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

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Sanofi

Status and phase

Active, not recruiting
Phase 3

Conditions

Plasma Cell Myeloma

Treatments

Drug: Dexamethasone
Drug: Lenalidomide
Drug: Bortezomib
Drug: Isatuximab SAR650984

Study type

Interventional

Funder types

Industry

Identifiers

NCT03319667
2017-002238-21 (EudraCT Number)
U1111-1194-2121 (Other Identifier)
EFC12522

Details and patient eligibility

About

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 bortezomib, lenalidomide, and dexamethasone, in patients with newly diagnosed multiple myeloma (NDMM) not eligible for transplant. Secondary Objectives: To evaluate in both randomized (isatuximab, bortezomib, lenalidomide and dexamethasone combination (IVRd) and bortezomib, lenalidomide and dexamethasone combination (VRd)) arms: Complete response (CR) rate, as defined by the International Myeloma Working Group (IMWG) criteria. Minimal residual disease (MRD) negativity rate in patients with CR. Very good partial response or better rate, as defined by the IMWG criteria. Overall survival (OS). To evaluate the overall response rate (ORR) as per IMWG criteria. To evaluate the time to progression (TTP) overall and by MRD status. To evaluate PFS by MRD status. To evaluate the duration of response (DOR) overall and by MRD status. To evaluate time to first response (TT1R). To evaluate time to best response (TTBR). To evaluate progression-free survival on next line of therapy (PFS2). To evaluate the sustained MRD negativity >12 months rate. To evaluate safety. To determine the pharmacokinetic (PK) profile of isatuximab in combination with bortezomib, lenalidomide, and dexamethasone (IVRd arm only). To evaluate the immunogenicity of isatuximab in patients receiving isatuximab (IVRd and crossover arms). To assess disease-specific and generic health-related quality of life (HRQL), disease and treatment-related symptoms, health state utility, and health status.

Full description

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 ± 3 days), a continuous treatment period and a crossover period (when applicable). The cycle duration is 28 ± 3 days during the continuous treatment and crossover periods.

Enrollment

475 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Trial design

475 participants in 3 patient groups

Isatuximab/Bortezomib/Lenalidomide/Dexamethasone = IVRd arm
Experimental group
Description:
Induction treatment with 4x6-week cycles with intravenous (IV) isatuximab + subcutaneous (SC) bortezomib + oral lenalidomide + IV or oral dexamethasone Continuous treatment with 4-week cycles with IV isatuximab + oral lenalidomide + IV or oral dexamethasone
Treatment:
Drug: Isatuximab SAR650984
Drug: Bortezomib
Drug: Dexamethasone
Drug: Lenalidomide
Bortezomib/Lenalidomide/Dexamethasone = VRd arm
Active Comparator group
Description:
Induction treatment with 4x6-week cycles with SC bortezomib + oral lenalidomide + IV or oral dexamethasone Continuous treatment with 4-week cycles with oral lenalidomide + IV or oral dexamethasone
Treatment:
Drug: Bortezomib
Drug: Dexamethasone
Drug: Lenalidomide
Isatuximab/Lenalidomide/Dexamethasone = IRd crossover arm
Other group
Description:
4-weeks cycles with IV isatuximab + oral lenalidomide + IV or oral dexamethasone
Treatment:
Drug: Isatuximab SAR650984
Drug: Dexamethasone
Drug: Lenalidomide

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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