Phase I Dose Finding Study Assessing Safety and Tolerability of SST0001 in Advanced Multiple Myeloma.
Multicenter, open label, uncontrolled Phase I First In Man trial in advanced refractory
multiple myeloma, to determine the Maximum Tolerated Dose (MTD) of SST0001 given
subcutaneously (sc) once daily for 5 or 10 days, in a cycle of 28 days. A starting dose of
25 mg (flat dose) is given once daily for 5 days (from Day 1 to Day 5). In the subsequent
cohort 25 mg are administered once daily for 10 days (from Day 1 to 5 and from Day 8 to 12).
Dose escalation with SST0001 administered for 10 days is performed in subsequent cohorts,
depending on toxicities observed.
Indirect pharmacokinetics based on Activated Partial Thromboplastin Time (aPTT)
modifications in all patients (minimum of 3 patients in each cohort) during the first cycle
Pharmacodynamics in all patients during the first cycle of treatment, based on modifications
of coagulation parameters.
During the study any hints of anti-tumor activity will also be evaluated based on use of
surrogate parameters (monoclonal serum and urine protein modifications).
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose (MTD).
Maximum tolerated dose (MTD) (based upon first cycle study drug related dose limiting toxicities [DLTs]) of SST0001 given subcutaneously over repeated administration during each treatment cycle. MTD definition: ≥ 2/6 patients with a DLT at the first cycle (28 days).
28 days of first cycle of therapy.
Alessandro Rambaldi, MD
USC Ematologia, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy
Italy: National Institute of Health