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A prospective Phase II study of Isatuximab Rescue for Inadequate response to Lenalidomide and Dexamethasone in transplant ineligible patients with newly diagnosed multiple myeloma
Australasian Myeloma Research Consortium
Other Non-Commercial Sponsor
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.