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

This study is currently recruiting participants.
Verified May 2013 by Case Comprehensive Cancer Center
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01301963
First received: February 22, 2011
Last updated: May 10, 2013
Last verified: May 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Refractory Multiple Myeloma
 Drug: plerixafor
Biological: filgrastim
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Ability to reach target collection of 5 x 10^6 CD34+ cells/kg [ Time Frame: In =< 2 days of leukaphereses ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients achieving target goal CD34+ cells dose [ Time Frame: In =< 5 days of leukaphereses ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Using the Wilcoxon Rand Sum Test

  • Compare need for hospitalization during mobilization between mobilization groups [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Compare need for remobilization between mobilization groups [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Using the Chi-square test or Fisher's exact test, as appropriate.


Estimated Enrollment: 90
Study Start Date: July 2011
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I
Patients receive G-CSF SC QD on days 1-4.
 Biological: filgrastim
Given SC
Other Names:
  • G-CSF
  • Neupogen
Experimental: Arm II
Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8.
 Drug: plerixafor
Given SC
Other Names:
  • AMD 3100
  • Mozobil
Biological: filgrastim
Given SC
Other Names:
  • G-CSF
  • Neupogen

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • At time of transplant: white blood cell count >/= 2.5 x 10^9/L
  • At time of transplant: absolute neutrophil count >/= 1.2 x 10^9/L
  • At time of transplant: platelet count >/=100 x 10^9/L
  • At time of transplant: 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01301963

Locations
United States, Ohio
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Hien K. Duong     216-444-2529     duongh@ccf.org    
Principal Investigator: Hien K. Duong            
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Hillard Lazarus, MD     216-844-3629     hillard.lazarus@uhhospitals.org    
Principal Investigator: Hillard Lazarus, MD            
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Hien Duong 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
  More Information

No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01301963     History of Changes
Other Study ID Numbers: CASE3A10, NCI-2011-00186
Study First Received: February 22, 2011
Last Updated: May 10, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
 Lenograstim
JM 3100
Lenalidomide
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 23, 2013