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RecruitingLast updated:15 August 2023

This phase III study is evaluating different methods of administered targeted therapy (isatuximab) when given in additional to combination therapy (pomalidomide and dexamethasone) in people with relapsed or refractory multiple myeloma who have had previous treatmentA Randomized, Phase 3, Open Label Study Evaluating Subcutaneous Versus Intravenous Administration of Isatuximab in Combination With Pomalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)

Clinical summary

Summary

Eligible participants will be randomly allocated to either the Experimental Arm or the Active Comparator Arm. In the Experimental Arm, participants will receive isatuximab administered via subcutaneous injection weekly for 4 weeks during Cycle 1 (Days 1, 8, 15 and 22) and Day 1 and 15 of subsequent cycles. In the Active Comparator Arm, participants will receive isatuximab administered via intravenous infusion weekly for 3 weeks during Cycle 1 (Days 1, 8, 15 and 22) and Day 1 and 15 of each subsequent cycle. Each cycle will be 28 days in duration. All participants will also receive pomalidomide, to be taken orally on Day 1 to Day 21 of each cycle at the time that is is most convenient for the participants prior to or after isatuximab administration, preferably at the same time every day, as well as dexamethasone to betaken orally on Day 1, 8, 15 and 22 (to be repeated every 28 days).

Age

People18+

Phase

III

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Trial Identifiers

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Commercial Sponsor

Sanofi

Scientific Title

A Randomized, Phase 3, Open Label Study Evaluating Subcutaneous Versus Intravenous Administration of Isatuximab in Combination With Pomalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)

Eligibility

Inclusion

  • You have certain types of non-cancer medical conditions.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Exclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.
Message

Clinical trials have complex eligibility criteria.

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