RecruitingPhase 3NCT06952478

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


Sponsor

Celltrion

Enrollment

486 participants

Start Date

Aug 12, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing CT-P44 (a biosimilar version of daratumumab) to the already-approved Darzalex Faspro (daratumumab), both given under the skin (subcutaneously) in combination with lenalidomide and dexamethasone, for patients with relapsed or refractory multiple myeloma. The goal is to show that CT-P44 works as well and is as safe as Darzalex Faspro. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with multiple myeloma that has relapsed (come back) or is refractory (no longer responding to treatment) - You have achieved at least a partial response to at least one prior treatment - Your disease has progressed on your most recent line of therapy **You may NOT be eligible if...** - You have previously received daratumumab or any other anti-CD38 targeted therapy - Your disease is resistant or intolerant to lenalidomide - Your overall health or other conditions would make study participation unsafe or inappropriate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCT-P44(Daratumumab)

CT-P44 1800 mg will be administered as SC injection in combination with Rd until each patient's PD, unacceptable toxicity or Cycle 26, whichever occurs first.

BIOLOGICALDarzalex Faspro(Daratumumab)

Darzalex Faspro 1800 mg will be administered as SC injection in combination with Rd until each patient's PD, unacceptable toxicity or Cycle 13, whichever occurs first.


Locations(1)

Taipei Veterans General Hospital

Taipei, Beitou District, Taiwan

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NCT06952478