- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02335983
Phase 1b Study of Weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Multiple Myeloma
Phase 1b Study of Carfilzomib Administered Once Weekly in Combination With Lenalidomide and Dexamethasone in Subjects With Multiple Myeloma
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
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California
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Bakersfield, California, Stati Uniti, 93309
- Research Site
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Bakersfield, California, Stati Uniti
- CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center
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Burbank, California, Stati Uniti, 91505
- Research Site
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Burbank, California, Stati Uniti
- Providence Saint Joseph Medical Center
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Fountain Valley, California, Stati Uniti, 92708
- Research Site
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Fountain Valley, California, Stati Uniti
- Compassionate Care Research Group, Inc.
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Los Angeles, California, Stati Uniti, 90017
- Research Site
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Los Angeles, California, Stati Uniti, 90095-1686
- Research Site
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Los Angeles, California, Stati Uniti
- Los Angeles Hematology / Oncology Medical Group
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Whittier, California, Stati Uniti, 90603
- Research Site
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Colorado
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Aurora, Colorado, Stati Uniti, 80045
- Research Site
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Aurora, Colorado, Stati Uniti
- University of Colorado
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District of Columbia
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Washington, District of Columbia, Stati Uniti, 20057
- Research Site
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Washington, District of Columbia, Stati Uniti
- Lombardi Cancer Center, Pediatric Hematology Oncology
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Florida
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Fort Myers, Florida, Stati Uniti
- Florida Cancer Specialists
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Fort Myers, Florida, Stati Uniti, 33905
- Research Site
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Tampa, Florida, Stati Uniti, 33612
- Research Site
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Tampa, Florida, Stati Uniti
- H. Lee Moffitt Cancer Center & Research Institute
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West Palm Beach, Florida, Stati Uniti, 33401
- Research Site
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West Palm Beach, Florida, Stati Uniti
- Florida Cancer Specialists
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Illinois
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Chicago, Illinois, Stati Uniti
- University of Chicago Medical Center
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02114
- Research Site
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Boston, Massachusetts, Stati Uniti
- Dana Farber Partners Cancer Care
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48109
- Research Site
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New Jersey
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Hackensack, New Jersey, Stati Uniti, 07601
- Research Site
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Hackensack, New Jersey, Stati Uniti
- John Theurer Cancer Center at Hackensack University Medical Center
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New York
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New York, New York, Stati Uniti, 10021
- Research Site
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New York, New York, Stati Uniti, 10065
- Research Site
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New York, New York, Stati Uniti
- Memorial Sloan Kettering
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New York, New York, Stati Uniti
- Weill Cornell Medical College
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New York, New York, Stati Uniti
- Clinical Research Alliance
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New York, New York, Stati Uniti
- Morton Coleman, MD
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Stony Brook, New York, Stati Uniti, 11794
- Research Site
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Stony Brook, New York, Stati Uniti
- Stony Brook University Medical Center
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North Carolina
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Durham, North Carolina, Stati Uniti, 27705
- Research Site
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Durham, North Carolina, Stati Uniti
- Durham Veterans Affairs Medical Center
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Ohio
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Cincinnati, Ohio, Stati Uniti, 45242
- Research Site
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Cincinnati, Ohio, Stati Uniti
- Sarah Cannon Research Institute
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Oregon
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Bend, Oregon, Stati Uniti, 97701
- Research Site
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Bend, Oregon, Stati Uniti
- Bend Memorial Clinic
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South Carolina
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Charleston, South Carolina, Stati Uniti, 29424
- Research Site
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Charleston, South Carolina, Stati Uniti
- Medical University of South Carolina, Hollings Cancer Center
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Greenville, South Carolina, Stati Uniti, 29607
- Research Site
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Greenville, South Carolina, Stati Uniti
- Greenville Health System
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Greenville, South Carolina, Stati Uniti
- Saint Francis Hospital Cancer Center
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South Dakota
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Sioux Falls, South Dakota, Stati Uniti, 57105
- Research Site
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Sioux Falls, South Dakota, Stati Uniti
- Avera Cancer Institute
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Tennessee
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Germantown, Tennessee, Stati Uniti, 38138
- Research Site
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Memphis, Tennessee, Stati Uniti
- The West Clinic, PC
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Nashville, Tennessee, Stati Uniti, 37203
- Research Site
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Nashville, Tennessee, Stati Uniti, 37232
- Research Site
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Nashville, Tennessee, Stati Uniti
- Vanderbilt University Medical Center
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Nashville, Tennessee, Stati Uniti
- Tennessee Oncology, PLLC / The Sarah Cannon Research lnstitute
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Utah
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Salt Lake City, Utah, Stati Uniti, 84112
- Research Site
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Salt Lake City, Utah, Stati Uniti
- Huntsman Cancer Institute
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Washington
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Seattle, Washington, Stati Uniti, 98104
- Research Site
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Seattle, Washington, Stati Uniti
- Swedish Cancer Institute
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Wisconsin
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Milwaukee, Wisconsin, Stati Uniti
- Aurora Health Care, Aurora Cancer Care
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Wauwatosa, Wisconsin, Stati Uniti, 53226
- Research Site
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Key Inclusion Criteria:
- Newly diagnosed or relapsed multiple myeloma
- Measureable disease by serum M protein, or urine M protein, or serum free light chain (SFLC) and an abnormal serum kappa lambda ratio (for subjects without detectable serum or urine M-protein), or serum quantitative immunoglobulin A (glgA) (for immunoglobulin (Ig) A subjects whose disease can only be reliable measured by qlgA).
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2
- Left ventricular ejection fraction (LVEF) ≥ 40%
Key Exclusion Criteria:
- Waldenström macroglobulinemia
- For newly diagnosed multiple myeloma: multiple myeloma of IgM subtype
For relapsed disease:
- If treated with a lenalidomide and dexamethasone combination, progression during the first 3 months after initiating treatment.
- Any progression during treatment if the lenalidomide and dexamethasone regimen was the most recent line of therapy.
- Any prior treatment with carfilzomib
- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- Plasma cell leukemia (> 2.0 × 10^9/L circulating plasma cells by standard differential)
- Myelodysplastic syndrome
- Amyloidosis
- Prior treatment with carfilzomib or oprozomib
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: RRMM Dose-evaluation: Carfilzomib 56 mg/m²
Participants with relapsed or refractory multiple myeloma (RRMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death. Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8. |
Administered once weekly by 30-minute intravenous (IV) infusion on days 1, 8, and 15 of each 28-day cycle.
Altri nomi:
Administered orally once daily on days 1-21 of each 28-day cycle.
Altri nomi:
Administered by mouth or IV at 40 mg on days 1, 8, and 15 of each 28-day cycle and on day 22 of cycles 1 to 8.
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Sperimentale: RRMM Dose-evaluation: Carfilzomib 70 mg/m²
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death. Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8. |
Administered once weekly by 30-minute intravenous (IV) infusion on days 1, 8, and 15 of each 28-day cycle.
Altri nomi:
Administered orally once daily on days 1-21 of each 28-day cycle.
Altri nomi:
Administered by mouth or IV at 40 mg on days 1, 8, and 15 of each 28-day cycle and on day 22 of cycles 1 to 8.
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Sperimentale: RRMM Dose-expansion: Carfilzomib 70 mg/m²
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death. Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8. |
Administered once weekly by 30-minute intravenous (IV) infusion on days 1, 8, and 15 of each 28-day cycle.
Altri nomi:
Administered orally once daily on days 1-21 of each 28-day cycle.
Altri nomi:
Administered by mouth or IV at 40 mg on days 1, 8, and 15 of each 28-day cycle and on day 22 of cycles 1 to 8.
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Sperimentale: NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²
Participants with newly diagnosed multiple myeloma (NDMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death. Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1 day 1, 56 mg/m² on cycle 1 days 8 and 15, and then 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8. |
Administered once weekly by 30-minute intravenous (IV) infusion on days 1, 8, and 15 of each 28-day cycle.
Altri nomi:
Administered orally once daily on days 1-21 of each 28-day cycle.
Altri nomi:
Administered by mouth or IV at 40 mg on days 1, 8, and 15 of each 28-day cycle and on day 22 of cycles 1 to 8.
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Sperimentale: NDMM Dose-expansion: Carfilzomib 70 mg/m²
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death. Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8. |
Administered once weekly by 30-minute intravenous (IV) infusion on days 1, 8, and 15 of each 28-day cycle.
Altri nomi:
Administered orally once daily on days 1-21 of each 28-day cycle.
Altri nomi:
Administered by mouth or IV at 40 mg on days 1, 8, and 15 of each 28-day cycle and on day 22 of cycles 1 to 8.
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Sperimentale: NDMM Dose-expansion: Carfilzomib 56 mg/m²
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death. Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8. |
Administered once weekly by 30-minute intravenous (IV) infusion on days 1, 8, and 15 of each 28-day cycle.
Altri nomi:
Administered orally once daily on days 1-21 of each 28-day cycle.
Altri nomi:
Administered by mouth or IV at 40 mg on days 1, 8, and 15 of each 28-day cycle and on day 22 of cycles 1 to 8.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Number of Participants With Adverse Events (AEs)
Lasso di tempo: From the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
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Safety and tolerability were evaluated according to the type, incidence, and severity of adverse events. An AE is defined as any untoward medical occurrence in a clinical trial subject. The event does not necessarily have a causal relationship with study treatment. A serious adverse event is defined as an AE that meets at least 1 of the following serious criteria:
The severity of each AE was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03 where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening, and Grade 5 = Death. |
From the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
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Change From Baseline in Hemoglobin Levels
Lasso di tempo: Baseline and Cycle 1, days 8 and 15 and Cycle 2 days 1, 8, and 15
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Baseline and Cycle 1, days 8 and 15 and Cycle 2 days 1, 8, and 15
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Change From Baseline in Platelet Count
Lasso di tempo: Baseline and Cycle 1, days 8 and 15 and Cycle 2 days 1, 8, and 15
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Baseline and Cycle 1, days 8 and 15 and Cycle 2 days 1, 8, and 15
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Change From Baseline in Neutrophil Count
Lasso di tempo: Baseline and Cycle 1, days 8 and 15 and Cycle 2 days 1, 8, and 15
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Baseline and Cycle 1, days 8 and 15 and Cycle 2 days 1, 8, and 15
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Change From Baseline in Bilirubin
Lasso di tempo: Baseline and Cycle 2 day 1
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Baseline and Cycle 2 day 1
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Change From Baseline in Creatinine
Lasso di tempo: Baseline and Cycle 1, days 8 and 15 and Cycle 2 days 1, 8, and 15
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Baseline and Cycle 1, days 8 and 15 and Cycle 2 days 1, 8, and 15
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Maximum Plasma Concentration of Carfilzomib on Day 8 of Cycle 1 by Dose Group
Lasso di tempo: Day 8 of Cycle 1 at predose, 15 minutes after the start of infusion, at the end of infusion, and 15 and 60 minutes after the end of infusion
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Day 8 of Cycle 1 at predose, 15 minutes after the start of infusion, at the end of infusion, and 15 and 60 minutes after the end of infusion
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Time to Maximum Plasma Concentration of Carfilzomib on Day 8 of Cycle 1 by Dose Group
Lasso di tempo: Day 8 of Cycle 1 at predose, 15 minutes after the start of infusion, at the end of infusion, and 15 and 60 minutes after the end of infusion
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Day 8 of Cycle 1 at predose, 15 minutes after the start of infusion, at the end of infusion, and 15 and 60 minutes after the end of infusion
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Area Under the Curve From Time Zero to Time of Last Quantifiable Concentration of Carfilzomib on Day 8 of Cycle 1 by Dose Group
Lasso di tempo: Day 8 of Cycle 1 at predose, 15 minutes after the start of infusion, at the end of infusion, and 15 and 60 minutes after the end of infusion
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Day 8 of Cycle 1 at predose, 15 minutes after the start of infusion, at the end of infusion, and 15 and 60 minutes after the end of infusion
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Overall Response Rate (ORR)
Lasso di tempo: Response assessments were performed on day 1 of each treatment cycle from cycle 2 and then every 8 weeks during follow-up until disease progression. Median time on follow-up was 10.6 months in RRMM participants and 6.9 months in NDMM participants.
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Response was determined by the investigator based on the International Myeloma Working Group Uniform Response Criteria (IMWG URC). ORR was defined as the percentage of participants who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). Responses must have been confirmed in 2 consecutive assessments at any time prior to initiation of any new therapy. Disease assessments included serum protein electrophoresis (SPEP) with immunofixation, urine protein electrophoresis (UPEP; 24-hour assessment) with immunofixation, serum free light chain (SFLC), quantitative immunoglobulins, bone marrow aspirates to determine percent plasma cell involvement, and skeletal imaging for plasmacytoma evaluation. |
Response assessments were performed on day 1 of each treatment cycle from cycle 2 and then every 8 weeks during follow-up until disease progression. Median time on follow-up was 10.6 months in RRMM participants and 6.9 months in NDMM participants.
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Complete Response Rate (CRR)
Lasso di tempo: Response assessments were performed on day 1 of each treatment cycle from cycle 2 and then every 8 weeks during follow-up until disease progression. Median time on follow-up was 10.6 months in RRMM participants and 6.9 months in NDMM participants.
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Complete Response Rate (CRR) is defined as the percentage of participants who achieved a best overall response of either stringent complete response (sCR) or complete response (CR) in accordance with International Myeloma Working Group-Uniform Response Criteria (IMWG-URC). sCR: As for CR, and absence of clonal plasma cells in bone marrow (BM) CR: Negative serum and urine immunofixation, disappearance of any soft tissue plasmacytomas, < 5% plasma cells in BM, and normal SFLC ratio in participants with measurable disease only by SFLC. |
Response assessments were performed on day 1 of each treatment cycle from cycle 2 and then every 8 weeks during follow-up until disease progression. Median time on follow-up was 10.6 months in RRMM participants and 6.9 months in NDMM participants.
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Progression-free Survival (PFS)
Lasso di tempo: From first dose of study drug until the end of follow-up; Median time on follow-up was 10.6 months in RRMM participants and 6.9 months in NDMM participants.
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PFS is defined as the time from the first day of study treatment to the earlier of disease progression or death due to any cause. Disease progression was determined by the investigator according to IMWG-URC. Progressive Disease (PD): Increase of 25% from lowest value in serum M-component (absolute increase ≥ 0.5 g/dL), urine M-component (absolute increase ≥ 200 mg per 24 hours) and/or the difference between involved and uninvolved FLC levels (absolute increase >10 mg/dL) in patients without measurable serum and urine M-protein levels, and/or any new or increase in size of bone lesions or soft tissue plasmacytomas, or development of hypercalcemia. PFS was analyzed using Kaplan-Meier methods. Participants who were alive with no documented PD, started new anticancer therapy before documentation of PD or death, had death or PD immediately after > 1 consecutively missed assessment visit, were lost to follow-up or withdrew consent were censored at the date of last disease assessment. |
From first dose of study drug until the end of follow-up; Median time on follow-up was 10.6 months in RRMM participants and 6.9 months in NDMM participants.
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Duration of Response (DOR)
Lasso di tempo: From first dose of study drug until the end of follow-up; Median time on follow-up was 10.6 months in RRMM participants and 6.9 months in NDMM participants.
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Duration of response (DOR) was calculated for participants who achieved a confirmed PR or better based on Investigator assessment and according to the IMWG URC.
Duration of overall response is defined as the time from first documentation of response to disease progression or death due to any cause.
DOR was analyzed using Kaplan-Meier methods.
Participants who were alive with no documented PD, started new anticancer therapy before documentation of PD or death, had death or PD immediately after > 1 consecutively missed disease assessment visit, were lost to follow-up, or withdrew consent were censored at the date of last disease assessment.
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From first dose of study drug until the end of follow-up; Median time on follow-up was 10.6 months in RRMM participants and 6.9 months in NDMM participants.
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Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Amy Kimball, MD, Amgen
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattia cardiovascolare
- Malattie vascolari
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Neoplasie
- Malattie linfoproliferative
- Disturbi immunoproliferativi
- Malattie ematologiche
- Disturbi emorragici
- Disturbi emostatici
- Paraproteinemie
- Disturbi delle proteine del sangue
- Mieloma multiplo
- Neoplasie, plasmacellule
- Effetti fisiologici delle droghe
- Agenti autonomi
- Agenti del sistema nervoso periferico
- Agenti antinfiammatori
- Agenti antineoplastici
- Fattori immunologici
- Antiemetici
- Agenti gastrointestinali
- Glucocorticoidi
- Ormoni
- Ormoni, sostituti ormonali e antagonisti ormonali
- Agenti antineoplastici, ormonali
- Inibitori dell'angiogenesi
- Agenti di modulazione dell'angiogenesi
- Sostanze per la crescita
- Inibitori della crescita
- Desametasone
- Lenalidomide
Altri numeri di identificazione dello studio
- CFZ013
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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