SC versus IV isatuximab in combination with pomalidomide and dexamethasone in RRMM
Verified

What's the purpose of this trial?

This is a randomized, multicenter, Phase 3, open-label study evaluating subcutaneous (SC) vs intravenous (IV) administration of isatuximab in combination with pomalidomide and dexamethasone (Pd) in RRMM patients (study participants) who have received at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor (PI).

This trial is currently open and accepting patients.


What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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


Additional Trial Information

Phase 1

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Arkansas

Highlands Oncology Group

Springdale, AR

Not Yet Accepting

Florida

Mayo Clinic (Jacksonville)

Jacksonville, FL

Not Yet Accepting

Mississippi

Forrest General Cancer Center

Hattiesburg, MS

Not Yet Accepting

New Jersey

Morristown Medical Center Atlantic Health System

Morristown, NJ

Not Yet Accepting

Pennsylvania

Main Line Health Lankenau Medical Center

Wynnewood, PA

Not Yet Accepting

South Carolina

Charleston Hematology Oncology Associates PA West Ashley

Charleston, SC

Not Yet Accepting

Gibbs Cancer Center and Research Spartanburg Regional Healthcare System

Spartanburg, SC

Not Yet Accepting

Utah

George E. Wahlen Department of Veterans Affairs Medical Center

Salt Lake City, UT

Not Yet Accepting

Wisconsin

UW Cancer Center at ProHealth Care

Waukesha, WI

Not Yet Accepting
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