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

Eastern Cooperative Oncology Group

Status and phase: Completed; Phase 2

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

Treatments: Biological: therapeutic allogeneic lymphocytes

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00003153

ECOG-E1A97

CDR0000065938

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 estimated patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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