Trial of Romidepsin and Bortezomib for Multiple Myeloma

Stopped early · Phase 2

Conditions studied: Multiple Myeloma

In brief

This is a phase II, open-label, multicenter, dual-strata study designed to evaluate the efficacy and safety of IV romidepsin given in combination with IV bortezomib for multiple myeloma (MM) patients with refractory or relapsed disease. Patients will be enrolled into one of two strata, bortezomib-resistant or bortezomib non-resistant.

Key facts

Study ID

NCT00765102

Run by

Celgene

People needed

32

Starts

2008-09-01

Expected to finish

2010-03-01

Last updated by the study team

2019-11-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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consent before any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care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:
• Plasmacytomas on tissue biopsy.
• Bone marrow plasmacytosis (>30% plasma cells).
• 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:
• Bone marrow plasmacytosis (10 to 30% plasma cells)
• Monoclonal immunoglobulin present but of lesser magnitude than given under major criteria
• Lytic bone lesions.
• 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

You may not qualify 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;
• Uncontrolled hypertension, i.e., blood pressure (BP) of ≥160/95; patients who have a history of hypertension controlled by medication must be on a stable dose (for at least one month) and meet all other inclusion criteria; or
• 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

Where it is running

• Loma Linda University Cancer Center — Loma Linda, California, United States
• Desert Cancer Care, Inc — Rancho Mirage, California, United States
• Santa Barbara Hematology Oncology Medical Group, Inc. — Santa Barbara, California, United States
• James R Berenson, MD, Inc. — West Hollywood, California, United States
• Georgia Cancer Specialists I, PC — Atlanta, Georgia, United States
• Center for Cancer and Blood Disorders — Bethesda, Maryland, United States
• Mecklenburg Medical Group — Charlotte, North Carolina, United States
• Baylor Sammons Cancer Center — Dallas, Texas, United States
• Dallas Oncology Consultants, P.A. — Duncanville, Texas, United States
• Oncology Consultants, P.A — Houston, Texas, United States
• Central Utah Clinic, PC — Provo, Utah, United States
• Virginia Mason Medical Centre — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.