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A Phase 1/2, Open Label Study of SL-401 in Combination with Pomalidomide and Dexamethasone In Relapsed and Refractory Multiple Myeloma
Full description
This study is a phase 1/2 multicenter, open-label study of SL-401 (tagraxofusp-erzs) in combination with standard doses of pomalidomide and dexamethasone in patients with relapsed and refractory multiple myeloma (MM). The study will be conducted in 2 phases: Phase 1 is the dose-escalation phase to determine the maximum tested dose (MTD) of SL-401 in combination with standard doses of pomalidomide and dexamethasone. In Phase 1, each evaluated SL-401 dose level will incorporate an initial "Run-in Cycle" (i.e. cycle 1) of single agent SL-401 in at least 3 patients; following the Run-in Cycle, patients who have not experienced a dose-limiting toxicity (DLT) will receive combination SL-401/pomalidomide and dexamethasone in cycles 2 and beyond. All patients in Phase 2 will receive 1 cycle of SL-401 monotherapy in cycle 1, followed by combination of SL-401/pomalidomide/dexamethasone in cycle 2 and beyond. The dose of SL-401 will be the MTD of SL-401 or MTD given in combination with pomalidomide/dexamethasone determined during Phase 1.
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Inclusion criteria
Eligible patients will be considered for inclusion if they meet all of the following criteria. (All necessary baseline studies for determining eligibility must be obtained within 21 days prior to enrollment.)
Male or female patient who is at least 18 years of age.
Patient has given voluntary written informed consent before performance of any study-related procedures not part of standard (non-investigational) medical care.
Patient has been previously diagnosed with MM based on standard criteria.
Patient has received:
Patient has an Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2.
Patient has measurable disease defined as at least 1 of the following:
Clinical Laboratory Inclusion Criteria: The following laboratory results must be met within 14 days (or as stipulated) prior to study drug (treatment) administration:
Left ventricular ejection fraction (LVEF) ≥ institutional lower limit of normal as measured by multigated acquisition scan (MUGA) scan or 2-dimensional echocardiography (ECHO) within 28 days prior to start of therapy and no clinically significant abnormalities on a 12-lead electrocardiogram (ECG).
Females of childbearing potential (FCBP)* must have a negative serum or urine pregnancy test prior to initiation of the SL-401 Run in Cycle (if required) and repeated with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting Pomalidomide and must either commit to continued abstinence from heterosexual intercourse or begin 2 acceptable methods of birth control, 1 highly effective method and 1 additional effective method at the same time, at least 28 days before she starts taking Pomalidomide through 30 days after the last dose of Pomalidomide and 60 days after the last dose of SL-401. FCBP must also agree to ongoing pregnancy testing during the entire duration of treatment. Men must agree to use a latex or synthetic condom during sexual contact with a FCBP even if they have had a vasectomy from the time of signing the informed consent form through 60 days after the last dose of Pomalidomide or SL-401. These same patients must not donate sperm. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. All patients enrolled into this study, must agree to be registered in and must comply with all requirements of the Pomalidomide REMS(TM) program.
Exclusion criteria
Patients will be ineligible for this study if they meet any 1 of the following criteria:
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9 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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