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Trial registered on ANZCTR


Registration number
ACTRN12619000362190
Ethics application status
Approved
Date submitted
6/02/2019
Date registered
7/03/2019
Date last updated
11/02/2021
Date data sharing statement initially provided
7/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public 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
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
Secondary ID [1] 297316 0
AMaRC 18-02
Universal Trial Number (UTN)
Trial acronym
IRIL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 311422 0
Condition category
Condition code
Cancer 310054 310054 0 0
Myeloma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients will be given Lenalidomide as oral capsules, 25mg, daily on days 1 to 21 followed by a 7-day rest in a 28-day cycle and Dexamethasone as oral 4mg tablets, at a dose of 40mg (20mg for patients age >75 years) on days 1, 8, 15 and 22 in a 28-day cycle at the start of treatment; patients who are already on Lenalidomide and Dexamethasone (Ld) are still able to be enrolled into the study provided that they have not completed 4 cycles of Ld.
After completion of four cycles of Ld, patients who have not achieved at least a partial response (PR) which will be assessed via a blood sample, will have the addition of Isatuximab. In addition to Ld, Isatuximab is to be administered IV at a dose of 10 mg/kg weekly for the first month, then fortnightly (every 14 days) thereafter.
For these patients who remain on Ld, after completion of six cycles of Ld, patients who have not achieved a very good partial response (VGPR) will move onto Isatuximab , Lenalidomide and Dexamaethasone (ILd), whereas patients who have achieved VGPR or greater will remain on Ld. For these patients who remain on Ld, after completion of nine cycles of Ld, patients who have not achieved a complete response (CR) will move onto ILd, whereas patients who have achieved CR or greater will remain on Ld. At any point in time, patients who progress on Ld while on study will also move onto ILd. Treatment will be given until disease progression on ILd or unacceptable toxicity whichever occurs first.

Adherence is monitored through hospital drug administration records and tablet adherence through drug packet return.
Intervention code [1] 313570 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 318954 0
The percentage of achievement of partial response or greater following completion of an additional 6 cycles of lenalidomide and dexamethasone, which will be assessed by serum assay
Timepoint [1] 318954 0
When the first 15 patients who switch to ILd therapy after 4 cycles of Ld therapy have been assessed after 6 cycles of ILd therapy or withdrawn earlier.
Secondary outcome [1] 366527 0
To assess safety and tolerability of combination isatuximab lenalidomide and dexamethasone (ILd) via adverse events and laboratory results (serum assay, haematology and biochemistry blood panel).
Timepoint [1] 366527 0
Assessments at the end of every 28 day cycle during therapy and thereafter follow-up at 3 monthly intervals until study closure or until all patients on study have been followed for at least 12 months.
Secondary outcome [2] 366528 0
To assess the overall survival (OS) of patients receiving and dexamethasone with or without requiring rescue by additional isatuximab via from hospital records and follow up
Timepoint [2] 366528 0
At the completion of the study
Secondary outcome [3] 367679 0
To assess the progression free survival (PFS) of patients receiving and dexamethasone with or without requiring rescue by additional isatuximab via from hospital records and follow up
Timepoint [3] 367679 0
At the completion of the study

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 age
18 Years
Maximum age
No limit
Gender
Both 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,TAS,WA,VIC
Recruitment hospital [1] 13054 0
The Alfred - Prahran
Recruitment hospital [2] 13055 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [3] 15361 0
Epworth Freemasons (Clarendon Street) - East Melbourne
Recruitment hospital [4] 15362 0
Royal Hobart Hospital - Hobart
Recruitment hospital [5] 15363 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [6] 18706 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [7] 18707 0
St George Hospital - Kogarah
Recruitment hospital [8] 18708 0
Border Medical Oncology - Albury
Recruitment hospital [9] 18709 0
Concord Repatriation Hospital - Concord
Recruitment hospital [10] 18710 0
Calvary Mater Newcastle - Waratah
Recruitment postcode(s) [1] 25560 0
3004 - Prahran
Recruitment postcode(s) [2] 25561 0
3065 - Fitzroy
Recruitment postcode(s) [3] 28678 0
3002 - East Melbourne
Recruitment postcode(s) [4] 28679 0
7000 - Hobart
Recruitment postcode(s) [5] 28680 0
5042 - Bedford Park
Recruitment postcode(s) [6] 33147 0
6150 - Murdoch
Recruitment postcode(s) [7] 33148 0
2217 - Kogarah
Recruitment postcode(s) [8] 33149 0
2640 - Albury
Recruitment postcode(s) [9] 33150 0
2139 - Concord
Recruitment postcode(s) [10] 33151 0
2298 - Waratah

Funding & Sponsors
Funding source category [1] 301883 0
Other Collaborative groups
Name [1] 301883 0
Australasian Myeloma Research Consortium
Address [1] 301883 0
55 Commercial Rd, Melbourne VIC 3004
Country [1] 301883 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australasian Myeloma Research Consortium
Address
55 Commercial Rd, Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 301634 0
None
Name [1] 301634 0
Address [1] 301634 0
Country [1] 301634 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302571 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 302571 0
55 Commercial Road, Melbourne, VIC, 3004
Ethics committee country [1] 302571 0
Australia
Date submitted for ethics approval [1] 302571 0
Approval date [1] 302571 0
04/02/2019
Ethics approval number [1] 302571 0

Summary
Brief 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90698 0
A/Prof Hang Quach
Address 90698 0
St, Vincent's Hospital Melbourne
41 Victoria Pde, Fitzroy VIC 3065
Country 90698 0
Australia
Phone 90698 0
+61396548906
Fax 90698 0
Email 90698 0
hang.quach@svhm.org.au
Contact person for public queries
Name 90699 0
Miss Flora Yuen
Address 90699 0
Alfred Hospital
55 Commercial Road, Melbourne VIC 3004
Country 90699 0
Australia
Phone 90699 0
+61390765407
Fax 90699 0
Email 90699 0
flora.yuen@alfred.org.au
Contact person for scientific queries
Name 90700 0
A/Prof Hang Quach
Address 90700 0
St, Vincent's Hospital Melbourne
41 Victoria Pde, Fitzroy VIC 3065
Country 90700 0
Australia
Phone 90700 0
+61396548906
Fax 90700 0
Email 90700 0
hang.quach@svhm.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results