Multiple myeloma at first presentation
Conditions
Interventions
Product Name: CARFILZOMIB
Product Code: PR-171
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Carfilzomib
CAS Number: 868540-17-4
Other descriptive name: CARFILZOMIB
C
Sponsors
Erasmus MC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Patients with a confirmed diagnosis of multiple myeloma stage II or III according to the Salmon & Durie criteria (see appendix I); · Age 18-65 years inclusive; · WHO performance status 0-3 (WHO=3 is allowed only when caused by MM and not by co-morbid conditions) (see appendix II); · Negative urine pregnancy test at inclusion if applicable; · Written informed consent. 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 145 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: · Known intolerance of Thalidomide;· Systemic AL amyloidosis;· Non-secretory MM;· Waldenstrom’s macroglobulinemia or IgM MM;· Previous chemotherapy or radiotherapy except 2 cycles of Melphalan/Prednisone or local radiotherapy in case of local myeloma progression;· Severe cardiac dysfunction (NYHA classification II-IV, see appendix);· Significant hepatic dysfunction (serum bilirubin ³ 30 mmol/L or transaminases ³ 2.5 times normal level), unless related to myeloma;· Creatinine clearance (measured or calculated) 3x ULN· ANC 3.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish the feasibility and efficacy of carfilzomib in combination with thalidomide and dexamethasone in patients with Multiple Myeloma at first presentation. ;Secondary Objective: - To investigate the clinical efficacy of carfilzomib in combination with thalidomide and dexamethasone for response in remission induction of Multiple Myeloma at first presentation. - To investigate the clinical efficacy of carfilzomib in combination with thalidomide and dexamethasone for response in consolidation treatment of Multiple Myeloma at first presentation. - To assess the stem cell harvest following carfilzomib in combination with thalidomide and dexamethasone ;Primary end point(s): Response (Complete response (CR), very good partial response (VGPR), overall response (OR)):After induction prior to HDM/ASCTAfter HDM/ASCT prior to consolidation treatmentAt end of consolidation treatment;Timepoint(s) of evaluation of this end point: after induction after HDM/ASCT after consolidation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy and toxicity of induction treatment; Efficacy and toxicity of consolidation treatment; Feasibility of good quality stem cell harvest; Progression-free survival (PFS); Overall Survival (OS).;Timepoint(s) of evaluation of this end point: These endpoints will be evaluated when applicable data for all patients are available | — |
Countries
Netherlands
Contacts
Public ContactSarah Lonergan
Erasmus MC
Outcome results
None listed