Clinical Trial: Rituximab in Treating Patients With Multiple Myeloma

This study has been completed.

Sponsored by: Cleveland Clinic Foundation Hospital
Information provided by: National Cancer Institute (NCI)

Purpose

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.

Condition Treatment or Intervention Phase
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
 Drug: melphalan
 Drug: prednisone
 Drug: rituximab
Phase II

MedlinePlus related topics:  Multiple Myeloma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Rituximab in Patients with Multiple Myeloma

Further Study Details: 

Study start: November 1998

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.

PROTOCOL 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.

Eligibility

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--Prior/Concurrent Therapy--

--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

Location Information


Ohio
      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195,  United States

Study chairs or principal investigators

Mohamad Ahmed Hussein,  Study Chair,  Cleveland Clinic Foundation Hospital   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000066613; CCF-IRB-2603; NCI-V98-1462
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003554
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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