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

Primary Purpose

Refractory Multiple Myeloma

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
plerixafor
filgrastim
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Multiple Myeloma

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
  • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm I

Arm II

Arm Description

Patients receive G-CSF SC QD on days 1-4.

Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of Patients Achieving Target Goal CD34+ Cells Dose
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.
Compare Days of Apheresis Between Mobilization Groups
Using the Wilcoxon Rand Sum Test
Compare Need for Hospitalization During Mobilization Between Mobilization Groups
Compare Need for Remobilization Between Mobilization Groups
Using the Chi-square test or Fisher's exact test, as appropriate.

Full Information

First Posted
February 22, 2011
Last Updated
July 7, 2014
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01301963
Brief Title
Filgrastim With or Without Plerixafor in Treating Patients With Multiple Myeloma Previously Treated With Lenalidomide
Official Title
Comparison of Plerixafor and G-CSF Versus G-CSF Alone for Stem Cell Mobilization in Patients With Multiple Myeloma Previously Treated With Lenalidomide
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Terminated
Why Stopped
Slow Accrual
Study Start Date
July 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Active Comparator
Arm Description
Patients receive G-CSF SC QD on days 1-4.
Arm Title
Arm II
Arm Type
Experimental
Arm Description
Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8.
Intervention Type
Drug
Intervention Name(s)
plerixafor
Other Intervention Name(s)
AMD 3100, Mozobil
Intervention Description
Given SC
Intervention Type
Biological
Intervention Name(s)
filgrastim
Other Intervention Name(s)
G-CSF, Neupogen
Intervention Description
Given SC
Primary Outcome Measure Information:
Title
Ability to Reach Target Collection of 5 x 10^6 CD34+ Cells/kg
Time Frame
In =< 2 days of leukaphereses
Secondary Outcome Measure Information:
Title
Percentage of Patients Achieving Target Goal CD34+ Cells Dose
Time Frame
In =< 5 days of leukaphereses
Title
Compare Hematopoietic Stem Cells/kg Collections Between Different Mobilization Regimens in Those Patients Who Are Crossed Over From One Mobilization Regimen to the Other
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.
Time Frame
By day 1
Title
Compare Days of Apheresis Between Mobilization Groups
Description
Using the Wilcoxon Rand Sum Test
Time Frame
Day 1
Title
Compare Need for Hospitalization During Mobilization Between Mobilization Groups
Time Frame
Day 1
Title
Compare Need for Remobilization Between Mobilization Groups
Description
Using the Chi-square test or Fisher's exact test, as appropriate.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hien Duong, MD
Organizational Affiliation
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hillard Lazarus, MD
Organizational Affiliation
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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