A Study of Weekly Carfilzomib in Combination With Dexamethasone for Progressive Multiple Myeloma

Completed · Phase 1/Phase 2

Conditions studied: Multiple Myeloma

In brief

The study had the following primary objectives: * Phase 1: to determine the maximum tolerated dose (MTD) of once-weekly (QW) carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior therapies * Phase 2: to estimate the overall response rate (ORR) for patients with relapsed or refractory multiple myeloma who received 1 to 3 prior therapies treated with carfilzomib and dexamethasone QW at the MTD established in phase 1.

Key facts

Study ID

NCT01677858

Run by

Amgen

People needed

116

Starts

2012-07-04

Expected to finish

2018-10-31

Last updated by the study team

2022-09-23

Who can join

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

You may qualify if…

• Multiple myeloma with relapsing or progressive disease at study entry
• Measurable disease, as defined by 1 or more of the following (assessed within 21 days prior to enrollment):
• 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/lambda ratio
• Prior treatment with 1 to 3 prior regimens for multiple myeloma for Phase 1 and Phase 2 (induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as 1 line of therapy
• Age ≥ 18 years
• Life expectancy ≥ 6 months
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Adequate hepatic function within 21 days prior to enrollment, with bilirubin < 1.5 × the upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 × ULN
• Left ventricular ejection fraction (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 21 days prior to enrollment. Screening ANC is to be independent of growth factor support for ≥ 1 week
• Hemoglobin ≥ 8.0 g/dL within 21 days prior to enrollment. Use of erythropoietic stimulating factors and red blood cell (RBC) transfusions per institutional guidelines is allowed; however, most recent RBC transfusion must have been at least 7 days prior to obtaining screening hemoglobin
• Platelet count ≥ 50,000/mm³ (≥ 30,000/mm³ if myeloma involvement in the bone marrow is > 50%) within 21 days prior to enrollment. 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 ≥ 30 mL/min within 21 days prior to enrollment. Calculation based on 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 21 days prior to enrollment 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 an FCBP

You may not qualify if…

• Multiple myeloma of Immunoglobulin M (IgM) subtype
• POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
• Plasma cell leukemia (> 2.0 × 10\^9/L circulating plasma cells by standard differential)
• Waldenström's macroglobulinemia
• Amyloidosis
• Glucocorticoid therapy (prednisone > 30 mg/day or equivalent) within 7 days prior to enrollment
• Cytotoxic chemotherapy with approved or investigational anticancer therapeutics within 28 days prior to enrollment
• Treatment with bortezomib (Velcade®), thalidomide (Thalomid®) or lenalidomide (Revlimid®) within 21 days prior to enrollment
• Focal radiation therapy within 7 days prior to enrollment. Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to enrollment (ie, prior radiation must have been to < 30% of the bone marrow)
• Immunotherapy within 21 days prior to enrollment
• Major surgery within 21 days prior to enrollment
• 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 enrollment
• Acute active infection requiring systemic antibiotics, antiviral (except antiviral therapy directed at hepatitis B virus [HBV]), or antifungal agents within 14 days prior to enrollment
• Known human immunodeficiency virus (HIV) seropositivity
• Known hepatitis B or C virus infection (except for patients with HBV who are 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 enrollment
• Female patients who are pregnant or lactating

Where it is running

• Arizona Oncology Associates — Tucson, Arizona, United States
• Comprehensive Blood and Cancer Center (CCBC) — Bakersfield, California, United States
• California Cancer Associates for Research and Excellence — Encinitas, California, United States
• Robert A. Moss, M.D., FACP, Inc. — Fountain Valley, California, United States
• California Cancer Associates for Research and Excellence — Fresno, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Monterey Bay Oncology — Salinas, California, United States
• Sansum Clinic — Santa Barbara, California, United States
• Central Coast Medical Oncology Corporation — Santa Maria, California, United States
• James R. Berenson M.D. Inc. — West Hollywood, California, United States
• The Oncology Insititute of Hope and Innovation — Whittier, California, United States
• Rocky Mountain Cancer Centers — Denver, Colorado, United States
• Florida Cancer Specialists - South — Fort Myers, Florida, United States
• Florida Cancer Specialists - North — Tampa, Florida, United States
• Illinois Cancer Care — Galesburg, Illinois, United States
• Illinois Cancer Specialists — Hinsdale, Illinois, United States
• Illinois Cancer Specialists — Niles, Illinois, United States
• Fort Wayne Oncology & Hematology — Fort Wayne, Indiana, United States
• Horizon Oncology Research, Inc. — Lafayette, Indiana, United States
• Center for Cancer and Blood Disorders (CCBD) — Bethesda, Maryland, United States
• Hematology-Oncology Associates of Northern NJ, PA — Morristown, New Jersey, United States
• New Mexico Cancer Care Alliance — Albuquerque, New Mexico, United States
• Clinical Research Alliance — New York, New York, United States
• Hudson Valley Hematology Oncology Associates — Poughkeepsie, New York, United States
• Willamette Valley Cancer Institute and Research Center — Eugene, Oregon, United States

Full record on ClinicalTrials.gov

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