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NCT06952478Active, not recruitingPhase 3

A Study to Compare Pharmacokinetics, Efficacy and Safety of Subcutaneous CT-P44 and Darzalex Faspro in Combination With Lenalidomide and Dexamethasone in Patients With Refractory or Relapsed Multiple Myeloma

A Double-Blind, Randomized, Active-Controlled, Parallel-group, Phase 1/3 Study to Compare Pharmacokinetics, Efficacy and Safety of Subcutaneous CT-P44 and Darzalex Faspro in Combination With Lenalidomide and Dexamethasone in Patients With Refractory or Relapsed Multiple Myeloma

Source: ClinicalTrials.gov · Last updated 27 Oct 2026

Brief summary (registry, in English)

This study is a phase 1/3 study to Compare Pharmacokinetics, Efficacy and Safety of Subcutaneous CT-P44 and Darzalex Faspro in Combination with Lenalidomide and Dexamethasone in Patients with Refractory or Relapsed Multiple Myeloma

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
473 (actual)
First submitted
29 Apr 2025
Start date
12 Aug 2025
Primary completion date
8 Mar 2027
Lead sponsor
Celltrion
NCT number
NCT06952478
EU CT number
2024-518588-36-00

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 473
  • From 12 Aug 2025 to the primary completion date, 8 Mar 2027
  • 5 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • \[Main Inclusion Criteria\]
  • Male or female with 18 years of age or older.
  • Patient must have documented multiple myeloma (MM) according to IMWG criteria
  • Patient must have a documented relapsed or refractory disease.
  • Patient must have achieved a response (PR or better based on investigator's determination of response by the IMWG criteria) to at least one prior regimen.
  • Patient must have a PD or clinical relapse, as defined by the IMWG criteria on or after their last line of therapy.
    • \[Main Exclusion Criteria\]
  • Patient whose body weight is of \>120 kg
  • Patient has received daratumumab or any other drug specifically targeting CD38 previously.
  • Patient's disease shows evidence of refractoriness or intolerance to lenalidomide.
  • Patient is known or suspected of not being able to comply with the study protocol (e.g., psychological disorder) or the patient has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (e.g., compromise their well-being) or that could prevent, limit, or confound the protocol-specified assessments.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Institut Catala d'Oncologia
Coordinator of this site? Confirm its status
BadalonaSpainActive, not recruiting
Hospital Universitario Virgen De La Macarena
Coordinator of this site? Confirm its status
SevillaSpainActive, not recruiting
Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu
Coordinator of this site? Confirm its status
TorunPolandActive, not recruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Coordinator of this site? Confirm its status
WarsawPolandActive, not recruiting
Taipei Veterans General Hospital
Coordinator of this site? Confirm its status
TaipeiTaiwanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.