Hospital Universitario Virgen de la Victoria | Cardiology Department
Status and phase
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About
Study consists of two parts, a part 1 dose escalation and a part 2 cohort expansion in combination with dexamethasone and carfilzomib intravenously across two cohorts with a monotherapy component as well.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
A confirmed diagnosis of multiple myeloma (must have an M-component in serum and/or urine)
Measurable disease defined as:
i. M-spike ≥ 500mg/dL, or ii. Urine protein M-spike of ≥ 200 mg/day, or iii. Serum free light chains ≥ 10 mg/dL, and an abnormal κ:λ ratio
Participant has documented relapsed or progressive MM on or after any regimen or who are refractory to the most recent line of therapy.
i. Relapsed MM is defined as previously treated MM that progresses and requires initiation of salvage therapy but does not meet the criteria for refractory MM.
ii. Refractory MM is defined as disease that is nonresponsive (failure to achieve minimal response or development of progressive disease) while on primary or salvage therapy or progresses within 60 days of last therapy.
Participants in Part 1 should have failed all other available options including having had ≥ 3 prior lines of therapy including a proteasome inhibitor, IMiD agent, and an anti-CD38 monoclonal antibody.
Participants in Part 2 should have had and failed ≥ 1 but ≤ 7 prior lines of therapy and will have had prior treatment with both a proteasome inhibitor and an IMiD agent.
Note: A line of therapy consists of greater ≥ 1 complete cycle of a single agent, a regimen consisting of combination of several drugs, or a planned sequential therapy of various regimens. Induction therapy with consolidation and maintenance following stem cell transplant is considered a single line of therapy.
Prior treatment with carfilzomib is allowed but the patient must not be considered carfilzomib refractory and not have had carfilzomib within the past 6 months
Positivity for t(11;14) by validated fluorescence in situ hybridization (FISH) testing assay in a pre-defined laboratory
a. fresh bone marrow aspirate sample must be collected at screening and sent to central laboratory for t(11;14) FISH testing.
Adequate organ function defined as:
Exclusion criteria
Participant has any of the following conditions:
Significant cardiovascular disease, including but not limited to:
Known infection with human immunodeficiency virus (HIV)
Serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection as follows:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Primary purpose
Allocation
Interventional model
Masking
167 participants in 2 patient groups
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Central trial contact
BeiGene
Data sourced from clinicaltrials.gov
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