A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Isatuximab in Patients With Multiple Myeloma
- 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.
- 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).
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||An Open-label, Dose-escalation and Multi-center Study to Evaluate the Safety, Pharmacokinetics and Efficacy of SAR650984 (Isatuximab) in Patients With Relapsed/Refractory Multiple Myeloma|
- Part A: Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 4 weeks ]
- 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 [ Time Frame: 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: Overall Response Rate (ORR) [ Time Frame: 4 months ]
- Assessment of PK parameters: partial area under the serum concentration time curve (AUC) [ Time Frame: 1 week after first treatment ]
- Assessment of PK parameters: maximum observed concentration (Cmax) [ Time Frame: 1 week after first treatment ]
- 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 [ Time Frame: 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: Duration of Response (DOR) [ Time Frame: Up to 12 months from the last patient in ]
- Part B: Clinical Benefit Rate (CBR) [ Time Frame: Up to 12 months from the last patient in ]
- Part B: Progression Free Survival (PFS) [ Time Frame: Up to 12 months from the last patient in ]
- Part B: Levels of isatuximab antibodies [ Time Frame: Up to 12 months from the last patient in ]
|Study Start Date:||September 1, 2015|
|Estimated Study Completion Date:||February 28, 2019|
|Estimated Primary Completion Date:||February 28, 2019 (Final data collection date for primary outcome measure)|
Isatuximab (escalating dose) on Days 1, 8, 15, and 22, then Days 1 and 15 in 28-day cycles up to disease progression
Pharmaceutical form: solution for infusion
Route of administration: intravenous
Other Name: SAR650984
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02514668
|Contact: For site information, send an email with site number to||Contact-Us@sanofi.com|
|United States, Arizona|
|Investigational Site Number 840003||Recruiting|
|Scottsdale, Arizona, United States, 85054|
|United States, California|
|Investigational Site Number 840004||Recruiting|
|San Francisco, California, United States, 94117|
|United States, Michigan|
|Investigational Site Number 840011||Recruiting|
|Detroit, Michigan, United States, 48201|
|United States, Missouri|
|Investigational Site Number 840015||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|United States, New Jersey|
|Investigational Site Number 840005||Recruiting|
|Hackensack, New Jersey, United States, 07601|
|United States, North Carolina|
|Investigational Site Number 840010||Recruiting|
|Durham, North Carolina, United States, 27707|
|United States, Ohio|
|Investigational Site Number 840013||Recruiting|
|Canton, Ohio, United States, 44718|
|United States, Tennessee|
|Investigational Site Number 840001||Recruiting|
|Nashville, Tennessee, United States, 37232|
|United States, Utah|
|Investigational Site Number 840002||Recruiting|
|Salt Lake City, Utah, United States, 84112-5550|
|United States, Wisconsin|
|Investigational Site Number 840006||Recruiting|
|Milwaukee, Wisconsin, United States, 53226|
|Investigational Site Number 250004||Recruiting|
|Pessac Cedex, France, 33604|
|Investigational Site Number 250003||Recruiting|
|Pierre Benite, France, 69310|
|Investigational Site Number 250001||Recruiting|
|Poitiers, France, 86021|
|Investigational Site Number 250006||Recruiting|
|Vandoeuvre-Les-Nancy, France, 54511|
|Study Director:||Clinical Sciences & Operations||Sanofi|