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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003153
First received: November 1, 1999
Last updated: February 25, 2009
Last verified: July 2004
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
Biological: therapeutic allogeneic lymphocytes
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 22
Study Start Date: February 1998
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003153

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Wisconsin
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226-3596
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Neal Flomenberg, MD Kimmel Cancer Center (KCC)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00003153     History of Changes
Other Study ID Numbers: CDR0000065938, ECOG-E1A97
Study First Received: November 1, 1999
Last Updated: February 25, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
refractory multiple myeloma

Additional relevant MeSH terms:
Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 23, 2014