Clinical trial NCT02572492 (phase 2, status: unknown status)
Conditions: multiple myeloma
ICD codes: C90.01, C90.02, C90.00
Drugs: induction with car-cy-dex and conditioning with carfilzomib and highdose melphalan, carfilzomib/dexamethasone maintenance, observation without carfilzomib/dexamethasone maintenance
SMILES: CC(C)C[C@H](NC(=O)[C@H](CCC1=CC=CC=C1)NC(=O)CN1CCOCC1)C(=O)N[C@@H](CC1=CC=CC=C1)C(=O)N[C@@H](CC(C)C)C(=O)[C@@]1(C)CO1, CC(C)C[C@H](NC(=O)[C@H](CCC1=CC=CC=C1)NC(=O)CN1CCOCC1)C(=O)N[C@@H](CC1=CC=CC=C1)C(=O)N[C@@H](CC(C)C)C(=O)[C@@]1(C)CO1
Eligibility criteria:

        Inclusion Criteria:

          -  Myeloma diagnosis according to IMWG criteria

          -  First treatment demanding relapse after HDT according to IMWG criteria

          -  More than 2.0 x 10m CD34+ stem cells / kg body weight in the freezer for stem cell
             support

          -  Signed informed consent given prior to any study related activities have been
             performed

          -  Age > 18 years

        Exclusion Criteria:

        Demographic

          -  Allogeneic transplantation scheduled as a part of the treatment

          -  Treatment demanding relapse less than one year after HDT

          -  Myeloma treatment after the first HDT, except radiotherapy, bisphosphonates, denosumab
             and corticosteroids less than 6 days for symptom control

          -  Patients not having received HDT as first line treatment

          -  Previous treatment with carfilzomib

          -  Expected survival of less than six months

          -  Performance status (WHO) ≥ 3

        Laboratory

          -  Serum M-component < 5 g/l and urine M-component < 200 mg/l

          -  Any of the following laboratory abnormalities:

               -  Absolute neutrophil count (ANC) < 1.0 × 109/L

               -  Hemoglobin < 5 mmol/L (<80 g/L) (prior RBC transfusion or recombinant human
                  erythropoietin use is permitted)

               -  Platelet count < 50 × 109/L (< 30 × 109/L if myeloma involvement in the bone
                  marrow is > 50%)

               -  Serum ALT or AST > 3.5 times the upper limit of normal and serum direct bilirubin
                  > 34 µmol/L (2 mg/dL)

               -  Creatinine clearance (CrCl) < 15 mL/minute, either measured or calculated using a
                  standard formula

        Concurrent conditions

          -  Concurrent disease making treatment with carfilzomib, cyclophosphamide or
             dexamethasone unsuitable

          -  Significant neuropathy (Grades 3-4, or Grade 2 with pain) within 14 days prior to
             enrolment

          -  Major surgery within 21 days prior to enrolment

          -  Acute active infection requiring treatment

          -  Known or suspected hypersensitivity or intolerance to melphalan, dexamethasone or
             Captisol® (a cyclodextrin derivative)

          -  Uncontrolled or severe cardiovascular disease including myocardial infarction within 6
             months of enrolment, NYHA Class III or IV heart failure, uncontrolled angina,
             clinically significant pericardial disease, uncontrolled severe arrhythmias, or
             cardiac amyloidosis

          -  LVEF <40%, determined by 2-D transthoracic echocardiogram (ECHO) or Multigated
             Acquisition Scan (MUGA)

          -  Pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14
             days prior to enrolment

          -  Serious hepatic disorder, including active hepatitis B or C infection

          -  Other serious medical or psychiatric illness likely to interfere with participation in
             this clinical study

          -  Use of any investigational agents or experimental medical device within 28 days prior
             to enrolment into the study

        Ethical/other

          -  Pregnant or lactating females

          -  Females of childbearing potential must agree to ongoing pregnancy testing and to
             practice contraception

          -  Male subjects must agree to practice contraception