Bendamustine Hydrochloride, Etoposide, Dexamethasone, and Filgrastim For Peripheral Blood Stem Cell Mobilization in Treating Patients With Refractory or Recurrent Lymphoma or Multiple Myeloma

PRIMARY OBJECTIVES:

I. To estimate the frequency of bendamustine (bendamustine hydrochloride) combined with GCSF
(filgrastim) and dexamethasone to successfully mobilize peripheral blood stem cells (PBSCs)
(as determined by collecting a minimum of 2 x 10^6 cluster of differentiation (CD)34+/kg).

SECONDARY OBJECTIVES:

I. To evaluate the response rate to bendamustine by diagnosis using established
disease-specific response criteria.

II. To examine the number of apheresis cycles required to collect a minimum of 2 x 10^6
CD34+ cells/kg and ideally >= 5 x 10^6 CD34+ cells/kg (when achievable).

III. To assess the impact of bendamustine on B and T-lymphocyte populations in the
peripheral blood (CD20+ cells, natural killer [NK] cells, CD4+25+ foxP3- regulatory cells,
and CD8 cells).

OUTLINE:

Patients receive bendamustine hydrochloride intravenously (IV) over 30-60 minutes on days 1
and 2, etoposide IV over 60-240 minutes on days 1-3, dexamethasone orally (PO) on days 1-4,
and filgrastim subcutaneously (SC) beginning on day 5 and continuing until peripheral blood
stem cell collection is complete. Patients undergo leukapheresis daily for a minimum of 3
days or until > 5 x 10^6 CD34+/kg has been collected.

After completion of study treatment, patients are followed for up to 5 years.

Inclusion Criteria:

- Patients must have relapsed or primary refractory lymphoid malignancy (including
B-cell, T-cell, or Hodgkin lymphoma), or multiple myeloma; other transplant eligible
diagnoses (e.g. germ cell tumor) can be included with principal investigator (PI)
approval

- World Health Organization (WHO) classification of patients' malignancies must be
provided

- Patients with lymphoid malignancies must have a computed tomography (CT) of chest,
abdomen, and pelvis within six weeks of enrollment; patients with evidence of
lymphadenopathy in the neck must have a CT of neck

- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of
0 or 1

- Absolute neutrophil count (ANC) >= 1,500/mm^3

- Platelets >= 100,000/mm^3 (without transfusion or growth factor support)

- Creatinine clearance (CrCl) greater than 50/ml per minute (all tests must be
performed within 28 days prior to registration)

- Total bilirubin < 1.5 times upper limit of normal

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times upper
limit of normal

- All patients must be informed of the investigational nature of this study and have
given written consent in accordance with institutional and federal guidelines

- Adequate venous access plan in place for apheresis procedure

- Three or fewer prior myelotoxic treatment regimens (specific regimens include
ifosfamide, carboplatin and etoposide [ICE]; cisplatin, cytarabine, and dexamethasone
[DHAP]; methotrexate [MTX]/high-dose cytarabine [HiDAC]; cyclophosphamide,
vincristine, doxorubicin, and dexamethasone [hyperCVAD]; bortezomib, thalidomide,
dexamethasone and 4-day continuous infusions of cisplatin, doxorubicin,
cyclophosphamide, and etoposide [VTD-PACE])

Exclusion Criteria:

- Patients known positive for human immunodeficiency virus (HIV), or infectious
hepatitis type B or C

- Pregnant or nursing women; men or women of reproductive potential may not participate
unless they have agreed to use an effective contraceptive method

- Greater than six prior cycles of lenalidomide therapy

- Patients who have previously demonstrated resistance to bendamustine therapy (i.e. no
response or progression w/in 6 months)

- Fludarabine or other nucleoside analog (except gemcitabine or cytarabine) therapy
within 24 months of registration; patients with limited exposure to fludarabine/other
nucleoside analog therapy within 24 months may be considered eligible with review and
approval by the PI or Co-PI prior to study entry

- Symptomatic cardiopulmonary disease

- Prior autologous or allogeneic transplantation

- Prior radioimmunotherapy within 12 weeks of registration

- Prior failed (< 5 x 10^6 CD34/kg) PBSC collection due to inability to mobilize stem
cells

- Prior pelvic or spinal irradiation

- Previous systemic chemotherapy/immunotherapy within 3 weeks before study entry

- Concurrent use of other anti-cancer agents or experimental treatments

- Known allergy or intolerance to bendamustine, mannitol, GCSF or dexamethasone

- More than 3 cycles of myelotoxic salvage chemotherapy within the past 4 months
(specific regimens include ICE, DHAP, MTX/HiDAC, hyperCVAD, VTD-PACE)