Combination Chemotherapy in Treating Patients With Multiple Myeloma
|First Received Date ICMJE||November 1, 1999|
|Last Updated Date||July 17, 2013|
|Start Date ICMJE||November 1998|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00003493 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Combination Chemotherapy in Treating Patients With Multiple Myeloma|
|Official Title ICMJE||Phase II Trial of Doxil, Vincristine and Decadron in Multiple Myeloma|
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of liposomal doxorubicin, vincristine, and dexamethasone in treating patients with newly diagnosed or previously treated multiple myeloma.
OBJECTIVES: I. Assess the response rate and duration of response of multiple myeloma treated with doxorubicin HCl liposome, vincristine, and dexamethasone. II. Define the qualitative and quantitative toxic effects of this regimen in these patients.
OUTLINE: Patients are stratified into newly diagnosed (group A) and previously treated (group B) patients. Patients receive doxorubicin HCl liposome IV over 2.5 hours, followed by vincristine by bolus IV over 5 minutes on day 1. Dexamethasone is administered orally or by IV on days 1-4. Treatment is repeated every 4 weeks for a minimum of 6 courses, and 2 courses after maximum response unless unacceptable toxic effects or disease progression occur. Patients are followed until death.
PROJECTED ACCRUAL: A maximum of 33 patients from group A and 34 patients from group B will be accrued for this study within 6-14 months.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Primary Purpose: Treatment|
|Condition ICMJE||Multiple Myeloma and Plasma Cell Neoplasm|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Enrollment ICMJE||Not Provided|
|Completion Date||April 2004|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
DISEASE CHARACTERISTICS: Histologically proven newly diagnosed or previously treated multiple myeloma At least one chemotherapy regimen and no more than four regimens Pancytopenia related to multiple myeloma allowed At least 50% plasma cells in the bone marrow Splenomegaly OR Plasma cell leukemia No solitary bone or solitary extramedullary plasmacytoma
PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: WBC at least 2,500/mm3 OR neutrophil count at least 1,000/mm3 (previously treated patients with platelet count at least 75,000/mm3 must have a neutrophil count of greater than 500/mm3) Platelet count at least 75,000/mm3 (previously treated patients must have platelet count at least 45,000/mm3) Thrombocytopenia related to idiopathic thrombocytopenic purpura or B12 or folate deficiency allowed Hepatic: Bilirubin no greater than upper limit of normal (ULN) ALT or AST no greater than 2 times ULN (unless greater than 1/3 of liver is involved by tumor, in which case ALT or AST must be no greater than 5 times ULN) Renal: Not specified Cardiovascular: LVEF at least 50% by MUGA scan or echocardiogram No New York Heart Association class II or greater cardiac disease Other: Not pregnant or nursing Fertile patients must use effective contraception No prior malignancies within 5 years, except: Adequately treated basal or squamous cell skin cancer Adequately treated carcinoma in situ of the cervix No uncontrollable physical, mental, or emotional disorders No history of hypersensitivity to doxorubicin HCL or liposomal or PEGylated formulations of other drugs No active infection requiring IV antibiotics
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Patients who have previously failed treatment with doxorubicin HCl liposome, vincristine, and dexamethasone (VAD) are allowed if anthracycline therapy has been at least 6 months, and prior anthracycline exposure no greater than 300 mg/m2 No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed Concurrent radiotherapy to control pain or prevent fractures allowed Surgery: Prior surgery allowed if recovered
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00003493|
|Other Study ID Numbers ICMJE||CCF-IRB-2006, CDR0000066532, SEQUUS-CCF-IRB-2006, NCI-V98-1459|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||The Cleveland Clinic|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Cancer Institute (NCI)|
|Verification Date||August 2001|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP