A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Isatuximab in Patients With Multiple Myeloma
- Registration Number
- NCT02514668
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
* Part A: To evaluate the safety of SAR650984 (isatuximab) in patients with relapsed/refractory multiple myeloma (RRMM).
* Part B: To evaluate the activity of SAR650984 (isatuximab) as assessed by overall response rate (ORR) in RRMM patients previously treated with daratumumab.
Secondary Objectives:
* Part A:
* To determine the pharmacokinetics (PK) of SAR650984 (isatuximab) in patients with RRMM.
* Part B:
* To evaluate the safety of SAR650984 (isatuximab).
* To evaluate the efficacy of SAR650984 (isatuximab) as assessed by duration of response (DOR), clinical benefit rate (CBR) and progression free survival (PFS).
* To assess the pharmacokinetics (PK) of SAR650984 (isatuximab) and daratumumab at baseline.
* To evaluate the immunogenicity of SAR650984 (isatuximab).
- Detailed Description
Study duration for an individual patient will include a screening period for inclusion of up to 3 weeks, the treatment period and, a follow up period. Treatment with SAR650984 (isatuximab) may continue until disease progression, unacceptable adverse event, or other reason for discontinuation.
After study treatment discontinuation, an end of treatment visit will be done at 30 days to assess safety and PK, and at 30 and 60 days for anti-drug antibody (ADA). If the ADA is positive at Day 60, ADA will be repeated every 30 days until ADA is negative.
Patients with partial remission or better who discontinue treatment for reasons other than progression of disease will be followed monthly until progression or initiation of subsequent therapy, the final analysis cutoff date, whichever comes first.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Isatuximab Isatuximab Isatuximab (escalating dose) on Days 1, 8, 15, and 22, then Days 1 and 15 in 28-day cycles up to disease progression
- Primary Outcome Measures
Name Time Method Part B: Overall Response Rate (ORR) 4 months Part A: Number of patients with adverse events (AEs) and changes in laboratory tests and vital signs according to the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) version 4.03 grade scaling Up to 30 days following the last administration of study treatment or up to 12 months for ongoing related AE, ongoing serious AE and new related AE Part A: Dose Limiting Toxicities (DLTs) Up to 4 weeks
- Secondary Outcome Measures
Name Time Method Part B: Number of patients with AEs and changes in laboratory tests and vital signs according to the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) version 4.03 grade scaling Up to 30 days following the last administration of study treatment or up to 12 months for ongoing related AE, ongoing serious AE and new related AE Part B: Progression Free Survival (PFS) Up to 12 months from the last patient in Part B: Levels of isatuximab antibodies Up to 12 months from the last patient in Part B: Clinical Benefit Rate (CBR) Up to 12 months from the last patient in Assessment of PK parameters: partial area under the serum concentration time curve (AUC) 1 week after first treatment Part B: Duration of Response (DOR) Up to 12 months from the last patient in Assessment of PK parameters: maximum observed concentration (Cmax) 1 week after first treatment
Trial Locations
- Locations (18)
Investigational Site Number 840013
🇺🇸Canton, Ohio, United States
Investigational Site Number 840003
🇺🇸Scottsdale, Arizona, United States
Investigational Site Number 250008
🇫🇷Creteil Cedex, France
Investigational Site Number 250006
🇫🇷Vandoeuvre-Les-Nancy Cedex, France
Investigational Site Number 250002
🇫🇷Nantes Cedex 01, France
Investigational Site Number 840004
🇺🇸San Francisco, California, United States
Investigational Site Number 840011
🇺🇸Detroit, Michigan, United States
Investigational Site Number 840015
🇺🇸Saint Louis, Missouri, United States
Investigational Site Number 840005
🇺🇸Hackensack, New Jersey, United States
Investigational Site Number 840010
🇺🇸Durham, North Carolina, United States
Investigational Site Number 840006
🇺🇸Milwaukee, Wisconsin, United States
Investigational Site Number 840001
🇺🇸Nashville, Tennessee, United States
Investigational Site Number 840002
🇺🇸Salt Lake City, Utah, United States
Investigational Site Number 203002
🇨🇿Brno, Czechia
Investigational Site Number 250005
🇫🇷Montpellier Cedex 5, France
Investigational Site Number 250004
🇫🇷Pessac, France
Investigational Site Number 203001
🇨🇿Praha 2, Czechia
Investigational Site Number 250001
🇫🇷Poitiers, France