A Multicenter, Open-label, Phase 1b Study of Carfilzomib, Cyclophosphamide and Dexamethasone in Newly Diagnosed Multiple Myeloma Subjects
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
multiple myeloma
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Carfilzomib Type: Drug
Name: Cyclophosphamide Type: Drug
Name: Dexamethasone Type: Drug
Overall Status
Recruiting
Summary
This is a Phase 1b, multicenter, open-label dose-escalation study of twice-weekly carfilzomib in combination with cyclophosphamide and dexamethasone (CCd) as initial therapy for subjects with newly diagnosed multiple myeloma.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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 × 10E9/L

8. Platelet count ≥ 50 × 10E9/L

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

Exclusion Criteria:

1. Planned autologous 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
Locations
California Cancer Associates for Research and Excellence
Encinitas, California, United States
Status: Recruiting
James R. Berenson, MD
West Hollywood, California, United States
Status: Recruiting
The Oncology Institute of Hope and Innovation
Whittier, California, United States
Status: Recruiting
Horizon Oncology Research
Lafayette, Indiana, United States
Status: Recruiting
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
Status: Recruiting
Clinical Research Alliance
New York, New York, United States
Status: Recruiting
Tennessee Oncology
Nashville, Tennessee, United States
Status: Recruiting
Texas Oncology
Austin, Texas, United States
Status: Recruiting
Virginia Oncology Associates
Norfolk, Virginia, United States
Status: Recruiting
Start Date
August 2013
Completion Date
February 2017
Sponsors
Onyx Therapeutics, Inc.
Source
Onyx Pharmaceuticals
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page