Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients

Description

Primary Objective: To demonstrate the benefit of isatuximab in combination with pomalidomide and low-dose dexamethasone in the prolongation of Progression Free Survival (PFS) as compared to pomalidomide and low-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma (MM). Secondary Objectives: - To evaluate the Overall Response Rate (ORR) as per International Myeloma Working Group (IMWG) criteria in each arm. - To compare the Overall Survival (OS) between the two arms. - To evaluate the Time To Progression (TTP) in each arm. - To evaluate the Progression Free Survival (PFS) in high risk cytogenetic population in each arm. - To evaluate the Duration of Response (DOR) in each arm. - To evaluate the safety in both treatment arms. - To determine the Pharmacokinetic profile of isatuximab in combination with pomalidomide. - To evaluate the immunogenicity of isatuximab. - To assess disease-specific and generic health-related quality of life (HRQL), disease and treatment-related symptoms, health state utility, and health status.

Study Start Date

December, 22 2016

Estimated Completion Date

January 2021

Interventions

  • Drug: pomalidomide
  • Drug: isatuximab SAR650984
  • Drug: dexamethasone

Study ID

Sanofi -- EFC14335

Status

Recruiting

Trial ID

NCT02990338

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

300

Sponsor

Sanofi

Inclusion criteria :
  • Age superior or equal to 18 years or country's legal age of majority if the legal age is superior to 18 years old.
  • Patients must have a documented diagnosis of multiple myeloma with evidence of measurable disease i.e. serum M protein superior or equal to 0.5 g per dL measured using serum protein immunoelectrophoresis and or urine M protein superior or equal to 200 mg per 24 hours measured using urine protein immunoelectrophoresis.
  • Patients must have received at least 2 prior lines of anti-myeloma therapy, which must include at least 2 consecutive cycles of lenalidomide and a proteasome inhibitor (bortezomib, carfilzomib or ixazomib) given alone or in combination.
  • Patients must have failed treatment with lenalidomide and a proteasome inhibitor (bortezomib, carfilzomib, or ixazomib) alone or in combination.
  • Patients must have progressed on or within 60 days after end of previous therapy before to study entry, i.e., refractory to the last line of treatment. Exclusion criteria:
  • Primary refractory multiple myeloma defined as patients who have never achieved at least a minimal response (MR) with any treatment during the disease course.
  • Free Light Chain measurable disease only.
  • Prior therapy with pomalidomide.
  • Any anti-myeloma drug treatment within 14 days before randomization, including dexamethasone.
  • Eastern Cooperative Oncology Group performance status superior to 2.
  • Platelets inferior to 75 000 cells per µL if inferior to 50% of bone marrow (BM) nucleated cells are plasma cells, and inferior to 30 000 cells per µL if superior or equal to 50% of BM nucleated cells are plasma cells. Platelet transfusion is not allowed within three days before the screening visit.
  • Absolute neutrophils count inferior to 1000 per ?L (1 x 10E9/L). The use of G-CSF is not allowed to reach this level.
  • Creatinine clearance inferior to 30 mL per min (MDRD Formula).
  • Total bilirubin superior to 2 x ULN (Upper Limit of Normal).
  • Corrected serum calcium superior to 14 mg per dL (superior to 3.5 mmol per L).
  • Aspartate aminotransferase (AST) and/or Alanine Aminotransferase (ALT) superior to 3 x ULN.
  • Hypersensitivity to IMiDs (thalidomide or lenalidomide) defined as any hypersensitivity reaction leading to stop IMiDs within the 2 first cycles or toxicity, which does meet intolerance definition.
  • Hypersensitivity to dexamethasone, sucrose histidine (as base and hydrochloride salt), and polysorbate 80 or any of the components of study therapy that are not amenable to premedication with steroids, or H2 blockers that would prohibit further treatment with these agents.
  • Significant cardiac dysfunction
  • myocardial infarction within 12 months unstable, poorly controlled angina pectoris.
  • Pregnant or breastfeeding woman or female who intends to become pregnant during the participation in the study.
  • Male participants who disagree to practice true abstinence or disagree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and at least 3 months following study treatment discontinuation, even if he has undergone a successful vasectomy.
  • All patients who disagree to refrain from donating blood while on study treatment and for 4 weeks after discontinuation from this study treatment. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
  • Gender

    All

    Ages

    18 Years and older

    Accepts Healthy Volunteers

    No

    Study Locations and Contact Information (11)

    Study Location Distance Name Phone Email
    Investigational Site Number 8400006 - Boston, Massachusetts 2.4 miles None None None
    Investigational Site Number 8400006 - Boston, Massachusetts 2.4 miles None None None
    Investigational Site Number 8400106 - Boston, Massachusetts 2.8 miles None None None
    Investigational Site Number 8400106 - Boston, Massachusetts 2.8 miles None None None
    Investigational Site Number 8400007 - Canton, Ohio 545.2 miles None None None
    Investigational Site Number 8400007 - Canton, Ohio 545.2 miles None None None
    Investigational Site Number 8400010 - Fort Wayne, Indiana 735.9 miles None None None
    Investigational Site Number 8400004 - Rochester, Minnesota 1,083.1 miles None None None
    Investigational Site Number 8400004 - Rochester, Minnesota 1,083.1 miles None None None
    Investigational Site Number 8400002 - Plantation, Florida 1,238.1 miles None None None
    Investigational Site Number 8400003 - Scottsdale, Arizona 2,284.5 miles None None None

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