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Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation

Sponsor: European Myeloma Network B.V.

NCT ID: NCT05243797

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
Teclistamab (drug), Lenalidomide (drug)
How long the study runs
Study runs about 115 months (dates as stated)
About the drug or intervention
Teclistamab — drug: Teclistamab will be administered via a subcutaneous injection (SC) · Lenalidomide — drug: Lenalidomide will be administered orally
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
1,594
Started
2022-09-08
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for multiple myeloma
  • • Phase3 - 1,594 participants
  • • This is a multicenter, randomized, open-label, Phase 3 study in participants with newly diagnosed multiple myeloma to evaluate the benefits of teclistamab in combination with lenalidomide and teclistamab alone versus lenalidomide alone as maintenance therapy after autologous stem cell transplant

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with multiple myeloma

Where?

  • • London - Hammersmith Hospital - Imperial College NHS Healthcare Trust
  • • London - University College London (UCL)
  • • Sutton - The Royal Marsden Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

This is a multicenter, randomized, open-label, Phase 3 study in participants with newly diagnosed multiple myeloma to evaluate the benefits of teclistamab in combination with lenalidomide and teclistamab alone versus lenalidomide alone as maintenance therapy after autologous stem cell transplant.

Multiple Myeloma

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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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

Biomarkers mentioned

PR

What the study is looking for

  • ✓Must have a new diagnosis of multiple myeloma according to IMWG criteria and have received induction +/- consolidation.
  • ✓Must not be intolerant to the starting dose of lenalidomide.
  • ✓Must not have received any maintenance therapy.
  • ✓Have an ECOG performance status score of 0, 1, or 2 at screening and immediately prior to the start of...
  • ✓Have clinical laboratory values within prespecified range.

Who cannot take part

  • ✗Received any prior BCMA-directed therapy.
  • ✗Any previous therapy with an immune cell redirecting agent or gene modified adoptive cell therapy (eg, chimeric...
  • ✗Discontinued treatment due to any AE related to lenalidomide as determined by the investigator.
  • ✗Progressed on multiple myeloma therapy at any time prior to screening.
  • ✗Received a cumulative dose of corticosteroids equivalent to ≥140 mg of prednisone within the 14 days prior to first...
See the full criteria
Inclusion Criteria: * Must have a new diagnosis of multiple myeloma according to IMWG criteria and have received induction +/- consolidation. * Must have received only one line of therapy and achieved at least a partial response (≥PR) as per IMWG 2016 response criteria (Kumar 2016) without evidence of progression at the time of first treatment dose. * Must not be intolerant to the starting dose of lenalidomide. * Must not have received any maintenance therapy. * Have an ECOG performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment * Have clinical laboratory values within prespecified range. Exclusion Criteria: * Received any prior BCMA-directed therapy. * Any previous therapy with an immune cell redirecting agent or gene modified adoptive cell therapy (eg, chimeric antigen receptor modified T cells, NK cells). * Discontinued treatment due to any AE related to lenalidomide as determined by the investigator. * Progressed on multiple myeloma therapy at any time prior to screening. * Received a cumulative dose of corticosteroids equivalent to ≥140 mg of prednisone within the 14 days prior to first treatment dose. * Received a live, attenuated vaccine within 4 weeks before first treatment dose. Non-live vaccines or non-replicating authorized for emergency use (eg. COVID-19) are allowed.

Where Is This Study? (3 UK sites)

Hammersmith Hospital - Imperial College NHS Healthcare Trust

London, United Kingdom

Recruiting
Hospital R&D contact (matched)

Donna Copeland

donna.copeland@nhs.net---

University College London (UCL)

London, United Kingdom

Recruiting
Hospital R&D contact (matched)

Rajinder Sidhu - Associate Director, Research Governance and Operations

uclh.jro-communications@nhs.net020 3447 9825

The Royal Marsden Hospital

Sutton, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

How to Get in Touch

Christine Witty

Sponsor contact

CONTACT

+31 10 268 70 65 Christine.Witty@emn.org

Sabrin Tahri

Sponsor contact

CONTACT

+31 10 268 70 65 Sabrin.Tahri@emn.org
Data sourced from ClinicalTrials.gov · Last verified: 2026-10