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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

Phase 2
18 Years
Not Enrolling
Multiple Myeloma and Plasma Cell Neoplasm

Thank you

Trial Information

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


- 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.

Inclusion Criteria


- 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



- 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Neal Flomenberg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Kimmel Cancer Center (KCC)


United States: Federal Government

Study ID:




Start Date:

February 1998

Completion Date:

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • refractory multiple myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Medical College of Wisconsin Cancer Center Milwaukee, Wisconsin  53226