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An Open-Label, Single-Arm, Phase 2 Study of Carfilzomib in Patients With Relapsed Multiple Myeloma

Phase 2
18 Years
Open (Enrolling)
Multiple Myeloma

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Trial Information

An Open-Label, Single-Arm, Phase 2 Study of Carfilzomib in Patients With Relapsed Multiple Myeloma

Inclusion Criteria:

Disease Related

- Multiple myeloma

- Subjects must have measurable disease, defined as one or more of the following:

- Serum M-protein ≥ 1 g/dL

- Urine M-protein ≥ 200 mg/24 hours

- Subjects must have been responsive (i.e., achieve an MR or better) to standard, first
line therapy

- Relapsed and/or refractory or progressive disease after at least one, but no more
than three, prior therapeutic treatments or regimens for multiple myeloma. Refractory
disease is defined as ≤ 25% response or progression during therapy or within 60 days
after completion of therapy. Induction therapy and stem cell transplant will be
considered as one regimen


- Males and females ≥18 years of age

- Life expectancy of more than three months

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2


- Adequate hepatic function, with bilirubin < 2.0 times the upper limit of normal, and
AST and ALT of < 3.0 times the upper limit of normal

- Uric acid, if elevated, must be corrected to within laboratory normal range prior to

- Total WBC count ≥ 2,000/mm3, absolute neutrophil count > 1,000/mm3, hemoglobin ≥ 8.0
g/dL, and platelet count > 50,000/mm3

- Subjects should be platelet transfusion independent

- Screening ANC should be independent of G-CSF or GM-CSF support for ≥ 1 week and of
pegylated G-CSF for ≥ 2 weeks

- Subjects may receive RBC transfusion or receive supportive care such as
erythropoietin and darbepoetin in accordance with institutional guidelines

- Calculated or measured creatinine clearance of ≥ 30 mL/minute, calculated using the
formula of Cockcroft and Gault [(140 - Age) X Mass (kg) / (72 X Creatinine mg/dL)].
Multiply result by 0.85 if female.

- Serum creatinine ≤ 2 mg/dL

Ethical / Other

- Written informed consent in accordance with federal, local, and institutional

- Female subjects of child-bearing potential must have a negative serum pregnancy test
within seven days of the first dose and agree to use dual methods of contraception
during and for 3 months following last dose of drug. Post menopausal females (> 45
years old and without menses for > 1 year) and surgically sterilized females are
exempt from a pregnancy test. Male subjects must use an effective barrier method of
contraception during study and for 3 months following the last dose if sexually
active with a female of child-bearing potential.

- Subjects must be able to receive outpatient treatment and laboratory monitoring at
the institute that administers agent.

Exclusion Criteria:

Disease Related

- Multiple Myeloma IgM

- Subjects previously treated with any proteasome inhibitor (under Amendment 2)

- Subjects must not be primary refractory to standard first-line therapy

- Subjects with non-secretory multiple myeloma, defined as < 1 g/dL M-protein in serum,
< 200 mg/24 hr M-protein in urine

- Subjects with disease measurable only by serum free light chain (SFLC) analysis

- Glucocorticoid therapy (prednisone >10 mg/day orally or equivalent) within the last
three weeks

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

- Plasma cell leukemia

- Chemotherapy with approved or investigative anticancer therapeutics, including
steroid therapy, within the three weeks prior to first dose

- Radiation therapy or immunotherapy in the previous four weeks; localized radiation
therapy within 1 week prior to first dose

- Participation in an investigational therapeutic study within three weeks or within
five drug half-lives (t1/2) prior to first dose, whichever time is greater

- Prior treatment with carfilzomib

Concurrent Conditions

- Major surgery within three weeks before Day 1

- Congestive heart failure (New York Heart Association class III to IV), symptomatic
ischemia, conduction abnormalities uncontrolled by conventional intervention, or
myocardial infarction in the previous six months

- Acute active infection requiring systemic antibiotics, antivirals or antifungals
within 2 weeks prior to first dose

- Known or suspected HIV infection or subjects who are HIV seropositive

- Active hepatitis A, B, or C infection

- Non-hematologic malignancy within the past three years except a) adequately treated
basal cell or squamous cell skin cancer, b) carcinoma in situ of the cervix, or c)
prostate cancer < Gleason Grade 6 with stable PSA

- Subjects with treatment related myelodysplastic syndrome

- Significant neuropathy (Grade 3, 4 or Grade 2 with pain) at the time of study

- Subjects with known contraindication to receiving allopurinol

- Subjects in whom the required program of oral and intravenous fluid hydration is
contraindicated, e.g., due to pre-existing pulmonary, cardiac, or renal impairment

- Subjects with known or suspected amyloidosis Subjects with pleural effusions
requiring thoracentesis or ascites requiring paracentesis

- Any 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

Ethical / Other

- Female subjects who are pregnant or lactating

- Serious psychiatric or medical conditions that could interfere with treatment

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Best Overall Response Rate

Outcome Time Frame:

2 to 12 months

Safety Issue:


Principal Investigator

Mai Le, MD

Investigator Role:

Study Director

Investigator Affiliation:

Onyx Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

September 2007

Completion Date:

November 2013

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



MD Anderson Cancer Center Houston, Texas  77030-4096
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Mayo Clinic Scottsdale Scottsdale, Arizona  85259
Washington University School of Medicine Saint Louis, Missouri  63110
Harrington Cancer Center Amarillo, Texas  79106
Hackensack University Medical Center Hackensack, New Jersey  07601
University of Kentucky College of Medicine Lexington, Kentucky  40536-0084
Summa Health System Akron, Ohio  44312
St. Vincent's Comprehensive Cancer Center New York, New York  10011
Northwestern University Chicago, Illinois  60611
Tower Cancer Research Foundation Beverly Hills, California  90211
Cleveland Clinic Cleveland, Ohio  44195
H. Lee Moffitt Cancer Center & Research Institute Tampa, Florida  33612
Gabrail Cancer Center Canton, Ohio  44718
Dayton Clinical Oncology Program Dayton, Ohio  45420
Texas Oncology Cancer Center Austin, Texas  78731
Mayo Clinic Rochester Rochester, Minnesota  55905
Emory University Winship Cancer Institute Atlanta, Georgia  30322
Jackson Oncology Associates Jackson, Mississippi  39202
Montgomery Cancer Center Mt. Sterling, Kentucky  40353
Rocky Mountain Blood and Marrow Transplant Program Denver, Colorado  80218
Signal Point Clinical Research Center, LLC Middletown, Ohio  45042
Therapeutic Research Institute of Orange County Laguna Hills, California  92653
Oncology & Hematology Assoc. of W. Broward Tamarac, Florida  33321
Orchard Research Skokie, Illinois  60076
Hattiesburg Clinic Hattiesburg, Mississippi  39401