biological therapy in treating patients with multiple myeloma that has recurred following bone marrow transplantation

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

Summary: rationale: white blood cells from donors may be able to kill cancer cells in patients with multiple myeloma that has recurred following bone marrow transplantation. purpose: this phase ii trial is studying how well giving donor white blood cells works in treating patients with recurrent multiple myeloma who have undergone bone marrow transplantation.

objectives: * assess the response rate of patients with recurrent multiple myeloma after an allogeneic marrow transplant from a genotypically hla identical sibling donor treated with donor lymphocyte infusions as salvage therapy . * evaluate the safety and toxicity of this treatment when used as salvage therapy in these patients. outline: patients receive initial cell dose of donor lymphocytes (cd3+ cells) iv over 15-30 minutes. patients with rapidly progressive disease may skip the initial cell dose and proceed directly to dose escalation to receive cd3+ cells at a higher cell dose. patients who achieve complete response to the initial treatment may receive up to 2 additional courses of escalating doses of cd3+ cells 8-12 weeks apart in the absence of unacceptable toxicity. patients are evaluated at 4 and 8 weeks after each infusion. patients with disease progression at 8 weeks are retreated at that time. patients who achieve partial response or stable disease at 8 weeks are re-evaluated at 12 weeks and may then be retreated. patients are followed every 2 weeks for 3 months, once a month for 9 months, and then every 2 months thereafter. projected accrual: a total of 22 patients will be accrued for this study within 2 years.

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

Keywords: refractory multiple myeloma