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