A Multicenter, Open-label, Phase 1b Study of Carfilzomib, Cyclophosphamide and Dexamethasone in Newly Diagnosed Multiple Myeloma Subjects

Completed · Phase 1

Conditions studied: Multiple Myeloma

In brief

The primary objective was to determine the maximum tolerated dose of carfilzomib given twice weekly in combination with cyclophosphamide and dexamethasone for patients with newly diagnosed multiple myeloma.

Key facts

Study ID

NCT01980589

Run by

Amgen

People needed

22

Starts

2013-08-01

Expected to finish

2016-03-01

Last updated by the study team

2017-05-30

Who can join

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

You may qualify if…

• Newly diagnosed multiple myeloma
• Measurable disease, as defined by 1 or more of the following
• Serum M-protein ≥ 0.5 g/dL, or
• Urine M-protein ≥ 200 mg/24 hours, or
• In subjects without detectable serum or urine M-protein, serum free light chain (SFLC) > 100 mg/L (involved light chain) and an abnormal kappa lambda ( κ/λ) ratio
• Males and females ≥ 18 years of age
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Adequate hepatic function
• Left ventricular ejection fraction (LVEF) ≥ 40%
• Absolute neutrophil count (ANC) ≥ 1.0 × 10\^9/L
• Platelet count ≥ 50 × 10\^9/L
• Calculated or measured creatinine clearance (CrCl) of ≥ 15 mL/min

You may not qualify if…

• Planned autologous hematopoietic stem cell transplantation (HSCT) for the initial therapy of newly diagnosed multiple myeloma
• Multiple myeloma of immunoglobulin M (IgM) subtype
• Prior systemic treatment for multiple myeloma
• Glucocorticoid therapy within 14 days prior to enrollment that equals or exceeds the equivalent of dexamethasone 160 mg
• Known amyloidosis
• Active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within 6 months prior to enrollment.
• Known human immunodeficiency virus (HIV) seropositive, hepatitis C infection, and/or hepatitis B (subjects with hepatitis B surface antigen [SAg] or core antibody receiving and responding to antiviral therapy directed at hepatitis B are allowed)
• Significant neuropathy (Grades ≥ 2) within 14 days prior to enrollment
• Any other clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent

Where it is running

• California Cancer Associates for Research and Excellence — Encinitas, California, United States
• James R. Berenson, MD — West Hollywood, California, United States
• The Oncology Institute of Hope and Innovation — Whittier, California, United States
• Horizon Oncology Research — Lafayette, Indiana, United States
• Center for Cancer and Blood Disorders — Bethesda, Maryland, United States
• Clinical Research Alliance — New York, New York, United States
• Tennessee Oncology — Nashville, Tennessee, United States
• Texas Oncology — Austin, Texas, United States
• Virginia Oncology Associates — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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