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Study of Isatuximab Combined With Bortezomib + Cyclophosphamide + Dexamethasone (VCD) and Bortezomib + Lenalidomide + Dexamethasone (VRD) in Newly Diagnosed Multiple Myeloma (MM) Non Eligible for Transplant or No Intent for Immediate Transplantation

NCT02513186 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-01-29

No results posted yet for this study

Summary

Primary Objectives:

* VCDI cohort:

* To determine the maximum tolerated dose (MTD) and recommended dose (RD) of SAR650984 isatuximab when administered in combination with bortezomib (Velcade®) , cyclophosphamide, and dexamethasone (VCDI) based on the dose-limiting toxicity(ies) (DLTs) observed in patients with newly diagnosed multiple myeloma non-eligible for transplantation
* To evaluate safety and preliminary efficacy (overall response rate and complete response rate) of isatuximab administered at the selected dose in combination with bortezomib based regimin VCDI according to IMWG criteria.
* VRDI Part A cohort and Part B cohort:

* To evaluate the preliminary efficacy (complete response \[CR\] rate) of isatuximab administered at the selected dose in combination with bortezomib based regimen: VRDI, (bortezomib, lenalidomide, dexamethasone) according to IMWG criteria in adult patients with newly diagnosed MM non eligible for transplantation or no intent for immediate transplantation.

Secondary Objectives:

* VCDI cohort:

* To characterize the overall safety profile of SAR650984 in combination with VCD regimen, including cumulative toxicities.
* To characterize the pharmacokinetic (PK) profile of SAR650984/isatuximab and each combination drug in VCDI regimen.
* To evaluate the immunogenicity of SAR650984 in combination treatments.
* To evaluate the preliminary efficacy of VCDI regimen in terms of duration of response and progression-free survival.
* To assess the relationship between clinical effects (adverse event \[AE\] and/or tumor response) and CD38 receptor density.
* VRDI Part A cohort and Part B cohort:

* To characterize the overall safety profile of isatuximab in combination with VRD regimen.
* To evaluate the infusion duration (only applicable for VRDI Part B cohort)
* To characterize the PK profile of isatuximab and each combination drug in VRDI regimen.
* To evaluate the immunogenicity of isatuximab in combination treatments.
* To evaluate the preliminary efficacy of VRDI regimen in terms of ORR, DOR, and PFS.
* To evaluate the impact of M protein measurement without isatuximab interference (via the SEBIA HYDRASHIFT 2/4 isatuximab IFE test) on CR and BOR assessment.
* To assess the relationship between clinical effects (AE and/or tumor response) and CD38 receptor density (only applicable for VRDI Part A cohort).
* To assess MRD negativity rate in patients achieving a CR or VGPR and explore correlation with clinical outcome.

Conditions

  • Plasma Cell Myeloma

Interventions

DRUG

lenalidomide

Pharmaceutical form: tablet Route of administration: oral

DRUG

bortezomib

Pharmaceutical form: lyophilized powder for subcutaneous injection Route of administration: subcutaneous

DRUG

cyclophosphamide

Pharmaceutical form: tablet Route of administration: oral

DRUG

dexamethasone

Pharmaceutical form: tablet or solution for infusion Route of administration: oral or intravenous

DRUG

isatuximab SAR650984

Pharmaceutical form: solution for infusion Route of administration: intravenous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2022-01-28
Completion
2024-01-22

Countries

  • France
  • Germany
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02513186 on ClinicalTrials.gov