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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

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

NCT06952478•Celltrion

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

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.

Locations (1)

Taipei Veterans General Hospital

Taipei, Beitou District, Taiwan

Key Dates

Start Date

August 12, 2025

Primary Completion Date

November 15, 2027

Completion Date

June 25, 2029

Last Updated

August 15, 2025

Enrollment

486

ESTIMATED participants

Conditions

Refractory or Relapsed Multiple Myeloma

Interventions

CT-P44(Daratumumab)

BIOLOGICAL

Darzalex Faspro(Daratumumab)

BIOLOGICAL

Contacts

JoonSoo Ha

CONTACT

+82 32 850 5727 joonsoo.ha@celltrion.com

NaRae Ryu

CONTACT

+82 32 850 5731 narae.ryu@celltrion.com

Clinical Study of CAR-BCMA T in Patients With Refractory or Relapsed Multiple Myeloma

NCT03716856

Refractory or Relapsed Multiple Myeloma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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