Last updated on April 2019

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


Brief description of study

Primary Objectives:

VCDI cohort:

  • To determine the maximum tolerated dose (MTD) and recommended dose (RD) of isatuximab when administered in combination with bortezomib, 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 in combination with bortezomib, dexamethasone, and cyclophosphamide in patients with newly diagnosed multiple myeloma non-eligible for transplantation.

VRDI cohort parts A and B:

  • To evaluate preliminary efficacy (complete response rate) of isatuximab in combination with bortezomib, dexamethasone, and lenalidomide in patients with newly diagnosed multiple myeloma non-eligible for transplantation or no intent for immediate transplantation.

Secondary Objectives:

  • To characterize the overall safety profile of isatuximab in combination with each bortezomib-based regimen, including cumulative toxicities.
  • To characterize the pharmacokinetic (PK) profile of isatuximab and each combination drug in each isatuximab/bortezomib based regimen.
  • To evaluate the immunogenicity of isatuximab in combination treatments.
  • To evaluate the preliminary efficacy of both bortezomib based regimens in terms of duration of response, overall response rate and progression-free survival.
  • To assess the relationship between clinical effects (adverse event [AE] and/or tumor response) and CD38 receptor density (VCDI and VRDI part only).
  • To evaluate the infusion duration.
  • To assess the minimal residual disease (MRD) negativity rate in patients achieving a Complete Response (CR) or Very Good Partial Response (VGPR).

Detailed Study Description

The duration of the study for an individual patient will include:

  • A period to assess eligibility (screening or baseline period) of up to 3 weeks for VCDI cohort, up to 28 days for VRDI cohort;
  • for patients in the VCDI cohort: a treatment period including up to 12 induction treatment cycles (50-week duration).
  • for patients in the VRDI cohort: a treatment period including up to 4 induction cycles (24 week duration).
  • Following induction, both cohorts have maintenance periods consisting of 4 week cycles until progression, unacceptable AE, or patient willingness to discontinue and an end-of-treatment visit at least 30 days following the last administration of treatment.
  • Patients that discontinue therapy for reasons other than progression will have follow-up visits until progression or until the patient receives another anticancer therapy, whichever is earlier.

Clinical Study Identifier: NCT02513186

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Recruitment Status: Open


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