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RecruitingLast updated: 28 March 2024

IBIS Study: The purpose of this study is to determine whether the combination of Iberdomide, Isatuximab and Dexamethasone combined improves response to treatment in people with multiple myeloma that have progressed on prior treatmentInvestigating the effect of an immuno-therapeutic salvage strategy incorporating Iberdomide, Isatuximab and Dexamethasone on progression free survival for ‘functional’ high-risk (FHR) multiple myeloma patients

Clinical summary

Summary

Eligible participants will receive Iberdomide, Isatuximab and Dexamethasone. 

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).

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. Treatment will be given until disease progression, unacceptable toxicity, or withdrawal of consent.

Conditions

This trial is treating patients with high-risk multiple myeloma

Cancer

Blood Cancers Haematological

Age

People8+

Phase

II

Trial Acronym

IBIS Study

More information

Trial Identifiers

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Trial sponsor

Australasian Myeloma Research Consortium

Scientific Title

Investigating the effect of an immuno-therapeutic salvage strategy incorporating Iberdomide, Isatuximab and Dexamethasone on progression free survival for ‘functional’ high-risk (FHR) multiple myeloma patients

Eligibility

Inclusion

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.

Exclusion

 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.

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You are able to swallow medication by mouth.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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