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NCT00113919 · REGISTRY CONDITION SEARCH

UARK 2003-25: A Study of Intravenous (IV) Busulfan (Busulfex®) in Multiple Myeloma Patients

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

Phase
PHASE1, PHASE2
Status at capture
TERMINATED
Registry last update
2017-10-16

The purpose of this study is to find out if patients with high risk disease because of age or kidney status can be treated more safely with a drug called Busulfex® followed by autologous transplant compared to treatment with the standard drug called melphalan, which has been shown to be quite difficult to tolerate in patients with poor kidney function and patients over the age of 65 when given in high doses.

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

Maximal Dose of Busulfex® Given in a 2, 3, or 4 Day Period With Acceptable Toxicity to Myeloma Patients

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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 symptomatic multiple myeloma requiring treatment * Patients must have been approved for single or tandem autologous transplant * Patients must be \> or = 65 years of age or diagnosed with renal insufficiency, defined as having a creatinine \> 3 mg/dl or a creatinine clearance \< 30 ml/minute * Patients must not have a history of chronic obstructive or chronic restrictive pulmonary disease. Patients must have adequate pulmonary function studies \> 50% of predicted on mechanical aspects (FEV1, FVC, etc) and diffusion capacity (DLCO) \> 50% of predicted, * Patients must have an ECHO or MUGA performed within 60 days prior to registration, LVEF \> 40%. * Bilirubin, SGOT, SGPT must be less than 1.5 times the upper limit of normal * Patients must have evaluable myeloma marker for response such as: \*Serum M protein \>1g/dl or urine M protein \>1g/24 hours and/or; \*Bone marrow plasmacytosis with \>20% plasma cells and/or; \*Extramedullary plasmacytosis; \*MRI/PET scan has focal lesions due to myeloma. * Patients must be able to receive full doses of DT-PACE, in the opinion of the treating investigator, with the exception of cisplatin. * Patients must have a performance status of 0-2 based on SWOG criteria unless the patient's status is due to active myeloma * All patients must be informed of the investigational nature of the study and have signed an IRB-approved informed consent in accordance with institutional and federal guidelines. Exclusion Criteria: * Serum transaminases \> 1.5 x ULN and direct bilirubin \> 1.5 mg/dl * HIV positive or active Hepatitis B or Hepatitis C infection; (if serology is positive a quantitative PCR will be done). * Patients with a prior malignancy in whom life expectancy is more likely to be determined by the prior malignancy than the myeloma. Patients must not currently be receiving therapy for the prior malignancy. * Pregnant or nursing women. Women of childbearing potential must have a negative pregnancy test documented within one week of registration. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    study-specific treatment: Busulfex according to study design: Level I 3.2 mg/kg over 6 hours x 2 days Level II 3.2 mg/kg over 6 hours x 3 days Level III 3.2 mg/kg over 6 hours x 4 days Level IV 4.3 mg/kg over 6 hours x 3 days Level V 5.6 mg/kg over 6 hours x 2 days Level VI 6.4 mg/kg over 6 hours x 2 days
    intervention Names
    1. Drug: Busulfan
    label
    Busulfan
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Busulfan
    description
    Dexamethasone 40 mg PO 1-4 Thalidomide 200 mg PO 1-6 Cisplatin\* 10 mg/m, Continuous infusion 1-4 Adriamycin\*\* 10 mg/m2, Continuous infusion 1-4 Cyclophosphamide 400 mg/2, Continuous infusion 1-4 Etoposide 40 mg/m2, Continuous infusion 1-4 All doses will be based on calculated body weight (actual weight + ideal body weight ÷ 2) and height, and not to exceed a BSA of 2.0 m2 The daily dose of cyclophosphamide, etoposide, and cisplatin will be mixed in a 1L bag of NS to be UAMS infused over 24 hours. Adriamycin will be mixed in at least 50cc D5W to be infused over 24 hours
    name
    Busulfan
    other Names
    1. Busulfex
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
14
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    maximal dose of Busulfex® that can be given in a two, three, or four day period with acceptable toxicity to myeloma patients, who either are \> or = 65 years of age or have renal insufficiency, defined as creatinine \> 3g/dL or creatinine clearance \< 30 ml/min
    measure
    Maximal Dose of Busulfex® Given in a 2, 3, or 4 Day Period With Acceptable Toxicity to Myeloma Patients
    time Frame
    three years
Full study description
brief Summary
The purpose of this study is to find out if patients with high risk disease because of age or kidney status can be treated more safely with a drug called Busulfex® followed by autologous transplant compared to treatment with the standard drug called melphalan, which has been shown to be quite difficult to tolerate in patients with poor kidney function and patients over the age of 65 when given in high doses.
detailed Description
This trial will determine the maximal dose of Busulfex® that can be given in a two, three, or four day period with acceptable toxicity to myeloma patients, who either are \> or = 65 years of age or have renal insufficiency, defined as creatinine \> 3g/dL or creatinine clearance \< 30 ml/min.
Source references
Source notices and limitations
    Discovery and provenance
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      payload
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      id
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      occurrences
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        exact text
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        0
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      query cond
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      query disease state id
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      source file
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      source file sha256
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      source json pointer
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      source kind
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      source string sha256
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    Preserved source evidence · Not medical advice