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RECRUITING
NCT06952478
PHASE3

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

Sponsor: Celltrion

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

486

Start Date

2025-08-12

Completion Date

2029-06-25

Last Updated

2025-08-15

Healthy Volunteers

No

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.

Locations (1)

Taipei Veterans General Hospital

Taipei, Beitou District, Taiwan