Taipei Veterans General Hospital
Taipei, Beitou District, 11217, Taiwan
Location status: Recruiting
NCT Number: NCT06952478
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
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 3
Taipei, Beitou District, 11217, Taiwan
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
[Main Inclusion Criteria]
[Main Exclusion Criteria]
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.
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.
Time frame: Week 0 ~ Week 24
AUCWeek0-1 and AUCWeek8-10 of daratumumab.
Time frame: Week 0 ~ Week 24
Proportion of patients who will achieve VGPR or better (sCR + CR + VGPR) based on the confirmed BOR.
Contact information is provided by the study sponsor or research team.
JoonSoo Ha
CONTACT
NaRae Ryu
CONTACT
Celltrion
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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