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



Status:Active, not recruiting
Conditions:Blood Cancer, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:August 2013
End Date:April 2016

Use our guide to learn which trials are right for you!

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.


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
We found this trial at
9
sites
6410 Rockledge Dr #660
Bethesda, Maryland 20817
(301) 571-0019
Center for Cancer & Blood Disorders Widely recognized for its compassionate, expert care, the Center...
?
mi
from
Bethesda, MD
Click here to add this to my saved trials
Austin, Texas 78731
?
mi
from
Austin, TX
Click here to add this to my saved trials
?
mi
from
Encinitas, CA
Click here to add this to my saved trials
Lafayette, Indiana
?
mi
from
Lafayette, IN
Click here to add this to my saved trials
250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
New York, New York 10021
?
mi
from
New York, NY
Click here to add this to my saved trials
5900 Lake Wright Dr
Norfolk, Virginia 23502
(757) 466-8683
Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
West Hollywood, California 90069
?
mi
from
West Hollywood, CA
Click here to add this to my saved trials
?
mi
from
Whittier, CA
Click here to add this to my saved trials