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 Consortium0 个研究点目标入组 68 人开始时间: 2019年3月7日最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•1. Patient has voluntarily agreed and has given written informed consent to both the main study and the correlative study.
•2. Male and Female patients, 18 years or older of age
•3. Diagnosed with MM (diagnosis of MM as per IMWG)
•4. Measurable M-component in serum or urine, In patients with no detectable M-component, an abnormal FLC ratio on the serum FLC assay
•5. No prior therapies (except radiotherapy or short
•course of corticosteroids equivalent to dexamethasone 160mg in the last 28 days) or have
•started Ld as first line therapy but not completed cycle 4 of Ld and whose response status is SD or better
•6. ECOG performance status 0-2
•7. Adequate liver function (ALT, AST and GGT less than or equal to 2.5 x institutional upper limit of normal; GGT less than or equal to'1.5 x institutional upper limit of normal )
•8. CrCl >15ml/min
•9. Hb greater than or equal to 80g/L, Platelet count greater than or equal to 75 x 10^9/L, absolute neutrophil count greater than or equal to 1.0 x 10^9/L
•10. No contraindication to the use of any of the study drugs
•11. Life expectancy of greater than 6 months
•12. Patients must be registered on and abide by the Celgene i-access Risk Management Program before receiving first dose of lenalidomide (www.iaccesscelgene.com)

•1. Primary amyloidosis
•2. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study
•requirements
•3.Pregnant or lactating women.
•4. Known acquired immunodeficiency syndrome (AIDS-related illness) or known HIV disease requiring antiviral treatment, or active hepatitis A, B, or C infection

发起方

Australasian Myeloma Research Consortium