Clinical trial NCT00066638 (phase 2, status: completed)
Conditions: ds stage ii plasma cell myeloma, ds stage iii plasma cell myeloma, refractory plasma cell myeloma
ICD codes: D46.4, D46.1, D46.A, D46.0, D46.20, D46.21, D46.22
Drugs: romidepsin
SMILES: C\C=C1/NC(=O)[C@H]2CSSCC\C=C\[C@H](CC(=O)N[C@H](C(C)C)C(=O)N2)OC(=O)[C@@H](NC1=O)C(C)C
Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed stage IIa or IIIa
             multiple myeloma

          -  Patient has progressive disease and has had 1, 2, 3, or 4 prior lines of therapy

          -  Bilirubin < 2.0 mg/dL

          -  SGOT/SGPT =< 2.5 X institutional upper limit of normal

          -  Serum creatinine =< 1.5 mg/dl OR creatinine clearance >= 60 mL/min/1.73 m^2 for
             patients with creatinine levels above institutional normal

          -  Karnofsky Performance Status equal or greater than 70%; KPS 60% will be allowed if
             reduced KPS is due to advanced skeletal disease

          -  Measurable disease as defined by serum M protein >= 1.0 gm/dl measured by serum
             protein electrophoresis or free light chain measurement, or quantitative
             immunoglobulins and/or urinary M protein excretion >= 200 mg/24 hrs

          -  Ejection fraction >= 50% and normal baseline EKG tracing

          -  No known central nervous system abnormality including neoplastic, vascular,
             inflammatory, degenerative or epilepsy

          -  Life expectancy of greater than 12 weeks

          -  Leukocytes >= 3,000/uL

          -  Absolute neutrophil count >= 1,500/uL

          -  Platelets >= 100,000/uL

          -  Patients in whom cytopenias are considered to be due to myeloma marrow infiltration
             will be allowed as long as they meet the following criteria:

               -  Bone marrow biopsy displaying >= normal cellularity for age and >= 50%
                  involvement by myeloma

               -  ANC > 1,000 and platelets > 50,000

          -  Women of child-bearing potential and men must agree to use adequate contraception
             (hormonal or barrier method of birth control; abstinence) prior to study entry and for
             the duration of study participation; should a woman become pregnant or suspect she is
             pregnant while participating in this study, she should inform her treating physician
             immediately

          -  Ability to understand and the willingness to sign written informed consent

        Exclusion Criteria:

          -  Administration of chemotherapy or radiotherapy within 4 weeks (6 weeks for
             nitrosoureas or mitomycin C) prior to enrollment or unresolved adverse events due to
             agents administered more than 4 weeks earlier

          -  Prior treatment with a histone deacetylase inhibitor

          -  Patients may not be receiving any other investigational agent

          -  History of second cancer (except for adequately treated basal cell or squamous cell
             skin cancer, in situ cervical cancer, or other cancer for which the patient has been
             disease free >= 5 years)

          -  Non secretory disease or plasma cell leukemia (> 2000 circulating plasma cells/uL)

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to depsipeptide

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Patients with left ventricular hypertrophy or history of arrhythmias including atrial
             fibrillation, myocardial infarction or congestive heart failure; patients may not be
             taking hydrochlorothiazides

          -  Patients that are pregnant or lactating will be excluded from this trial

          -  Known HIV positivity; patients infected with the HIV virus will be excluded from this
             trial