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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-518588-36-00 | EU Trial (CTIS) Number |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-P44 | Experimental | CT-P44 1800mg SC (subcutaneous) |
|
| Darzalex Faspro | Active Comparator | Darzalex Faspro 1800mg SC (subcutaneous) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| PK equivalence of CT-P44 and Darzalex Faspro | AUCWeek0-1 and AUCWeek8-10 of daratumumab. | Week 0 ~ Week 24 |
| Therapeutic equivalence of CT-P44 and Darzalex Faspro | Proportion of patients who will achieve VGPR or better (sCR + CR + VGPR) based on the confirmed BOR. | Week 0 ~ Week 24 |
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[Main Inclusion Criteria]
[Main Exclusion Criteria]
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JoonSoo Ha | Contact | +82 32 850 5727 | joonsoo.ha@celltrion.com | |
| NaRae Ryu | Contact | +82 32 850 5731 | narae.ryu@celltrion.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Veterans General Hospital | Recruiting | Taipei | Beitou District | 11217 | Taiwan |
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| 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. |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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