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Keep this study
Lead
Celgene
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients must fulfill all of the following criteria to be eligible for study participation:
Male or female patients aged ≥ 18 years old
Has given voluntary written informed consent before any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care
Previously diagnosed with multiple myeloma (MM) based on standard criteria as follows:
* Major criteria:
1. Plasmacytomas on tissue biopsy.
2. Bone marrow plasmacytosis (\>30% plasma cells).
3. Monoclonal immunoglobulin spike on serum electrophoresis IgG \>3.5 g/dL or IgA \>2.0 g/dL; kappa or lambda light chain excretion \>1 g/day on 24 hour urine protein electrophoresis
* Minor criteria:
1. Bone marrow plasmacytosis (10 to 30% plasma cells)
2. Monoclonal immunoglobulin present but of lesser magnitude than given under major criteria
3. Lytic bone lesions.
4. Normal IgM \<50 mg/dL, IgA \<100 mg/dL or IgG \<600 mg/dL
Any of the following sets of criteria will confirm the diagnosis of MM:
Any two of the major criteria
Major criterion 1 plus minor criterion 2, 3, or 4.
Major criterion 3 plus minor criterion 1 or 3.
Minor criteria 1, 2, and 3 or 1, 2, and 4.
Currently has MM with:
o Measurable disease, defined as a monoclonal immunoglobulin spike on serum electrophoresis of \>=1 gm/dL and/or urine monoclonal immunoglobulin spike of \>=200 mg/24 hours, or evidence of lytic bone disease
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
Life-expectancy \> 3 months
All women of childbearing potential must use an effective barrier method of contraception. Male patients should use a barrier method of contraception during the treatment period and for 3 months thereafter
Patients must meet the following laboratory criteria at Baseline (Day 1 of Cycle 1, before study drug administration):
* Platelet count ≥ 100\*10\^9/L
* Absolute neutrophil count ≥ 1.5\*10\^9/L
* OR if the bone marrow is extensively infiltrated
* Platelet count ≥ 75\*10\^9/L
* Absolute neutrophil count ≥ 1.0\*10\^9/L
Patients must meet the following laboratory criteria at the Screening visit conducted within 14 days of enrollment (Day 1, Cycle 1):
* o Aspartate transaminase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine transaminase/serum glutamic pyruvic transaminase (ALT/SGPT) ≤ 3.0\*upper limit of normal (ULN)
* Serum bilirubin ≤ 2.0\*ULN
* Calculated or measured creatinine clearance: ≥30 mL/minute. Patient with a creatinine \>10mL/min and \<30 mL/min due to significant myelomatous involvement of the kidneys may be enrolled in the study after receipt of approval from the lead investigator and sponsor
* Serum potassium ≥ 3.8 mmol/L
* Serum magnesium \>1.8 mg/dL
* Serum phosphorus ≥ lower limit of normal (LLN)
* Any cardiac arrhythmia requiring an anti-arrhythmic medication (excluding stable doses of beta-blockers)
POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes)
Plasma cell leukemia
Primary amyloidosis
Patients with a prior malignancy within the last 5 years (except for basal or squamous cell carcinoma, or in situ cancer of the cervix)
Severe hypercalcemia, i.e., serum calcium ≥14 mg/dL (3.5 mmol/L)
Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
Other concurrent severe and/or uncontrolled medical or psychiatric conditions.
Concomitant use of drugs that may cause a prolongation of the QTc
Concomitant use of CYP3A4 inhibitors
Patients who have hypersensitivity to bortezomib, boron or mannitol
Patients who are pregnant or breast-feeding
Patients with any significant history of non-compliance to medical regimens or unwilling or unable to comply with the instructions given to him/her by the study staff
You may not be if
Patients are ineligible for entry if any of the following criteria are met:
Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) or thalidomide, lenalidomide, arsenic trioxide, bortezomib, or glucocorticosteroids within 3 weeks prior to the first dose of romidepsin
Prior major surgery within 3 weeks prior to the first day of treatment
Use of any investigational agent within 4 weeks of study entry
Prior therapy with romidepsin
Any known cardiac abnormalities such as:
* Congenital long QT syndrome;
* QTc interval ≥ 500 milliseconds;
* Myocardial infarction within 6 months of Day 1. Subjects with a history of myocardial infarction between 6 and 12 months prior to the first day of cycle one who are asymptomatic and have had a negative cardiac risk assessment (treadmill stress test, nuclear medicine stress test, or stress echocardiogram) since the event may participate;
* Other significant electrocardiogram (ECG) abnormalities including 2nd degree atrio-ventricular (AV) block type II, 3rd degree AV block, or bradycardia (ventricular rate less than 50 beats/min);
* Symptomatic coronary artery disease (CAD), e.g., angina Canadian Class II-IV In any patient in whom there is doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present;
* An ECG recorded at screening showing evidence of cardiac ischemia (ST depression depression of ≥2 mm, measured from isoelectric line to the ST segment). If in any doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present;
* Congestive heart failure (CHF) that meets New York Heart Association (NYHA) Class II to IV definitions and/or ejection fraction \<40% by Multi Gated Acquisition Scan (MUGA scan) or \<50% by echocardiogram and/or MRI;
* A known history of sustained ventricular tachycardia (VT), ventricular fibrillation (VF), Torsade de Pointes, or cardiac arrest unless currently addressed with an automatic implantable cardioverter defibrillator (AICD);
* Hypertrophic cardiomegaly or restrictive cardiomyopathy from prior treatment or other causes;
Clareo Health | Trial of Romidepsin and Bortezomib for Multiple Myeloma
