Clinical Benefit of SAR650984, Bortezomib, Lenalidomide and Dexamethasone Combination in NDMM Patients Not Eligible for Transplant
| Status: | Recruiting |
|---|---|
| Conditions: | Hematology, Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 3/27/2019 |
| Start Date: | December 7, 2017 |
| End Date: | January 2025 |
| Contact: | Trial Transparency email recommended (Toll free number for US & Canada) |
| Email: | Contact-Us@sanofi.com |
| Phone: | 800-633-1610 |
A Phase 3 Randomized, Open-label, Multicenter Study Assessing the Clinical Benefit of Isatuximab (SAR650984) in Combination With Bortezomib (Velcade®), Lenalidomide (Revlimid®) and Dexamethasone Versus Bortezomib, Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma (NDMM) Not Eligible for Transplant
Primary Objective:
To demonstrate the benefit of isatuximab (I) in combination with bortezomib (V), lenalidomide
(R) and dexamethasone (d) in the prolongation of progression free survival (PFS) as compared
with bortezomib, lenalidomide and dexamethasone in patients with newly diagnosed multiple
myeloma (NDMM) not eligible for transplant.
Secondary Objectives:
- To evaluate in both randomized arms: very good partial response (VGPR) or better rate as
defined by the International Myeloma Working Group (IMWG) criteria, minimal residual
disease (MRD) negativity rate in patients with complete response (CR) or VGPR, CR rate
per IMWG criteria, time to progression (TTP) and overall by MRD status, PFS in MRD
negative patients, duration of response (DOR) and overall by MRD status, time to first
response (TT1R), PFS on next line of therapy (PFS2), overall survival (OS), overall
response rate (ORR) (including crossover arm) per IMWG criteria (including crossover
arm), safety (including crossover arm), and to assess disease-specific and generic
health-related quality of life (HRQL)
- To determine the pharmacokinetic (PK) profile of isatuximab in combination with
bortezomib, lenalidomide, and dexamethasone (excluding crossover arm)
- To evaluate the immunogenicity of isatuximab in patients receiving isatuximab (including
crossover arm)
To demonstrate the benefit of isatuximab (I) in combination with bortezomib (V), lenalidomide
(R) and dexamethasone (d) in the prolongation of progression free survival (PFS) as compared
with bortezomib, lenalidomide and dexamethasone in patients with newly diagnosed multiple
myeloma (NDMM) not eligible for transplant.
Secondary Objectives:
- To evaluate in both randomized arms: very good partial response (VGPR) or better rate as
defined by the International Myeloma Working Group (IMWG) criteria, minimal residual
disease (MRD) negativity rate in patients with complete response (CR) or VGPR, CR rate
per IMWG criteria, time to progression (TTP) and overall by MRD status, PFS in MRD
negative patients, duration of response (DOR) and overall by MRD status, time to first
response (TT1R), PFS on next line of therapy (PFS2), overall survival (OS), overall
response rate (ORR) (including crossover arm) per IMWG criteria (including crossover
arm), safety (including crossover arm), and to assess disease-specific and generic
health-related quality of life (HRQL)
- To determine the pharmacokinetic (PK) profile of isatuximab in combination with
bortezomib, lenalidomide, and dexamethasone (excluding crossover arm)
- To evaluate the immunogenicity of isatuximab in patients receiving isatuximab (including
crossover arm)
The duration of the study for each patient will include a screening period of up to 4 weeks,
an induction period of 24 weeks (4 cycles with a duration of 42 ± 4 days), a continuous
treatment period and a crossover period (when applicable). The cycle duration is 28 ± 4 days
during the continuous treatment and crossover periods.
an induction period of 24 weeks (4 cycles with a duration of 42 ± 4 days), a continuous
treatment period and a crossover period (when applicable). The cycle duration is 28 ± 4 days
during the continuous treatment and crossover periods.
Inclusion criteria :
- Multiple myeloma (IMWG criteria).
- Newly diagnosed multiple myeloma not eligible for transplant due to age (≥ 65 years)
or patients < 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.
We found this trial at
10
sites
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