Clinical trial NCT01346787 (phase 2, status: active, not recruiting)
Conditions: multiple myeloma
ICD codes: C90.01, C90.02, C90.00
Drugs: carfilzomib, cyclophosphamide, dexamethasone
SMILES: [H][C@@]12C[C@@H](C)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C
Eligibility criteria:

        Inclusion Criteria:

          -  Patient is of a legally consenting age as defined by local regulations.

          -  Patient is age ≥ 65 year of age or who are ineligible for autologous stem cell
             transplantation.

          -  Patient is, in the investigator(s) opinion, willing and able to comply with the
             protocol requirements.

          -  Patient has given voluntary written informed consent before performance of any
             study-related procedure not part of normal medical care, with the understanding that
             consent may be withdrawn by the patient at any time without prejudice to their future
             medical care.

          -  Female patient is either post-menopausal or surgically sterilized or willing to use an
             acceptable method of birth control (i.e., a hormonal contraceptive, intrauterine
             device, diaphragm with spermicide, condom with spermicide, or abstinence) for the
             duration of the study.

          -  Male patient agrees to use an acceptable method for contraception (i.e., condom or
             abstinence) for the duration of the study.

          -  Patient is a newly diagnosed MM patient.

          -  Patient has measurable disease, defined as follows: any quantifiable serum monoclonal
             protein value (generally, but not necessarily, ≥ 0.5 g/dL of M-protein) and, where
             applicable, urine light-chain excretion of >200 mg/24 hours. For patients with oligo
             or non-secretory MM, it is required that they have measurable plasmacytoma > 2 cm as
             determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan) or an
             abnormal free light chain ratio (n.v.: 0.26-1.65). We anticipate that less than 10% of
             patients admitted to this study will be oligo- or non-secretory MM with free light
             chains only in order to maximize interpretation of benefit results.

          -  - Patient has a Karnofsky performance status ≥60%.

          -  Patient has a life-expectancy >3 months.

          -  Patient has the following laboratory values within 14 days before Baseline (day

             1 of the Cycle 1, before study drug administration):

          -  Platelet count ≥50 x 109/L (≥30 x 109 /L if myeloma involvement in the bone marrow is
             > 50%) within 14 days prior to drug administration).

          -  Absolute neutrophil count (ANC) ≥ 1 x 109/L without the use of growth factors.

          -  Corrected serum calcium ≤14 mg/dL (3.5 mmol/L)

          -  Alanine transaminase (ALT): ≤ 3 x the ULN.

          -  Total bilirubin: ≤ 2 x the ULN.

          -  Calculated or measured creatinine clearance: ≥ 15 mL/minute

        Exclusion Criteria:

          -  - Patients with non-secretory MM, unless serum free light chains are present and the
             ratio is abnormal.

          -  Pregnant or lactating females

          -  Patient has active infectious hepatitis type B or C or HIV.

          -  Patients with myocardial infarction or unstable angina ≤ 4 months or other clinically
             significant heart disease (e.g., CHF NY Heart Association class III or IV,
             uncontrolled hypertension, history of labile hypertension, or history of poor
             compliance with an antihypertensive regimen)

          -  Peripheral neuropathy > CTCAE grade 2 and ≥ grade 2 painful peripheral neuropathy
             (with the difference being in the exclusion of patients with Grade 2 painful PN).

          -  Known history of allergy to Capsidol (a cyclodextrin derivative used to solubilize
             carfilzomib)

          -  Contraindication to any of the required concomitant drugs or supportive treatments,
             including hypersensitivity to all anticoagulation and antiplatelet options, antiviral
             drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment.

          -  Subjects with pleural effusions requiring thoracentesis or ascites requiring
             paracentesis within 14 days prior to baseline;

          -  Patient has any other clinically significant illness that would, in the investigator's
             opinion, increase the patient's risk for toxicity.

          -  Patients with a prior malignancy within the last 5 years (except for basal or squamous
             cell carcinoma, or in situ cancer of the cervix or breast, or localized prostate
             cancer of Gleason score <7 with a stable PSA)