Status:
ACTIVE_NOT_RECRUITING
A Study to Investigate the Clinical Benefit of Isatuximab in Combination With Bortezomib, Lenalidomide and Dexamethasone in Adults With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant
Lead Sponsor:
Sanofi
Conditions:
Plasma Cell Myeloma
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Primary Objective: -To demonstrate the benefit of isatuximab in combination with bortezomib, lenalidomide, and dexamethasone in the prolongation of progression free survival (PFS) as compared to bort...
Detailed Description
The duration of the study for each participant will include a screening period of up to 4 weeks, an induction period of 24 weeks (4 cycles with a duration of 42 ± 3 days), a continuous treatment perio...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Inclusion criteria :
- Multiple myeloma (IMWG criteria).
- Newly diagnosed multiple myeloma not eligible for transplant due to age (≥ 65 years) or participants \< 65 years with comorbidities impacting possibility of transplant.
- Evidence of measurable disease.
- Written informed consent.
- Exclusion criteria:
- Age \< 18 years.
- Prior treatment for multiple myeloma.
- Any other prior or ongoing disease/health conditions incompatible with the study objectives.
- Organ function values not met.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ( PS) \> 2.
- Hypersensitivity to the study medications.
- Pregnant, breastfeeding, or woman of child bearing potential unwilling to use recommended contraception methods.
- Male participants who disagree to follow the study contraceptive counseling.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
December 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2027
Estimated Enrollment :
475 Patients enrolled
Trial Details
Trial ID
NCT03319667
Start Date
December 7 2017
End Date
June 30 2027
Last Update
November 27 2024
Active Locations (104)
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1
Investigational Site Number: 8400006
Fort Myers, Florida, United States, 33901
2
Investigational Site Number: 8400004
St. Petersburg, Florida, United States, 33705
3
Investigational Site Number: 8400007
Kansas City, Missouri, United States, 64132
4
Investigational Site Number: 8400005
Nashville, Tennessee, United States, 37203