A Phase II study of Selinexor (KPT-330) combined with bortezomib and dexamethasone (SVd) for induction and consolidation for patients with progressive or refractory Multiple Myeloma.
Conditions
Interventions
Trade Name: Velcade
Product Name: bortezomib
Product Code: 1000268
Pharmaceutical Form: Powder and solution for solution for injection
Product Name: selinexor (25 mg)
Product Code: KPT-330
Pharmaceut
Sponsors
Erasmus MC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Documented diagnosis of multiple myeloma and measurable disease (serum M-protein = 5 g/L or urine M-protein = 200 mg/24 hours or abnormal FLC ratio with involved free light chain (FLC) > 100 mg/L); • Documented progression as per the IMWG uniform response criteria (Durie, 2006) during or after the anti-myeloma regimen; or never achieved a response better than PD after at least 2 cycles of their previous anti-myeloma regimen. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 37 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Prior resistance/refractory disease to bortezomib • Systemic AL amyloidosis • Non secretory myeloma • Known CNS involvement • Absolute neutrophil count (ANC) 14 mg/dL (> 3.5 mmol/L). • Hemoglobin < 8 g/dL (< 4.9 mmol/L; prior RBC transfusion or recombinant human erythropoietin use is permitted).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the safety and tolerability of selinexor at 3 different dose levels in combination with bortezomib/dexamethasone & determine the recommended dose level (RDL) of selinexor for Part II;Secondary Objective: • Evaluate the response (sCR, CR, VGPR, PR) after 8 cycles of selinexor, bortezomib and dexamethasone. ;Primary end point(s): • Dose-limiting toxicity (DLT) as defined in paragraph 4.1, and recommended phase II dose (RDL) of selinexor when combined with bortezomib and dexamethasone;Timepoint(s) of evaluation of this end point: in cycle 1, twice a month in all other cycles. ? After induction treatment cycle 2 and 4. ? After High-dose Melphalan and autologous stem cell transplantation (if applicable) ? After consolidation treatment cycle 2 and 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: in cycle 1, twice a month in all other cycles. ? After induction treatment cycle 2 and 4. ? After High-dose Melphalan and autologous stem cell transplantation (if applicable) ? After consolidation treatment cycle 2 and 4 ;Secondary end point(s): • Toxicity | — |
Countries
Netherlands
Contacts
Public ContactSarah Lonergan
Erasmus MC
Outcome results
None listed