Clinical Benefit of SAR650984, Bortezomib, Lenalidomide and Dexamethasone Combination in NDMM Patients Not Eligible for Transplant (IMROZ)

Overview

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), PFS in MRD negative patients, duration of response (DOR), 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.

SparkCures ID 975
Trial Phase Phase 3
Enrollment 440 Patients
Treatments
Trial Sponsors
  • Sanofi
NCT Identifier

NCT03319667

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion criteria :

  • Symptomatic 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.
  • Asymptomatic 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.

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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