Clinical Trials List
Protocol NumberEFC15951
NCT Number(ClinicalTrials.gov Identfier)NCT05405166
Active
2023-05-02 - 2027-03-19
Phase III
Not yet recruiting2
Recruiting1
A Randomized, Phase 3, Open Label Study Evaluating Subcutaneous Versus Intravenous Administration of Isatuximab in Combination With Pomalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)
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Trial Applicant
-
Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- CHENG-HONG TSAI Division of Hematology & Oncology
- HSIN-AN HOU Division of Hematology & Oncology
- 田豐銘 Division of Hematology & Oncology
- MEI-FANG CHENG Division of Radiology
- Shang-Ju Wu Division of Hematology & Oncology
- MING YAO Division of Hematology & Oncology
- Tai-Chung Huang Division of Hematology & Oncology
- Chien-Chin Lin Division of Hematology & Oncology
- Wen-Chien Chou Division of Hematology & Oncology
- BANG-BIN CHEN Division of Radiology
- - - Division of Hematology & Oncology
- Chieh-Lung Cheng Division of Hematology & Oncology
- Chien-Yuan Chen Division of Hematology & Oncology
- 劉高郎 Division of Radiology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Sin-Syue Li Division of Hematology & Oncology
- Ya-Ping Chen Division of Hematology & Oncology
- Ya-Ting Hsu Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Plasma Cell Myeloma Recurrent
Objectives
This trial is called IRAKLIA. This is a randomized, phase 3, multinational, multicenter trial to evaluate the subcutaneous (SC) versus intravenous (IV) administration of isatuximab plus pomalidomide and dexamethasone for the treatment of relapsed and/or refractory multiple myeloma. effects in patients with myeloma. This trial is expected to enroll approximately 534 subjects, including 7 in Taiwan, and will last approximately 50 months.
Test Drug
Isatuximab
Active Ingredient
Isatuximab
Isatuximab
Isatuximab
Dosage Form
Subcutaneous administration
IV injection
IV injection
Dosage
1400 mg/mL
20
20
Endpoints
‧ Overall response rate (ORR): defined as stringent complete response (sCR), complete response ( CR), very good partial response (VGPR) and partial response (PR).
‧ Steady state pre-dose observed concentration (Ctrough) (corresponding to cycle 6 day 1 [C6D1] before dosing)
‧ Steady state pre-dose observed concentration (Ctrough) (corresponding to cycle 6 day 1 [C6D1] before dosing)
Inclution Criteria
Inclusion Criteria:
Participants with multiple myeloma who have received at least one prior line of anti-myeloma therapy, which must include lenalidomide and a proteasome inhibitor given alone or in combination.
Measurable serum M-protein (≥ 0.5 g/dL) and/or urine M-protein (≥ 200 mg/24 hours) and/or serum free light chain (FLC) assay (Involved FLC assay ≥10 mg/dL and abnormal serum FLC ratio (<0.26 or >1.65)).
Participants with multiple myeloma who have received at least one prior line of anti-myeloma therapy, which must include lenalidomide and a proteasome inhibitor given alone or in combination.
Measurable serum M-protein (≥ 0.5 g/dL) and/or urine M-protein (≥ 200 mg/24 hours) and/or serum free light chain (FLC) assay (Involved FLC assay ≥10 mg/dL and abnormal serum FLC ratio (<0.26 or >1.65)).
Exclusion Criteria
Exclusion Criteria:
Primary refractory multiple myeloma participants
Participants with prior anti-CD38 treatment: (a) administered less than 9 months before randomization or, (b) intolerant to the anti-CD38 previously received
Prior therapy with pomalidomide
Participants with inadequate biological tests.
Significant cardiac dysfunction
Participants diagnosed or treated for another malignancy within 3 years prior to randomization with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, and in situ malignancy, or low risk prostate cancer after curative therapy
Concomitant plasma cell leukemia
Active primary amyloid light -chain amyloidosis
Known acquired immunodeficiency syndrome (AIDS)-related illness or known human immunodeficiency virus (HIV) disease requiring antiviral treatment
Know active Hepatitis A infection. Current active or chronic hepatitis B (HBV) or hepatitis C (HCV) infection. Participants with chronic HBV or HCV disease that is controlled under antiviral therapy are allowed.
Women of childbearing potential or male participant with women of childbearing potential who do not agree to use highly effective method of birth control
Primary refractory multiple myeloma participants
Participants with prior anti-CD38 treatment: (a) administered less than 9 months before randomization or, (b) intolerant to the anti-CD38 previously received
Prior therapy with pomalidomide
Participants with inadequate biological tests.
Significant cardiac dysfunction
Participants diagnosed or treated for another malignancy within 3 years prior to randomization with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, and in situ malignancy, or low risk prostate cancer after curative therapy
Concomitant plasma cell leukemia
Active primary amyloid light -chain amyloidosis
Known acquired immunodeficiency syndrome (AIDS)-related illness or known human immunodeficiency virus (HIV) disease requiring antiviral treatment
Know active Hepatitis A infection. Current active or chronic hepatitis B (HBV) or hepatitis C (HCV) infection. Participants with chronic HBV or HCV disease that is controlled under antiviral therapy are allowed.
Women of childbearing potential or male participant with women of childbearing potential who do not agree to use highly effective method of birth control
The Estimated Number of Participants
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Taiwan
7 participants
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Global
534 participants
