects happen from taking linvoseltamab compared to EPd * How long participants live while receiving treatment or after treatment with linvoseltamab compared to EPd * If there is any improvement in pain after treatment with linvoseltamab compared to EPd
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
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ of antimyeloma therapy must be lenalidomide refract
- ✓ previously received a CD38 antibody
What the study is looking for
- ✓Age 18 years or older (or legal adult age in the country) at the time of the screening visit.
- ✓activity scale (ECOG) performance status ≤1. Patients with ECOG 2 solely due to local symptoms...
- ✓Patients must have cancer that can be measured on scans for response assessment as per the 2016 IMWG response assessment criteria, as...
- ✓healthy blood and liver function within 7 days of randomization, as well as adequate kidney and...
- ✓expected to live at least 6 $2
Who cannot take part
- ✗Diagnosis of plasma cell leukemia, amyloidosis, Waldenström macroglobulinemia, or POEMS syndrome (polyneuropathy,...
- ✗Prior treatment with elotuzumab and/or pomalidomide
- ✗Participants with known MM brain lesions or meningeal involvement
- ✗Treatment with any systemic anti-cancer therapy within 5 half-lives or within 28 days before first administration of...
- ✗Prior treatment with B-cell maturation antigen (BCMA) directed immunotherapies Note: BCMA antibody-drug conjugates...
See the full criteria
Where Is This Study? (8 UK sites)
Addenbrooke's Hospital
Cambridge CB2 0QQ, United Kingdom
Western General Hospital
Edinburgh EH4 2XU, United Kingdom
Queen Elizabeth Hospital Birmingham
Birmingham B15 2TH, United Kingdom
Barts Health NHS Trust
London EC1A 7BE, United Kingdom
Guy's & St Thomas' NHS Foundation Trust
London SE1 9RT, United Kingdom
Royal Marsden Hospital
London SW7 3RP, United Kingdom
Hammersmith Hospital
London W12 0HS, United Kingdom
The Christie NHS Foundation Trust
Manchester M20 4BX, United Kingdom
How to Get in Touch
Clinical Trials Administrator
Sponsor contactCONTACT
