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
- Diseases
- Multiple myeloma
- 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
Sites (5)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Catala d'Oncologia Coordinator of this site? Confirm its status | Badalona | Spain | Active, not recruiting |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu Coordinator of this site? Confirm its status | Torun | Poland | Active, not recruiting |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.