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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase II Study of Salvage Cellular Immunotherapy for Patients With Persistent or Recurrent Multiple Myeloma After Allogeneic Bone Marrow Transplantation From an HLA-Matched Sibling Donor

Conditions
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Multiple Myeloma and Plasma Cell Neoplasm

Intervention / Treatment
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* Biological: therapeutic allogeneic lymphocytes


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: therapeutic allogeneic lymphocytes|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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refractory multiple myeloma