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

PHASE3RecruitingINTERVENTIONAL
Enrollment

486

Participants

Timeline

Start Date

August 12, 2025

Primary Completion Date

November 15, 2027

Study Completion Date

June 25, 2029

Conditions
Refractory or Relapsed Multiple Myeloma
Interventions
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.

Trial Locations (1)

11217

RECRUITING

Taipei Veterans General Hospital, Taipei

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Celltrion

INDUSTRY

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 | Biotech Hunter | Biotech Hunter