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AUTOLOGOUS, ALLOGENEIC, OR SYNGENEIC BONE MARROW TRANSPLANTATION IN HODGKIN'S DISEASE, NON-HODGKIN'S LYMPHOMA, AND MULTIPLE MYELOMA


Phase 2
N/A
70 Years
Not Enrolling
Both
Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm

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Trial Information

AUTOLOGOUS, ALLOGENEIC, OR SYNGENEIC BONE MARROW TRANSPLANTATION IN HODGKIN'S DISEASE, NON-HODGKIN'S LYMPHOMA, AND MULTIPLE MYELOMA


OBJECTIVES: I. Assess the toxicities, response rate, and duration of response associated
with high-dose cyclophosphamide, etoposide, carmustine or high-dose cyclophosphamide and
total-body irradiation followed by autologous, allogeneic, or syngeneic bone marrow
transplant in patients with refractory or high-risk non-Hodgkin's lymphoma, Hodgkin's
disease, or multiple myeloma. II. Evaluate any prognostic factors.

OUTLINE: Patients with prior radiotherapy (greater than 2,000 cGy) receive cyclophosphamide
IV over 2 hours and etoposide IV over at least 30 minutes on days -7 through -4 followed by
carmustine IV over 2 hours on day -3. Patients receive allogeneic or autologous bone marrow
transplantation on day 0. Patients with or without prior radiotherapy (less than 2,000 cGy)
receive cyclophosphamide IV over 2 hours on days -8 through -5 followed by total body
irradiation on days -4 through -1. Patients receive allogeneic or autologous bone marrow
transplantation on day 0. Prior to autologous bone marrow transplantation and following
myeloablative chemotherapy, patients undergo mobilization consisting of cytarabine
subcutaneously every 12 hours for 6 doses. Approximately 24 hours later, patients receive
sargramostim (GM-CSF) subcutaneously. Peripheral blood stem cells are collected every 1-3
days beginning when blood counts recover and continuing until sufficient number of cells are
reached.

PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven Hodgkin's disease (HD), non-Hodgkin's
lymphoma (NHL), and multiple myeloma (MM) meeting the following requirements: Refractory
to or at high risk following prior therapy Responded with at least a partial response to
last cytoreductive regimen No bulky disease (individual tumor diameter larger than 5 cm)
Eligible HD: CNS involvement at original presentation and currently in complete response
(CR) Relapsed within 1 year following completion of front-line MOPP or ABVD Relapsed at
any time following front-line MOPP/ABVD or other hybrid Eligible NHL: Any grade lymphoma
with CNS involvement at original presentation and currently in CR High-grade lymphomas
(International Working Formulation H-J) with marrow involvement at original presentation
and currently in CR, EXCEPT: Immunoblastic lymphoma and large cell (IWF G and H) with bone
marrow involvement with small cleaved cell at original presentation
High-/intermediate-grade lymphomas (IWF D-J) in relapse after adequate front-line therapy
High-/intermediate-grade lymphomas (IWF D-J) that failed to achieve CR with adequate
front-line therapy Low-grade lymphomas (IWF A-C) with B symptoms at original presentation
and relapse after front-line therapy Low-grade lymphomas (IWF A-C) in relapse within 1
year following last chemotherapy Low-grade lymphomas (IWF A-C) with documented histologic
conversion Eligible MM: Diagnosis based on either presence of both Group I diagnostic
criteria OR One Group I criterion and all Group II criteria Group I diagnostic criteria:
Plasma cells and/or myeloma cells greater than 10% in bone marrow Biopsy-proven
plasmacytoma in bone or soft tissue Group II diagnostic criteria: Monoclonal serum protein
spike Urinary myeloma protein Osteolytic lesions on radiologic examination Generalized
osteoporosis suffices if plasma cells in marrow exceed 30% Myeloma cells in at least 2
peripheral blood smears Stage II/III disease documented sometime during clinical course
Stage III defined by presence of at least 1 of the following: Hemoglobin less than 8.5
g/dl Serum calcium greater than 12 mg/dl Advanced lytic bone lesions High M-component
production rates: IgG greater than 7 g/dl IgA greater than 5 g/dl Urinary light chain
greater than 4 g/24 hours Stage II disease defined by absence of Stage III characteristics
but presence of at least 1 of the following: Hb less than 10 g/dl More than 1 osteolytic
lesion, none advanced IgG greater than 5 g/dl IgA greater than 3 g/dl Bone marrow donor
available for lymphoma patients with marrow involvement Perfosfamide-purged autologous
transplant allowed in patients with no matched sibling donor if: Marrow involvement is
limited (less than 30% tumor cells on smears and in bilateral iliac crest biopsies) AND
Age is under 60 Donor requirements: Excellent physical condition by history, lab studies,
PE No physiologic, psychologic, or medical inability to tolerate the procedure No
increased anesthetic risk No HIV infection Priority of multiple donors (in order given):
ABO compatible Age over 18 Same sex as recipient A new classification scheme for adult
non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or
"aggressive" lymphoma will replace the former terminology of "low", "intermediate", or
"high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS: Age: 70 and under Performance status: 0-2 Life expectancy: No
severe limitation due to nonmalignant disease Hematopoietic: Not specified Hepatic: No
severe hepatic disease Bilirubin no greater than 2.0 mg/dL Transaminases no greater than 3
times normal Renal: No severe renal disease Creatinine no greater than 1.5 mg/dL
Creatinine clearance at least 60 mL/min Cardiovascular: No symptomatic cardiac disease
LVEF at least 50% Pulmonary: No severe pulmonary disease FEV1 and FVC at least 75% of
normal Other: No history of severe cystitis with cyclophosphamide No HIV infection No
severe personality disorder or severe mental illness No other condition that would
markedly increase the morbidity and mortality of transplantation (e.g., substance abuse)
Patients with borderline parameters of organ function, performance status, or mental
status are entered at the discretion of the transplant team

PRIOR CONCURRENT THERAPY: See Disease Characteristics

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Roger Dansey, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000063370

NCT ID:

NCT00002552

Start Date:

October 1993

Completion Date:

October 2003

Related Keywords:

  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • recurrent adult Hodgkin lymphoma
  • refractory multiple myeloma
  • recurrent small lymphocytic 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
  • recurrent mantle cell lymphoma
  • recurrent marginal zone lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • adult unfavorable prognosis Hodgkin lymphoma
  • childhood unfavorable prognosis Hodgkin lymphoma
  • Neoplasms
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201