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Clinical Trials List

Protocol NumberCT-P44 3.1
NCT Number(ClinicalTrials.gov Identfier)NCT06952478
Active

2025-03-01 - 2029-12-31

Others

Recruiting6

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

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator 張正雄 Division of Hematology & Oncology
Chang Bing Show Chwan Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shang-Yi Huang Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 戴明燊 Division of Hematology & Oncology
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Jen Liu Division of General Internal Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林炫聿 Division of Hematology & Oncology
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tsai-Yun Chen
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Refractory or Relapsed Multiple Myeloma

Objectives

Proving PK equivalence and therapeutic equivalence

Test Drug

皮下注射劑

Active Ingredient

CT-P44 (Daratumumab)

Dosage Form

220

Dosage

1,800 mg/15 mL

Endpoints

• AUCWeek0-1 and AUCWeek8-10 for Daratumumab.

• The proportion of patients who, according to IMWG criteria, would achieve a VGPR or better response (sCR + CR + VGPR) based on a confirmed BOR during week 24 after randomization of the last patient.

Inclution Criteria

[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.

Exclusion Criteria

[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.

The Estimated Number of Participants

  • Taiwan

    50 participants

  • Global

    486 participants

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