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Rituximab in Treating Patients With Multiple Myeloma
This study has been completed.
Study NCT00003554   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes

November 1, 1999
February 6, 2009
November 1998
 
 
 
Complete list of historical versions of study NCT00003554 on ClinicalTrials.gov Archive Site
 
 
 
Rituximab in Treating Patients With Multiple Myeloma
Rituxan in the Management of Multiple Myeloma

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them.

PURPOSE: Phase II trial to study the effectiveness of the monoclonal antibody rituximab in treating patients with multiple myeloma that is newly diagnosed.

OBJECTIVES: I. Evaluate the role of rituximab in inducing apoptosis of malignant plasma cells in patients with multiple myeloma. II. Evaluate the role of this regimen in improving the response rate to melphalan and prednisone in these patients. III. Determine whether the regimen decreases residual disease in these patients. IV. Evaluate the toxic effects of this regimen in these patients.

OUTLINE: Patients receive rituximab IV every week for 4 weeks. Treatment is repeated every 6 months for six courses. Treatment may be discontinued after four courses if uncontrolled infection occurs. Patients also receive oral melphalan and prednisone for 4 days which begin after the first course of rituximab. Treatment is repeated every 4-6 weeks for at least nine courses.

PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study within 12-24 months.

Phase II
Interventional
Treatment
Multiple Myeloma and Plasma Cell Neoplasm
  • Biological: rituximab
  • Drug: melphalan
  • Drug: prednisone
 
Baz R, Fanning S, Kunkel L, Gaballa S, Karam MA, Reed J, Kelly M, Hussein M. Combination of rituximab and oral melphalan and prednisone in newly diagnosed multiple myeloma. Leuk Lymphoma. 2007 Dec;48(12):2338-44.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

DISEASE CHARACTERISTICS: Histologically proven, newly diagnosed multiple myeloma Eligible if pancytopenia related to multiple myeloma At least 50% plasma cells in the bone marrow OR Splenomegaly OR Plasma cell leukemia No solitary extramedullary plasmacytoma or plasma cell dyscrasia

PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: If less than 50% plasma cells in bone marrow: WBC at least 2,500/mm3 OR Absolute neutrophil count at least 1,000/mm3 (greater than 500/mm3 if platelet count at least 75,000/mm3) Platelet count greater than 45,000/mm3 (thrombocytopenia related to idiopathic thrombocytopenic purpura or vitamin B12 or folate deficiency allowed) Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) ALT or AST less than 2 times ULN (if greater than one third of liver involved, then no greater than 5 times ULN) No severe hepatic disease Renal: Creatinine no greater than 2.0 mg/dL Other: No severe infection requiring intravenous antibiotics Not pregnant or nursing Fertile patients must use effective contraception No prior malignancy within 5 years except for treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix No Type I hypersensitivity or anaphylactic reactions to murine proteins or to any component of rituximab

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow transplantation Concurrent sargramostim (GM-CSF) allowed for severe, symptomatic neutropenia Chemotherapy: At least 4 weeks since investigational drugs Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No concurrent use of investigational drugs or devices Concurrent epoetin alfa allowed for anemia Plasmapheresis allowed at study onset to treat renal failure

Both
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003554
 
CDR0000066613, CCF-IRB-2603, NCI-V98-1462
The Cleveland Clinic
 
Study Chair: Mohamad A. Hussein, MD The Cleveland Clinic
National Cancer Institute (NCI)
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP