Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-28 @ 4:28 AM
Study NCT ID:
NCT01660750
Status:
COMPLETED
Last Update Posted:
2017-10-18
First Post:
2012-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety Study of Carfilzomib, Cyclophosphamide & Dexamethasone Prior to ASCT in Patients With Newly Diagnosed Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C524865', 'term': 'carfilzomib'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D002123', 'term': 'Calcium Dobesilate'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-16', 'studyFirstSubmitDate': '2012-08-07', 'studyFirstSubmitQcDate': '2012-08-07', 'lastUpdatePostDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events as a measure of safety and tolerability', 'timeFrame': 'Throughout treatment, estimated to be 4-6 months per patients', 'description': 'Review of adverse events for safety and to determine the maximum tolerated dose of the combination treatment.'}], 'secondaryOutcomes': [{'measure': 'Overall Response after induction therapy', 'timeFrame': 'Every 28 days during induction therapy, estimated to be 4-6 months', 'description': 'Overall response (PR, VGPR, CR, sCR)'}, {'measure': 'Overall Response post ASCT', 'timeFrame': '3 and 6 months post ASCT', 'description': 'Overall Response (PR, VGPR, CR, sCR) at 3 and 6 months post ASCT.'}, {'measure': 'Time to Progression', 'timeFrame': 'Througout treatment and 3 and 6 months post ASCT', 'description': 'Time to progression will be noted if it occurs within 6 months post ASCT.'}, {'measure': 'Progression Free Survival', 'timeFrame': 'up to 6 months post ASCT'}, {'measure': 'Time to Next Therapy', 'timeFrame': 'up to 6 months post ASCT', 'description': 'Time to Next Therapy if occurs within 6 months post ASCT'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['newly diagnosed multiple myeloma', 'transplant eligible multiple myeloma'], 'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'This is a dose finding pilot study to evaluate the safety and determine the maximum tolerated dose of the combination of carfilzomib and cyclophosphamide with dexamethasone (Car-Cy-Dex) prior to autologous stem cell transplant (ASCT) in patients with newly diagnosed transplant eligible multiple myeloma.', 'detailedDescription': 'This is a dose finding pilot study to evaluate the safety and determine the maximum tolerated dose of the combination of carfilzomib and cyclophosphamide with dexamethasone (Car-Cy-Dex) prior to autologous stem cell transplant (ASCT) in patients with newly diagnosed transplant eligible multiple myeloma. The study will also explore the efficacy of Car-Cy-Dex including overall response after induction therapy, overall response at 3 and 6 months post ASCT, and time to progression, progression free survival, and time to next therapy if it occurs within 6 months post ASCT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Cytopathologically or histologically confirmed diagnosis of MM\n* Measurable disease, as indicated by one or more of the following:\n* Serum M-protein ≥ 1.0 g/dL\n* Urine Bence Jones protein ≥ 200 mg/24 hr\n* Elevated Free Light Chain as per the International Myeloma Working Group (IMWG) criteria\n* Males and females ≥ 18 years of age\n* Life expectancy of more than 5 months\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2\n* 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\n* Serum Creatinine Clearance(CrCl) ≥ 30 mL/min, either measured or calculated using a standard formula (e.g. Cockcroft and Gault)\n* Additional Laboratory Requirements\n* Absolute neutrophil count (ANC) ≥1.0 x 109/L\n* Hemoglobin ≥8 g/dL \\[transfusion permitted\\]\n* Platelet count ≥50.0 x 109/L\n* 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\n* Patients may receive RBC or platelet transfusions, if clinically indicated, in accordance with institutional guidelines\n* Written informed consent in accordance with federal, local, and institutional guidelines\n* Patients must agree to practice contraception\n* Male patients must agree not to donate semen or sperm.\n\nExclusion Criteria:\n\n* Patients with non-secretory or hyposecretory MM\n* 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)\n* Plasma cell leukemia\n* Pregnant or lactating females\n* Major surgery within 21 days prior to first dose\n* 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\n* Acute active infection requiring systemic antibiotics, antivirals, or antifungals within 14 days prior to first dose\n* 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.\n* Serious psychiatric or medical conditions that could interfere with treatment\n* 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\n* 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.)\n* 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\n* Patients with primary systemic amyloidosis."}, 'identificationModule': {'nctId': 'NCT01660750', 'acronym': '11-MM-01', 'briefTitle': 'A Safety Study of Carfilzomib, Cyclophosphamide & Dexamethasone Prior to ASCT in Patients With Newly Diagnosed Myeloma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Criterium, Inc.'}, 'officialTitle': 'A Multi-Center Phase Ib, Open-Label, Dose-Finding Pilot Study to Evaluate the Combination of Carfilzomib and Cyclophosphamide With Dexamethasone Prior to ASCT in Patients With Transplant Eligible Newly Diagnosed Myeloma', 'orgStudyIdInfo': {'id': 'AMyC 11-MM-01'}, 'secondaryIdInfos': [{'id': 'CAR-IST-520', 'type': 'OTHER', 'domain': 'Onyx Pharmaceuticals'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Carfilzomib, Cyclophosphamide, Dexamethasone', 'description': 'All eligible subjects will receive Carfilzomib, Cyclophosphamide, and Dexamethasone.', 'interventionNames': ['Drug: Carfilzomib', 'Drug: Cyclophosphamide', 'Drug: Dexamethasone']}], 'interventions': [{'name': 'Carfilzomib', 'type': 'DRUG', 'otherNames': ['PR-171', 'Kyprolis'], 'description': 'IV over 30 minutes on Days 1,2,8,9,15, and 16 every 28 days', 'armGroupLabels': ['Carfilzomib, Cyclophosphamide, Dexamethasone']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['Cytoxan'], 'description': 'PO on days 1, 8, and 15 every 28 days', 'armGroupLabels': ['Carfilzomib, Cyclophosphamide, Dexamethasone']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['Decadron'], 'description': '40 mg weekly PO or IV on Days 1, 8, 15, and 22, every 28 days.', 'armGroupLabels': ['Carfilzomib, Cyclophosphamide, Dexamethasone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Samuel Oschin Comprehensive Cancer Center at Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92262', 'city': 'Palm Springs', 'state': 'California', 'country': 'United States', 'facility': 'Comprehensive Cancer Center at Desert Regional Medical Center', 'geoPoint': {'lat': 33.8303, 'lon': -116.54529}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusettes Memorial', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Research Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Jatin Shah, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AMyC'}, {'name': 'Brian GM Durie, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AMyC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Criterium, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Amgen', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}