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

August 12, 2025 updated by: Celltrion

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

486

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
    • Beitou District
      • Taipei, Beitou District, Taiwan, 11217
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

[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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CT-P44
CT-P44 1800mg SC (subcutaneous)
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.
Active Comparator: Darzalex Faspro
Darzalex Faspro 1800mg SC (subcutaneous)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PK equivalence of CT-P44 and Darzalex Faspro
Time Frame: Week 0 ~ Week 24
AUCWeek0-1 and AUCWeek8-10 of daratumumab.
Week 0 ~ Week 24
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.
Week 0 ~ Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celltrion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2025

Primary Completion (Estimated)

November 15, 2027

Study Completion (Estimated)

June 25, 2029

Study Registration Dates

First Submitted

April 29, 2025

First Submitted That Met QC Criteria

April 29, 2025

First Posted (Actual)

May 1, 2025

Study Record Updates

Last Update Posted (Estimated)

August 15, 2025

Last Update Submitted That Met QC Criteria

August 12, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT-P44 3.1
  • 2024-518588-36-00 (Ctis)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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