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

NCT06952478 — Phase 3, Active not recruiting, 473 participants, Celltrion

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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

RegistryNCT06952478
StatusActive not recruiting
PhasePhase 3
Study typeInterventional; randomized, parallel, masking: quadruple, treatment
Enrollment473 (Actual)
SponsorCelltrion (Industry)
ConditionsRefractory or Relapsed Multiple Myeloma
InterventionsCT-P44(Daratumumab), Darzalex Faspro(Daratumumab) (Biological)
Datesstart 2025-08-12, primary completion 2027-03-08 (estimated), completion 2028-09-18 (estimated), first posted 2025-05-01, last updated 2026-10-21
Locations1 site in Taiwan

Related Papers Related Patents Related Grants Related Experts
All trials for Refractory or Relapsed Multiple Myeloma All trials of CT-P44(Daratumumab) All trials of Darzalex Faspro(Daratumumab)

-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

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+Arms and interventions

ArmTypeInterventionsDescription
CT-P44ExperimentalBiological: CT-P44(Daratumumab)CT-P44 1800mg SC (subcutaneous)
Darzalex FasproActive comparatorBiological: Darzalex Faspro(Daratumumab)Darzalex Faspro 1800mg SC (subcutaneous)
  • CT-P44(Daratumumab) (Biological): 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(Daratumumab) (Biological): Darzalex Faspro 1800 mg will be administered as SC injection in combination with Rd until each patient's PD, unacceptable toxicity or Cycle 6, whichever occurs first.

+Outcome measures

Primary outcomes

  • PK equivalence of CT-P44 and Darzalex Faspro [Week 0 ~ Week 24]: AUCWeek0-1 and AUCWeek8-10 of daratumumab.

+Eligibility

Sex: All, ages: 18 Years to any

\[Main Inclusion Criteria\]

* Male or female with 18 years of age or older.
* Patient must have documented multiple myeloma (MM) according to IMWG criteria
* Patient must have a documented relapsed or refractory disease.
* Patient must have achieved a response (PR or better based on investigator's determination of response by the IMWG criteria) to at least one prior regimen.
* Patient must have a PD or clinical relapse, as defined by the IMWG criteria on or after their last line of therapy.

\[Main Exclusion Criteria\]

* Patient whose body weight is of >120 kg
* Patient has received daratumumab or any other drug specifically targeting CD38 previously.
* Patient's disease shows evidence of refractoriness or intolerance to lenalidomide.
* Patient is known or suspected of not being able to comply with the study protocol (e.g., psychological disorder) or the patient has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (e.g., compromise their well-being) or that could prevent, limit, or confound the protocol-specified assessments.

+Locations (1)

FacilityCityCountryStatus
Taipei Veterans General HospitalTaipei, Beitou DistrictTaiwan