Phase 1b Study of Weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Multiple Myeloma
NCT ID: NCT02335983
Last Updated: 2020-11-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
107 participants
INTERVENTIONAL
2015-04-30
2019-10-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Carfilzomib
Administered once weekly by 30-minute intravenous (IV) infusion on days 1, 8, and 15 of each 28-day cycle.
Lenalidomide
Administered orally once daily on days 1-21 of each 28-day cycle.
Dexamethasone
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.
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.
Carfilzomib
Administered once weekly by 30-minute intravenous (IV) infusion on days 1, 8, and 15 of each 28-day cycle.
Lenalidomide
Administered orally once daily on days 1-21 of each 28-day cycle.
Dexamethasone
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.
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.
Carfilzomib
Administered once weekly by 30-minute intravenous (IV) infusion on days 1, 8, and 15 of each 28-day cycle.
Lenalidomide
Administered orally once daily on days 1-21 of each 28-day cycle.
Dexamethasone
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.
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.
Carfilzomib
Administered once weekly by 30-minute intravenous (IV) infusion on days 1, 8, and 15 of each 28-day cycle.
Lenalidomide
Administered orally once daily on days 1-21 of each 28-day cycle.
Dexamethasone
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.
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.
Carfilzomib
Administered once weekly by 30-minute intravenous (IV) infusion on days 1, 8, and 15 of each 28-day cycle.
Lenalidomide
Administered orally once daily on days 1-21 of each 28-day cycle.
Dexamethasone
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.
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.
Carfilzomib
Administered once weekly by 30-minute intravenous (IV) infusion on days 1, 8, and 15 of each 28-day cycle.
Lenalidomide
Administered orally once daily on days 1-21 of each 28-day cycle.
Dexamethasone
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.
Interventions
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Carfilzomib
Administered once weekly by 30-minute intravenous (IV) infusion on days 1, 8, and 15 of each 28-day cycle.
Lenalidomide
Administered orally once daily on days 1-21 of each 28-day cycle.
Dexamethasone
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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).
3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2
4. Left ventricular ejection fraction (LVEF) ≥ 40%
Exclusion Criteria
2. For newly diagnosed multiple myeloma: multiple myeloma of IgM subtype
3. For relapsed disease:
1. If treated with a lenalidomide and dexamethasone combination, progression during the first 3 months after initiating treatment.
2. Any progression during treatment if the lenalidomide and dexamethasone regimen was the most recent line of therapy.
3. Any prior treatment with carfilzomib
4. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
5. Plasma cell leukemia (\> 2.0 × 10\^9/L circulating plasma cells by standard differential)
6. Myelodysplastic syndrome
7. Amyloidosis
8. Prior treatment with carfilzomib or oprozomib
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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Amy Kimball, MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Bakersfield, California, United States
CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center
Bakersfield, California, United States
Research Site
Burbank, California, United States
Providence Saint Joseph Medical Center
Burbank, California, United States
Research Site
Fountain Valley, California, United States
Compassionate Care Research Group, Inc.
Fountain Valley, California, United States
Research Site
Los Angeles, California, United States
Research Site
Los Angeles, California, United States
Los Angeles Hematology / Oncology Medical Group
Los Angeles, California, United States
Research Site
Whittier, California, United States
Research Site
Aurora, Colorado, United States
University of Colorado
Aurora, Colorado, United States
Research Site
Washington D.C., District of Columbia, United States
Lombardi Cancer Center, Pediatric Hematology Oncology
Washington D.C., District of Columbia, United States
Research Site
Fort Myers, Florida, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Research Site
Tampa, Florida, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Research Site
West Palm Beach, Florida, United States
Florida Cancer Specialists
West Palm Beach, Florida, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Research Site
Boston, Massachusetts, United States
Dana Farber Partners Cancer Care
Boston, Massachusetts, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
Hackensack, New Jersey, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
Research Site
New York, New York, United States
Research Site
New York, New York, United States
Clinical Research Alliance
New York, New York, United States
Memorial Sloan Kettering
New York, New York, United States
Morton Coleman, MD
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Research Site
Stony Brook, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Research Site
Durham, North Carolina, United States
Durham Veterans Affairs Medical Center
Durham, North Carolina, United States
Research Site
Cincinnati, Ohio, United States
Sarah Cannon Research Institute
Cincinnati, Ohio, United States
Research Site
Bend, Oregon, United States
Bend Memorial Clinic
Bend, Oregon, United States
Research Site
Charleston, South Carolina, United States
Medical University of South Carolina, Hollings Cancer Center
Charleston, South Carolina, United States
Research Site
Greenville, South Carolina, United States
Greenville Health System
Greenville, South Carolina, United States
Saint Francis Hospital Cancer Center
Greenville, South Carolina, United States
Research Site
Sioux Falls, South Dakota, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Research Site
Germantown, Tennessee, United States
The West Clinic, PC
Memphis, Tennessee, United States
Research Site
Nashville, Tennessee, United States
Research Site
Nashville, Tennessee, United States
Tennessee Oncology, PLLC / The Sarah Cannon Research lnstitute
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Research Site
Salt Lake City, Utah, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Research Site
Seattle, Washington, United States
Swedish Cancer Institute
Seattle, Washington, United States
Aurora Health Care, Aurora Cancer Care
Milwaukee, Wisconsin, United States
Research Site
Wauwatosa, Wisconsin, United States
Countries
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References
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Biran N, Siegel D, Berdeja JG, Raje N, Cornell RF, Alsina M, Kovacsovics T, Fang B, Kimball AS, Landgren O. Weekly carfilzomib, lenalidomide, and dexamethasone in relapsed or refractory multiple myeloma: A phase 1b study. Am J Hematol. 2019 Jul;94(7):794-802. doi: 10.1002/ajh.25498. Epub 2019 May 13.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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CFZ013
Identifier Type: -
Identifier Source: org_study_id