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Trial registered on ANZCTR


Registration number
ACTRN12621001037897
Ethics application status
Approved
Date submitted
16/06/2021
Date registered
6/08/2021
Date last updated
21/01/2024
Date data sharing statement initially provided
6/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
An immune-therapeutic salvage strategy for ‘functional’ high-risk (FHR) multiple myeloma incorporating Iberdomide, Isatuximab, and Dexamethasone (Iber-IsaDex) – the IBIS study
Scientific title
An immune-therapeutic salvage strategy for ‘functional’ high-risk (FHR) multiple myeloma incorporating Iberdomide, Isatuximab, and Dexamethasone (Iber-IsaDex) – the IBIS study
Secondary ID [1] 304372 0
AMaRC 20-01
Universal Trial Number (UTN)
Trial acronym
IBIS Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 322162 0
Condition category
Condition code
Blood 319854 319854 0 0
Haematological diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients will be administered the following treatment in a 28-day cycle:
Isatuximab 10mg/kg intravenously weekly for 4 weeks and then fortnightly thereafter.
Iberdomide 1.6mg orally days 1-21 of each 28-day cycle
Dexamethasone 40mg orally weekly (20mg for patients >75 years)

Treatment will be given until disease progression or unacceptable toxicity, withdrawal of consent whichever occurs first. Adherence is monitored through hospital drug administration records and tablet adherence through drug packet return.
Intervention code [1] 320735 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327885 0
To assess the efficacy of the combination of Iberdomide, Isatuximab and Dexamethasone in patients with functional’ high-risk myeloma measeured by the patient's best response to treatment assessed by using the 2016 International Myeloma Working Group (IMWG) criteria.
Timepoint [1] 327885 0
At the completion of the study
Secondary outcome [1] 396876 0
To assess overall survival (OS) with Iberdomide, Isatuximab and Dexamethasone in patients
Timepoint [1] 396876 0
At the completion of the study
Secondary outcome [2] 396884 0
To assess minimal residual disease (MRD) negativity with EuroFlow next generation flow cytometry [NGF] via bone marrow aspirate sample
Timepoint [2] 396884 0
At time of achievement of complete response (CR) as observed by blood serum assay and bone marrow assessments.
Secondary outcome [3] 396885 0
To document the safety and deliverability of Iberdomide, Isatuximab, and Dexamethasone combination therapy via adverse events and laboratory results (serum assay, haematology and biochemistry blood panel).
Timepoint [3] 396885 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 24 months.

Eligibility
Key inclusion criteria
1. Male and Female patient greater or equal to 18 years of age
2. Able to provide written consent.
3. Myeloma patients who have progressed as per IMWG criteria within 12 months of commencing first line of therapy.
4. Measurable disease as define by any of the following:
- Serum M-component greater than 5 g/L, and/or
- Urine M-component greater than 200 mg/24 h, and/or
- Involved serum FLC level greater than100mg/L.
5. No contraindication to the use of any of the study drugs and able to comply with trial requirements.
6. Adequate liver function (total bilirubin less than 2.0x ULN, ALT less than 5.0x ULN) unless considered secondary to MM.
7. Absolute neutrophil count equal to or greater than 1.0 x 10^9/L
8. Platelet count equal to or greater than 50 x 10^9/L (equal to or greater than 30 x 10^9/L if MM involvement in the marrow is greater than 50%), patients should not have received platelet transfusions within 7 days of the screening platelet count.
9. Hb equal to or greater than 80g/L, red cell transfusions as per institutional protocol are allowed.
10. Has provided written informed consent.
11. Women of childbearing potential must have a negative serum pregnancy test within the 72 hours prior to the first study drug administration, during treatment and after treatment
12. Women of childbearing potential and male subjects who are sexually active with WOCBP must agree to use 2 highly effective methods of contraception during the study and for 30 days following the last dose of study treatment including a male condom.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who have had myocardial infarction within 6 months prior to enrolment, or New York Hospital Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
2. Any other serious or uncontrolled medical or psychiatric illness that could, in the investigators’ opinion, potentially interfere with the completion of treatment according to this protocol.
3. Known ongoing or active systemic infection, active hepatitis B or C infection, or known human immunodeficiency positivity.
4. Women who are pregnant or lactating. Women of child-bearing potential must have a negative urine pregnancy test at Screening.
5. Any patient who is unable or unwilling to meet the requirements of the IBER pregnancy prevention programme.
6. Active malignancy with the exception of any of the following:
• Adequately treated basal cell carcinoma, squamous cell carcinoma or in situ cervical cancer.
• Adequately treated stage 1 cancer from which the subject is currently in remission from and has been in remission for > 2 years.
• Stage 1 prostate cancer that does not require treatment.
• Any other cancer from which the subject has been disease-free for > 2 years.
7. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. This condition must be discussed with the patient prior to signing consent and registration in the trial.
8. Participation in other clinical trials for the treatment of multiple myeloma, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial.

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
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/01/2023
Actual
24/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
16
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19605 0
The Alfred - Melbourne
Recruitment hospital [2] 26065 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [3] 26066 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [4] 26067 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [5] 26068 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [6] 26069 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [7] 26070 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 34240 0
3004 - Melbourne
Recruitment postcode(s) [2] 41919 0
2298 - Waratah
Recruitment postcode(s) [3] 41920 0
3065 - Fitzroy
Recruitment postcode(s) [4] 41921 0
5000 - Adelaide
Recruitment postcode(s) [5] 41922 0
3220 - Geelong
Recruitment postcode(s) [6] 41923 0
2010 - Darlinghurst
Recruitment postcode(s) [7] 41924 0
2139 - Concord

Funding & Sponsors
Funding source category [1] 308744 0
Other Collaborative groups
Name [1] 308744 0
Australasian Myeloma Research Consortium
Country [1] 308744 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] 309776 0
None
Name [1] 309776 0
Address [1] 309776 0
Country [1] 309776 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308664 0
Alfred Hospital Ethic Committee
Ethics committee address [1] 308664 0
Ethics committee country [1] 308664 0
Australia
Date submitted for ethics approval [1] 308664 0
13/01/2022
Approval date [1] 308664 0
29/10/2022
Ethics approval number [1] 308664 0

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

Contacts
Principal investigator
Name 111474 0
Prof Andrew Spencer
Address 111474 0
Alfred Hospital
55 Commercial Road
Melbourne VIC 3004
Country 111474 0
Australia
Phone 111474 0
+61 390763393
Fax 111474 0
+61390765531
Email 111474 0
[email protected]
Contact person for public queries
Name 111475 0
Khoa Le
Address 111475 0
Alfred Hospital
55 Commercial Road
Melbourne VIC 3004
Country 111475 0
Australia
Phone 111475 0
+61 390767851
Fax 111475 0
+61390765531
Email 111475 0
[email protected]
Contact person for scientific queries
Name 111476 0
Andrew Spencer
Address 111476 0
Alfred Hospital
55 Commercial Road
Melbourne VIC 3004
Country 111476 0
Australia
Phone 111476 0
+61 3907623393
Fax 111476 0
+61390765531
Email 111476 0
[email protected]

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 Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.