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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-00186 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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Slow Accrual
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Active Comparator | Patients receive G-CSF SC QD on days 1-4. |
|
| Arm II | Experimental | Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| plerixafor | Drug | Given SC |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Ability to Reach Target Collection of 5 x 10^6 CD34+ Cells/kg | In =< 2 days of leukaphereses |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Achieving Target Goal CD34+ Cells Dose | In =< 5 days of leukaphereses | |
| 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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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Hien Duong, MD | Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Principal Investigator |
| Hillard Lazarus, MD | Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I: Control | Patients receive G-CSF SC QD on days 1-4. filgrastim: Given SC |
| FG001 | Arm II: Experimental | Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8. plerixafor: Given SC filgrastim: Given SC |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I | Patients receive G-CSF SC QD on days 1-4. filgrastim: Given SC |
| BG001 | Arm II | Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8. plerixafor: Given SC filgrastim: Given SC |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ability to Reach Target Collection of 5 x 10^6 CD34+ Cells/kg | due to low enrollment (10% of anticipated participants), no analysis is being done on data collected in this study | Posted | In =< 2 days of leukaphereses |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I: Control | Patients receive G-CSF SC QD on days 1-4. filgrastim: Given SC |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hien Duong, MD | CCCC | 216-445-5531 | duongh@ccf.org |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| C088327 | plerixafor |
| D000069585 | Filgrastim |
| D016179 | Granulocyte Colony-Stimulating Factor |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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| filgrastim | Biological | Given SC |
|
|
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.
| By day 1 |
| Compare Days of Apheresis Between Mobilization Groups | Using the Wilcoxon Rand Sum Test | Day 1 |
| Compare Need for Hospitalization During Mobilization Between Mobilization Groups | Day 1 |
| Compare Need for Remobilization Between Mobilization Groups | Using the Chi-square test or Fisher's exact test, as appropriate. | Day 1 |
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland | Ohio | 44195 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
| Secondary | Percentage of Patients Achieving Target Goal CD34+ Cells Dose | Due to low enrollment (10% of anticipated participants), no analysis is being done on data collected in this study | Posted | In =< 5 days of leukaphereses |
|
|
| Secondary | Compare Hematopoietic Stem Cells/kg Collections Between Different Mobilization Regimens in Those Patients Who Are Crossed Over From One Mobilization Regimen to the Other | 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. | Not Posted | By day 1 |
| Secondary | Compare Days of Apheresis Between Mobilization Groups | Using the Wilcoxon Rand Sum Test | Not Posted | Day 1 |
| Secondary | Compare Need for Hospitalization During Mobilization Between Mobilization Groups | Not Posted | Day 1 |
| Secondary | Compare Need for Remobilization Between Mobilization Groups | Using the Chi-square test or Fisher's exact test, as appropriate. | Not Posted | Day 1 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Arm II: Experimental | Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8. plerixafor: Given SC filgrastim: Given SC | 0 | 4 | 0 | 4 |
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |