Ixazomib-pomalidomide-dexamethasone as Second or Third-line Combination Treatment for Patients Wi… (NCT04790474) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Ixazomib-pomalidomide-dexamethasone as Second or Third-line Combination Treatment for Patients With Relapsed and Refractory Multiple Myeloma Previously Treated With Daratumumab, Lenalidomide and Bortezomib
Israel61 participantsStarted 2021-03-25
Plain-language summary
Adult patients with a confirmed diagnosis of symptomatic and relapsed and/or refractory MM, after receiving bortezomib, lenalidomide and daratumumab during first and second lines, will be eligible to be enrolled in this study.
During the first three treatment cycles, patients will be seen twice (Days 1 and 15 of the cycle). Starting from cycle 4 and on, patients will be assessed once per cycle (Day 1), until disease progression, for disease response and progression according to the International Myeloma Working Group (IMWG) criteria. After progression, all patients will be followed for survival; for this purpose, patients will be contacted every 12 weeks until death or termination of the study by the Sponsor.
Patients may continue to receive treatment for 24 months or until disease progression (PD) or unacceptable toxicity, the earlier of the three. Dose modifications may be made based on toxicities. Patients who complete study therapy will continue to receive treatment per standard of care.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female patients, 18 years of age or older.
✓. Multiple myeloma diagnosed according to standard IMWG criteria
✓. Patients must have measurable disease defined by at least one of the following five measurements:
✓. Patients received one or two prior lines of therapy which must have included bortezomib, lenalidomide-and daratumumab.
✓. Patients must meet the following clinical laboratory criteria:
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
✓. Female patients who:
✓. Male patients, even if surgically sterilized (i.e., status postvasectomy), who:
Exclusion criteria
✕. Patient underwent an allogeneic transplantation
✕. Female patients who are lactating or pregnant.
What they're measuring
1
Progression-Free Survival-PFS
Timeframe: Up to 2 years from last patient enrollment
✕. Major surgery within 14 days before enrollment.
✕. Central nervous system involvement
✕. Concomitant use of any other antineoplastic treatment with activity against MM (with the exception of ≤40 mg Dexamethasone per day or equivalent for no longer than 4 days).
✕. Infection requiring systemic antibiotic therapy or other serious infection within 14 days before enrollment
✕. Diagnosis of Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome, plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome.
✕. Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.