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

NCT ID: NCT01980589

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2016-03-31

Brief Summary

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Carfilzomib, Cyclophosphamide and Dexamethasone (CCd)

Participants received carfilzomib, cyclophosphamide and dexamethasone for up to eight 28-day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.

Group Type: EXPERIMENTAL

Carfilzomib

Intervention Type: DRUG

Carfilzomib administered as a 30-minute intravenous (IV) infusion on Days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. On Days 1 and 2 of Cycle 1, all participants received carfilzomib at 20 mg/m².

Cyclophosphamide

Intervention Type: DRUG

Cyclophosphamide administered orally (PO) at the dose of 300 mg/m² on Days 1, 8, and 15 of each 28-day cycle.

Dexamethasone

Intervention Type: DRUG

Dexamethasone administered PO or IV at 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle.

Interventions

Carfilzomib

Carfilzomib administered as a 30-minute intravenous (IV) infusion on Days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. On Days 1 and 2 of Cycle 1, all participants received carfilzomib at 20 mg/m².

Intervention Type: DRUG

Cyclophosphamide

Cyclophosphamide administered orally (PO) at the dose of 300 mg/m² on Days 1, 8, and 15 of each 28-day cycle.

Intervention Type: DRUG

Dexamethasone

Dexamethasone administered PO or IV at 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle.

Intervention Type: DRUG

Other Intervention Names

PR-171; PR171; Kyprolis® (carfilzomib) for Injection

Eligibility Criteria

Inclusion Criteria

1. Newly diagnosed multiple myeloma

2. 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

3. Males and females ≥ 18 years of age

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

5. Adequate hepatic function

6. Left ventricular ejection fraction (LVEF) ≥ 40%

7. Absolute neutrophil count (ANC) ≥ 1.0 × 10^9/L

8. Platelet count ≥ 50 × 10^9/L

9. Calculated or measured creatinine clearance (CrCl) of ≥ 15 mL/min

Exclusion Criteria

1. Planned autologous hematopoietic stem cell transplantation (HSCT) for the initial therapy of newly diagnosed multiple myeloma

2. Multiple myeloma of immunoglobulin M (IgM) subtype

3. Prior systemic treatment for multiple myeloma

4. Glucocorticoid therapy within 14 days prior to enrollment that equals or exceeds the equivalent of dexamethasone 160 mg

5. Known amyloidosis

6. 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.

7. 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)

8. Significant neuropathy (Grades ≥ 2) within 14 days prior to enrollment

9. 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

• 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

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

Countries

United States

Other Identifiers

2012-003

Identifier Type: -

Identifier Source: org_study_id