Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:15 PM
Study NCT ID:
NCT00258258
Status:
TERMINATED
Last Update Posted:
2013-02-01
First Post:
2005-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Paricalcitol and Zoledronate in Treating Patients With Relapsed or Refractory Multiple Myeloma or Other Plasma Cell Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}], 'ancestors': [{'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': 'C084656', 'term': 'paricalcitol'}, {'id': 'D000077211', 'term': 'Zoledronic Acid'}], 'ancestors': [{'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'Withdrawn due to low accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'lastUpdateSubmitDate': '2013-01-31', 'studyFirstSubmitDate': '2005-11-22', 'studyFirstSubmitQcDate': '2005-11-22', 'lastUpdatePostDateStruct': {'date': '2013-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['refractory multiple myeloma'], 'conditions': ['Multiple Myeloma and Plasma Cell Neoplasm']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Paricalcitol may cause multiple myeloma cells to look more like normal cells, and to grow and spread more slowly. Paricalcitol may also stop the growth of the cancer cells by blocking blood flow to the cancer. Zoledronate may delay or prevent bone metastases in patients with multiple myeloma. Giving paricalcitol together with zoledronate may be an effective treatment for multiple myeloma or other plasma cell disorders.\n\nPURPOSE: This clinical trial is studying the side effects and best dose of paricalcitol when given with zoledronate in treating patients with relapsed or refractory multiple myeloma or other plasma cell disorders.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the maximum tolerated dose of paricalcitol when used with zoledronate in patients with relapsed or refractory multiple myeloma or other plasma cell disorders.\n\nSecondary\n\n* Determine the toxic effects of this regimen in these patients.\n* Determine the antimyeloma activity of paricalcitol in patients treated with this regimen.\n\nOUTLINE: This is an open-label, dose-escalation study of paricalcitol.\n\nPatients receive paricalcitol IV over 15 minutes on days 1, 8, and 15 and zoledronate IV over 15 minutes on day 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.\n\nCohorts of 3-6 patients receive escalating doses of paricalcitol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.\n\nPROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of relapsed or refractory multiple myeloma (MM) or other plasma cell disorder (PCD)\n\n * At least one previous treatment for MM or PCD required\n\nPATIENT CHARACTERISTICS:\n\nPerformance status\n\n* ECOG 0-2 OR\n* Karnofsky 60-100%\n\nLife expectancy\n\n* At least 3 months\n\nHematopoietic\n\n* Not specified\n\nHepatic\n\n* Not specified\n\nRenal\n\n* Calcium ≤ 10.5 mg/dL\n* No renal stone formation within the past 5 years for patients who have had curative therapy for a condition associated with the risk of stones (e.g., hyperparathyroidism, bladder dysfunction, obstructive uropathy) OR had a single episode of confirmed urolithiasis\n* No calculi in urinary tract confirmed by renal ultrasonography, kidney, ureter, and bladder (KUB) x-ray, or other imaging modality\n\nCardiovascular\n\n* No symptomatic congestive heart failure\n* No unstable angina pectoris\n* No uncontrolled cardiac arrhythmia\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during study and for 3 months after study completion\n* No osteonecrosis of the jaw\n* No history of allergic reaction attributed to compounds of similar chemical or biological composition of calcitriol, paricalcitol, or zoledronate\n* No uncontrolled intercurrent illness that would preclude study compliance\n* No ongoing or active infection\n* No psychiatric illness or social situation that may preclude study compliance\n\nPRIOR CONCURRENT THERAPY:\n\nChemotherapy\n\n* More than 4 weeks since prior chemotherapy\n\nEndocrine\n\n* More than 4 weeks since prior high-dose steroids\n\nOther\n\n* No other concurrent investigational agents or therapies for multiple myeloma or plasma cell disorders\n* No concurrent digoxin'}, 'identificationModule': {'nctId': 'NCT00258258', 'briefTitle': 'Paricalcitol and Zoledronate in Treating Patients With Relapsed or Refractory Multiple Myeloma or Other Plasma Cell Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Roswell Park Cancer Institute'}, 'officialTitle': 'An Open Label Dose Escalation Study of Intravenous Paricalcitol (ZEMPLAR™) [19-NOR-1 ALPHA, 25 - (OH)D] With Zoledronic Acid (Zometa™) in Patients With Multiple Myeloma', 'orgStudyIdInfo': {'id': 'I 38504'}, 'secondaryIdInfos': [{'id': 'RPCI-I-38504'}, {'id': 'NOVARTIS-RPCI-I-38504'}, {'id': 'ABBOTT-RPCI-I-38504'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'paricalcitol', 'type': 'DRUG'}, {'name': 'zoledronic acid', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14263-0001', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Asher A. Chanan-Khan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Roswell Park Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roswell Park Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}