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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1195-6028 | Other Identifier | UTN |
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Primary Objective:
To evaluate the pharmacokinetics (PK) of isatuximab.
Secondary Objectives:
The duration of the study for an individual patient will include a screening period of up to 21 days, a treatment period of repeated 28-day cycles, and a follow-up period. End of treatment visit will be done at 30 (±7) days after last treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isatuximab | Experimental | Administered intravenously every week in Cycle 1 (4 weeks) followed by every 2 weeks (Q2W) in subsequent cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isatuximab SAR650984 | Drug | Pharmaceutical form: Concentrate for solution Route of administration: Intravenous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of PK: Cmax | To evaluate the maximum observed concentration (Cmax) | Cycle 1, up to 168 hours after start of infusion |
| Assessment of PK: tmax | To evaluate the time to reach Cmax (tmax) | Cycle 1, up to 168 hours after start of infusion |
| Assessment of PK: AUC0-168h | To evaluate area under the plasma concentration versus time curve over the dosing interval (AUC0-168h) | Cycle 1, up to 168 hours after start of infusion |
| Assessment of PK: Ceoi | To evaluate the concentration observed at the end of an IV infusion (Ceoi) | Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1; Cycle duration is 28 days |
| Assessment of PK: Ctrough | To evaluate concentration observed just before investigational medicinal product (IMP) administration during repeated dosing (Ctrough) | Up to approximately 40 weeks (Cycle 10) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Treatment Emergent Adverse Events (TEAEs)/Serious Adverse Events (SAE) based on standard and systematic assessment including infusion associated reactions (IARs), laboratory test abnormalities, vital signs and ECOG performance status | Up to 30 days after the last IMP administration |
| Anti-tumor activity: Overall response (ORR) |
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Inclusion criteria:
Known diagnosis of symptomatic multiple myeloma.
At least 2 prior lines of therapies which must include treatment with at least 1 of an immunomodulatory drug (IMiD) or a proteasome inhibitor (PI). The patients must have received an IMiD or a PI for ≥2 cycles or ≥2 months of treatment.
Patients must have been responsive to at least 1 prior line of therapy (minimal response or better).
Refractory to the most recently received IMiD or PI included therapy (ie, patients must have progressed during or within 60 days of completion of treatment with IMiD or PI). For patients who have received more than 1 type of IMiD or PI, their disease must be refractory to the most recent one.
Measurable disease defined as at least 1 of the following:
Written informed consent.
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 1560003 | Beijing | 100191 | China | |||
| Investigational Site Number 1560002 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39528489 | Derived | Sun M, Jing H, Qu X, Dong F, Li Y, Feng Z, Ziti-Ljajic S, Semiond D, Li L, Qi J, Qiu L. Phase 1 study of isatuximab monotherapy in Chinese patients with relapsed/refractory multiple myeloma. Sci Rep. 2024 Nov 11;14(1):27550. doi: 10.1038/s41598-024-59186-1. |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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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 |
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| ID | Term |
|---|---|
| C000599209 | isatuximab |
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Proportion of patients achieving: stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) according to International Myeloma Working Group (IMWG 2016) criteria |
| Up to 12 months after last patient treated |
| Anti-Tumor Activity: Duration of response (DOR) | Time from the date of the first determined response to the date of subsequent determined progressive disease or death, whichever happens earlier | Up to 12 months after last patient treated |
| Anti-Tumor Activity: Time to progression (TTP) | Time interval from the date of first IMP administration to the date of the first assessed disease progression using IMWG criteria | Up to 12 months after last patient treated |
| Anti-Tumor Activity: Progression free survival (PFS) | Time interval from the date of first IMP administration to the date of the first documentation of disease progression or death due to any cause, whichever comes first | Up to 12 months after last patient treated |
| Anti-Tumor Activity: Overall survival (OS) | Time interval from the date of first IMP administration to death due to any cause | Up to 12 months after last patient treated |
| Immunogenicity | To evaluate the presence of antidrug antibodies (ADA) to isatuximab | Up to 13 months (10 cycles + 3 months) after last patient treated |
| Nanjing |
| 210029 |
| China |
| Investigational Site Number 1560001 | Tianjin | 300020 | China |
| 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 |