Phase 2 Study of Isatuximab Plus Lenalidomide and Dexamethasone in Highly Toxicity-vulnerable Subjects With Newly Diagnosed Multiple Myeloma

Summary

This 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.

Description

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Isatuximab

  Pharmaceutical form: Solution for infusion Route of administration: Intravenous Isatuximab:10 mg/kg intravenous or 1400 mg subcutaneous (SC) via on-body delivery system (OBDS) will be administered in cycles 1-24.

• Drug
  Lenalidomide

  Pharmaceutical form: Capsule for oral use, Route of administration: Oral Lenalidomide capsule will be given oral, the dose will be adjusted according to glomerular filtration rate (GFR): 15 mg daily if GFR \> 60 mL/min, 5 mg daily if GFR 30-60 mL/min, 2.5 mg daily if GFR \< 30 mL/min. Note that dialysis-dependence comprises an exclusion criterion for this study. Lenalidomide will be continued until disease progression, excessive toxicity or death.

• Drug
  Dexamethasone

  Pharmaceutical form: Tablet for oral use, Route of administration: Oral Dexamethasone tablet will be given oral: 20 mg given on days 1, 8, 15 and 22 of cycles 1-8. Administration may continue beyond cycle 8, if needed, for the prevention of infusion reactions.

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