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Rituxan in the Management of Multiple Myeloma

Phase 2
Not Enrolling
Multiple Myeloma and Plasma Cell Neoplasm

Thank you

Trial Information

Rituxan in the Management of Multiple Myeloma

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

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

Inclusion Criteria

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Mohamad A. Hussein, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic


United States: Federal Government

Study ID:




Start Date:

November 1998

Completion Date:

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma



Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195