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

• Register: ClinicalTrials.gov
• Last refreshed on: 15 April 2024
• Main ID: NCT03319667
• Date of registration: 18/09/2017
• Prospective Registration: Yes
• Primary sponsor: Sanofi
• Public title: Clinical Benefit of SAR650984, Bortezomib, Lenalidomide and Dexamethasone Combination in NDMM Patients Not Eligible for Transplant IMROZ
• Scientific title: A Phase 3 Randomized, Open-label, Multicenter Study Assessing the Clinical Benefit of Isatuximab (SAR650984) in Combination With Bortezomib (Velcade®), Lenalidomide and Dexamethasone Versus Bortezomib, Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant
• Date of first enrolment: December 7, 2017
• Target sample size: 475
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03319667
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Australia, Belgium, China, Czechia, Denmark, France, Germany, Greece, Italy, Japan, Lithuania, Mexico, New Zealand, Poland, Portugal, Russian Federation, Spain, Sweden, Taiwan, Turkey, United States

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Plasma Cell Myeloma

Intervention(s)

Drug: Isatuximab SAR650984

Drug: Lenalidomide

Drug: Bortezomib

Drug: Dexamethasone

Primary Outcome(s)

Progression free survival (PFS) [Time Frame: Up to approximately 100 months after the First Patient In (FPI)]

Secondary Outcome(s)

Assessment of PK parameter: Ctrough [Time Frame: Cycle 1 Day 8/Day 15/Day 29 (pre-dose) and Day 1 (pre-dose) of Cycle 2, 3, 4, 5, 6, 7, 8, 9 and 10 (Duration of each cycle for Cycles 1-4: 6 weeks; Duration of each cycle for Cycles 5-10: 4 weeks)]

PFS on next line of therapy (PFS2) [Time Frame: Up to approximately 110 months after the FPI]

PRO: QLQ-MY20 [Time Frame: Up to approximately 100 months after the FPI]

Adverse Events [Time Frame: Up to 30 days after end of treatment (EOT) visit]

Complete response rate (CR) [Time Frame: Up to approximately 100 months after the FPI]

Patient reported outcome (PRO): QLQ-C30 [Time Frame: Up to approximately 100 months after the FPI]

Sustained MRD negativity =12 months rate [Time Frame: Up to approximately 100 months after the FPI]

Overall survival (OS) [Time Frame: Up to approximately 110 months after the FPI]

PFS in MRD negative patients [Time Frame: Up to approximately 100 months after the FPI]

Time to first response (TT1R) [Time Frame: Up to approximately 100 months after the FPI]

Very good partial response (VGPR) or better rate [Time Frame: Up to approximately 100 months after the FPI]

Duration of response (DOR) [Time Frame: Up to approximately 100 months after the FPI]

Overall response rate (ORR) [Time Frame: Up to approximately 100 months after the FPI assessment]

PRO: EQ-5D-5L [Time Frame: Up to approximately 100 months after the FPI]

Time to best response (TTBR) [Time Frame: Up to approximately 100 months after the FPI]

Immunogenicity [Time Frame: Up to approximately 100 months after the FPI]

Minimal residual disease (MRD) negativity rate for patients with CR [Time Frame: Up to approximately 100 months after the FPI]

Time to progression (TTP) [Time Frame: Up to approximately 100 months after FPI]

Secondary ID(s)

EFC12522

2017-002238-21

U1111-1194-2121

Source(s) of Monetary Support

Please refer to primary and secondary sponsors