Biological Therapy in Treating Patients With Multiple Myeloma That Has Recurred Following Bone Marrow Transplantation

Eastern Cooperative Oncology Group22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Interventions

therapeutic allogeneic lymphocytesBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, United States

Data from ClinicalTrials.gov

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