Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-02-22 @ 3:56 PM
Study NCT ID:
NCT02315157
Status:
WITHDRAWN
Last Update Posted:
2025-10-15
First Post:
2014-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bendamustine Hydrochloride in Treating Patients With Previously Treated Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D007952', 'term': 'Leukemia, Plasma Cell'}], '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'}, {'id': 'D007938', 'term': 'Leukemia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069461', 'term': 'Bendamustine Hydrochloride'}], 'ancestors': [{'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Withdrawn by PI', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2018-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-13', 'studyFirstSubmitDate': '2014-12-09', 'studyFirstSubmitQcDate': '2014-12-10', 'lastUpdatePostDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose of bendamustine', 'timeFrame': '2 days', 'description': 'Defined as the dose where no more than 1 out of 6 patients experience dose-limiting toxicities. Toxicities will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.'}], 'secondaryOutcomes': [{'measure': 'Incidence of toxicity (NCI CTCAE version 4.0)', 'timeFrame': 'Up to 92 days following the last administration of study treatment', 'description': 'Graded according to NCI CTCAE version 4.0'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Partial Response'], 'conditions': ['Multiple Myeloma', 'Plasma Cell Leukemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.KimmelCancerCenter.org', 'label': 'Sidney Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center'}, {'url': 'http://hospitals.jefferson.edu/', 'label': 'Jefferson University Hospitals'}]}, 'descriptionModule': {'briefSummary': 'This phase I trial studies the side effects and best dose of bendamustine hydrochloride in treating patients with previously treated multiple myeloma. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To identify a maximum tolerated dose of bendamustine (bendamustine hydrochloride) in patients with multiple myeloma.\n\nSECONDARY OBJECTIVES:\n\nI. To evaluate the safety of escalating doses of bendamustine in patients with multiple myeloma.\n\nII. To describe the response after bendamustine\n\nOUTLINE: This is a dose-escalation study.\n\nPatients receive bendamustine hydrochloride intravenously (IV) over 60-180 minutes on days 1 and 2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with multiple myeloma who have not achieved a CR following at least 4 cycles of induction therapy\n2. Age up to 80 years\n3. ECOG Performance Status of 0 or 1\n4. Left ventricular ejection fraction =/\\> 40%. No uncontrolled arrhythmias or symptomatic cardiac disease\n5. FEV1, FVC and DLCO =/\\> 40%. No symptomatic pulmonary disease.\n6. Serum bilirubin \\<2 x upper limit of normal, alkaline phosphatase \\<3 x upper limit of normal. No evidence of chronic active hepatitis or cirrhosis. No effusion or ascites \\> 1 L prior to drainage.\n7. HIV negative\n8. Negative beta HCG test in woman with child bearing potential, defined as not post-menopausal for 12 months or no previous sterilization\n9. Patients or guardian able to sign informed consent\n10. Availability of previously collected autologous stem cells (at least 3.0 x 106 CD34 cells/kg)\n11. Calculated GFR \\> 50 ml/minute\n\nExclusion Criteria:\n\n1. Patients with uncontrolled hypertension (systolic \\> 140, diastolic \\> 90 despite antihypertensive therapy\n2. Patients with uncontrolled bacteria, viral or fungal infections (currently taking medication and progression of clinical symptoms)\n3. New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities\n4. Relapsed/refractory myeloma'}, 'identificationModule': {'nctId': 'NCT02315157', 'briefTitle': 'Bendamustine Hydrochloride in Treating Patients With Previously Treated Multiple Myeloma', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'Phase I Study of Escalating-Doses of Bendamustine for Patients With Previously Treated Multiple Myeloma', 'orgStudyIdInfo': {'id': '14D.244'}, 'secondaryIdInfos': [{'id': '2014-009', 'type': 'OTHER', 'domain': 'CCRRC'}, {'id': 'JT 5775', 'type': 'OTHER', 'domain': 'JeffTrial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bendamustine 200 mg/m2', 'description': 'Patients receive bendamustine hydrochloride IV over 60-180 minutes on days 1 and 2 (total dose 400 mg/m2).', 'interventionNames': ['Drug: Bendamustine']}, {'type': 'EXPERIMENTAL', 'label': 'Bendamustine 250 mg/m2', 'description': 'Patients receive bendamustine hydrochloride IV over 60-180 minutes on days 1 and 2 (total dose 500 mg/m2).', 'interventionNames': ['Drug: Bendamustine']}], 'interventions': [{'name': 'Bendamustine', 'type': 'DRUG', 'otherNames': ['Treakisym', 'Ribomustin', 'Levact', 'Treanda', 'SDX-105'], 'description': 'Given IV', 'armGroupLabels': ['Bendamustine 200 mg/m2', 'Bendamustine 250 mg/m2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Manish Sharma, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thomas Jefferson University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sidney Kimmel Cancer Center at Thomas Jefferson University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}