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NCT01110135 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2017-05-24

This phase II trial is studying how well giving bendamustine hydrochloride, etoposide, dexamethasone, and filgrastim together for peripheral stem cell mobilization works in treating patients with refractory or recurrent lymphoma or multiple myeloma. Giving chemotherapy, such as bendamustine hydrochloride, etoposide, and dexamethasone, before a peripheral stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as filgrastim, and certain chemotherapy drugs helps stem cells move from the bone marrow to the blood so they can be collected and stored

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Successful Mobilization and Collection of PBSCs

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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)
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60-240 minutes on days 1-3, dexamethasone PO on days 1-4, and filgrastim 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. .
    intervention Names
    1. Drug: bendamustine hydrochloride
    2. Drug: dexamethasone
    3. Biological: filgrastim
    4. Procedure: leukapheresis
    5. Other: laboratory biomarker analysis
    6. Other: flow cytometry
    7. Drug: etoposide
    label
    Treatment (chemotherapy and colony-stimulating factor)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Treatment (chemotherapy and colony-stimulating factor)
    description
    Given IV
    name
    bendamustine hydrochloride
    other Names
    1. bendamustin hydrochloride
    2. bendamustine
    3. cytostasan hydrochloride
    4. Treanda
    type
    DRUG
  2. arm Group Labels
    1. Treatment (chemotherapy and colony-stimulating factor)
    description
    Given PO
    name
    dexamethasone
    other Names
    1. Aeroseb-Dex
    2. Decaderm
    3. Decadron
    4. DM
    5. DXM
    type
    DRUG
  3. arm Group Labels
    1. Treatment (chemotherapy and colony-stimulating factor)
    description
    Given SC
    name
    filgrastim
    other Names
    1. G-CSF
    2. Neupogen
    type
    BIOLOGICAL
  4. arm Group Labels
    1. Treatment (chemotherapy and colony-stimulating factor)
    description
    Given IV
    name
    leukapheresis
    type
    PROCEDURE
  5. arm Group Labels
    1. Treatment (chemotherapy and colony-stimulating factor)
    description
    Correlative studies
    name
    laboratory biomarker analysis
    type
    OTHER
  6. arm Group Labels
    1. Treatment (chemotherapy and colony-stimulating factor)
    description
    Correlative studies
    name
    flow cytometry
    type
    OTHER
  7. arm Group Labels
    1. Treatment (chemotherapy and colony-stimulating factor)
    description
    Given IV
    name
    etoposide
    other Names
    1. EPEG
    2. VP-16
    3. VP-16-213
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
43
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Count of participants with successful mobilization and collection of PBSCs. Defined as collection of \> 2 x 10\^6 CD34/kg. The current study will be deemed to be potentially efficacious if the observed rate of success is at least 80%.
    measure
    Successful Mobilization and Collection of PBSCs
    time Frame
    Within 7 days of apheresis and within 6 weeks of receiving bendamustine hydrochloride
Full study description
brief Summary
This phase II trial is studying how well giving bendamustine hydrochloride, etoposide, dexamethasone, and filgrastim together for peripheral stem cell mobilization works in treating patients with refractory or recurrent lymphoma or multiple myeloma. Giving chemotherapy, such as bendamustine hydrochloride, etoposide, and dexamethasone, before a peripheral stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as filgrastim, and certain chemotherapy drugs helps stem cells move from the bone marrow to the blood so they can be collected and stored
detailed Description
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.
Source references
Source notices and limitations
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    Preserved source evidence · Not medical advice