NCT06952478

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 486 (estimated)
• Sponsor: Celltrion · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Refractory or Relapsed Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	CT-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.
BIOLOGICAL	Darzalex 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.

Timeline

• Start date: 2025-08-12
• Primary completion: 2027-11-15
• Completion: 2029-06-25
• First posted: 2025-05-01
• Last updated: 2025-08-15

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated drug study