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

E

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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