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