ACTRN12621001037897
Recruiting
Phase 2
An immune-therapeutic salvage strategy for ‘functional’ high-risk (FHR) multiple myeloma incorporating Iberdomide, Isatuximab, and Dexamethasone (Iber-IsaDex) – the IBIS study
Australasian Myeloma Research Consortium0 sites50 target enrollmentAugust 6, 2021
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Multiple Myeloma
- Sponsor
- Australasian Myeloma Research Consortium
- Enrollment
- 50
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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.
Outcomes
Primary Outcomes
Not specified
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