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RecruitingLast updated:20 July 2023

IRIL: This trial is evaluating the effectiveness of a targeted therapy (Isatuximab) for patients with newly diagnosed multiple myeloma, who are unable to have a transplant and have had an inadequate response to treatment with lenalidomide and dexamethasoneA prospective Phase II study of Isatuximab Rescue for Inadequate response to Lenalidomide and Dexamethasone in transplant ineligible patients with newly diagnosed multiple myeloma

Clinical summary

Summary

Patients eligible to participate in this trial will initially receive orally administered Lenalidomide on Days 1-21 of a 28 day cycle and orally administered Dexmaethasone on Days 1, 8, 15 and 22 of the 28 day cycle. Blood tests will assess the level of response of the multiple myeloma to the treatment after 4, 6 or 9 cycles of treatment. If the patient has not had partial or complete response they will also receive intravenous administration of Isatuximab, which will be administered weekly for the first month and fortnightly thereafter. Treatment will continue until disease progression while receiving Isatuximab or unacceptable toxicity occurs.

Treatment Type

Radiotherapy

Age

People18+

Phase

II

Trial Acronym

IRIL

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Trial Identifiers

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Commercial Sponsor

Austin Health, Australasian Myeloma Research Consortium

Scientific Title

A prospective Phase II study of Isatuximab Rescue for Inadequate response to Lenalidomide and Dexamethasone in transplant ineligible patients with newly diagnosed multiple myeloma

Eligibility

Inclusion

  • You have certain types of non-cancer medical conditions.

Exclusion

  • You are able to swallow medication by mouth.
  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had a certain type of treatment or surgical procedure.
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Clinical trials have complex eligibility criteria.

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