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An Open-label, Single-arm, Phase 2 Study of Carfilzomib in Patients With Relapsed and Refractory Multiple Myeloma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

Thank you

Trial Information

An Open-label, Single-arm, Phase 2 Study of Carfilzomib in Patients With Relapsed and Refractory Multiple Myeloma


Inclusion Criteria:



- Disease Related

- Multiple myeloma

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

- Serum M-protein ≥ 1 g/dL

- Urine M-protein ≥ 200 mg/24 hours

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

- Refractory to the most recently received therapy. Refractory disease is defined
as ≤ 25% response or progression during therapy or within 60 days after
completion of therapy.

- Subjects must have received ≥ 2 prior regimens for relapsed disease. Induction
therapy and stem cell transplant will be considered as one regimen

- Subjects must have received prior treatment with bortezomib, and either
thalidomide or lenalidomide

- Subjects must have received an alkylating agent either alone or in combination
wiht other myeloma treatments (history of stem cell transplant is acceptable)

- Subjects must have received an anthracycline either alone or in combination with
other myeloma treatments, unless not clinically indicated

- Demographic

- Males and females > 18 years of age

- Life expectancy of more than three months

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

- Laboratory

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

- 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 red blood cell (RBC) or platelet transfusions or receive
supportive care such as erythropoietin and darbepoetin in accordance with
institutional guidelines

- Calculated and 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.

- Ethical / Other

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

- 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.

Exclusion Criteria:

- Disease Related

- Multiple Myeloma IgM

- Subjects who failed to achieve at least a confirmed MR(≥ 25% reduction in
M-protein for ≥ 6 weeks)

- Subjects with non-secretory multiple myeloma, defined as < 1 g/dL M-protein in
serum and < 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 Day 1, 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
- Subjects with treatment related myelodysplastic syndrome

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

- 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:

Interventional

Study Design:

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

Outcome Measure:

Overall Response Rate

Outcome Time Frame:

2 to 12 months

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

PX-171-003

NCT ID:

NCT00511238

Start Date:

August 2007

Completion Date:

November 2013

Related Keywords:

  • Multiple Myeloma
  • Onyx
  • PR171
  • carfilzomib
  • multiple myeloma
  • relapsed
  • refractory
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Wake Forest UniversityWinston-Salem, North Carolina  27103
University of MichiganAnn Arbor, Michigan  48109-0624
MD Anderson Cancer CenterHouston, Texas  77030-4096
Roswell Park Cancer InstituteBuffalo, New York  14263
Mayo Clinic ScottsdaleScottsdale, Arizona  85259
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Washington University School of MedicineSaint Louis, Missouri  63110
Rush University Medical CenterChicago, Illinois  60612-3824
Scripps ClinicLa Jolla, California  92037
Hackensack University Medical CenterHackensack, New Jersey  07601
City of Hope National Medical CenterLos Angeles, California  91010
Florida Cancer SpecialistsFort Myers, Florida  33901
University of California, San FranciscoSan Francisco, California  94143
University of UtahSalt Lake City, Utah  
University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Tower Cancer Research FoundationBeverly Hills, California  90211
Cleveland ClinicCleveland, Ohio  44195
University of KentuckyLexington, Kentucky  40536-0098
Gabrail Cancer CenterCanton, Ohio  44718
Emory University Winship Cancer InstituteAtlanta, Georgia  30322
Sarah Cannon Research InstituteNashville, Tennessee  37203
Northwestern UniverstiyChicago, Illinois  60611
Mayo Clinic - RochesterRochester, Minnesota  55905
Northwest Cancer CenterHouston, Texas  77042
Southern Cancer CenterMobile, Alabama  36608
St. Vincent Catholic Medical CenterNew York, New York  10011
Oncology & Hematology CareCincinnati, Ohio  45236