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NCT Number: 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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Taipei Veterans General Hospital

Taipei, Beitou District, 11217, Taiwan

Location status: Recruiting

Location contact

Chia-Jen Liu

CONTACT

[email protected]

+88622871212166600 000000000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

[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 as defined by the IMWG criteria on or after their last line of therapy.

[Main Exclusion Criteria]

  • 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.

Treatment and study plan

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 13, whichever occurs first.

Primary outcomes

  1. PK equivalence of CT-P44 and Darzalex Faspro

    Time frame: Week 0 ~ Week 24

    AUCWeek0-1 and AUCWeek8-10 of daratumumab.

  2. Therapeutic equivalence of CT-P44 and Darzalex Faspro

    Time frame: Week 0 ~ Week 24

    Proportion of patients who will achieve VGPR or better (sCR + CR + VGPR) based on the confirmed BOR.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Celltrion

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
May 1, 2025
Registry last updated
Aug 15, 2025

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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