Biological Therapy in Treating Patients With Multiple Myeloma That Has Recurred Following Bone Marrow Transplantation
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 confirmed recurrent or persistent multiple myeloma at least 6 months following allogeneic bone marrow transplantation (BMT) from an HLA identical sibling Must meet one of following criteria to be considered persistent, recurrent, or progressive disease: Residual detectable disease 6-12 months after BMT, as determined by the M protein level or bone marrow involvement, without further evidence of clinical or laboratory improvement on 2 consecutive measurements 4 weeks apart Complete response not achieved 12 or more months after BMT and there is no evidence of progressive improvement At least 25% increase of serum paraprotein (greater than 1.0 g/dL) as measured on two occasions or a 50% increase in urinary light chain excretion (greater than 150 mg/day) as measured on 2 occasions A 10% increase in plasma cells in the bone marrow Disease in complete response but with recurrence of M protein and 10% point increase in myeloma cells in the marrow allowed No lytic lesions alone or new soft tissue plasmacytoma as sole evidence of progression PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: More than 4 weeks Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 times upper limit of normal Renal: Not specified Other: No active infection Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Must have received prior allogeneic bone marrow transplantation from an HLA A;B;DR genotypically matched sibling donor No concurrent interferon therapy for relapsed disease Chemotherapy: At least 4 weeks since cyclosporine, methotrexate, azathioprine, or other graft versus host disease (GVHD) prophylaxis/treatment without evidence of flare of GVHD At least 4 weeks since prior chemotherapy for relapsed disease Endocrine therapy: Must be receiving a dose no greater than 0.25 mg/kg prednisone for at least 4 weeks prior to registration without flare of GVHD No prior prednisone dose greater than 0.25 mg/kg in the past 4 weeks Must receive concurrent prednisone of a dose no greater than 0.25 mg/kg Concurrent corticosteroids allowed Radiotherapy: Concurrent palliative radiotherapy allowed if evidence of other evaluable disease other than irradiated bony sites Surgery: Not specified
Sites / Locations
- Beth Israel Deaconess Medical Center
- Medical College of Wisconsin Cancer Center