NCT01301963 · REGISTRY CONDITION SEARCH

Filgrastim With or Without Plerixafor in Treating Patients With Multiple Myeloma Previously Treated With Lenalidomide

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

Phase: PHASE3
Status at capture: TERMINATED
Registry last update: 2014-08-06

This clinical trial studies filgrastim (G-CSF) with or without plerixafor in treating patients with multiple myeloma (MM) previously treated with lenalidomide. Giving colony-stimulating factors, such as G-CSF, and plerixafor helps stem cells move from the patient's 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

Ability to Reach Target Collection of 5 x 10^6 CD34+ Cells/kg

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outcome · POSTED

Percentage of Patients Achieving Target Goal CD34+ Cells Dose

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outcome · NOT POSTED

Compare Hematopoietic Stem Cells/kg Collections Between Different Mobilization Regimens in Those Patients Who Are Crossed Over From One Mobilization Regimen to the Other

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outcome · NOT POSTED

Compare Days of Apheresis Between Mobilization Groups

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outcome · NOT POSTED

Compare Need for Hospitalization During Mobilization Between Mobilization Groups

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outcome · NOT POSTED

Compare Need for Remobilization Between Mobilization Groups

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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: * Diagnosis of MM by International Myeloma Working Group Criteria * In first or second complete or partial remission or stable refractory but not actively progressing myeloma according to the classifications provided by The Center for International Blood \& Marrow Transplant Research * Received at least 2 cycles of lenalidomide therapy * Patients with MM scheduled to undergo stem cell harvest for possible allogeneic stem cell transplant (ASCT) * At least 2 weeks since last exposure to lenalidomide * Eastern Cooperative Oncology Group performance status of 0 or 1 * Prior to the start of mobilization: * white blood cell count \>/= 2.5 x 10\^9/L * absolute neutrophil count \>/= 1.2 x 10\^9/L * platelet count \>/=100 x 10\^9/L * creatinine clearance \>/= 30mL/minute * If childbearing potential, must either agree to complete abstinence from heterosexual intercourse or effective means of contraception during stem cell mobilization; female patients will undergo pregnancy test prior to stem cell mobilization therapy Exclusion Criteria: * Had prior autologous or allogeneic transplantation * Received pegfilgrastim within 3 weeks or G-CSF within 14 days of first dose of G-CSF for mobilization * Failed previous hematopoietic stem cell collections or collection attempts * Received radiation therapy to the pelvic area * Received lenalidomide within 2 weeks of first dose of G-CSF for mobilization * Had received experimental therapy within 4 weeks of enrolling in study * Current or prior history of other malignancies, excluding basal cell carcinoma of the skin
healthy Volunteers: false
minimum Age: 19 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Patients receive G-CSF SC QD on days 1-4.
intervention Names
Biological: filgrastim
label
Arm I
type
ACTIVE_COMPARATOR
description
Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8.
intervention Names
Drug: plerixafor
Biological: filgrastim
label
Arm II
type
EXPERIMENTAL

interventions

arm Group Labels
Arm II
description
Given SC
name
plerixafor
other Names
AMD 3100
Mozobil
type
DRUG
arm Group Labels
Arm I
Arm II
description
Given SC
name
filgrastim
other Names
G-CSF
Neupogen
type
BIOLOGICAL

Study design

allocation

RANDOMIZED

intervention Model

CROSSOVER

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 9
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

measure
Ability to Reach Target Collection of 5 x 10^6 CD34+ Cells/kg
time Frame
In =< 2 days of leukaphereses

secondary Outcomes

measure
Percentage of Patients Achieving Target Goal CD34+ Cells Dose
time Frame
In =< 5 days of leukaphereses
description
Patients will be randomized to receive either G-CSF or Plerixafor with G-CSF. All patients will undergo at least 2 days of leukopheresis. Cells/kg between these 2 arms will be compared. For those patients that do not reach the target goal will undergo a wash-out period and cross over to the other study arm.
measure
Compare Hematopoietic Stem Cells/kg Collections Between Different Mobilization Regimens in Those Patients Who Are Crossed Over From One Mobilization Regimen to the Other
time Frame
By day 1
description
Using the Wilcoxon Rand Sum Test
measure
Compare Days of Apheresis Between Mobilization Groups
time Frame
Day 1
measure
Compare Need for Hospitalization During Mobilization Between Mobilization Groups
time Frame
Day 1
description
Using the Chi-square test or Fisher's exact test, as appropriate.
measure
Compare Need for Remobilization Between Mobilization Groups
time Frame
Day 1

Full study description

brief Summary: This clinical trial studies filgrastim (G-CSF) with or without plerixafor in treating patients with multiple myeloma (MM) previously treated with lenalidomide. Giving colony-stimulating factors, such as G-CSF, and plerixafor helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored
detailed Description: PRIMARY OBJECTIVES: I. Ability to reach target collection of 5 x 10\^6 CD34+ cells/Kg with =\< 2 days of leukaphereses using one of two mobilization regimens. SECONDARY OBJECTIVES: I. Percentage of patients achieving target goal CD34+ cell dose (as above) in =\< 5 days of leukaphereses. II. Compare collections between different mobilization regimens in those patients who are crossed over from one mobilization regimen to the other. III. Compare days of apheresis, need for hospitalization during mobilization, and need for remobilization between mobilizing groups. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive G-CSF subcutaneously (SC) once daily (QD) on days 1-8. ARM II: Patients receive G-CSF SC QD on days 1-7 and plerixafor SC QD on days 4-7. After completion of study treatment, patients are followed up at 14 days.

Source references

Source notices and limitations

Discovery and provenance

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exact text
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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 kind
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source string sha256
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source url
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Preserved source evidence · Not medical advice