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Closed (no longer recruiting)Last updated: 7 February 2024

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.

Conditions

This trial is treating patients with Multiple Myeloma

Cancer

Blood Cancers Haematological

Age

People18+

Phase

II

Trial Acronym

IRIL

More information

Trial Identifiers

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Trial 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

 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)

Exclusion

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

Inclusion

  • 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.

Exclusion

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

Clinical trials have complex eligibility criteria.

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