A Safety Study of Carfilzomib, Cyclophosphamide & Dexamethasone Prior to ASCT in Patients With Newly Diagnosed Myeloma
NCT ID: NCT01660750
Last Updated: 2017-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
29 participants
INTERVENTIONAL
2013-01-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Carfilzomib, Cyclophosphamide, Dexamethasone
All eligible subjects will receive Carfilzomib, Cyclophosphamide, and Dexamethasone.
Carfilzomib
IV over 30 minutes on Days 1,2,8,9,15, and 16 every 28 days
Cyclophosphamide
PO on days 1, 8, and 15 every 28 days
Dexamethasone
40 mg weekly PO or IV on Days 1, 8, 15, and 22, every 28 days.
Interventions
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Carfilzomib
IV over 30 minutes on Days 1,2,8,9,15, and 16 every 28 days
Cyclophosphamide
PO on days 1, 8, and 15 every 28 days
Dexamethasone
40 mg weekly PO or IV on Days 1, 8, 15, and 22, every 28 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Measurable disease, as indicated by one or more of the following:
* Serum M-protein ≥ 1.0 g/dL
* Urine Bence Jones protein ≥ 200 mg/24 hr
* Elevated Free Light Chain as per the International Myeloma Working Group (IMWG) criteria
* Males and females ≥ 18 years of age
* Life expectancy of more than 5 months
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
* Adequate hepatic function, with bilirubin \< 2 times the upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3.5 times ULN
* Serum Creatinine Clearance(CrCl) ≥ 30 mL/min, either measured or calculated using a standard formula (e.g. Cockcroft and Gault)
* Additional Laboratory Requirements
* Absolute neutrophil count (ANC) ≥1.0 x 109/L
* Hemoglobin ≥8 g/dL \[transfusion permitted\]
* Platelet count ≥50.0 x 109/L
* Screening ANC should be independent of granulocyte-and granulocyte/macrophage colony stimulating factor (G-CSF and GM-CSF) support for at least 1 week and of pegylated G-CSF for at least 2 weeks
* Patients may receive RBC or platelet transfusions, if clinically indicated, in accordance with institutional guidelines
* Written informed consent in accordance with federal, local, and institutional guidelines
* Patients must agree to practice contraception
* Male patients must agree not to donate semen or sperm.
Exclusion Criteria
* Prior treatment for MM (prior radiation therapy or dexamethasone up to 160 mg for spinal cord compression is allowed. Other limited field radiation involving ≤ 1/3 of the pelvic area is also allowed)
* Plasma cell leukemia
* Pregnant or lactating females
* Major surgery within 21 days prior to first dose
* Congestive heart failure (CHF) (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 14 days prior to first dose
* Patients receiving active treatment or intervention for any other malignancy or patients who, at the Investigator's discretion, may require active treatment or intervention for any other malignancy within 8 months of starting study treatment.
* Serious psychiatric or medical conditions that could interfere with treatment
* Significant neuropathy (Grade 3, Grade 4, or Grade 2 with pain) at the time of the first dose and/or within 14 days before study treatment
* Contraindication to any of the required concomitant drugs, including antiviral (e.g. Valacyclovir) and proton-pump inhibitor (e.g. lansoprazole). Corticosteroid therapy in a dose equivalent to dexamethasone ≥ 1.5 mg/day or prednisone ≥ 10 mg/day. (Steroid use is allowed if necessary to treat spinal cord compression and/or hypocalcaemia.)
* Patients in whom the required program of oral and IV fluid hydration is contraindicated, e.g. due to pre-existing pulmonary, cardiac, or renal impairment
* Patients with primary systemic amyloidosis.
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Criterium, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jatin Shah, MD
Role: PRINCIPAL_INVESTIGATOR
AMyC
Brian GM Durie, MD
Role: PRINCIPAL_INVESTIGATOR
AMyC
Locations
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Samuel Oschin Comprehensive Cancer Center at Cedars-Sinai Medical Center
Los Angeles, California, United States
Comprehensive Cancer Center at Desert Regional Medical Center
Palm Springs, California, United States
University of Massachusettes Memorial
Worcester, Massachusetts, United States
Duke University Medical Center
Durham, North Carolina, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Countries
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Other Identifiers
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CAR-IST-520
Identifier Type: OTHER
Identifier Source: secondary_id
AMyC 11-MM-01
Identifier Type: -
Identifier Source: org_study_id