Phase 3 Study Evaluating Subcutaneous vs Intravenous Isatuximab in Combination with Pomalidomide and Dexamethasone in Patients with Relapsed and/or Refractory Multiple Myeloma



The goal of this clinical trial is to learn more about the safety and effectiveness of isatuximab given by subcutaneous injection versus intravenous infusion. Both subcutaneous and intravenous isatuximab will be studied in combination with pomalidomide and dexamethasone in patients who have relapsed and/or refractory multiple myeloma.

SparkCures ID 1305
Trial Phase Phase 3
Enrollment 534 Patients
Trial Sponsors
  • Sanofi
NCT Identifier


Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  • Participants with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor, and with measurable serum M-protein (≥ 0.5 g/dL) and/or urine M-protein (≥ 200 mg/24 hours) and/or serum free light chain (FLC) assay (Involved FLC assay ≥10 mg/dL and abnormal serum FLC ratio (<0.26 or >1.65))

Exclusion Criteria:

  • Participants less than 18 years old, participants with Eastern Cooperative Oncology Group performance status more than 2
  • Primary refractory multiple myeloma participants
  • Participants refractory to anti-CD38 with a wash-out period inferior to 9 months or intolerant to anti-CD38 mAb agents
  • Prior therapy with pomalidomide
  • Participants with inadequate biological tests.
  • Significant cardiac dysfunction
  • Participants diagnosed or treated for another cancer within 3 years prior to randomization with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, and in situ malignancy, or low risk prostate cancer after curative therapy
  • Concomittant plasma cell leukemia
  • Active primary amyloid-light (AL) amyloidosis
  • Known acquired immunodeficiency syndrome (AIDS)-related illness or known human immunodeficiency virus (HIV) disease requiring antiviral treatment
  • Hepatitis A, B, or C active infection
  • Women of childbearing potential or male participant with women of childbearing potential who do not agree to use highly effective method of birth control

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial

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