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ACTIVE NOT RECRUITINGPhase3

A Study of Daratumumab

Sponsor: Janssen Research & Development, LLC

NCT ID: NCT05438043

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
Daratumumab (drug), Carfilzomib (drug), Dexamethasone (drug), Lenalidomide (drug)
How long the study runs
Study runs about 73 months (dates as stated)
About the drug or intervention
Daratumumab — drug: Daratumumab will be administered either intravenously or subcutaneously. · Carfilzomib — drug: Carfilzomib will be administered intravenously. · Dexamethasone — drug: Dexamethasone will be administered either orally or intravenously. · Lenalidomide — drug: Lenalidomide will be administered orally. · Pomalidomide — drug: Pomalidomide will be administered orally.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
Not specified
Who
All
Number of participants
213
Started
2022-12-15
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for multiple myeloma
  • • Phase3 - 213 participants
  • • The purpose of this study is to provide ongoing access to study treatments for participants with multiple myeloma or smoldering multiple myeloma benefiting from treatment in certain Janssen Research and Development (R\&D) studies that use daratumumab as part of the study treatment regimen: access for all participants regardless of treatment group in daratumumab studies and access to participants in daratumumab-containing arms in the non-daratumumab studies will be allowed from studies which have reached clinical cutoff for final analysis

Who can take part?

  • • Adults
  • • Diagnosed with multiple myeloma

Where?

  • • Leeds - St James University Hospital
  • • Leicester - Leicester Royal Infirmary Haematology
  • • Surrey - Royal Marsden Hospital
  • • Wolverhampton - New Cross Hospital

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

About This Trial

The purpose of this study is to provide ongoing access to study treatments for participants with multiple myeloma or smoldering multiple myeloma benefiting from treatment in certain Janssen Research and Development (R\&D) studies that use daratumumab as part of the study treatment regimen: access for all participants regardless of treatment group in daratumumab studies and access to participants in daratumumab-containing arms in the non-daratumumab studies will be allowed from studies which have reached clinical cutoff for final analysis. Certain long-term safety data will continue to be collected from study participants.

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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Still need:

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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: Not specified
  • Who can join: All genders

Biomarkers mentioned

methave a negative

Treatment history

Treatments you must have had:

  • ✓ for, the study and is willing to participate in the study

What the study is looking for

  • ✓Investigator's assessment that the benefit of continued study treatment will outweigh the risks
  • ✓A female participant of childbearing potential must have a negative pregnancy test at screening and must agree to...
  • ✓A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum...
  • ✓Willing and able to adhere to the lifestyle restrictions specified in this protocol

Who cannot take part

  • ✗Has taken any disallowed therapies or treatment for the disease under study between the completion of the parent...
  • ✗Vaccinated with an investigational vaccine (except for Coronavirus disease \[COVID-19\])or live attenuated or...
See the full criteria
Inclusion Criteria: * Participants must be actively receiving daratumumab (either as monotherapy or in combination with other study treatment) in certain Janssen research and development (R\&D) studies or receiving other study treatment in a Janssen R\&D daratumumab study for participants with multiple myeloma or smoldering multiple myeloma which has reached clinical cutoff for final analysis continue to benefit from study treatment, not have experienced disease progression or unmanageable toxicity while receiving daratumumab, not have met the withdrawal criteria set forth in the parent study, and have had the last dose of study treatment within the previous 3 months * Investigator's assessment that the benefit of continued study treatment will outweigh the risks * A female participant of childbearing potential must have a negative pregnancy test at screening and must agree to further serum or urine pregnancy tests during the study * A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 3 months after receiving the last dose of study treatment * Must sign an informed consent form (ICF; or their legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study * Willing and able to adhere to the lifestyle restrictions specified in this protocol Exclusion Criteria: * Has taken any disallowed therapies or treatment for the disease under study between the completion of the parent study and the planned first dose of study treatment * Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments * Known allergies, hypersensitivity, or intolerance to study treatments or their excipients (refer to the daratumumab investigator brochure (IB) and local country prescribing information for dexamethasone, carfilzomib, pomalidomide, and lenalidomide) * Vaccinated with an investigational vaccine (except for Coronavirus disease \[COVID-19\])or live attenuated or replicating viral vector vaccines within 4 weeks prior to enrollment

Where Is This Study? (4 UK sites)

St James University Hospital

Leeds LS9 7TF, United Kingdom

Leicester Royal Infirmary Haematology

Leicester LE1 5WW, United Kingdom

Hospital R&D contact (matched)

Carolyn Maloney

uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351

Royal Marsden Hospital

Surrey SM2 5PT, United Kingdom

Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

New Cross Hospital

Wolverhampton WV10 0QP, United Kingdom

Hospital R&D contact (matched)

Sarah Glover

rwh-tr.rdpmteam@nhs.net01902 695065
Data sourced from ClinicalTrials.gov · Last verified: 2026-09