An immune-therapeutic salvage strategy for ‘functional’ high-risk (FHR) multiple myeloma incorporating Iberdomide, Isatuximab, and Dexamethasone (Iber-IsaDex) – the IBIS study
- Conditions
- Multiple MyelomaBlood - Haematological diseases
- Registration Number
- ACTRN12621001037897
- Lead Sponsor
- Australasian Myeloma Research Consortium
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
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.
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.[ At the completion of the study]
- Secondary Outcome Measures
Name Time Method To assess overall survival (OS) with Iberdomide, Isatuximab and Dexamethasone in patients[ At the completion of the study];To assess minimal residual disease (MRD) negativity with EuroFlow next generation flow cytometry [NGF] via bone marrow aspirate sample[ At time of achievement of complete response (CR) as observed by blood serum assay and bone marrow assessments. ];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).[ 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.]