Isatuximab

Source: Plasma Cell Neoplasms (Including Multiple Myeloma) Treatment (PDQ®)–Health Professional Version, National Cancer Institute.

Source updated: April 25, 2025 · Captured 2026-09-09.

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Context: Treatment of Relapsed or Refractory Multiple Myeloma / Treatment Options for Relapsed or Refractory Multiple Myeloma / Monoclonal antibodies

Isatuximab is a monoclonal antibody directed against CD38.

Evidence (isatuximab):

In a prospective randomized trial of 387 patients with relapsed or refractory disease, Pd was given with or without isatuximab.[15]

Source links and citations

In a prospective randomized trial of 387 patients with relapsed or refractory disease, Pd was given with or without isatuximab.[15]

With a median follow-up of 35.3 months, the median OS was 24.6 months (95% CI, 20.3–31.3) for patients who received isatuximab plus PD and 17.7 months (95% CI, 14.4–26.2) for patients who received Pd alone (HR, 0.76; 95% CI, 0.57–1.01; 2-sided P = .056).

In a prospective randomized trial of 387 patients with relapsed or refractory disease, Pd was given with or without isatuximab.[15]

Similarly, the median PFS was 17.5 months (95% CI, 14.9–19.2) for the isatuximab group and 12.9 months (95% CI, 10.1–16.6) for the Pd group (HR, 0.76; 95% CI, 0.58–0.99; P = .020).[15][Level of evidence B1]

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In a prospective randomized trial of 302 patients with relapsed or refractory disease, the combination of carfilzomib and dexamethasone was given with or without isatuximab.

With a median follow-up of 20.7 months, the 2-year PFS rate was 68.9% (95% CI, 60.7%–75.8%) for patients who received isatuximab group and 45.7% (95% CI, 35.2%–55.6%) for patients who received carfilzomib and dexamethasone alone (HR, 0.53; 99% CI, 0.32–0.89; 2-sided P = .0014).[16][Level of evidence B1]

Source links and citations

There are no data comparing isatuximab with daratumumab, both of which target CD38. There are no data proving that isatuximab has efficacy in patients with disease that is resistant to daratumumab.

Publication references

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Preserved source evidence · Not medical advice