Study of the Safety and Pharmacokinetics of Carfilzomib in Subjects With Relapsed and Refractory Multiple Myeloma and Varying Degrees of Renal Function

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Onyx Pharmaceuticals ( Onyx Therapeutics, Inc. )
ClinicalTrials.gov Identifier:
NCT00721734
First received: July 22, 2008
Last updated: November 12, 2013
Last verified: November 2013

July 22, 2008
November 12, 2013
September 2008
November 2012   (final data collection date for primary outcome measure)
To assess the influence of renal impairment on the pharmacokinetics (PK) of carfilzomib in subjects with Multiple Myeloma (MM) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00721734 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of the Safety and Pharmacokinetics of Carfilzomib in Subjects With Relapsed and Refractory Multiple Myeloma and Varying Degrees of Renal Function
Phase 2 Study of the Safety and Pharmacokinetics of Carfilzomib in Subjects With Relapsed and Refractory Multiple Myeloma and Varying Degrees of Renal Function

The purpose of this study is to assess the influence of renal impairment on carfilzomib in subjects with Multiple Myeloma (MM).

Not Provided
Interventional
Phase 2
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Multiple Myeloma
  • Renal Insufficiency
Drug: Carfilzomib for Injection, PR-171
Carfilzomib, will be administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle.
Experimental: carfilzomib
Intervention: Drug: Carfilzomib for Injection, PR-171
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
November 2012
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Written informed consent in accordance with federal, local, and institutional guidelines
  2. Males and females ≥ 18 years of age
  3. Multiple Myeloma
  4. Documented relapsed or progressive disease (PD) after receiving at least two prior treatment regimens (induction therapy with autologous stem cell transplant and maintenance is considered a single regimen), and must have achieved a minimal response or better to at least one of the regimens
  5. Current measurable disease, as indicated by one or more of the following:

    • Serum M-protein ≥ 0.5 g/dL
    • Urine M-protein ≥ 200 mg/24 hours
    • Serum Free Light Chain assay : Involved FLC level ≥ 10 mg/dL provided serum FLC ratio is abnormal
  6. Life expectancy of more than three months
  7. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  8. Adequate hepatic function, with bilirubin < 2 times the upper limit of normal (ULN) and alanine aminotransferase (ALT) < 3 times ULN
  9. Total white blood cell (WBC) count ≥ 2,000/mm3
  10. Absolute neutrophil count (ANC) ≥ 1,000/mm3
  11. Hemoglobin ≥ 7 gm/dL

    • Subjects may receive red blood cell (RBC) transfusions or supportive care with erythropoietin or darbepoetin in accordance with institutional guidelines
  12. Platelet count ≥ 30,000/ mm3
  13. 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
  14. Male subjects must use an effective barrier method of contraception during study and for three months following the last dose if sexually active with a female of child-bearing potential

Exclusion Criteria:

  1. Glucocorticoid therapy in a dose equivalent to prednisone ≥ 20 mg/day within 14 days prior to first dose of study drug
  2. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
  3. Plasma cell leukemia
  4. Chemotherapy with approved or investigative anticancer therapeutics, including steroid therapy dose as defined above, within 14 days prior to first dose of study drug or antibody therapy within 6 weeks prior to first dose of study drug
  5. Radiation therapy or immunotherapy within 3 weeks prior to first dose; localized radiation therapy within 1 week prior to first dose
  6. Participation in an investigational therapeutic study within 14 days prior to first dose of study drug
  7. Prior carfilzomib treatment
  8. Pregnant or lactating females
  9. Major surgery within 3 weeks prior to first dose of study drug
  10. Congestive heart failure (New York Heart Association Class III to IV), symptomatic ischemia, conduction abnormalities or myocardial infarction in the three months prior to first dose of study drug
  11. Uncontrolled hypertension
  12. Recent history of acute active infection requiring systemic antibiotics, antivirals, or antifungals within two weeks prior to first dose of study drug
  13. Known or suspected HIV infection, known HIV seropositivity
  14. Active hepatitis A, B, or C infection
  15. Other malignancy within the past 3 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 7 with stable prostate specific antigen (PSA) levels
  16. Any clinically significant medical or psychiatric disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
  17. Significant neuropathy (Grade 3, Grade 4, or Grade 2 with pain) at the time of the first dose and/or within 14 days prior to enrollment
  18. Subjects in whom the required program of oral hydration and intravenous fluid hydration is contraindicated, e.g., due to preexisting pulmonary or cardiac impairment
  19. Subjects with pleural effusions requiring routine thoracentesis or ascites requiring routine paracentesis
  20. Subjects with a known contraindication to receiving dexamethasone or allopurinol
  21. Receipt of granulocyte- and granulocyte/ macrophage- colony stimulating factor (G-CSF and GM-CSF) within 1 week prior to first dose of study drug
  22. Receipt of pegylated G-CSF within 2 weeks prior to first dose of study drug
  23. RBC and platelet transfusions within 7 days prior to first dose of study drug
  24. Subjects with known or suspected cardiac amyloidosis
  25. Subjects with myelodysplastic syndrome
  26. Subjects undergoing peritoneal dialysis
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00721734
PX-171-005
No
Onyx Pharmaceuticals ( Onyx Therapeutics, Inc. )
Onyx Therapeutics, Inc.
Not Provided
Study Director: Alvin Wong, PharmD Onyx Therapeutics, Inc.
Onyx Pharmaceuticals
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP