None listed
Conditions
Brief summary
The purpose of this study is to determine whether the combination of Iberdomide, Isatuximab and Dexamethasone combined 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, you have been diagnosed with multiple myeloma and you have demonstrated disease progression within 12 months of commencing first-line therapy. Study Details Eligible participants will receive Iberdomide, Isatuximab and Dexamethasone. 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 this combination of treatment of multiple myeloma patients early in the course of their disease.
Interventions
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
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.
Sponsors
Australasian Myeloma Research Consortium
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed