Oblimersen, Thalidomide, and Dexamethasone in Treating Patients With Relapsed 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 refractory multiple myeloma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically and clinically confirmed multiple myeloma Relapsed and/or refractory after chemotherapy or transplantation Patients with prior allogeneic transplantation must not have evidence of active graft-vs-host disease requiring immune suppression Measurable disease defined by quantitative immune globulin levels in serum and/or urine and bone marrow plasmacytosis Patients with nonsecretory disease are eligible provided at least 1 plasmacytoma lesion is accurately measurable by MRI or CT scan No known CNS involvement PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 OR Karnofsky 60-100% Life expectancy More than 3 months Hematopoietic See Disease Characteristics Absolute neutrophil count at least 1,000/mm^3* Platelet count at least 50,000/mm^3* NOTE: *Unless secondary to bone marrow plasmacytosis (more than 80% involvement) Hepatic Bilirubin less than 2 times normal AST/ALT no greater than 3 times upper limit of normal Renal Creatinine no greater than 2 mg/dL Cardiovascular No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other Seizures allowed if under adequate control No severe skin reactions from prior thalidomide No prior allergic reactions attributed to agents used in this study No sensory or motor neuropathy grade II or greater No other uncontrolled concurrent illness that would preclude study therapy No ongoing or active infection No psychiatric illness or social situations that would preclude study compliance Not pregnant or nursing Negative pregnancy test Fertile patients must use 2 effective methods of contraception for 1 month before, during, and for 1 month after study participation PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics See Chemotherapy At least 6 weeks since prior thalidomide Chemotherapy See Disease Characteristics No more than 4 prior chemotherapy regimens, including autologous and/or allogeneic stem cell transplantation regimens At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy Concurrent continuous steroids allowed for chronic treatment of disorders other than myeloma Radiotherapy Not specified Surgery Not specified Other No prior oblimersen No other concurrent anticancer therapies or investigational agents No concurrent combination antiretroviral therapy for HIV-positive patients
Sites / Locations
- Greenebaum Cancer Center at University of Maryland Medical Center
- St. Vincent's Comprehensive Cancer Center - Manhattan