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Australian Clinical Trials

Clinical Trial Details

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

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Trial Information

Broad Health Condition Cancer

Specific Health ConditionMyeloma

Trial FocusTreatment

Recruitment Details

Recruitment status
Recruiting

Recruitment State
NSW,TAS,WA,VIC

Hospital
The Alfred - Prahran
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Epworth Freemasons (Clarendon Street) - East Melbourne
Royal Hobart Hospital - Hobart
Flinders Medical Centre - Bedford Park
Fiona Stanley Hospital - Murdoch
St George Hospital - Kogarah
Border Medical Oncology - Albury
Concord Repatriation Hospital - Concord
Calvary Mater Newcastle - Waratah

Postcode
3004 - Prahran
3065 - Fitzroy
3002 - East Melbourne
7000 - Hobart
5042 - Bedford Park
6150 - Murdoch
2217 - Kogarah
2640 - Albury
2139 - Concord
2298 - Waratah

Anticipated date of first participant enrolment25/03/2019

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Trial summary

The purpose of this study is to determine whether Isatuximab (a new drug), when combined with chemotherapy, improves response to treatment. 

Who is it for?

You may be eligible to participate in this trial if you are aged 18 years or over, have been newly diagnosed with multiple myeloma and are not a candidate for high dose chemotherapy and autologous stem cell transplant.

Study Details
Eligible participants will receive lenalidomide and dexamethasone (Ld). Participants who have inadequate response to upfront treatment with Ld, will have the addition of Isatuximab. Treatment (each cycle is 28 days) will be given until disease progression, unacceptable toxicity, or withdrawal of consent. 
Participants will be required to have blood samples taken at the beginning of each cycle along with a medical exam in order for researchers to monitor whether the treatment is safe and whether it is effectively treating the myeloma.
It is hoped that the findings of this trial will establish the benefits of Isatuximab in combination with Ld for the treatment of multiple myeloma patients early in the course of their disease. 

Eligibility

Key inclusion criteria

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)

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate? No

Key exclusion criteria

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
Contact details and further information

Sponsor Primary Sponsor Type: Other Collaborative groups
Primary Sponsor Name: Australasian Myeloma Research Consortium
Primary Sponsor Address: 55 Commercial Rd, Melbourne VIC 3004
Primary Sponsor Country: Australia

Trial IDACTRN12619000362190

Contact person for information and recruitmentMiss
Flora Yuen
Alfred Hospital 55 Commercial Road, Melbourne VIC 3004
+61390765407

Email contact Further information iconflora.yuen@alfred.org.au

Australia