TriangleNCT00721734 · REGISTRY CONDITION SEARCH
Study of the Safety and Pharmacokinetics of Carfilzomib in Patients With Relapsed and Refractory Multiple Myeloma and Varying Degrees of Renal Function
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2017-05-02
The purpose of this study is to assess the influence of renal impairment on carfilzomib in patients with Multiple Myeloma (MM).
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Clearance (CL) of Carfilzomib on Day 1 of Cycle 1
Clearance (CL) of Carfilzomib on Day 15 of Cycle 1
Clearance (CL) of Carfilzomib on Day 15 of Cycle 2
Maximum Observed Plasma Concentration of Carfilzomib on Day 1 of Cycle 1
Maximum Observed Plasma Concentration of Carfilzomib on Day 15 of Cycle 1
Maximum Observed Plasma Concentration of Carfilzomib on Day 15 of Cycle 2
Area Under the Plasma Curve Extrapolated to Infinity (AUCinf) for Carfilzomib on Day 1 of Cycle 1
Area Under the Plasma Curve Extrapolated to Infinity (AUCinf) for Carfilzomib on Day 15 of Cycle 1
Area Under the Plasma Curve Extrapolated to Infinity (AUCinf) for Carfilzomib on Day 15 of Cycle 2
Area Under the Concentration Time Curve to the Last Measurable Concentration (AUClast) for Carfilzomib on Day 1 of Cycle 1
Area Under the Concentration Time Curve to the Last Measurable Concentration (AUClast) for Carfilzomib on Day 15 of Cycle 1
Area Under the Concentration Time Curve to the Last Measurable Concentration (AUClast) for Carfilzomib on Day 15 of Cycle 2
Percentage of Carfilzomib Excreted Via Renal Elimination on Day 1 of Cycle 1
Percentage of Carfilzomib Excreted Via Renal Elimination on Day 15 of Cycle 1
Percentage of Carfilzomib Metabolites Excreted Via Renal Elimination on Day 1 of Cycle 1
Percentage of Carfilzomib Metabolites Excreted Via Renal Elimination on Day 15 of Cycle 1
Plasma Protein Binding (PPB) of Carfilzomib
Overall Response Rate (ORR)
Clinical Benefit Rate (CBR)
Duration of Response
Time to Progression (TTP)
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- 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 (FLC) 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 human immunodeficiency virus (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
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Carfilzomib, 15 mg/m², was administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
- intervention Names
- Drug: Carfilzomib
- label
- Carfilzomib
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Carfilzomib
- description
- Carfilzomib was administered intravenously (IV) at a rate of approximately 10 mL/minute.
- name
- Carfilzomib
- other Names
- PR-171
- Kyprolis®
- type
- DRUG
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 50
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Plasma concentrations of carfilzomib was determined by a validated liquid chromatography tandem mass spectrometry (LC MS/MS) method. The lower limit of quantitation (LLOQ) was 0.300 ng/mL. Concentration values that were below the LLOQ (BLQ) were set to zero. Pharmacokinetic (PK) parameters were calculated from the individual plasma concentrations of carfilzomib using a noncompartmental method.
- measure
- Clearance (CL) of Carfilzomib on Day 1 of Cycle 1
- time Frame
- Cycle 1, Day 1 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.
- secondary Outcomes
- measure
- Clearance (CL) of Carfilzomib on Day 15 of Cycle 1
- time Frame
- Cycle 1, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.
- measure
- Clearance (CL) of Carfilzomib on Day 15 of Cycle 2
- time Frame
- Cycle 2, Day 15, before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.
- measure
- Maximum Observed Plasma Concentration of Carfilzomib on Day 1 of Cycle 1
- time Frame
- Cycle 1, Day 1, before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.
- measure
- Maximum Observed Plasma Concentration of Carfilzomib on Day 15 of Cycle 1
- time Frame
- Cycle 1, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.
- measure
- Maximum Observed Plasma Concentration of Carfilzomib on Day 15 of Cycle 2
- time Frame
- Cycle 2, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.
- measure
- Area Under the Plasma Curve Extrapolated to Infinity (AUCinf) for Carfilzomib on Day 1 of Cycle 1
- time Frame
- Cycle 1, Day 1, before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.
- measure
- Area Under the Plasma Curve Extrapolated to Infinity (AUCinf) for Carfilzomib on Day 15 of Cycle 1
- time Frame
- Cycle 1, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.
- measure
- Area Under the Plasma Curve Extrapolated to Infinity (AUCinf) for Carfilzomib on Day 15 of Cycle 2
- time Frame
- Cycle 2, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.
- measure
- Area Under the Concentration Time Curve to the Last Measurable Concentration (AUClast) for Carfilzomib on Day 1 of Cycle 1
- time Frame
- Cycle 1, Day 1 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.
- measure
- Area Under the Concentration Time Curve to the Last Measurable Concentration (AUClast) for Carfilzomib on Day 15 of Cycle 1
- time Frame
- Cycle 1, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.
- measure
- Area Under the Concentration Time Curve to the Last Measurable Concentration (AUClast) for Carfilzomib on Day 15 of Cycle 2
- time Frame
- Cycle 2, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.
- description
- The percentage of carfilzomib excreted in urine was calculated as the total amount excreted over 24 hours/dose.
- measure
- Percentage of Carfilzomib Excreted Via Renal Elimination on Day 1 of Cycle 1
- time Frame
- Cycle 1, Day 1, 0-5 and 5-24 hours post-dose
Full study description
- brief Summary
- The purpose of this study is to assess the influence of renal impairment on carfilzomib in patients with Multiple Myeloma (MM).
Source references
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-1336d216cbd1bbff780dac70
- edge id
- nct-edge-baaa5c1a58119f0b6da3
- requested nct id
- NCT00721734
- primary nct id
- NCT00721734
- source kind
- ctgov_condition_query
- source record id
- Source null
- source file sha256
- 2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
- payload sha256
- ecd06b7c593239bc393c3d0674a7a0704aec2d9e7fbcac1dbfbb0687e6fe0866
- payload
- clinical indication matching status
- condition_index_match_asserted_by_registry_not_reviewed
- end exclusive
- true
- id
- nct-edge-baaa5c1a58119f0b6da3
- link basis
- returned_by_explicit_condition_and_posted_results_filter_query
- nct id
- NCT00721734
- occurrences
- context exact
- NCT00721734
- end
- 11
- exact text
- NCT00721734
- start
- 0
- offset unit
- unicode_code_points
- query cond
- Plasma Cell Neoplasms
- query disease state id
- ds-plasma-cell-neoplasms
- source file
- /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
- source file sha256
- 2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
- source json pointer
- /studies/852/protocolSection/identificationModule/nctId
- source kind
- ctgov_condition_query
- source record id
- Source null
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- f5bfa0a4dc03cdeebbe5af7259721cfe6937a0e7b2a3d1567bebc794d00f4ee3
Preserved source evidence · Not medical advice