Infusional Carfilzomib in Patients With Relapsed or Refractory Multiple Myeloma



Status:Completed
Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:May 2011
End Date:January 2016

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

Phase II Study of Infusional Carfilzomib in Patients With Relapsed or Refractory Multiple Myeloma

The purpose of this study is to test a new drug called carfilzomib. It is a type of drug
called a proteasome inhibitor. Proteasome breaks down proteins that are no longer useful to
the cell. When the proteasome is turned off by a drug (like carfilzomib), useless proteins
cannot be broken down. Instead the proteins build up and cause the cell to die. Myeloma
cells make a lot of protein and are especially in need of a functional proteasome to
survive.

Carfilzomib is not approved for use by the Food and Drug Administration to treat myeloma. It
is considered an experimental drug. Previous studies have shown that carfilzomib is safe to
use. This study will look at what the effects, good and/or bad, carfilzomib has on myeloma.


Inclusion Criteria:

- Participants must meet all of the following inclusion criteria to be eligible to
enroll in this study.

- Patients meeting the criteria for symptomatic multiple myeloma that has relapsed or
is refractory to at least 2 prior lines of therapy.

- Previous therapy with bortezomib.

- Previous therapy with thalidomide or lenalidomide.

- Patients must have measurable disease and therefore must have at least one of the
following:

Serum M-protein ≥1 gm/dL (≥10 gm/L) Urine M-protein ≥200 mg/24 hr Serum FLC assay:
involved FLC ≥10 mg/dL (≥100 mg/L) provided serum FLC ratio is abnormal.

- Age ≥ 18 years

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Adequate hepatic
function, with serum ALT ≤ 3.5 times the upper limit of normal and serum direct
bilirubin ≤ 2 mg/dL (34 µmol/L) within 14 days prior to enrollment

- Absolute neutrophil count (ANC) ≥ 1.0 × 109/L within 14 days prior to enrollment
Hemoglobin ≥ 8 g/dL (80 g/L) within 14 days prior to enrollment (participants may be
receiving red blood cell [RBC] transfusions in accordance with institutional
guidelines)

- Platelet count ≥ 50 × 109/L (≥ 30 × 109/L if thought to be secondary to myeloma
involvement of the bone marrow ) within 14 days prior to enrollment (platelet
transfusions are allowed)

- Creatinine clearance (CrCl) ≥ 15 mL/minute within 14 days prior to enrollment, either
estimated or calculated using a standard formula (eg, Cockcroft and Gault)

- Females of childbearing potential (FCBP) must agree to ongoing pregnancy testing and
to practice contraception.

- Male participants must agree to practice contraception.

Exclusion Criteria:

- Prior treatment with carfilzomib.

- Known CNS involvement with myeloma

- Pregnant or lactating females

- Major surgery within 21 days prior to registration.

- Acute active infection requiring treatment (systemic antibiotics, antivirals, or
antifungals) within 7 days prior to enrollment

- Known human immunodeficiency virus infection

- Active hepatitis B or C infection

- Unstable angina or myocardial infarction within 4 months prior to enrollment, NYHA
Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular
arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia
or Grade 3 conduction system abnormalities unless participant has a pacemaker

- Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to
enrollment.

- Concurrent malignancies, except for treated non-melanoma skin cancer and cervical
carcinoma in situ.

- Significant neuropathy (Grades 3-4, ) within 14 days prior to enrollment

- Known history of allergy to Captisol® (a cyclodextrin derivative used to solubilize
carfilzomib)

- Contraindication to any of the required concomitant drugs or supportive treatments,
including options, antiviral drugs, or intolerance to hydration due to preexisting
pulmonary or cardiac impairment

- Concurrent therapy with any other anticancer therapeutic with activity against
multiple myeloma

- Concurrent therapy with investigative agents (e.g., antibiotics or antiemetics)
We found this trial at
1
site
1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
?
mi
from
New York, NY
Click here to add this to my saved trials