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Myeloblative Therapy With Autologous Hematopoietic Stem Cell Transplantation in Patients With Multiple Myeloma and B-Cell Malignancies


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm

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Trial Information

Myeloblative Therapy With Autologous Hematopoietic Stem Cell Transplantation in Patients With Multiple Myeloma and B-Cell Malignancies


OBJECTIVES:

- Determine the safety and efficacy of myeloablative therapy with autologous
hematopoietic stem cell transplantation in patients with multiple myeloma and other
B-cell malignancies.

- Determine the efficacy and pretransplantation prognostic factors associated with
myeloablative therapy in these patients.

- Determine engraftment kinetics of granulocytes and platelets, as well as blood product
transfusion requirements following hematopoietic stem cell transplantation.

OUTLINE: Patients must have hematopoietic stem cell procurement completed prior to
myeloablative therapy. Patients receive high dose chemotherapy with autologous hematopoietic
stem cell transplantation and supportive care. Melphalan is administered in one dose on day
-1 at least 12 hours before stem cell infusion. Peripheral blood stem cells and/or bone
marrow is reinfused on day 0. Filgrastim (G-CSF) or sargramostim (GM-CSF) is administered
beginning on day 1 posttransplantation and continuing until blood counts recover.

Patients who are not candidates for tandem transplant may receive melphalan plus total body
irradiation (TBI). Melphalan is administered IV on day -4. Total body irradiation is
administered three times a day on days -3 and -2 and twice on day -1. At least 4 hours must
elapse between each treatment. Hematopoietic stem cells are reinfused on day -1 upon
completion of TBI or on day 0.

If patient is ineligible for melphalan plus TBI, the alternative single high dose regimen of
melphalan plus cyclophosphamide is administered. Melphalan, for these patients, is given in
two equal doses on day -4 followed by two consecutive days of cyclophosphamide on days -3
and -2. Hematopoietic stem cells are reinfused on day 0.

A second transplant may be considered, preferably between 3 and 6 months after the first
transplant. The preferred regimen for the second transplant is melphalan alone or melphalan
plus TBI as described above. The alternative regimens for the second dose therapy are
melphalan alone or melphalan plus cyclophosphamide. For patients receiving melphalan alone,
melphalan is administered in one dose on day -1 at least 12 hours before stem cell infusion.
Hematopoietic stem cells are reinfused on day 0 for both alternative regimens.

Patients are followed for response from treatment for a minimum of 4 weeks and then
periodically for survival.

PROJECTED ACCRUAL: A minimum of 10 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed multiple myeloma or other B-cell malignancy including
non-Hodgkin's lymphoma, Waldenstrom's macroglobulinemia, or amyloidosis

- Non-Hodgkin's lymphoma with T-cell immunophenotypes included

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- Not specified

Hematopoietic:

- WBC at least 2,000/mm^3 (unless due to disease)

- Platelet count at least 100,000/mm^3 (unless due to disease)

Hepatic:

- Not specified

Renal:

- Not specified

Cardiovascular:

- LVEF at least 40%

Pulmonary:

- DLCO or FVC and FEV1 at least 50% of predicted unless due to restriction from volume
loss secondary to disease

Other:

- HIV negative

- No overt infection or unexplained fever requiring broad spectrum antibiotics

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 2 weeks since prior biologic therapy

Chemotherapy:

- At least 2 weeks since other prior chemotherapy and recovered

Endocrine therapy:

- At least 2 weeks since prior endocrine therapy

- Concurrent steroids allowed

Radiotherapy:

- Not specified

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

David H. Vesole, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Medical College of Wisconsin

Authority:

United States: Federal Government

Study ID:

CDR0000065959

NCT ID:

NCT00003163

Start Date:

September 1997

Completion Date:

Related Keywords:

  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • refractory multiple myeloma
  • Waldenström macroglobulinemia
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III adult Burkitt lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV adult Burkitt lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent adult Burkitt lymphoma
  • primary systemic amyloidosis
  • contiguous stage II grade 1 follicular lymphoma
  • contiguous stage II grade 2 follicular lymphoma
  • contiguous stage II grade 3 follicular lymphoma
  • contiguous stage II adult diffuse small cleaved cell lymphoma
  • contiguous stage II mantle cell lymphoma
  • contiguous stage II adult diffuse mixed cell lymphoma
  • contiguous stage II adult immunoblastic large cell lymphoma
  • contiguous stage II adult diffuse large cell lymphoma
  • contiguous stage II adult Burkitt lymphoma
  • contiguous stage II adult lymphoblastic lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II adult diffuse small cleaved cell lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • noncontiguous stage II adult diffuse mixed cell lymphoma
  • noncontiguous stage II adult immunoblastic large cell lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult Burkitt lymphoma
  • noncontiguous stage II adult lymphoblastic lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • recurrent mantle cell lymphoma
  • noncontiguous stage II small lymphocytic lymphoma
  • noncontiguous stage II marginal zone lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • stage III small lymphocytic lymphoma
  • stage III marginal zone lymphoma
  • stage IV small lymphocytic lymphoma
  • stage IV marginal zone lymphoma
  • contiguous stage II marginal zone lymphoma
  • contiguous stage II small lymphocytic lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Neoplasms
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

Medical College of WisconsinMilwaukee, Wisconsin  53226