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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •18 and over
- •Performance status:
- •Life expectancy:
- •More than 4 weeks
- •Hematopoietic:
- •Not specified
- •Bilirubin no greater than 2.0 times upper limit of normal
- •Not specified
- •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
- •Not specified
排除标准
- 未提供