A Study to Evaluate the Safety and Pharmacokinetics of SAR650984 in Patients With Multiple Myeloma

Overview

The primary objective of this trial is to evaluate the safety of SAR650984 in patients with relapsed/refractory multiple myeloma (RRMM).

SparkCures ID 750
Trial Phase Phase 1
Enrollment 64 Patients
Treatments
Trial Sponsors
  • Sanofi
NCT Identifier

NCT02514668

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:

  • Patients must have a known diagnosis of multiple myeloma (MM) with evidence of measurable disease, as defined below, and have evidence of disease progression based on International Myeloma Working Group (IMWG) criteria:
    • Serum M-protein ≥1g/dL, or urine M-protein ≥200 mg/24 hours OR
    • In the absence of measurable M-protein, serum immunoglobulin free light chain ≥10 mg/dL, and abnormal serum immunoglobulin kappa lambda free light chain ratio.
  • Patients must have received at least 3 prior lines of therapy for MM and must include treatment with an immunomodulatory drug (IMiD) (for ≥2 cycles or ≥2 months of treatment) and a proteasome inhibitor (for ≥2 cycles or ≥2 months of treatment). Induction therapy and stem cell transplant (± maintenance) will be considered as one regimen within a line OR
  • Patients whose disease is double refractory to an IMiD and a proteasome inhibitor. For patients who have received more than one type of IMiD and proteasome inhibitor, their disease must be refractory to the most recent one.
  • Patients must have achieved a minimal response (MR) or better to at least one prior line of therapy.
  • Patients must have received an alkylating agent (for ≥2 cycles or ≥2 months of treatment) either alone or in combination with other MM treatments (history of stem cell transplant is acceptable). Treatment with high-dose Melphalan for stem cell transplantation meets this requirement.

Exclusion criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status >2.
  • Poor bone marrow reserve.
  • Poor organ function.
  • Known intolerance/hypersensitivity to IMiDs, dexamethasone, boron or mannitol, sucrose, histidine, or polysorbate 80.
  • Any serious active disease (including clinically significant infection that is chronic, recurrent, or active) or comorbid condition, which, in the opinion of the Investigator, could interfere with the safety, the compliance with the study, or with the interpretation of the results.
  • Any severe underlying medical conditions including presence of laboratory abnormalities, which could impair the ability to participate in the study or the interpretation of its results.

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

North Carolina

Resources

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