Safety, Efficacy, and Pharmacodynamics of a 60-Minute Infusion of Carfilzomib for Progressive Multiple Myeloma

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Multiple Myeloma

In brief

This is a Phase 1/2, multicenter, open label, dose-escalation, nonrandomized study to evaluate the safety, pharmacodynamics, and efficacy of a 60-minute infusion of carfilzomib for patients with progressive multiple myeloma.

Key facts

Study ID

NCT01792102

Run by

Oncotherapeutics

People needed

38

Starts

2013-04-01

Expected to finish

2018-12-01

Last updated by the study team

2018-03-05

Who can join

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

You may qualify if…

• MM with relapsing or progressive disease at study entry
• a. Defined as progressive MM on patient's last treatment regimen
• Measurable disease, as defined by one or more of the following (assessed within 14 days prior to first dose):
• Serum M-protein ≥ 0.5 g/dL, or
• Urine M-protein ≥ 200 mg/24 hours, or
• Only in patients who do not meet a or b, then use serum free light chain (SFLC) > 100 mg/L (involved light chain) and an abnormal kappa/lamda ratio
• Age ≥ 18 years
• Life expectancy ≥ 6 months
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• Adequate hepatic function within 14 days prior to first dose, with bilirubin < 1.5 × the upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 × ULN
• LVEF ≥ 40%. 2-D transthoracic echocardiogram (ECHO) is the preferred method of evaluation. Multigated Acquisition Scan (MUGA) is acceptable if ECHO is not available.
• Absolute neutrophil count (ANC) ≥ 1000/mm3 within 14 days prior to first dose. Screening ANC is to be independent of granulocyte colony stimulating factor support for ≥ 1 week and pegylated granulocyte colony stimulating factor for ≥ 2 weeks.
• Hemoglobin ≥ 8.0 g/dL within 14 days prior to enrollment. Use of erythropoietic stimulating factors and red blood cell (RBC) transfusions per institutional guidelines is allowed.
• Platelet count ≥ 75,000/mm3 (≥ 50,000/mm\^3 if myeloma involvement in the bone marrow is > 50%) within 14 days prior to first dose. Patients must not have received platelet transfusions for at least 7 days prior to obtaining the screening platelet count
• Calculated or measured creatinine clearance (CrCl) of ≥ 15 mL/min within 14 days prior to first dose. Calculation are based on a standard formula, such as the Cockcroft and Gault: [(140 - Age) x Mass (kg) / (72 x Creatinine mg/dL)]; multiply result by 0.85 if female
• Written informed consent in accordance with federal, local, and institutional guidelines
• Female patients of childbearing potential (FCBP) must have a negative serum pregnancy test within 14 days prior to first dose and agree to use an effective method of contraception during and for 3 months following last dose of drug (more frequent pregnancy tests may be conducted if required per local regulations). Postmenopausal females (> 45 years old and without menses for > 1 year) and surgically sterilized females are exempt from a pregnancy test
• Male patients must agree to use an effective barrier method of contraception during study and for 3 months following the last dose if sexually active with a FCBP

You may not qualify if…

• Multiple myeloma of IgM subtype
• POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
• Plasma cell leukemia (> 2.0 × 109/L circulating plasma cells by standard differential)
• Waldenström's macroglobulinemia
• Amyloidosis
• Glucocorticoid therapy (prednisone > 30 mg/day or equivalent) within 7 days prior to first dose
• Cytotoxic chemotherapy with approved or investigational anticancer therapeutics within 28 days prior to first dose
• Treatment with bortezomib, thalidomide or lenalidomide within 21 days prior to first dose
• Focal radiation therapy within 7 days prior to first dose. Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to enrollment (i.e., prior radiation must have been to < 30% of the bone marrow)
• Immunotherapy within 21 days prior to first dose
• Major surgery within 21 days prior to first dose
• Active congestive heart failure (New York Heart Association [NYHA] Classes III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within 6 months prior to first dose.
• Acute active infection requiring systemic antibiotics, antiviral (except antiviral therapy directed at HBV), or antifungal agents within 14 days prior to first dose
• Known human immunodeficiency virus (HIV) seropositivity
• Known hepatitis B or C virus infection (except for patients with HBV receiving and responding to HBV antiviral therapy: these patients are allowed)
• Patients with known cirrhosis
• Second malignancy within the past 3 years, except:
• Adequately treated basal cell or squamous cell skin cancer
• Carcinoma in situ of the cervix
• Prostate cancer < Gleason score 6 with stable prostate-specific antigen (PSA) over 12 months
• Breast carcinoma in situ with full surgical resection
• Treated medullary or papillary thyroid cancer
• Patients with myelodysplastic syndrome
• Significant neuropathy (Grades 3 to 4) within 14 days prior to first dose
• Peripheral neuropathy with pain ≥ G2 within 14 days prior to first dose

Where it is running

• James R. Berenson M.D. Inc. — West Hollywood, California, United States
• John Theuer Cancer Center Hackensack University Medical Center — Hackensack, New Jersey, United States

Full record on ClinicalTrials.gov

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