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A Phase II Trial Of Autologous Stem Cell Transplant Followed By Mini-Allogeneic Stem Cell Transplant In Lieu Of Standard Allogeneic Bone Marrow Transplantation For Treatment Of Multiple Myeloma


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

Thank you

Trial Information

A Phase II Trial Of Autologous Stem Cell Transplant Followed By Mini-Allogeneic Stem Cell Transplant In Lieu Of Standard Allogeneic Bone Marrow Transplantation For Treatment Of Multiple Myeloma


OBJECTIVES:

- Determine the incidence of early mortality in patients with multiple myeloma treated
with melphalan and autologous peripheral blood stem cell (PBSC) transplantation
followed by fludarabine, cyclophosphamide, and allogeneic PBSC transplantation.

- Determine the incidence of early allogeneic graft failure (before day 100 after
allogeneic PBSC transplantation) and the incidence of severe acute graft-versus-host
disease (GVHD) in patients treated with this regimen.

- Determine the toxicity of this regimen in these patients.

- Determine the overall and disease-free survival of patients treated with this regimen.

- Correlate changes in the T-cell population with clinical outcome, such as survival, in
patients treated with this regimen.

- Correlate changes in the T-cell population with the incidence of GVHD, use of
immunosuppressive agents, and effects of fludarabine in patients treated with this
regimen.

- Determine the degree of chimerism after allogeneic PBSC transplantation and the time
course over which it is established in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive melphalan IV over 15 minutes on day -1. Autologous peripheral blood stem
cells (PBSCs) are reinfused on day 0. Patients also receive sargramostim (GM-CSF)
subcutaneously (SC) or IV over at least 30 minutes daily beginning on day 1 and continuing
until blood counts recover. Beginning 100-182 days after autologous PBSC transplantation,
patients receive fludarabine IV over 30 minutes on days -6 to -2 and cyclophosphamide IV
over 1-2 hours on days -3 and -2. Allogeneic PBSCs are infused on day 0. Patients may
receive a second allogeneic PBSC infusion on day 1. Patients also receive GM-CSF SC or IV
over at least 30 minutes daily beginning on day 1 and continuing until blood counts recover.
Cyclosporine is administered IV or orally twice daily as graft-versus-host disease (GVHD)
prophylaxis, beginning on day -1 and continuing until day 60, followed by a taper in the
absence of GVHD.

Patients are followed for 5 years.

PROJECTED ACCRUAL: A total 19-46 patients will be accrued for this study within 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of multiple myeloma meeting 1 of the following criteria:

- Bone marrow plasmacytosis with at least 10% plasma cells

- Sheets of plasma cells

- Biopsy-proven plasmacytoma

- Meets at least 1 of the following criteria:

- Presence of myeloma (M)-protein in the serum

- Presence of M-protein in the urine

- Radiographic evidence of osteolytic lesions

- Generalized osteoporosis allowed if at least 20% plasma cells in bone
marrow

- No non-secretory myeloma

- Prior M-protein in serum or urine allowed provided patient is now in complete
remission

- Must be receiving conventional-dose chemotherapy as initial therapy or as salvage
therapy

- Must have HLA-A, -B, and -DR genotypically identical sibling donor

PATIENT CHARACTERISTICS:

Age:

- 18 to 70

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- See Disease Characteristics

Hepatic:

- AST no greater than 3 times upper limit of normal

- Bilirubin less than 2.0 mg/dL

Renal:

- Not specified

Cardiovascular:

- LVEF greater than 40% at rest if symptomatic cardiac disease is present

Pulmonary:

- DLCO greater than 50% of predicted (corrected for hemoglobin) if symptomatic
pulmonary disease is present

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior autologous or allogeneic peripheral blood stem cell or bone marrow
transplantation

Chemotherapy:

- See Disease Characteristics

- More than 28 days since prior chemotherapy (including primary chemotherapy for
hematopoietic stem cell collection)

- No other concurrent cytotoxic chemotherapy between autologous and allogeneic
transplantation

Endocrine therapy:

- Prior dexamethasone or other corticosteroids allowed

- Concurrent corticosteroids between autologous and allogeneic transplantation allowed

Radiotherapy:

- Concurrent radiotherapy between autologous and allogeneic transplantation allowed

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Neal Flomenberg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Kimmel Cancer Center (KCC)

Authority:

United States: Federal Government

Study ID:

CDR0000068551

NCT ID:

NCT00014508

Start Date:

April 2001

Completion Date:

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • refractory multiple myeloma
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

Name

Location

Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
CCOP - Northern New JerseyHackensack, New Jersey  07601
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Cancer Center at Tufts - New England Medical CenterBoston, Massachusetts  02111
MetroHealth's Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44106
Abramson Cancer Center at the University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve UniversityCleveland, Ohio  44106
Baptist Cancer Institute - JacksonvilleJacksonville, Florida  32207
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
MBCCOP-Our Lady of Mercy Cancer CenterBronx, New York  10466