Multiple Myeloma
Conditions
Keywords
Anti-CD38 monoclonal antibody
Brief summary
Primary Objective: To evaluate the pharmacokinetics (PK) of isatuximab. Secondary Objectives: * To evaluate the safety and tolerability of isatuximab. * To assess the preliminary antitumor effect of isatuximab. * To evaluate the immunogenicity of isatuximab.
Detailed description
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.
Interventions
Pharmaceutical form: Concentrate for solution Route of administration: Intravenous
Sponsors
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: * Serum M-protein ≥0.5 g/dL (≥5 g/L); * Urine M-protein ≥200 mg/24 hours. * Written informed consent.
Exclusion criteria
* \<18 years old. * Eastern Cooperative Oncology Group (ECOG) performance status \>2. * Life expectancy of less than 3 months. * Pretreated with any anticluster of differentiation (CD) 38 agent. * Concurrent plasma cell leukemia. * Known amyloidosis. * Disease measurable only by serum free light chain (FLC) analysis. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of PK: Cmax | Cycle 1, up to 168 hours after start of infusion | To evaluate the maximum observed concentration (Cmax) |
| Assessment of PK: tmax | Cycle 1, up to 168 hours after start of infusion | To evaluate the time to reach Cmax (tmax) |
| Assessment of PK: AUC0-168h | Cycle 1, up to 168 hours after start of infusion | To evaluate area under the plasma concentration versus time curve over the dosing interval (AUC0-168h) |
| Assessment of PK: Ceoi | Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1; Cycle duration is 28 days | To evaluate the concentration observed at the end of an IV infusion (Ceoi) |
| Assessment of PK: Ctrough | Up to approximately 40 weeks (Cycle 10) | To evaluate concentration observed just before investigational medicinal product (IMP) administration during repeated dosing (Ctrough) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-Tumor Activity: Overall survival (OS) | Up to 12 months after last patient treated | Time interval from the date of first IMP administration to death due to any cause |
| Adverse Events | Up to 30 days after the last IMP administration | 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 |
| Immunogenicity | Up to 13 months (10 cycles + 3 months) after last patient treated | To evaluate the presence of antidrug antibodies (ADA) to isatuximab |
| Anti-tumor activity: Overall response (ORR) | Up to 12 months after last patient treated | 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 |
| Anti-Tumor Activity: Duration of response (DOR) | Up to 12 months after last patient treated | Time from the date of the first determined response to the date of subsequent determined progressive disease or death, whichever happens earlier |
| Anti-Tumor Activity: Time to progression (TTP) | Up to 12 months after last patient treated | Time interval from the date of first IMP administration to the date of the first assessed disease progression using IMWG criteria |
| Anti-Tumor Activity: Progression free survival (PFS) | Up to 12 months after last patient treated | 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 |
Countries
China
Outcome results
None listed