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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
486
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.
Taipei Veterans General Hospital
Taipei, Beitou District, Taiwan
RECRUITINGPK equivalence of CT-P44 and Darzalex Faspro
AUCWeek0-1 and AUCWeek8-10 of daratumumab.
Time frame: Week 0 ~ Week 24
Therapeutic equivalence of CT-P44 and Darzalex Faspro
Proportion of patients who will achieve VGPR or better (sCR + CR + VGPR) based on the confirmed BOR.
Time frame: Week 0 ~ Week 24
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