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OncoMatch/Clinical Trials/NCT05145400

Isa-Rd for Frail and/or Much Older Patients With Newly Diagnosed Multiple Myeloma

Is NCT05145400 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Isatuximab and Lenalidomide for multiple myeloma.

Phase 2RecruitingUNC Lineberger Comprehensive Cancer CenterNCT05145400Data as of May 2026

Treatment: Isatuximab · Lenalidomide · DexamethasoneThis research study is investigating the safety and effectiveness of using combination of isatuximab, lenalidomide and dexamethasone for the treatment of newly diagnosed multiple myeloma (MM). The study team will use lower doses than is currently standard for these drugs. Lower doses will be used to avoid or possibly reduce any unwanted side effects commonly associated with these drugs. Using lower doses of the combination isatuximab, lenalidomide and dexamethasone, has not been approved by the Food and Drug Administration (FDA) for the treatment of newly diagnosed MM.

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Extracted eligibility criteria

Cancer type

Multiple Myeloma

Performance status

KARNOFSKY 0–70

Prior therapy

Max 1 prior line

Cannot have received: systemic anti-myeloma therapy

Exception: ≤ 28 days (generally one cycle) allowed; any prior therapy must be completed ≥ 14 days before starting study drugs

No prior systemic anti-myeloma therapy lasting more than 28 days (generally one cycle). Any prior therapy must be completed a minimum of 14 days before starting study drugs.

Lab requirements

Blood counts

Hemoglobin (Hgb) ≥ 8 g/dL (transfusion or erythropoietin permitted); ANC ≥ 1.0 x 10^9/L (growth factors permitted if due to MM); Platelets ≥ 50 × 10^9/L if < 50% BM plasma cells, ≥ 30 × 10^9/L if ≥ 50% BM plasma cells (transfusions permitted)

Kidney function

Any GFR as long as not currently dialysis-dependent

Demonstrate adequate organ function and laboratory values as defined in below.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center · Chapel Hill, North Carolina
  • Levine Cancer Institute · Charlotte, North Carolina
  • Duke Comprehensive Cancer Center · Durham, North Carolina
  • Novant Health New Hanover Regional Medical Center · Wilmington, North Carolina
  • The Ohio State University Comprehensive Cancer Center · Columbus, Ohio

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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