Clinical trial · Interventional
Rituximab in Treating Patients With Multiple Myeloma
Rituxan in the Management of Multiple Myeloma
NCT00003554CI-TRIAL-00011426completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| melphalan | Drug | Melphalan | ALIAS |
| prednisone | Drug | Prednisone | ALIAS |
| rituximab | Biological | Rituximab | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (1)
- RESULTBaz 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. doi: 10.1080/10428190701644330. PMID 18067008