Brostallicin in Treating Patients With Recurrent or Refractory Multiple Myeloma
Multiple Myeloma and Plasma Cell Neoplasm
About this trial
This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring stage III multiple myeloma, refractory multiple myeloma
Eligibility Criteria
DISEASE CHARACTERISTICS: Confirmed diagnosis of multiple myeloma based on prior or current demonstration of the following criteria*: Major criteria: Plasmacytoma on tissue biopsy Bone marrow plasmacytosis with at least 30% plasma cells Monoclonal globulin spike on serum electrophoresis exceeding 3.5 g/dL for IgG peaks or 2.0 g/dL for IgA peaks; greater than 1,000 mg/24hr of kappa or gamma light chain excretion on urine electrophoresis in the absence of amyloidosis Minor criteria: Bone marrow plasmacytosis with 10% to 30% plasma cells Monoclonal globulin spike present but less than levels in major criterion III above Lytic bone lesions Residual normal immunoglobulin M (IgM) no greater than 0.5 g/dL, IgA no greater than 0.1 g/dL, or IgG no greater than 0.6 g/dL NOTE: *Diagnosis of multiple myeloma requires a minimum of 1 major and 1 minor criterion (I and a together is not sufficient; must be I and b, I and c, I and d; II and b, II and c, II and d; III and a, III and c, III and d) or 3 minor criteria that must include a and b (a, b, and c; a, b, and d) Measurable disease defined by 1 of the following values: Serum myeloma (M) protein (IgG or IgA) level greater than 1.0 g/dL Urine M protein (light chain disease) at least 300 mg/24hr Soft tissue plasmacytoma with bidimensional measurement at least 20 x 20 mm (10 x 10 mm if spiral CT scan is used) Must have progressed during or within 12 months of discontinuing prior myelosuppressive chemotherapy (e.g., vincristine, doxorubicin, and dexamethasone (VAD) or melphalan) OR not responded after 2 courses of prior myelosuppressive chemotherapy No indolent or smoldering myeloma or localized plasmacytoma No known brain or leptomeningeal disease unless such lesions were previously irradiated, are currently not being treated with corticosteroids, and are associated with no clinical symptoms PATIENT CHARACTERISTICS: Age 18 and over Performance status Eastern Cooperative Oncology Group (ECOG) 0-2 Life expectancy At least 12 weeks Hematopoietic Absolute neutrophil count at least 1,500/mm^3 (at least 1,000/mm^3 if neutropenia due to replacement of the normal bone marrow cells by myeloma cells) Platelet count at least 100,000/mm^3 (at least 50,000/mm^3 if thrombocytopenia due to replacement of the normal bone marrow cells by myeloma cells) Hemoglobin at least 8.0 g/dL (no transfusion allowed) No hyperviscosity syndrome Hepatic Bilirubin no greater than 1.5 times upper limit of normal (ULN) Serum glutamate oxaloacetate transaminase (SGOT) no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Renal Creatinine no greater than 3.0 times ULN Calcium no greater than 12 mg/dL Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and sampling for study analysis HIV negative No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix No AIDS-related illness No active infectious process or other severe concurrent disease that would make the patient inappropriate for study entry No mental incapacity or psychiatric illness that would preclude giving informed consent or completing follow-up PRIOR CONCURRENT THERAPY: Biologic therapy See Chemotherapy No concurrent anticancer biological response modifiers No concurrent immunotherapy No concurrent sargramostim (GM-CSF) Chemotherapy See Disease Characteristics More than 2 years since prior high-dose chemotherapy with autologous bone marrow transplantation or stem cell support More than 4 weeks since prior myelosuppressive chemotherapy No other concurrent anticancer chemotherapy Endocrine therapy See Disease Characteristics No concurrent anticancer hormonal therapy No concurrent chronic steroids Acute pulse dosing required for treatment of a concurrent medical condition is allowed, provided treatment duration is no greater than 2 weeks No concurrent corticosteroids (e.g., dexamethasone) Radiotherapy More than 14 days since prior radiotherapy No prior radiotherapy to more than 25% of bone marrow No plans for radiotherapy within the next 6 months Concurrent palliative radiotherapy for skeletal pain allowed Surgery More than 14 days since prior surgery No plans for surgery within the next 6 months Other Acute toxic effects of prior therapy (except for alopecia and neurotoxicity) must have resolved to grade 0, 1, or the patient's baseline Treatment-related neurotoxicity must have resolved to the patient's baseline, not to exceed grade 2 Chronic bisphosphonates for bone pain allowed only for maintenance doses More than 2 weeks since prior nonmyelosuppressive antimyeloma therapy More than 2 weeks since prior macrolide antibiotics No other concurrent investigational agents No concurrent macrolide antibiotics No concurrent participation in another treatment clinical study
Sites / Locations
- Ireland Cancer Center
Arms of the Study
Arm 1
Experimental
Brostallicin