Patient case: 32-year-old female with inflammatory myofibroblastic tumor; genetic feature: RANBP2-ALK fusion

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

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.

Detailed description: 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: 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

Relevance to patient case: not relevant