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
NCT ID: NCT06952478
Last Updated: 2025-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
486 participants
INTERVENTIONAL
2025-08-12
2029-06-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CT-P44
CT-P44 1800mg SC (subcutaneous)
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.
Darzalex Faspro
Darzalex Faspro 1800mg SC (subcutaneous)
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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'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.
18 Years
ALL
No
Sponsors
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Celltrion
INDUSTRY
Responsible Party
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Locations
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Taipei Veterans General Hospital
Taipei, Beitou District, Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-518588-36-00
Identifier Type: CTIS
Identifier Source: secondary_id
CT-P44 3.1
Identifier Type: -
Identifier Source: org_study_id
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