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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003153
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 26, 2009
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

November 1, 1999
January 27, 2003
February 26, 2009
February 1998
February 2007   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00003153 on Archive Site
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Biological Therapy in Treating Patients With Multiple Myeloma That Has Recurred Following Bone Marrow Transplantation
Phase II Study of Salvage Cellular Immunotherapy for Patients With Persistent or Recurrent Multiple Myeloma After Allogeneic Bone Marrow Transplantation From an HLA-Matched Sibling Donor

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.


  • 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.

Phase 2
Primary Purpose: Treatment
Multiple Myeloma and Plasma Cell Neoplasm
Biological: therapeutic allogeneic lymphocytes
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Vesole DH, Zhang L, Flomenberg N, Greipp PR, Lazarus HM, Huff CA; ECOG Myeloma and BMT Committees. A Phase II trial of autologous stem cell transplantation followed by mini-allogeneic stem cell transplantation for the treatment of multiple myeloma: an analysis of Eastern Cooperative Oncology Group ECOG E4A98 and E1A97. Biol Blood Marrow Transplant. 2009 Jan;15(1):83-91. doi: 10.1016/j.bbmt.2008.10.030. Erratum in: Biol Blood Marrow Transplant. 2009 Oct;15(10):1346. Huff, Carol A [added].

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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February 2007   (Final data collection date for primary outcome measure)


  • 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



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • More than 4 weeks


  • Not specified


  • Bilirubin no greater than 2.0 times upper limit of normal


  • Not specified


  • No active infection
  • Not pregnant or nursing
  • Fertile patients must use effective contraception


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


  • 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


  • Concurrent palliative radiotherapy allowed if evidence of other evaluable disease other than irradiated bony sites


  • Not specified
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Study Chair: Neal Flomenberg, MD Sidney Kimmel Cancer Center at Thomas Jefferson University
National Cancer Institute (NCI)
July 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP