relapsed and/or refractory multiple myeloma
Conditions
Interventions
Sponsors
Shanghai Jiaotong University School of Medicine Ruijin-Hainan Hospital (Hainan Boao Research Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older; 2. Diagnosed as RRMM with evidence of measurable disease: (1) Serum M-protein >= 0.5 g/dL measured using serum protein immunoelectrophoresis and/or; (2) Urine M-protein >= 200 mg/24 h measured using urine protein immunoelectrophoresis; 3. Initiate IPd only on physicians decisions and independently of the purpose of the study; 4. A history of receiving at least two prior therapies including lenalidomide and a proteasome inhibitor (PI) prior to enrollment; 5. Patients must have given signed informed consent prior to submission of any patient data to the Sponsor and before the first administration of isatuximab.
Exclusion criteria
Exclusion criteria: 1. Patients with severe hypersensitivity to isatuximab or to any of its excipients; 2. Patient who is in pregnancy. Females of childbearing potential (FCBP) unwilling to prevent pregnancy per pomalidomide's package insert; 3. Patient with prior anti-CD38 monoclonal antibody treatment; 4. According to physician's decision, cannot tolerate any drug of the combination regimen; 5. Patient is participating in part of a clinical trial in which multiple myeloma (MM) treatment or disease management is protocol-specified.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: ORR (objective remmision rate), defined as the proportion of patients with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) as best overall response assessed by Investigator using the 2016 International Myeloma Working Group (IMWG) response ;Part 2: Adverse events including TEAEs (Treatment Emergent Adverse Events), TEAEs of Grade >= 3, SAEs (Serious Adverse Events), and AESIs (Adverse Events of Special Interest); | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1: PFS (Progression-Free Survival), defined as the time from isatuximab start date to disease progression based on Investigator assessment according to 2016 IMWG criteria or death from any cause, whichever happens first.;Part 1: OS (Overall Survival), defined as the time from Isatuximab start date to death from any cause;Part 1: DOR (Duration of Response), defined as the time from the date of the first response to the date of first progressive disease as assessed by investigator per IMWG criteria or death, whichever happens first. Duration of response is determined only for participants who have achieved a response >=&#;Part 1: TTR (Time to Response), defined as the time from the date of Isatuximab start date to the date of first response (PR or better) as assessed by investigator that is subsequently confirmed;Part 1: ORR, PFS, and OS observed from external historical group as appropriate.;Part 1: Adverse events (AEs);Part 2: PFS, defined as the time from isatuximab start date to disease progression based on Investigator assessment according to 2016 IMWG criteria or death from any cause, whichever happens first.;Part 2: OS, defined as the time from Isatuximab start date to death from any cause;Part 2: ORR, defined as the proportion of patients with sCR, CR, VGPR, and PR) as best overall response assessed by Investigator using the 2016 IMWG response criteria;Part 2: DOR, defined as the time from the date of the first response to the date of first progressive disease as assessed by investigator per IMWG criteria or death, whichever happens first. Duration of response is determined only for participants who have achieved a response >= PR;Part 2: TTR, defined as the time from the date of Isatuximab start date to the date of first response (PR or better) as assessed by investigator that is subsequently confirmed; | — |
Countries
China
Contacts
Public ContactWeili Zhao
Shanghai Jiaotong University School of Medicine Ruijin-Hainan Hospital (Hainan Boao Research Hospital)
Outcome results
None listed