Study of the Pharmacokinetics and Safety of Carfilzomib in Patients With Multiple Myeloma and Renal Disease

NCT ID: NCT01949532

Last Updated: 2017-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2017-01-31

Brief Summary

The purpose of this study is to see how the body and the cancer react to carfilzomib, including measuring the amount of the study drug in the blood at certain times following dosing. This study is being done in people with normal kidney function and those with end-stage renal disease to see if they respond differently to the study drug.

Detailed Description

Specifically, the purpose of this study is to assess the influence of end-stage renal disease (ESRD) on area under the curve (both area under the curve, from time 0 to the last concentration measured [AUC0-last] and area under the curve, from time 0 extrapolated to infinity [AUC0-inf]) of carfilzomib 56 mg/m² at Cycle 2 Day 1 (C2D1) in patients with relapsed multiple myeloma.

Conditions

Relapsed Multiple Myeloma; End-stage Renal Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Normal Renal Function

Participants with normal renal function (creatinine clearance \[CrCl\] ≥ 75 mL/min) received carfilzomib 20 mg/m² intravenous infusion (IV) on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles. Participants continued treatment until confirmed progressive disease, unacceptable toxicity, withdrawal of consent, study closure, or death.

Group Type: EXPERIMENTAL

Carfilzomib

Intervention Type: DRUG

Carfilzomib was administered by IV injection.

End Stage Renal Disease

Participants with end-stage renal disease (on hemodialysis) received carfilzomib 20 mg/m² intravenous infusion (IV) on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles. Participants continued treatment until confirmed progressive disease, unacceptable toxicity, withdrawal of consent, study closure, or death.

Group Type: EXPERIMENTAL

Carfilzomib

Intervention Type: DRUG

Carfilzomib was administered by IV injection.

Interventions

Carfilzomib

Carfilzomib was administered by IV injection.

Intervention Type: DRUG

Other Intervention Names

Kyprolis®

Eligibility Criteria

Inclusion Criteria

1. Relapsed multiple myeloma

2. Evaluable disease (serum protein electrophoresis [SPEP]/urine protein electrophoresis [UPEP]/serum free light chain [SFLC] criteria)

3. Received at least 1 prior treatment regimen or line of therapy for multiple myeloma

4. End-stage renal disease (ESRD) on hemodialysis or CrCl ≥ 75 mL/min

5. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2

6. Adequate organ and bone marrow function

7. Active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention or myocardial infarction within the protocol-specified period prior to enrollment

Exclusion Criteria

1. Immunoglobulin M (IgM) multiple myeloma

2. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)

3. Waldenström Macroglobulinemia

4. Active congestive heart failure (NYHA Class III-IV) ischemia, conduction abnormalities

5. Known human immunodeficiency virus (HIV), recent hepatitis B virus (HBV), hepatitis C virus (HCV)

6. Myelodysplastic Syndrome

7. Contraindication to test article, constituents, or required concomitant medications

8. Other investigational drugs

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

Karmanos Cancer Institute

Detroit, Michigan, United States

North Shore-LIJ Health System/Center for Advanced Medicine - North Shore University Hospital

Lake Success, New York, United States

Gabrail Cancer Center

Canton, Ohio, United States

Vanderbilt-Ingram Cancer Center, Henry-Joyce Cancer Clinic

Nashville, Tennessee, United States

Baylor Charles A. Sammons Cancer Center

Dallas, Texas, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Monash Health, Monash Medical Centre

Clayton, Victoria, Australia

St. Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia

The Alfred Hospital, Malignant Haematology and Stem Cell Transplant Department

Melbourne, Victoria, Australia

QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Sir Mortimer B. Davis-Jewish General Hospital

Montreal, Quebec, Canada

Countries

United States; Australia; Canada

Other Identifiers

20130401

Identifier Type: OTHER

Identifier Source: secondary_id

CFZ001

Identifier Type: -

Identifier Source: org_study_id